Radford University
Institutional Review Board
Policies and
Procedures
POLICIES AND PROCEDURES FOR
PROTECTING HUMAN SUBJECTS FROM RESEARCH RISKS
RADFORD UNIVERSITY INSTITUTIONAL REVIEW BOARD
Approved August 2007
INTRODUCTION
1.0 Purpose and Scope of this Manual
The
Institutional Review Board documents its written
procedures, according to 45 CFR 46 §115(a)(6), 45 CFR 46 §103(b)(4) and 45 CFR 46 §103(b)(5).
This manual contains current policies and procedures and
will be regularly updated to reflect new standards,
regulations and Radford University (RU) policy. The
policies set forth in this manual
are applicable to all faculty, staff, employees and
students at RU who propose to use humans as subjects in
research and development. The Radford University IRB
does not review research involving the use of
investigational drugs or devices and human research
subjects. Radford University policy mandates that all
proposed research involving human subjects must receive
Institutional Review Board (IRB) approval prior to
initiating the research. This includes review of
research done as part of a class or as a class
requirement. Failure to have human subjects research
reviewed by the IRB is a violation of University policy.
The
purpose of this document is to assist the Radford
University IRB in the review of research proposals
submitted for review by faculty, staff, employees, and
students of Radford University. The review procedures
of the IRB are designed to assist the investigator in
the protection of the safety and privacy of the
individual subject. Additionally, the review should
assure that the potential subject can make an informed
judgment that the likely results of participation in the
study justify the possible risks, stresses, or
violations of privacy of the subject.
Back to Table of
Contents
1.1 The Radford University Commitment
Radford
University research policies adhere, as closely as possible, to the federal
regulations set forth in Title 45 Code of Federal
Regulations Part 46 Subpart A (45
CFR 46 §101),
also known as “The Common Rule.” This set of federal
policies is developed to implement the basic ethical
principles endorsed in the Report of the National
Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research. Title 45 contains
three subparts (B, C, and D) which contain
regulations pertaining to research with Pregnant Women &
Human Fetuses, Prisoners, and Children, respectively.
In addition, Radford University research policies
adhere to the State of Virginia regulations governing
human research as promulgated in Title 32.1 Chapter 5.1
of the Code of Virginia (§32.1-162.16
through §32.1-162.20).
Further
information and additional forms may be obtained from
the IRB website,
the IRB office at 201 Walker Hall, or by calling (540)
831-5290. The IRB Administrator is available to respond to
questions or concerns.
Back
to Table of Contents
1.2 Administration of Research Ethics (Federal)
The Office of Human Research and
Protections (OHRP) provides
leadership on human research subject protections and
implements a program of compliance oversight for the
Department of Health and Human Services (DHHS)
regulations for the protection of human subjects – Title
45, Part 46 of the Code of Federal Regulations (45
CFR Part 46). OHRP works to support
and strengthen the nation’s system for protecting those
who volunteer to participate in research that is
conducted or supported by agencies of the DHHS. To
carry out its mission, OHRP has formal agreements with
more than 10,000 federally funded universities,
hospitals, and other medical and behavioral research
institutions in the United States and abroad wherein
they agree to abide by the human subject protection
regulations found in the Code of Federal Regulations (45
CFR Part 46).
OHRP
evaluates all written substantive allegations or
indications of noncompliance with DHHS regulations. The
relevant institution is notified of the allegation and
is asked to investigate the basis for the complaint.
The institution then provides a written report of their
investigation, along with relevant institutional IRB and
research records, to OHRP which determines what, if any,
regulatory action needs to be taken.
OHRP
provides guidance to IRB members and staff, as well as
scientists and research administrators on the complex
ethical and regulatory issues relating to human subjects
protections in medical and behavioral research. The
office conducts national educational workshops in
partnership with other related federal agencies and
organizations. OHRP also provides on-site technical
assistance to institutions conducting DHHS-sponsored
research. In addition, OHRP helps institutions assess
and improve their systematic protections for human
subjects through quality improvement programs.
OHRP
provides quality improvement consultation and research
ethics training to domestic and foreign institutions
involved in international biomedical and behavioral
research to help ensure that recognized ethical
protections are afforded to persons participating in
research conducted in countries outside the United
States. OHRP prepares policies and guidance documents
as well as interpretations thereof on human subject
protections and disseminates this information to the
research community. In addition, every institution
engaged in human subjects research conducted or
supported by DHHS must obtain an assurance of compliance
approved by the OHRP.
Office of Human Research
Protection
1101 Wootton Parkway, Suite
200
Rockville, MD 20852
Toll-Free Telephone within
the U.S. (866) 447- 4777
Telephone (301) 496- 7005
Fax: (301) 402- 0527
Email: ohrp@osophs.dhhs.gov
http://www.hhs.gov.ohrp
Back to Table of
Contents
1.3 Applicable State of Virginia Laws
Reporting Requirement
Section 63.2-1509 of the Code of Virginia provides that persons who, in their profession or
official capacity, have reason to suspect that a child
is an abused or neglected child, shall report the matter
immediately to the local department of the county or
city wherein the child resides or wherein the abuse or
neglect is believed to have occurred or to the
Department’s toll-free child abuse and neglect hotline: 800-552-7096.
Section 32.1-162.16 defines the following:
Legally authorized
representative means, in the following specified
order of priority, (i) the parent or parents having
custody of a prospective subject who is a minor, (ii)
the agent appointed under an advance directive, as
defined in §54.1-2982,
executed by the prospective subject, provided the
advance directive authorizes the agent to make decisions
regarding the prospective subject’s participation in
human research, (iii) the legal guardian of a
prospective subject, (iv) the spouse of the prospective
subject, except where a suit for divorce has been filed
and the divorce decree is not yet final, (v) an adult
child of the prospective subject, (vi) a parent of the
prospective subject when the subject is an adult, (vii)
an adult brother or sister of the prospective subject or
(viii) any person or judicial or other body authorized
by law or regulation to consent on behalf of a
prospective subject to such subject’s participation in
the particular human research. For the purposes of this
chapter, any person authorized by law or regulation to
consent on behalf of a prospective subject to such
subject’s participation in the particular human research
shall include an attorney in fact appointed under a
durable power of attorney, to the extent the power
grants the authority to make such a decision. The
attorney in fact shall not be employed by the person,
institution, or agency conducting the human research. No
official or employee of the institution or agency
conducting or authorizing the research shall be
qualified to act as a legally authorized representative.
Minimal risk means that the
risks of harm anticipated in the proposed research are
not greater, considering probability and magnitude, than
those ordinarily encountered in daily life or during the
performance of routine physical or psychological
examinations or tests.
Nontherapeutic research means human research in which there is no reasonable
expectation of direct benefit to the physical or mental
condition of the human subject.
Human research means any
systematic investigation, including research
development, testing and evaluation, utilizing human
subjects, that is designed to develop or contribute to
generalized knowledge. Human research shall not be
deemed to include research exempt from federal research
regulation pursuant to 45 CFR 46 §101(b).
Informed consent means the
knowing and voluntary agreement, without undue
inducement or any element of force, fraud, deceit,
duress, or other form of constraint or coercion, of a
person who is capable of exercising free power of
choice. For the purposes of human research, the basic
elements of information necessary to such consent shall
include:
1. A reasonable and comprehensible
explanation to the person of the proposed procedures or
protocols to be followed, their purposes, including
descriptions of any attendant discomforts, and risks and
benefits reasonably to be expected;
2. A disclosure of any appropriate
alternative procedures or therapies that might be
advantageous for the person;
3. An instruction that the person
may withdraw his consent and discontinue participation
in the human research at any time without prejudice to
him;
4. An explanation of any costs or
compensation which may accrue to the person and, if
applicable, the availability of third party
reimbursement for the proposed procedures or protocols;
and
5. An offer to answer and answers
to any inquiries by the person concerning the procedures
and protocols.
Back to Table of
Contents
1.4 Administration of Research Compliance- Radford
University
The Vice Provost for Academic Administration and Institutional Effectiveness, Dr. Ricky Slavings, Ph.D., is responsible for
the administration and oversight of research compliance
at Radford University. He oversees the functioning of
the Institutional Review Board (IRB).
For questions please contact:
W. Michael Reed, EdD
(540) 831- 5290
wreed11@radford.edu
Back to Table of
Contents
1.5
The Radford University Institutional Review Board (IRB)
The
Institutional Review Board for the Review of Human
Subjects Research (hereinafter IRB) is composed of five
or more individuals. The IRB must include a faculty
member with scientific expertise and faculty member with
non-scientific expertise, a non-university affiliated
community member, a member of the student body (graduate
or undergraduate) and one faculty member familiar with
student psychological adjustment issues. The IRB meets
throughout the calendar year on at least a monthly
basis. Members serve staggered three-year terms except
for student members, who will only serve for one
academic year. A Chair will be elected every other year to a two-year term. A Vice Chair will also be elected for a two-year term with the intent to become Chair at the end of that term. This will allow the Vice Chair to become familiar with IRB issues and procedures prior to becoming Chair. The University's IRB is appointed by and
responsible to the Vice Provost for Academic Administration and Institutional Effectiveness, who for purposes of federal registration is
also designated the Institutional Official.
Back to Table of
Contents
THE
INSTITUIONAL REVIEW
BOARD
2.0 General IRB Policies
The RU
IRB policies are governed by 45 CFR Part 46.
The Radford University IRB Registration Number is
IRB00003066 and the RU Federalwide Assurance Number is
FWA00004850. In addition, the Radford University IRB
and Carilion Health Systems IRB have a reciprocity
agreement registered under IRB00001142 and IRB00001190.
Back to Table of
Contents
2.0.1 Functions and
Responsibilities
1. The IRB will
conduct official business meetings only if (a) a quorum
(one-half
plus one of
members and/or alternates and the Chair) and (b) the
non-scientist
member is
present. Failure to fulfill both requirements will
suspend official
action until
quorum requirements are fulfilled. Only IRB members,
alternates,
and the Chair may
vote on official IRB business.
2. The IRB will
review, and have the authority to approve, require
modifications
in, or disapprove
all research activities involving human subjects,
including any
proposed changes
in previously approved human subjects research
protocols.
3. IRB members
will independently review and evaluate applications
prior to the
IRB meeting, and
will vote to approve, disapprove, require modifications,
or table
protocols. If a
member feels that an unbiased evaluation is not
feasible, they will
inform the IRB
Chair and not participate in an events involving that
protocol.
4. The IRB may
invite primary investigators (PIs) to attend the Board
meeting to
further explain or
discuss protocols. PIs will be required to leave before
any
deliberation by
the IRB takes place.
5. The IRB may
invite individuals with competence in special areas to
assist in
the review of
issues which require expertise beyond or in addition to
that
available on the
IRB. These individuals will not be voting members of
the IRB
and must sign a
non-disclosure agreement prior to the initiation of the
Board
meeting unless the
PI waives the right to confidentiality.
6. The primary
focus of the IRB is to reduce or eliminate proposed
risks in
human subjects
research. The IRB may request modifications to research
design
or methodology if
such modifications will reduce the risks contained
within the proposed
human subjects research.
7. The IRB,
Chair, or designated reviewer will review and approve
all potential
subject recruiting
advertisements.
8. The IRB
reserves the right to observe and review the consent
process or any
other part of
research involving human subjects. The IRB will ensure
that legally
effective informed
consent documents are obtained and documented for each
subject or
subject’s legally authorized representative.
9. The IRB will
ensure that adequate measures are in place to protect
the privacy
of research
subjects and maintain confidentiality of data.
10. The IRB will
determine when additional protections are required for
children,
pregnant women and
fetuses, prisoners, mentally-impaired persons,
non-English
speaking subjects
and other vulnerable subject populations. For research
involving
prisoners as subjects, a prisoner advocate or prisoner
representative
must be added to
the IRB. OHRP will be promptly notified when IRB
membership is
modified to satisfy this federal requirement.
Back
to Table of Contents
2.0.2 Confidentiality of the Review Process
Materials
provided to the Institutional Review Board will be
considered privileged information and the IRB shall
assure the confidentiality of the data contained
therein. Individuals providing consultation to the IRB
agree to sign a confidentiality agreement prior to the
receipt and review of submission documents.
Back
to Table of Contents
2.0.3 Suspension and Termination Policy
In any
instance in which IRB requirements are not being
followed, the IRB will inform (within five (5) working
days) the PI and the Radford University IRB Administrator, who will be asked to enforce the requirements.
In the event that the PI does not comply with these
additional measures, the Vice President for Research and
Planning will terminate the research. Such action will
be accompanied by a letter to the principal investigator
stating the reason for the action. If unanticipated
risks to the subjects, researcher noncompliance, or
research project termination by the Vice Provost for Academic Administration and Institutional Effectiveness occur, these will be reported to
the Secretary of the Department of Health and Human
Services and appropriate funding agencies by the Vice Provost for Academic Administration and Institutional Effectiveness within seven (7)
working days of the letter of termination to the
principal investigator. If the study is funded by a
non-federal agency, the funding agency will be contacted
and informed of the situation within the timeframe
described above.
Back
to Table of Contents
2.1 Meetings
The
Radford University IRB holds regular meetings usually on the
third Monday of each month from 3-5 PM. The
deadline for submission of research protocols requiring
full IRB review and approval is fifteen (15) working
days before the schedule meeting. Materials submitted
for review after the submission deadline will not be
considered for review by the IRB until the next
scheduled meeting. Graduate students must submit
protocols requiring full IRB review within ten (10)
working days of the scheduled meeting.
Back
to Table of Contents
2.2 IRB Meeting Minutes
The
minutes for each IRB meeting are recorded in writing per 45 CFR 46 §115(a)(2).
The IRB approves the previous month’s minutes at the
next IRB meeting. The final version of the approved
meeting minutes are signed by the IRB chair and kept on
file at the office of the IRB Administrator.
The meeting minutes must include:
1. Attendance, including designation of
advocates for vulnerable populations that
are present and visitors.
2. A list of all full IRB board studies
with the following information
(a) Actions taken and decisions
made by the Board, including disapprovals
(b) Vote on these actions
(numbers for, against and abstaining)
(c) Basis for requiring
modifications to the research protocol proposal or
informed consent documents or
for disapproving protocols
(d) Summary of any controversial
issue discussions and their resolution(s)
(e) Summary of discussions
pertaining to the protocol
(f) Documentation of
determinations required by regulations along with
project specific findings that
justify each determination. These
` determinations include:
(i) Waiver
or alteration of consent
(ii) Waiver
of consent documentation
(iii) Research
involving pregnant women and fetuses
(iv) Prisoners
(v) Children
Minutes will include separate
deliberations, actions, and votes for each protocol
undergoing consideration by the convened IRB. The
minutes will also reflect any potential conflict of
interest that a member of the IRB may have with a
particular protocol.
Back to Table of
Contents
2.3 Approval Timeframes
Exempt, expedited, and full review
studies are approved for a maximum period of one year
from the approval date. Expedited and full review
studies must be re-approved within ten (10) days of the
study’s expiration date, and the original anniversary
date is retained for all re-approvals.
2.3.1 Student Research with Human Subjects
Student research with human
subjects generally falls into two categories, (1) course
projects and (2) independent or directed research
projects.
A.
Course Projects
Course projects usually do not
lead to generalizable knowledge and are often not
undertaken with specific research goals in mind. These
projects do not need RU IRB approval unless they:
(1) Involve the questioning of children;
(2) Ask about illegal activities (e.g. underage
drinking) that can
be
subpoenaed by a court of law;
(3) Involve socially stigmatizing behavior and/or
attitudes;
(4) Involve the use of emotionally charged
subject matter
(5) Involve the use of videotaping and/or audio
taping
B.
Independent or Directed Research Projects
Anything not falling under §2.3.1(a) of this document must be reviewed and approved by the RU
IRB, the IRB Chair, or the Chair’s designee. This
includes:
(1) Honors theses
(2) Independent undergraduate research projects
(3) Master’s theses
(4) Non-thesis graduate research projects
It is the responsibility of the
faculty advisors to ensure that course projects are
conducted according to the standards of their relevant
discipline.
The faculty advisor is responsible
for determining whether an undergraduate program is
exempt from IRB review, and when a student project is
not classified as a course project, the faculty member
is responsible for assisting the students in preparation
of review materials for the IRB. The IRB Administrator is
available for assistance, but it is the primary
responsibility of the faculty member to direct the
preparation of these documents.
Back to Table of
Contents
2.4 Continuing Review
Notices
The IRB office will send PIs e-mail
notices sixty (60) days prior to the study expiration
date, and mail notices thirty (30) days prior to the
study’s expiration date for all expedited and full
review studies. One (1) past due letter will be mailed
to PIs, who will have (10) working days to comply,
before research termination procedures are implemented (§2.0.3 of this document).
Back to Table of
Contents
2.5 Research Protocol
Files
Protocol files are maintained in
locked offices in the IRB Office. Records
are retained per 45 CFR 46 §115(b).
Each protocol file contains the
following:
1. A copy of the IRB review form
2. Supplemental materials, which may
include consent documents,
questionnaires, recruitment
materials, training documents, etc.
3. Any correspondence with the IRB,
both formal and informal, related
to the research protocol.
4. Official notification of IRB
action
5. Any IRB requested changes to
original proposal
6. A copy of the approved informed
consent form
7. Application for continuation of
the research study, if applicable
8. Any application to amend
previously approved protocols
9. Reports of unanticipated problems
and related IRB review or action
10. Final report for any completed
studies
11. Investigator agreement form (for
faculty and students)
Back to Table of
Contents
2.6 Complaints, feedback,
concerns and issues
All complaints, feedback, concerns
or related issues about IRB procedures should be
directed to the IRB Administrator, who will bring the
complaints to the next IRB meeting. Complaints will be
formally documented and appropriate resolutions
annotated in protocol files. Any concerns about
implemented research, research compliance, or academic
misconduct should be directed to the IRB Administrator.
Back to Table of
Contents
GENERAL
RESEARCH
PROCEDURES
3.0 Confidentiality
Any promise to research
participants that their responses and data will be
confidential requires implementation of protocols that
will prevent the accidental and/or intentional breach of
confidentiality. All measures used to assure
confidentiality should be understood by research staff
before research is initiated, and once research is
initiated. All confidentiality procedures must be
brought before the RU IRB. Any research that will
address sensitive, stigmatizing, or illegal subjects
must explicitly outline the steps they will take to
ensure that any information linking participants to the
study will be maintained in confidence. If there is any
reasonable risk that data or participant identities
might be sought by law enforcement agencies or
subpoenaed by a court of law, a Certificate of Confidentiality should be obtained.
Back to Table of
Contents
3.1 Data Collection over
the Internet
Data Collection: Any data
collected from human subjects over computer networks
must be transmitted in encrypted format. If the content
of the responses would pose a risk to the respondents if
the information were shared, the highest level of
encryption must be used, within the limits of
feasibility and availability. This may require that
study subjects use a specific type or version of browser
software.
Data collected using online survey
instruments must not contain requests for identifying
information of subjects (this includes name, address,
email address, SSN and student ID number). In
circumstances that require respondent tracking, a
separate webpage should be used at the completion of the
survey that will allow the respondent to enter tracking
information that will not be linked to the completed
survey. The use of a unique study code within the
invitation document is highly recommended by the IRB.
Server Administration: It
is recommended that online data be collected by a
professionally administered survey server or that the
server be administered by a professionally trained
person with expertise in computer and internet
security. Access to the server should be limited to key
project personnel and be configured with firewalls to
minimize the possibility of external access to the
server data. There will be documented, regularly
scheduled security audits or security scans of the
server that should be provided to the IRB Administrator
for inclusion in the research protocol file. It is the
responsibility of the principal investigator to ensure
that any servers utilized adhere to these statutes.
Data Storage and Disposal:
If a server is used for data storage, personal
identifying information and IP addresses should be kept
separate from the data, and such data should be stored
in an encrypted format. Data backups should be stored
in a secured location that is environmentally controlled
and has limited access. Data destruction services
should be employed to ensure that no data can be
recovered from discarded electronic media. For projects
with minimal risk, if these data safeguards cannot be
implemented, then language in the informed consent
should be added indicating that complete confidentiality
cannot be guaranteed and/or that encryption of responses
is not provided
Back
to Table of Contents
3.2 Conflict of Interest
A conflict of interest arises when
an employee is involved in a particular matter as part
of their official duties within an outside organization
in which they also have a financial interest, or one
which is imputed to him/ her, i.e., the employee’s
spouse, minor children, an organization in which the
employee serves as officer, director, trustee, partner,
or employee, or a person or organization with which the
employee is negotiating for prospective or has an
arrangement for prospective employment.
A PI or IRB member is said to have
a conflict of interest whenever the PI or IRB member,
his or her spouse, or dependent child falls under any of
the following conditions:
1. The IRB member is an investigator
or co-investigator on the protocol;
2. Has entered into financial
arrangements with the sponsor or agent of the
sponsor;
3. Acts as an officer, director or
agent of the sponsor;
4. Has an equity interest in the
sponsor exceeding $10,000 or 3% of the
equity of the sponsor;
5. Has received payments or other
incentives from the sponsor that are
in excess of $10,000 total;
6. Has identified him or her self
for any other reason as having a conflict of
interest.
All investigators are required to
disclose any conflicts of interest on the IRB Initial
Review of Research Protocol Form.
Back to Table of
Contents
3.3 Record Retention
Requirements
All records collected, prepared,
and/or maintained by the IRB are open for inspection and
copying by the authorized representatives of OHRP, DHHS,
Sponsors, and Radford University officials during normal business hours and in
such a manner as promulgated by 45 CFR 46 §115(b).
Research protocol files, as defined
per §2.5 of this manual, shall be retained or archived
for three (3) years after study closure. At that time,
the files will be destroyed. As per §2.2 of this
manual, the minutes of each IRB meeting will be retained
by the office of the IRB Administrator and are kept for a
period of five (5) years, at which point they can be
destroyed.
Back
to Table of Contents
3.4 Guidelines on Compensation for Research
Subjects
Compensation of research subjects must not be large
enough to be considered coercive. The researcher and
the IRB must consider the socioeconomic status of the
subject pool while reviewing protocols involving payment
for research participation. Considerations for
compensation will be made on a per study basis by the
IRB.
The IRB
will consider the following issues regarding
compensation during review of the research:
1. Amount
of payment (monetary, extra credit, gift certificates,
etc.)
2. Method
of payment
3. The
inclusion of compensation within the study advertisement
4.
Prorating compensation during long-term studies (i.e.
study completion
incentive) or prorating when compensation exceeds
nominal amounts
5.
Payment will not be contingent on the participant
completing the study
procedures. If a subject decides to withdraw from the
study, they must be
compensated, at least partially, based on what study
procedures have been
completed.
6.
Socioeconomics of the subject pool
The use
of a lottery method is allowed, but the following must
be addressed in the informed consent:
1.
Potential odds and amount of winning
2.
Individual responsible for drawing the winner
3.
Individual responsible for observing the drawing, to
ensure the results
are
not biased.
Back
to Table of Contents
3.5 Equitable Subject Recruitment
The IRB
will evaluate all research applications to determine
that every effort has been made to recruit a diverse
subject pool. The proposed sampling protocols will be
evaluated to ensure that some classes of individuals are
not favored for participant selection because of ease of
selection, compromised positions or manipulability. The
IRB will require researchers to make every effort to
include women and members of minority groups in subject
pools if appropriate.
Back
to Table of Contents
3.6 Funded/ Sponsored Research
The
Office of Sponsored Programs and Grants Management will
not release funds from federally funded non-exempt
studies until the IRB Chair, or the Chair’s designee,
has the opportunity to compare the OPSGM proposal to the
IRB application. It is the responsibility of the
principal investigator to apprise the IRB of the
appropriate proposal number.
Back
to Table of Contents
3.7 Scientific Merit
Back
to Table of Contents
It is
not the responsibility of the IRB to comment or debate
the scientific merit of proposals submitted for review.
The merit of research is the responsibility of the
principal investigator and the appropriate personnel
within each department. The exception to this is when
the scientific merit, or lack thereof, increases the
risks to the research subjects or the research burden
upon any subjects.
INFORMED
CONSENT
4.0 Informed Consent
Except
in situations described in §4.3 and §4.4 of this manual, a researcher cannot enroll any human
subject into a research project without first obtaining
a legally effective, written informed consent from
either the subject or a legally authorized
representative of the subject prior to enrollment in the
research study. The RU IRB is responsible for reviewing
all informed consent documents. The information
contained in the informed consent must be presented in
language that is clear and understandable to the
subject. The informed consent cannot contain any
exculpatory language through which the subjects waive
any legal rights or releases, or appears to release, the
researcher, sponsor or Radford University from liability
for negligence. The consent process must provide
sufficient opportunity to withdraw from the research
project. Institutional pressures must be addressed in
the research design and will be further explained in §4.5. It is the responsibility of the principal
investigator to remove any coercive language and to
minimize other influences. The RU IRB will examine all
informed consents to ensure that all research protocols
protect research subjects from undue influence to
participate. An approved, stamped copy of the consent
form must be used for all study participants. A copy of
this approved, stamped form will also be included in the
research protocol file in the office of the IRB
Administrator.
Back to Table of
Contents
4.1 Essential Elements of Informed Consent
"Informed Consent" means an agreement between investigator and freely
participating subjects that informs them of their role,
the procedures, and potential hazards or risks and
describes all activity features that might reasonably be
expected to influence willingness to participate. The
following items are required in the informed consent per 45 CFR 46 §116 and §32.1-162.18 of the Code of
Virginia:
1. Research acknowledgement
Use
this section to explain to the participant that the
study is for
research purposes. The word research must be used in
the explanation.
2. Purpose
of the project
Explain why the research is being done and why you are
asking the
subject to participate.
3. Procedures
Describe what happens to the subject, what the subject
needs to do
as
part of the research and what the expected duration of
the experiment
will
be. This section should give detailed descriptions of
what will be
performed in a language that the participant can easily
comprehend.
4. Risks
Clearly explain the psychological, physical, and/or
social risks involved in this
research. This section should also outline how likely
it is that any of these
risks
will occur, and what will be done if they do occur.
5. Benefits
Clearly outline any potential direct benefits to the
subject. Explain clearly how
likely it is that these benefits will occur and outline
what the indirect benefits may
be.
If no benefits are known at the time of the research,
state, “There are no known direct benefits.”
6. Alternatives
Use
this section to clearly explain what will happen if the
subject
decides not to participate in the study, whether the
subject can get or do
the
same thing without participating and what else is
available if they
decide
not to participate.
7. Extent
of confidentiality or anonymity
Explain how any collected information or participation
status will be kept
confidential. This section should outline who will know
or need to
know
the information pertaining to this study. Where and how
the data
will
be stored should also be included in this statement.
8. Compensation
For
studies that have greater than minimal risk, explain who
will pay if the subject
becomes
injured. For studies that have payments or
reimbursement, this section
should be
used to explain how much will be paid, what kind of
reward it will be,
and what
the schedule of payment will be. For studies that have
multiple payment
disbursements, this section should also explain the
payment consequences of early withdrawal from the study.
9. Freedom
to withdraw
Participants must be free to withdraw at any time during
the course of the
study
without penalty. They will be compensated for the
portion of the
study
completed (if financial compensation is involved).
Studies using
students need to clearly state that withdrawal from the
study will not
result
in a reduction in points or grade in the course.
Subjects are free
to
refuse to answer any questions or to decline to respond
to situations that they
choose
without penalty.
10. Subject
responsibilities
This
section should have a statement that clearly outlines
the subject
responsibilities or the study director can have the
subject write the items in
to
confirm understanding of subject responsibilities.
11. Subject
permission
This
section should contain the following statement: “ I have
read
the
Consent Form and conditions of this project. I have had
all questions
answered and I hereby acknowledge the above and give my
voluntary
consent.”
12. Number
of subjects in the study
The
number of subjects or approximate number should be
stated here, or may be contained within
one of the sections described
above.
13. Contact
information
Use
this section to list the contacts for any pertinent
questions about
the
research, conduct or subject’s rights and/or whom to
contact in the
event
of injury. The investigator, faculty advisor (if
student is performing
the
research), and the RU Institutional Officer contact
information should be included.
It may be
necessary to include a statement addressing
unforeseeable risks and any additional costs that the
participant may incur. Language may be included in the
consent form that allows the PI to terminate the
participation of a subject without regard to the
subject’s consent. A copy of the signed consent form
should be given to the subject.
***Consent forms are not valid unless an unexpired
validation stamp from the RU IRB is present***
Back to Table of
Contents
4.2 Documentation of the Informed Consent
Federal
regulations require the written documentation of
informed consent when human subjects are used in
research, unless the research meets the criteria for
waiver of documentation of consent per §4.4 of this
document.
Informed consent at Radford University will be
documented in the following manner:
1. All
consent documents will, at a minimum, contain the
elements
promulgated in §4.1 of this document. Consent form
templates
are
available on the IRB website.
2.
Language contained in the informed consent will be at
the appropriate
reading level of the target subjects. Keep in mind that
the average adult has an 8th grade reading level.
3. The
consent forms will contain no grammatical or typographic
errors.
4. The
consent document will be submitted to the IRB office and
the
approved document will have a dated stamp that will have
the (a) date
of
approval, (b) date of expiration, and (c) initials of
the IRB Administrator.
5. There
will be no exculpatory language contained in the consent
form
through which the subject is made to waive or appear to
waive any rights.
6. For
non-English speaking participants, the consent form must
be written
in a
language understandable to the subject.
7. The
IRB approval stamp must be clearly visible on all copies
of consent
forms
that are given to subjects.
8. A
witness must be present when obtaining informed consent
from
children, prisoners, cognitively impaired individuals,
non-English
speaking, or any subjects to whom the consent form must
be read. The
witness is verifying that the subject was fully informed
and that the subject
voluntarily agreed to participate in the study. For
non-English speakers,
the
witness must be fluent in both English and the language
of the subject.
9. All
informed consents submitted to subjects will have an
official Radford
University logo.
Back to Table of
Contents
4.3 Waiver of Informed Consent
The
Radford University IRB may waive the requirements (45
CFR 46 §116(c); Code of Virginia §32.1-162.18) for
obtaining informed consent or approve a consent
procedure which does not include, or which alters, some
or all of the elements of informed consent listed in §
4.1, provided that:
1. The research is of minimal
risk
2. The
research could not be practically carried out without
the waiver
3. The
waiver will not adversely affect the rights and welfare
of the subjects
4.
Whenever appropriate, the subjects will be provided with
additional
pertinent information after participation
5. The
research is to be conducted by, or subject to the
approval of, state or
local
government officials, and is designed to study, evaluate
or otherwise
examine:
i. Public
benefit or service programs
ii.
Procedures for obtaining benefits or services under
those
programs
iii. Possible
changes in or alternatives to those programs or
procedures
iv. Possible
changes in methods or levels of payment for
benefits
or services under those programs
Back
to Table of Contents
4.4 Waiver of Informed Consent Documentation
In
accordance with 45 CFR 46 §117 and
the Code of Virginia §32-162.18(e), the
Radford University IRB may waive the requirement for the
documentation of informed consent for some or all
subjects if it finds:
1. The
research presents no more than minimal risk of harm to
subjects and
involves procedures that do not require written consent
when performed
outside of a research setting, or
2. The
only record linking the subject and the research would
be the consent
document and the principal risk would be potential harm
resulting from
breach of confidentiality.
Back
to Table of Contents
4.5 Additional Consent Information
In some
cases, the informed consent document will need
additional information. In particular, studies that
involve the use of sensitive items, deception, audio and
video recordings, students and extra credit, and
children have specific additional requirements.
Back
to Table of Contents
4.5.1 Studies that Involve Sensitive Questions
Risks
Section:
1. Be
specific regarding the potential risks (psychological,
social, legal, economic, dignity and/or physical).
Be aware of potential emotional distress during the
completion of surveys.
2.
Provide a detailed explanation of the study’s efforts to
reduce potential risks.
Confidentiality Section:
1.
Provide subject with contact information of professional
counselors within the area that are available for
his/her use.
2. Use
clear language that indicates any use of the counselors
by the subject will be at the subject’s expense.
3. Inform
the subject that any information provided that is
indicative of potential harm to themselves or others
must be
reported to the appropriate
authorities per legal mandate.
4.
Provide a thorough explanation of how the study will
ensure the confidentiality of this sensitive
information.
Back
to Table of Contents
4.5.2 Studies that Involve Deception
Deception should be employed only when there are no
alternative procedures available. In the situations
where deception is a necessary part of the experiment,
the RU IRB generally requires that preliminary consent
be obtained, when possible. The subject should be fully
debriefed at the conclusion of the experiment. The IRB
recognizes that there are instances in which no consent
can be obtained or debriefing done, but the researcher
should make reasonable attempts to obtain consent after
the deception has taken place. The IRB will make the
decision as to when the use of deception is acceptable,
to what extent it is unavoidable in order to perform the
research, and whether the benefits derived from the
deception research outweigh the risks.
The use
of major deception (e.g. leading a subject to believe
that he has committed a crime or has a disease) will
need to be clearly justified by the investigator, and
the merit of the research must counterbalance the risk
to the subject.
Debriefing
The IRB
requires debriefing of all deceived subjects involved in
studies that use unavoidable deception. The purpose of
debriefing is multifaceted: (1) to repair the breach of
informed consent inherent in deception studies, (2) to
remove any confusion and defuse any tensions that may be
generated by the use of deception, (3) to make clear to
all subjects, especially children, that deception is
permissible only in exceptional circumstances, and (4)
to repair the breach of trust (to the maximum extent
possible) that has occurred between the investigator and
the subject, and the potential breach of trust between
all researchers and all subjects.
The
written debriefing statement should express
regret for the necessity of deceiving the subject(s),
should explain what the deception was and why it was
necessary, it should offer the subjects a chance to ask
questions and should offer information about sources of
support or further counseling (in cases of significant
risk of negative reactions). When students are involved
in deception studies, it is also important to clearly
present the material in a way that introduces the
subjects to the broader conceptual and research issues
involved.
The
Debriefing Form
The
debriefing form is a separate document from the consent
form and must include the following sections:
1.
Apology for using deception
2.
Explanation of why deception was necessary
3. Offer
the subjects a chance to ask questions or work through
any
confusion that has resulted from the use of deception
4.
Clearly describe the extent the study can ensure
confidentiality
of
data gained from the deception
5.
Inform the subject that they have the right to have data
obtained
from
the research destroyed instead of used for data analysis
The IRB
requires that the study have subjects sign the
debriefing form to provide written consent for the use
of the data during data analysis.
Back
to Table of Contents
4.5.3 Studies Involving Audio or Video Recordings
Studies
involving the use of audio and/or video recording of
human subjects do not qualify for exempt status.
Subjects must provide full consent before any recording
can take place. Researchers must ensure that the study
participants are comfortable with the recording during
the consent process and during the course of the
experiment. Participants can stop the recording at
anytime and have the right to have those records
destroyed. A separate space must be left on the consent
form for the study participant to initial that
specifically provides consent for the audio and/or video
recording.
The use
of audio or video recordings in deception studies is a
very sensitive issue, and the Radford University IRB
will carefully weigh the options and alternatives for
these studies. The use of the Audio/ Video Use in
Deception Studies Form must be given to and signed by each participant. The use of audio and video
recording in deception studies should only be used if
there are no other reasonable alternatives.
Additional information to
provide in the informed consent documents:
Procedures section:
1. Inform
subjects that the study will involve audio and/or video
recording.
2. Inform
subjects whether or not these recordings are required to
participate in the study procedures.
3.
Optional recording should have an additional space at
the end of the consent document that allows
the study participant to
initial their consent specifically for the audio/video
recording.
Confidentiality Section:
1. How
the study will ensure the security of the tape(s).
2. Who
will be transcribing the recordings.
3. Who
will have access to the recordings.
4. When
and how the tapes will be erased/ destroyed.
Back to Table of
Contents
4.5.4 Studies Involving Students and Extra Credit
Additional language must be added to the compensation
section that clearly outlines the following:
1. The
amount of extra credit given for completion of each
study
sessions and for total completion of the study.
2. The
impact this extra credit will have on the student’s
grade
Back
to Table of Contents
4.5.5 Child Assent and Parental Permission
The use
of children or minors (< 18 years of age) as research
subjects requires additional safeguards to be in place.
Federal regulations require the assent of the child and parental or guardian permission in the place of
the consent of subjects. If guardianship is shared by
two individuals, both persons must give their permission
for the child to participate in a greater than minimal
risk research study (Code
of Virginia §32.1-162.18(a)).
Although children are legally incapable of giving
informed consent, they do possess the ability to assent
or dissent from participation. Children should be asked
whether or not they wish to participate in the research,
particularly if the research is encompassed in the
following:
1. Does
not involve an intervention
2.
Children can comprehend and appreciate what it means to
volunteer for the benefit of others.
The IRB
will determine, based upon the proposed protocol,
whether all children are capable of assenting to
participation, based upon the age, status, and condition
of the proposed subjects.
The
child should be given an explanation of the proposed
research procedures in a language that is appropriate to
the child’s age, experience, maturity, and condition.
This explanation should include discussion of any
discomforts and inconveniences that the child may
experience if he or she agrees to participate.
Child assent and parental permission
must be obtained for each participating minor, and a
witness must be present during the presentation of child
assent materials. The witness can be any adult present
during the time of the assent/ consent process, but
researchers actively involved in the assent process
cannot serve as a witness. Child assent and parental
permission templates are available on the IRB website.
The child assent form should be
written as simply as possible and should cover the
following points:
1. What the study is about
2. Why he/she was selected for the study
3. That taking part in the study is voluntary
4. The procedures that will be done
5. Potential benefits of the study
6. Potential risks of the study
7. Assurance that
he/she will be treated the same whether or not he/she
agrees to join the study
8. An invitation to ask questions about the study
9. Assurance that
he/she may withdraw from the study after discussing it
with his/her parents
For children less than 5 years of
age, a simple oral explanation of the study should
be given to each child before any study-related
procedures are conducted. This explanation is in
addition to parental permission. A form should be
available for the witness of the assent process to sign.
Children 5 to 12 years of age: Informed voluntary verbal assent should be obtained
without pressure from parents or investigators. The
“Request for Initial Review of Research Protocol” form
should include an example of the explanation to be
offered to the child. A sample child assent form is
available. The child’s assent should be solicited and
recorded in the presence of a parent, and the signed
parental permission form should include the following
statement: “This study has been explained to my child
in my presence, in language he/she can understand.
He/she has been encouraged to ask questions both now,
and in the future, about the research study.
Children 13-17 years of age: Investigators may
choose to handle the consent/assent requirements for
this group in one of two ways. They may either submit a
combined child assent/parental permission form that is
written at a level simple enough for both parent and
child to read and understand, (i.e., about a 6th grade reading level), or they may choose to submit a
permission form for parents and a separate assent form
for the child to read and sign. If a single form is
designed for both parent and child, it should be signed
by each after the study has been explained.
Back
to Table of Contents
4.5.6 Research
Conducted in Public Elementary and Secondary Schools
Investigators must determine
the locally applicable requirements for review and
approval of research that will be conducted in public
elementary or secondary schools.
When conducting research in
public elementary and secondary schools, investigators
are responsible for ensuring that the school has
confirmed in writing that it is in compliance with the Family Educational Rights and
Privacy Act (FERPA) and the Protection of Pupil Rights
Amendment (PPRA). FERPA
controls access to and disclosure of personal
identifiable student information and records; PPRA
controls the development and administration of surveys
that involve protected information in local educational
agencies and schools. Under FERPA, with certain
exceptions, the permission of parents or guardians must
be obtained before disclosing a student’s record or
personally identifiable information. Likewise under
PPRA, the permission of parents or guardians must be
obtained (or in some cases the parents must be allowed
to exclude their children from the survey) if an
investigator develops or administers a survey to
students that covers one of the following areas of
protected information:
1.
Political affiliations or beliefs of the student or the
student’s parents;
2. Mental
or psychological problems of the student or the
student’s family;
3. Sexual
behavior or attitudes;
4.
Illegal, anti-social, self-incriminating or demeaning
behavior;
5.
Critical appraisals of other individuals with whom
respondents have close family relationships;
6. Legally
recognized privileged or analogous relationships, such
as those with lawyers, physicians, or ministers;
7.
Religious practices, affiliations, or beliefs of the
student or the student’s parents; or,
8. Income
(other than that required by law to determine
eligibility for participation in a program or for
receiving
financial assistance under
such program.)
Investigators must provide a
letter of support from the school to the IRB with their
application when conducting research within the school
system. The letter should include a statement that the
school will comply with the Family Educational Rights
and Privacy Act (FERPA) and the Protection of Pupil
Rights Amendment (PPRA), and a statement that the school
supports the research. Research applications that do not
provide such a statement will be reviewed but not yet approved by the IRB.
Back to Table of
Contents
4.5.7 Wards of the State
Children who are wards of the
state or any other agency may be included in the
allowable categories of research if the research is:
1. related
to their status as wards, or
2.
conducted in settings in which a majority of children
who are subjects are not wards.
If the research involves
1. greater than minimal risk and has no prospect of direct
benefit to individual subjects, but is likely
to yield generalizable knowledge about the subject’s
disorder or condition (45
CFR 46 §406), or
2. the research is not otherwise
approvable but presents an opportunity to understand,
prevent, or alleviate a serious problem affecting the
health or welfare of children (45
CFR 46 §407),
investigators must make
provisions for a child advocate for each child who is a
ward of the state (45
CFR 46 §409; Code of Virginia §31-8 and §31-14.1).
The advocate must be an individual who has the
background and experience to act in, and agrees to act
in, the best interests of the child for the duration of
the child’s participation in the research and who is not
associated with the research in any way, except as a
member of the RU IRB. One person may serve as advocate
for more than one child. The advocate may not be a
child’s guardian or a person acting in loco parentis.
The PI’s research explanation must either provide for
this requirement or state that wards of the state will
be excluded from participation.
Back to Table of
Contents
4.5.8 Emancipated Minors
Emancipated minors are deemed
emancipated and treated as adults for all purposes.
Definitions of emancipated minors include those who are:
(1) self-supporting and/or not living at home, (2)
married, (3) pregnant or a parent, (4) in the military,
or (5) declared to be emancipated by a court. Many
states give decision making authority (i.e. without the
need for parental involvement) to some minors who are
otherwise unemancipated or who have decision-making
capacity (“mature minors”) or those minors who are
seeking treatment for certain medical conditions, such
as sexually transmitted diseases, pregnancy, and drug or
alcohol abuse. Since the situations in which minors are
deemed partially or totally emancipated vary from state
to state, the Radford University IRB has determined
that all persons under the age of 18 are not emancipated
minors for the purposes of participating as subjects in
research. However, if a researcher wishes to use
emancipated minors, the burden of legal proof as
promulgated by the Code of Virginia will be
assumed by the principal investigator. Otherwise,
anyone under the age of 18 (including enrolled RU
students) may not be used as a participant in human
subjects research without first obtaining parental
permission (unless waived) and the student’s assent.
Back
to Table of Contents
Definitions
Assent:
A child’s affirmative agreement to participate in
research. Mere failure to object, absent affirmative
agreement, should not be construed as assent.
Permission:
The consent of a parent(s) or guardian to the
participation of their child or ward in research.
Child:
A person who has not attained the legal age for consent,
or is not an emancipated minor, to treatments or
procedures involved in the research under the applicable
law of the jurisdiction in which the research will be
conducted.
Guardian:
An individual who is authorized under applicable state
or local law to give consent on behalf of a child for
general medical care and to give permission for the
child to take part in research.
Parent:
A child’s biological or adoptive mother or father. A
pregnant woman is not a parent until she gives birth to
a living child.
Privilege:
a special benefit, exemption from a duty, or immunity
from penalty, given to a particular person, a group or a
class of people.
Ward of the State:
A person who is housed by and receives protection and
necessities from the government (e.g. when a
governmental agency has custody of a minor or a mentally
incompetent person for his or her protection and care).
Back
to Table of Contents
TRAINING
IN THE PROTECTION OF HUMAN
SUBJECTS
5.0 Required Training
for Researchers
The
Radford University IRB and federal regulations require
that all persons conducting research involving human
subjects receive education in the responsible conduct of
such research. All prospective Radford University
researchers whose research requires interacting with
human subjects must complete the NIH Human Subjects Training. The researcher is
responsible for submitting the certification form to the IRB Administrator.
Certification must be received before any protocol
requiring IRB review will be approved. Proof of
education will be retained by the IRB and need not be
submitted except with an initial protocol. Certification
is valid for three years. After three years, it must be
renewed. Researchers who believe they have completed
education comparable to the online course should contact
the IRB Administrator.
Back to Table of
Contents
5.1 Training for IRB Members
IRB
members, alternates, and the prisoner advocate are
provided with training that provides information and
copies of the following information:
1. Policies and Procedures of the
IRB
2. Public website for the IRB
3. Quarterly education segments
distributed with the meeting agenda
Back to Table of
Contents
5.2 Training for IRB Staff Members
The
following is list of educational resources that all IRB
staff are required to review within three (3) months of
employment:
1. Policies and Procedures of the
IRB
2. Public website of the IRB
3. Collaborative Institutional
Training Initiative (CITI) Basic and
Intermediate Social/ Behavioral
Group 2 course and the IRB
Reference Resource module.
Attendance at regional and national meetings, such as PRIM&R,
is encouraged and supported for staff members.
Back to Table of
Contents
INITIAL
IRB REVIEW OF HUMAN SUBJECT RESEARCH PROTOCOLS
6.0
Initial Review Requirements
The
Radford University IRB reviews all human subject
research conducted by faculty, staff, and students,
regardless of the location of the research activity (on
or off campus), source of funding, and whether the
research is exempt under the Code of Federal Regulations
for Protection of Human Subjects (45
CFR 46). All forms
can be downloaded from the Radford University IRB
webpage.
All forms can be electronically submitted, although any
documents that require an original signature must have
the signature page printed, signed, and submitted to the IRB
Administrator. See Section 2.3 for the approval timeline
for IRB submissions.
The
following are required for all IRB submissions:
1. A
completed, signed copy of the Investigator Agreement
Form.
2. The
Request for Initial Review of Research Protocol Form
with an
original signature. The Request form and documents can
be electronically
submitted, but IRB review and approval will not occur
until the original
signature page(s) have been submitted.
3. Consent
document templates
(a) If minors are
involved, submit a copy of the proposed Parental
Permission Form and
Child Assent form(s)
(b) PIs may request
a Waiver of Informed Consent Documentation
(c) Exempt studies
will require the use of an information sheet that
contains all of the information
of a consent document, without a signature
line and without any IRB approval language.
4.
Bio-sketch or CV for all investigators
5.
Training verification- the NIH certificate must be submitted to the IRB
Administrator.
Back
to Table of Contents
6.1
Submission Schedule Requirements
There is
usually one IRB meeting per month. Meetings are usually held on the third
Monday of each month, except for the month of December,
when special dates are assigned. The deadline for
submission of any full board review packets is 15
working days (3 weeks) prior to the meeting date. Any
full board protocols received after the submission
deadline will not be reviewed until the next scheduled
IRB meeting. See the IRB website for meeting dates and
submission deadlines. If the study is eligible for
Expedited or Exempt review, it will be reviewed in the
order received.
The IRB
Administrator receives all research applications and
evaluates the protocol to determine the correct level of
review- Exempt, Expedited or Full Board. Any questions
about the appropriate review level, applicability of the
definition of human participants, jurisdiction of the
IRB, or any other matter relating to the necessity of
protocol review should be directed to the IRB
Administrator and the IRB Chair. IRB staff and/or the IRB
Chair review the agenda for protocols involving
vulnerable populations and ensure that the IRB includes
persons knowledgeable about or experienced in working
with these participants or obtains consultation.
Back to Table of
Contents
6.2
Exempt Review
Exempt
research must be of minimal risk. According to 45 CFR 46 §102(i), minimal risk means that the probability and magnitude of harm or
discomfort anticipated in the research are not greater
in and of themselves than those ordinarily encountered
in daily life or during the performance of routine
physical or psychological examinations or tests. If the protocol meets all
requirements for Exempt Review, it is reviewed by the
IRB Administrator, who will correspond with the PI via
phone or email until the study is acceptable. The study
is then available for review by the IRB Chair or the
Chair’s designee. All administratively approved
protocol titles and PIs will be reported in the
appropriate agenda and minutes to the IRB at the next
monthly meeting.
Listed
below are the six categories of human subjects research
that the federal government considers to be exempt.
Research must be of minimal risk. Any research
involving prisoners may not be granted exemption,
regardless of the risk level. Although not regulated by
federal regulations, the Radford University IRB does not
allow exemption of research that involves interventions
or interactions with individuals confined to behavioral
health facilities, nursing homes, or other facilities
where the individual’s freedom of movement is
restricted. Research with children (under age 18) is
eligible for exempt review under Category 2 of 45 CFR 46, §101(b)(2) only if the research involves surveys of children,
interviews of children, or observation of public
behavior where the investigator(s) do not participate in the activities being observed. Although
not regulated by federal regulations, the RU IRB does
not allow exemption for any studies involving
videotaping or audio taping.
Exempt
research must fall into one of following categories:
1. Research
conducted in established or commonly accepted
educational settings, involving normal educational
practices, such as
a.
research on regular and special education instructional
strategies, or
b. research on the
effectiveness of or the comparison among instructional
techniques,
curricula, or classroom management methods.
c.
the research is not FDA regulated
2. Research involving the use of
educational tests (cognitive, diagnostic, aptitude,
achievement),
survey procedures, interview procedures or observation
of public behavior, unless:
a. information obtained
is recorded in such a manner that human subjects can
be identified, directly or through identifiers linked to
the subjects; and
b. any disclosure of the
human subjects' responses outside the research could
reasonably place the subjects at risk of
criminal or civil liability or be damaging to
the subjects' financial standing, employability, or
reputation.
c. the research involves
surveys of children, interviews of children, or
observation of
public behavior of children where the investigator(s)
participate in the
activities being observed.
3. Research involving the use of
educational tests (cognitive, diagnostic, aptitude,
achievement), survey procedures, interview procedures,
or observation of publicbehavior that is not exempt
under paragraph (b)(2) of this section, if:
a. the human subjects
are elected or appointed public officials or candidates
for public office; or
b. federal statute(s)
require(s) without exception that the confidentiality of
the personally identifiable information will be
maintained throughout the research and thereafter.
(4) Research involving the
collection or study of existing data, documents,
records, pathological specimens, or diagnostic
specimens, if these sources are publicly available or if
the information is recorded by the investigator in such
a manner that subjects cannot be identified, directly or
through identifiers linked to the subjects.
(5) Research and demonstration
projects which are conducted by or subject to the
approval of department or agency heads, and which are
designed to study, evaluate, or otherwise examine:
(i) Public benefit or service programs; (ii) procedures
for obtaining benefits or services under those programs;
(iii) possible changes in or alternatives to those
programs or procedures; or (iv) possible changes in
methods or levels of payment for benefits or services
under those programs.
(6) Taste and food quality
evaluation and consumer acceptance studies, (i) if
wholesome foods without additives are consumed or (ii)
if a food is consumed that contains a food ingredient at
or below the level and for a use found to be safe, or
agricultural chemical or environmental contaminant at or
below the level found to be safe, by the Food and Drug
Administration or approved by the Environmental
Protection Agency or the Food Safety and Inspection
Service of the U.S. Department of Agriculture.
Back to Table of
Contents
6.2.1 Exempt Educational Research
Three
areas of exempt research are most pertinent to
educational research:
1.
Research conducted in educational settings, involving
normal educational
practices.
2.
Research using educational tests, surveys, interviews,
or observations of public
behavior.
3.
Secondary use of EXISTING data (data collected
[by anyone] before your study
for
some other purpose (e.g., prior test scores).
Additionally, signed consent forms are not be required
for exempt research, provided that the elements of
consent are clearly stated on the questionnaire
themselves or on a cover letter. Protocols not meeting
the above criteria are referred for expedited or full
board review.
Back
to Table of Contents
6.3 Expedited Review Process
Protocols
determined to be minimal risk, but not falling into any
exempt category, may be considered for expedited
review. The IRB Administrator and the IRB Chair review the protocols fulfilling
the requirements for expedited review to ensure
completeness and will correspond accordingly with the
PI(s) by phone or email until the packet is complete. A
reviewer then completes the Expedited review checklist.
The protocol is then available for review by the IRB,
the IRB Chair, or the Chair’s designee. Expedited
protocols cannot be disapproved by the IRB Administrator or the
IRB Chair/ Chair’s designee. If the PI is ultimately
unwilling to make these changes, then the expedited
study will be upgraded to the full board review
category. All expedited items (i.e., new protocol
review applications, amendments to previously approved
protocols, continuation requests, unanticipated
problems, study closures and/or terminations) are listed
in a monthly agenda and the corresponding minutes as a
method of informing IRB members.
Research
must meet all of the following criteria in order to be
reviewed by the IRB through an expedited review
procedure (45
CFR 46 §110):
1. Be of minimal risk to the subjects
2. Must not involve prisoners or mentally impaired
persons
3. Must be in one or more of the following
categories:
A. Clinical studies of :
(a) Research on drugs for which
an investigational new drug application (21 CFR
Part 312) is not required.
(Note: Research on marketed drugs that
significantly increases the risks or decreases the
acceptability of the risks
associated with the use of the product is not eligible
for expedited review.)
(b) Research on medical devices
for which (i) an investigational deviceexemption
application (21 CFR Part 812) is not required;
or (ii) the medical device is cleared/approved for
marketing and the medical device is being used in
accordance with its
cleared/approved labeling.
B. Collection of blood samples by finger stick,
heel stick, ear stick, or venipuncture as follows:
(a) from healthy, nonpregnant
adults who weigh at least 110 pounds. For these
subjects, the amounts drawn may
not exceed 550 ml in an 8 week period and collection may
not occur more frequently than 2 times per week; or
(b) from other adults and
children, considering the age, weight, and health of the
subjects, the collection procedure,
the amount of blood to be collected, and thefrequency
with which it will be collected. For these subjects, the
amount
drawn may not exceed the lesser of 50 ml or 3 ml
per kg in an 8 week period and collection may not occur
more frequently
than 2 times per week.
C. Prospective collection of
biological specimens for research purposes by
noninvasive means.
Examples:
(a) hair and nail clippings in a
nondisfiguring manner;
(b) deciduous teeth at time of
exfoliation or if routine patient care indicates a need
for extraction;
(c) permanent teeth if routine
patient care indicates a need for extraction;
(d) excreta and external
secretions (including sweat);
(e) uncannulated saliva
collected either in an unstimulated fashion or
stimulated by chewing gumbase or wax or by applying a
dilute citric solution to the tongue;
(f) placenta removed at
delivery;
(g) amniotic fluid obtained at
the time of rupture of the membrane prior to or during
labor;
(h) supra- and subgingival
dental plaque and calculus, provided the collection
procedure is not more invasive than routine
prophylactic scaling of the teeth and the process is
accomplished in accordance with accepted prophylactic
techniques;
(i) mucosal and skin cells
collected by buccal scraping or swab, skin swab, or
mouth washings;
(j) sputum collected after
saline mist nebulization.
D. Collection of data through
noninvasive procedures (not involving general anesthesia
or sedation) routinely employed in clinical
practice, excluding procedures involving x-rays or
microwaves. Where medical devices are employed,
they must be
cleared/approved for marketing. (Studies intended to
evaluate the safety and effectiveness of the medical
device are not
generally eligible for expedited review, including
studies of cleared medical devices for new indications.)
Examples:
(a) physical sensors that are
applied either to the surface of the body or at a
distance and do not involve input of significant
amounts of energy into the subject or an invasion of the
subjects privacy;
(b) weighing or testing sensory
acuity;
(c) magnetic resonance imaging;
(d) electrocardiography,
electroencephalography, thermography, detection of
naturally occurring radioactivity,
electroretinography, ultrasound, diagnostic infrared
imaging, doppler blood flow, and echocardiography;
(e) moderate exercise, muscular
strength testing, body composition assessment, and
flexibility testing where appropriate given
the age, weight, and health of the individual.
E. Research involving materials
(data, documents, records, or specimens) that have been
collected, or
will be collected solely for nonresearch purposes (such
as medical treatment or diagnosis).
F. Collection of data from voice,
video, digital, or image recordings made for research
purposes.
G. Research on individual or group
characteristics or behavior (including, but not
limited to, research on perception, cognition,
motivation, identity, language, communication, cultural
beliefs or practices, and social behavior) or research
employing survey, interview,
oral history, focus group, program evaluation, human
factors evaluation, or quality assurance
methodologies. (NOTE: Some research in this category may
be exempt from the HHS regulations for the
protection of human subjects. 45 CFR 46.101(b)(2)
and (b)(3). This listing refers only to research that is
not exempt.)
6.3.1 Online research may be restricted based on the probability of research subjects’ adverse reactions and will be considered on a case-by-case basis. Minimal risk research will be reviewed by a member of the Exempt Sub-committee who has the option to recommend further review by the Expedited Sub-committee; more than minimal risk research will be reviewed by a member of the Expedited Sub-committee who has the option to recommend a FULL BOARD review.
6.3.2 Researchers must insure that the storage of data of more than minimal risk is in an adequately encrypted format if the data are digital.
Back to Table of
Contents
6.4
Greater than Minimal Risk Protocols
All
protocols determined by the IRB staff to be more than
minimal risk (i.e. failing to meet the requirements of §6.2 or §6.3 of this document) are required by federal and state
regulation to be reviewed and approved by a fully
convened IRB. The Radford University Institutional
Review Board adheres to the following process to
facilitate the thorough review of each protocol
according to Federal (45
CFR 46 §111) and
State of Virginia (Code of Virginia §32.1-162.19)
regulations:
1. The IRB Chair
and the IRB Administrator specifically review the protocol
submission for
completeness and request changes to the protocol as
necessary. This review and request for changes is accomplished prior
to distributing protocol submission materials to Board
members.
2. The IRB
Administrator provides a complete set of documents to each
IRB member, who is asked
to review the protocol(s) and
supporting documents in detail. These documents are
mailed to all
Board members,
regardless of their intention to attend the meeting.
3. Prior to the
full IRB meeting, Board members may correspond with the
PI(s) and/or IRB staff to resolve
any questions.
Furthermore, any Board member may contact the PI, co-PI,
other IRB members, or
outside sources as necessary
to insure a thorough investigation of risks and
benefits of the proposed research.
4. All
submissions undergoing review (i.e., new protocols,
continuation requests, amendment requests, etc) are
discussed individually by the
IRB.
5. Researchers
are invited to be available during the meeting, either
by phone or in person, to respond to any
questions the Board may have.
**Note: Researchers are only present during discussion
and are dismissed prior
to final deliberations and
determinations.
6. For initial
review applications, all Board members are provided with
a Review Checklist (A or B) to complete.
Each member is responsible for completing the checklist
and returning it to the IRB Administrator.
7. After
complete and individual discussions, each protocol is
voted upon for one of four possible dispositions:
approve, disapprove, table, or
provide contingent approval.
a. Approved- The IRB accepts and endorses
without reservations
“approved” studies.
b. Approved with Contingencies- Studies
approved with
contingencies, the IRB accepts and endorses
provided the PI
concurs with the
requested changes and recommendations.
c. Tabled- A study may be tabled if the
Board did not have sufficient time,
expertise, or
appropriate personnel present
(e.g., prisoner advocate)
to vote on the
study, or because the Board needed substantive
clarification
or modifications
regarding the protocol or study documents to determine
whether to
approve or disapprove the study.
A study may be
contingently
approved when the convened IRB is able to stipulate specific
revisions
that require
concurrence by the investigator. If the IRB approves a
study with
contingencies, then the IRB
Chair or the Chair’s
designee may approve the revised research
protocol.
d. Disapproved- A protocol that is
disapproved is deemed to have risks
which
outweigh potential benefits or the protocol
is
significantly deficient
in several major
areas. A PI has the right to appeal the disapproval to
the Board and
ask to have the decision reconsidered.
Following
the presentation and discussion of protocols receiving
either initial or continuing review, a listing of
protocols reviewed and administratively approved for
continuation, a listing of protocol modifications, a
listing of unanticipated problems and a listing of those
protocols approved through expedited review procedures
and other information relating to ongoing research
activities are reported to the IRB. Protocols
requesting significant modifications or of special
interest to the IRB are discussed in detail, and voted
upon by the convened IRB. The PI is notified of the
status of the submitted protocol within 3 days of the
IRB meeting. Letters are sent to the PI through campus
mail.
There may
be times when the risks associated with a protocol are
such that continuing review should take place more
frequently than annually. In these cases, the IRB will
specify that the PI reports to the IRB either at a
shorter time interval or after a specified number of
subjects are enrolled. The PI’s reports must describe
the observed effects of the research activities and/or
how the subject(s) responded to the research
interventions. The determination will be recorded in
the IRB minutes and reports forwarded to the IRB by the
IRB office, when they are submitted.
Back to Table of
Contents
6.5
Non-compliance with IRB Policies and Decisions
Human
subjects research that deviates from the policies,
procedures, stipulations, decisions, state, or federal
law is non-compliant and subject to further inquiry by
the IRB, Radford University, and the Office of Human
Research Protections (OHRP). All reports and complaints
of non-compliance should be directed to the Radford
University IRB Administrator via email, telephone, or
in person. The RU IRB Administrator will immediately
investigate all allegations of non-compliance. If
necessary, the IRB Administrator will send the
investigator(s) in question a notice requesting the
immediate suspension of all specified research
activities while the issue of non-compliance is
reviewed. This is consistent with Federal Mandate 45 CFR 46 §113.
This initial notice will also include a statement
detailing the rationale for the IRB’s action. There are
three categories of non-compliance: general, serious, and
continuing.
1. General Non-compliance:
Any study deviating from the RU IRB policies and
procedures, federal
regulations, and/or state
law is in “general
non-compliance.” All
non-compliance studies will undergo an evaluation by the
IRB Chair. The IRB
Chair
will review the nature of the non-compliance and
make a
recommendation based upon each specific case. The IRB
Chair
issues recommendations to the IRB for a vote. If the IRB
rejects the IRB Chair’s
recommendations,
then the IRB must
propose conditions for successful resolution of the situation (see
“Possible Outcomes” below). Any PI with outstanding
study
closure
reports will not have any further IRB review privileges
until all reports have been
submitted.
2. Serious Non-compliance:
All non-compliance substantially affecting the
participants’ rights
and/or welfare, or impacting
upon the risks or benefits
is “serious
non-compliance.” The IRB will assess and vote upon all
serious non-compliance
determinations.
3. Continuing Non-compliance: In the event that the IRB finds reasonable evidence that restrictions,
procedures, stipulations, or
decisions of the IRB have been systematically or
habitually overlooked, the individuals in question may
be monitored to
ensure
that the quality of human subjects protection is
being upheld to the
satisfaction of the IRB and in compliance with the
federal
regulations promulgated
in 45 CFR 46 and Commonwealth of Virginia regulations set forth in §32.1-162.16 through
§32.1-162.20 of the Code of Virginia.
Possible Outcomes:
It is within the purview of the IRB to recommend the termination of
research activities given evidence that the person or
persons who would direct or have directed the scientific
and technical aspects of an activity have failed to
discharge responsibility for the protection of the
rights and welfare of human subjects (45
CFR 46 §113). The
IRB reserves the right to request additional
consultation and expertise to resolve non-compliance.
Back to Table of
Contents
6.6 Appeals Process
If the IRB FULL COMMITTEE decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond orally or in writing. The details of this opportunity should indicate that the PI has a right to appeal in person at the next scheduled meeting of the IRB FULL COMMITTEE that reviewed the research or to respond in writing to the IRB. After an in-meeting appeal or the receipt of a written appeal, the IRB FULL COMMITTEE will vote again. The second vote of the IRB FULL COMMITTEE will be final.
Back to Table of
Contents
CONTINUATION OF APPROVED
RESEARCH
7.0 Procedure for Continuation of Approved
Protocols
Continuing review of research must be substantive and
meaningful. In accordance with HHS regulations at 45 CFR 46.108(b) and at 46.115(a)(2),
continuing review by the convened IRB is required unless
the research is otherwise appropriate for expedited
review as described in OHRP Guidance on Categories of
Research That May Be Reviewed by the IRB Through an
Expedited Review Procedure(http://www.hhs.gov/ohrp/humansubjects/guidance/expedited98.htm).
Therefore, if research was initially approved by the
convened Board, continuing review will normally be
considered by the convened Board.
The RU IRB is responsible for conducting continuing
review of ongoing research to ensure that the rights and
welfare of human subjects are protected and to review
the progress of the entire study. Protocols must
continue to have ongoing IRB approval as long as the
research continues to involve human subjects, even when
research is permanently closed to the enrollment of new
subjects, all subjects have completed all
research-related interventions and only long term
follow-up is being conducted or the only remaining
activity is limited to data analysis of personally
identifiable information. At the time of initial
approval and then with subsequent continuing review, the
IRB determines the frequency and extent of continuing
review for each study appropriate to the degree of risk,
but not less than once per year. Most protocols undergo
continuing review annually, but the IRB has discretion
to require protocols to undergo continuing review more
frequently as warranted by such factors as:
1. The nature of the study
2. The degree of risk involved
3. The vulnerability of the study
subject population.
4. The PI has a history of
non-compliance with IRB policy
In specifying an approval period for studies of less
than 12 months, i.e., those deemed by the IRB to pose
higher risk to subjects or those PIs that historically
disregard IRB policies and procedures, the IRB may, at
its discretion, define the continuing review period with
either a time interval (e.g. 3 or 6 months), or a
maximum number of subjects (e.g. after 3 subjects). If
a continuing review period is defined by a maximum
number of subjects the IRB must also list a maximum time
interval. The minutes and/or comment sheets for such
projects should reflect these determinations regarding
risk and approval period.
Continuing to conduct research after expiration of IRB
approval is a violation of the Federal Regulations. If
IRB approval expires, research activities must stop.
These activities include:
1. the collection, use, or reporting
of any data
2. the performance of any study
interventions, unless the IRB finds that it is in the
best interests of individual
subjects to continue
participating in research
interventions or interactions;
3. the enrollment or screening of
any new subjects; and/or
4. receipt of any study funding.
The Continuation Request/Study
Closure Report submitted by Investigators and considered by the
IRB provides a status report on the progress of the
research.
The IRB may, at its discretion, require verification
from sources other than the investigator that no
material changes have occurred in the research since the
previous IRB review. Protocols that may require
verification include, but are not limited to, those
projects conducted by investigators who previously have
failed to comply with the requirements or determinations
of the IRB or Federal regulations and projects where
concern about possible material changes occurring
without IRB approval have been raised based upon
information provided in continuing review reports or
from other sources. The investigator may be required to
submit additional information as determined by the IRB.
All non-exempt protocols approved by the IRB are subject
to continuing review. When a protocol is first
approved, the IRB determines the appropriate approval
period. The approval period can be no more than 12
months and is based on the information available and the
perceived risk to the subject.
Investigator Responsibilities:
Investigators must submit typed answers to the
Continuation Request/Study Closure Report, and the most
recent copy of approved informed consent (if new subject
enrollment continues). Any revisions must be
submitted according to the revision guidelines.
Failure to respond to either the 60 day, 30 day or past
due notices within the specified time period will be
considered general non-compliance.
Office Responsibilities:
Continuing Review submissions received by the IRB Administrator are entered into the database and reviewed
for completeness (which includes the use of current forms and inclusion of all
required paperwork)
and accuracy. Investigators or their designee are
contacted as appropriate to provide clarification and/or
documentation prior to any applicable Board Review. Only submissions fulfilling all RU IRB
administrative requirements will be scheduled for the
meeting.
Reviewer Responsibilities:
During the week prior to the meeting (whenever
possible), all board members will receive an electronic
copy of all documents as described above.
A designated reviewer is assigned; and the designated
reviewer will receive a hard copy of all supporting
documents in addition to the electronic copy. The
reviewer is responsible for considering and evaluating
the responses provided by the Investigator on the
Continuing Review/Study Closure Report, for ensuring
that answers are complete and not in conflict with
information provided previously, and for presenting this
information to the convened Board. Additionally, the
reviewer should ensure that the currently approved or
proposed consent document is accurate and complete.
Investigators may be contacted as appropriate to provide
clarification and/or documentation prior to Board
Review. Copies of e-mail correspondence with
Investigators should be submitted to the Administrative
Office with continuing review paperwork for maintenance
in the IRB file.
The reviewer should present a brief review of the
protocol and information provided in the Continuing
Review Report to the Board and should make a
recommendation regarding the acceptability of granting
the renewal. In this assessment, the reviewer should
ensure that the criteria for approval continue to be
satisfied including consideration of the risks and
benefits and current safeguards for human subjects and
determine whether any new information has emerged that
might affect the risk/benefit ratio. The IRB should
ensure that new information or findings, which may
relate to the subjects’ willingness to continue
participation is provided to study subjects. Applicable
Reviewer Comment Sheets are provided and should be
completed and submitted as described in Review of
Research. The discussion of the continuing review
application is led by the designated assigned reviewers
and directed by the Chair. The entire membership is
expected to participate in the review of all protocols,
not just the protocols assigned to them. At the end of
the discussion, based on the information reviewed,
presented and discussed, the primary reviewer and/or
Chair make a recommendation for action, risk level and
approval period (continuing review interval based upon
risk to subjects). A vote is taken on each action and
recorded in the database.
Back
to Table of Contents
7.1 Amending Approved Protocols
Investigators are responsible for
reporting proposed changes in research activity to the
IRB, and for ensuring that changes in IRB approved
research are not initiated without IRB review and
approval except when necessary to eliminate apparent
immediate hazards to the subject.
Minor changes in previously approved research may be
reviewed utilizing an expedited process (See Expedited
Review Process: Revisions).
The IRB must consider and approve
all changes to previously approved research, no matter
how minor, before they are implemented. Proposed
changes may affect, but are not limited to, the
protocol, informed consent form, and changes in study
population. Investigators are responsible for
submitting proposed changes in research activity to the
IRB, and for ensuring that changes in IRB-approved
research are not initiated without IRB review and
approval except when necessary to eliminate apparent
immediate hazards to the subject. If changes to the
protocol are implemented for the safety of the subject
prior to IRB review and approval, such changes must be
reported to the IRB within 5 days, with any supporting
documentation necessary for the IRB to make a
determination that the change was consistent with
ensuring the subjects’ continued welfare. Information
relating to protocol changes will be provided to
subjects when such information may relate to the
subjects' willingness to continue to take part in the
research.
MAJOR revisions involve
changes that may increase the risk to subjects and
include, but are not limited to, a change in PI for Full
Board protocols and/or anything that would increase
potential risk or decrease potential benefits to
subjects. Major revisions are reviewed by the full Board
and will be scheduled for an IRB meeting according to
the IRB meeting deadlines. These revisions are placed on
the IRB agenda and are assigned to two designated
reviewers to present to the full Board for action. The
request must be reviewed with the same criteria for
concern for human subjects as used in the review of a
new protocol.
Investigator Responsibilities:
The preliminary determination of revision type is the
responsibility of the investigator. Investigators must
submit a completed Request for Modification Form and, if
necessary, a cover letter, explaining the revisions,
protocol, Informed Consent Form and/or other forms, and
any information to be provided to the subject to the IRB
Office. Changes to the protocol, consent, IRB forms, or
other documents must be indicated the track
modifications tool in Microsoft word. See the Request
for Modification form on the IRB website for more
information. In addition, "clean" copies of affected
documents must be submitted if revisions were made.
Office Responsibilities:
Major revisions received by the IRB Administrator are
entered into the database and reviewed for completeness
(which includes the use of current forms and inclusion
of all required paperwork).
Once complete, the submission, including all of the
supporting documents provided by the PI and those
provided by the IRB Administrator including a project
history, the last IRB-approved informed consent, and the
current protocol, is forwarded on for inclusion on
the applicable meeting agenda and determination of
review status. Reviewer Comment Sheets are attached to
each hard copy.
Back to Table of
Contents
7.2 Unanticipated
Problems: Identifying and Reporting
Federal Regulations (45
CFR 46 §103(b)(5)) require that
unanticipated problems involving risk to subjects or
others be promptly reported to the IRB, appropriate
institutional officials, and any supporting department
or agency head and OHRP. Although the regulations do
not define unanticipated problems, OHRP (2007) published
guidance on unanticipated problems.
Definitions
Unanticipated problem (UPR): any incident, experience, or outcome that meets all of the following criteria:
a. unexpected
(in terms of nature, severity, or frequency) given (a)
the research procedures
that are described in the
protocol-related documents,
such as the IRB-approved
research protocol and informed consent document; and (b)
the
characteristics of the subject population being studied;
b. related or
possibly related to participation in the research (possibly
related means there is a
reasonable possibility that the
incident, experience, or
outcome may have been
caused by the procedures involved in the research); and
c. suggests
that the research places subjects or others at a greater
risk of harm (including physical, psychological, economic, or
social
harm) than was previously known
or recognized. Events that do not cause
detectable harm or adverse effects to
subjects
or others may still represent unanticipated
problems.
Both risks to subjects and risks to other individuals (e.g., research
personnel, subjects’ family members) are included in the
concept of UPRs. Risks may reflect any type of
potential harm (e.g., physical, psychological, social,
economic).
Any major problems involving human
subjects should be reported to the IRB immediately. In
addition, any subjects exhibiting signs or symptoms of
the unanticipated problem should be referred to the IRB
Chair for assistance. Any minor problems involving the
conduct of the study or subject participation (including
recruitment, consent, screening and termination) should
be reported during the continuing review process.
Investigator Responsibilities:
The Principal Investigator is responsible for knowing
which unanticipated problems and/or adverse events
require expedited reporting and for completing the
applicable reporting forms (available at the IRB
website) and for submitting the reporting form and any
other supporting documentation to the IRB Administrator
within 5 working days of discovery. If an event,
incident, experience, or outcome is life-threatening or
fatal, the IRB must be notified by phone within 24
hours.
Office Responsibilities:
Reportable events (serious and unexpected adverse events
and/or unanticipated problems) received by the IRB
Administrator are entered into the database and reviewed
for completeness (which includes the use of current
forms and inclusion of all required paperwork).
Chair Responsibilities: The
IRB Chair will review any reports to determine if the
research has been associated with unexpected serious
harm to subjects and/or if there is any immediate risk
to subjects participating in the protocol. In such a
case, the Chair may immediately suspend the study or
enrollment in the study and refer the issue to the next
full board meeting for discussion. The Chair or
designee will notify the Investigator and appropriate
Institutional officials of the suspension (see §1.4).
Deaths that are unexpected and related or possibly
related to study interventions, or where a relationship
cannot be ruled out, will be referred from the Chair to
the full Board for review and may require the additional
oversight of the Institutional Official, Provost, and/or
the Radford University President .
If no immediate risk to human
subjects exists, and in the opinion of the Chair the
event(s), incident(s), experience(s), or outcome(s)
could result in an increase in perceived participant
risk, the Chair will address the event in a memo and
request the event be added to the agenda for the next
applicable full board meeting. If the event is clearly
not unexpected, does not suggest that the research
places subjects or others at a greater risk of harm
(including physical, psychological, economic, or social
harm) and/or is not serious and is not related to
or possibly related to participation in the study than
was previously known or recognized, the Chair may
determine that no further action is needed.
At the discretion of the Chair, any
event, incident, experience, or outcome can be forwarded
to the Board for consideration and determination. The
IRB Administrator will include the submission on the next
applicable agenda and notify the investigator in writing
that the submission has been forwarded to the Full Board
for review.
Back to Table of
Contents
RESEARCH
INVOLVING VULNERABLE POPULATIONS
8.0 Requirements for
Research Involving Vulnerable Populations
Federal regulations acknowledge the
special problems of research involving vulnerable
populations, such as children, prisoners, pregnant
women, mentally disabled persons, or economically or
educationally disadvantaged persons. The IRB also
considers terminally ill patients and institutional
residents as potentially vulnerable. When investigators
propose the inclusion of some or all subjects, including
RU Students and RU staff, who are likely to be
vulnerable to coercion or undue influence, the
Investigator and IRB will consider additional
safeguards, as necessary, to protect the rights and
welfare of these subjects.
Investigators wishing to include
potentially vulnerable populations as either the
“targeted” population or in the demographics of the
potential subject pool must provide information relevant
to their inclusion in the applicable paperwork for
consideration by the IRB. Information including but not
limited to subject selection, recruitment and consenting
procedures, and justification for the inclusion of
vulnerable subjects and any additional safeguards should
be included. IRB forms and form instructions have been
designed to elicit information that the IRB needs to
review, consider, and evaluate in order to make the
determinations required under regulation and approve
research.
When reviewing projects involving
vulnerable or potentially vulnerable subjects, the IRB
follows Full Board or Expedited Review Procedures (§6.3 and §6.4 of this
document) as applicable and will be sufficiently
qualified to review such projects either through
representation of individuals knowledgeable on the Board
or will rely on consultants to provide additional
expertise as needed. In its review, the IRB will
consider information provided by the PI and may request
additional information or clarification as needed before
approving the research. The IRB systematically
evaluates research and the protocol submission and
considers the inclusion of vulnerable subjects on a
protocol-by-protocol basis including the justification
for the inclusion of vulnerable subjects or populations
in the study and any additional safeguards that may be
needed to protect the rights and welfare of these
subjects and minimize risks. Additional safeguards may
include, but are not limited to:
1. Using an
adult third party not involved in the research to
witness informed
consent
2. The
inclusion of a consent monitor or subject advocate
3. A waiting
period between initial contact, consent discussion and
enrollment to allow time
for family discussion
and questions; and/or
4.
Provisions for additional consent protections such as
obtaining consent from a legally
authorized representative (LAR)
and/or assent from
subjects with limited autonomy.
In addition to the regulatory
criteria set forth for the approval of research, in the
absence of additional codified protections, when
reviewing projects that may involve vulnerable populations, the IRB may consider
approving research that involves vulnerable subjects if
at least one of the following conditions is met:
1. The research
does not involve more than minimal risk to the subject
2. The research
is likely to benefit the subject directly, even if the
risks are
considered to be more than minimal; or
3. The research
involves greater than minimal risk with no prospect of
direct benefit to individual
subjects, but is likely to yield
generalizable knowledge
about the subject's
disorder or condition.
For all research involving
vulnerable or potentially vulnerable subjects, IRB
records, including but not limited to, documents
submitted by the PI and reviewed and approved by the IRB
or Chair’s designated reviewer, minutes and/or comment
sheets (for projects undergoing full board or expedited
review) will document the inclusion of vulnerable
subjects, and protocol specific findings, additional
safeguards and determinations of the IRB for research
involving pregnant women, human fetuses, neonates,
prisoners, children, and/or other vulnerable populations.
The IRB must approve a protocol for
the enrollment of potentially vulnerable subjects prior
to their inclusion in the protocol. If the IRB does not
approve a project for the inclusion of vulnerable
subjects, the Investigator must revise the project prior
to the inclusion of any individual or class of
individuals deemed vulnerable or potentially
vulnerable. Any subject who may be considered
vulnerable enrolled in a project without prior IRB
approval should be reported in writing to the IRB within
5 business days of discovery.
Back to Table of
Contents
8.1 Inclusion of Pregnant
Women, Fetuses and Neonates in Research
Definitions:
Pregnancy: Encompasses the
period of time from implantation until delivery. A
woman shall be assumed to be pregnant if she exhibits
any of the presumptive signs of pregnancy, such as
missed menses, until the results of pregnancy testing
are negative, or until delivery.
Fetus: The product of
conception from implantation until delivery.
Neonate: A newborn.
Pregnant women or fetuses may be
involved in research if all of the following conditions
are met (45
CFR 46 §204):
1. Where scientifically appropriate, preclinical
studies, including studies on pregnant animals, and
clinical studies, including studies on nonpregnant
women, have been conducted and provide data for
assessing potential risks to pregnant women and fetuses;
2. The risk to the fetus is caused solely by
interventions or procedures that hold out the prospect
of direct benefit for the woman or the fetus; or, if
there is no such prospect of benefit, the risk to the
fetus is not greater than minimal and the purpose of the
research is the development of important biomedical
knowledge which cannot be obtained by any other means;
3. Any risk is the least possible for achieving the
objectives of the research;
4. If the research holds out the prospect of direct
benefit to the pregnant woman, the prospect of a direct
benefit both to the pregnant woman and the fetus, or no
prospect of benefit for the woman nor the fetus when
risk to the fetus is not greater than minimal and the
purpose of the research is the development of important
biomedical knowledge that cannot be obtained by any
other means, her consent is obtained in accord with the
informed consent provisions of subpart A of this part;
5. If the research holds out the prospect of direct
benefit solely to the fetus then the consent of the
pregnant woman and the father is obtained in accord with
the informed consent provisions of subpart A of this
part, except that the father's consent need not be
obtained if he is unable to consent because of
unavailability, incompetence, or temporary incapacity or
the pregnancy resulted from rape or incest.
6. Each individual providing consent under paragraph
(d) or (e) of this section is fully informed regarding
the reasonably foreseeable impact of the research on the
fetus or neonate;
7. For children (as defined in §4.5.8 of
this document) who are pregnant, assent and permission
are obtained in accord with the provisions of subpart D
of this part;
8. No inducements, monetary or otherwise, will be
offered to terminate a pregnancy;
9. Individuals engaged in the research will have no
part in any decisions as to the timing, method, or
procedures used to terminate a pregnancy; and
10. Individuals engaged in the research will have no
part in determining the viability of a neonate.
Neonates of uncertain viability and
nonviable neonates may be involved in research if all the following conditions are met (45
CFR 46 §205(a)):
1. Where scientifically appropriate, preclinical and
clinical studies have been conducted and provide data
for assessing potential risks to neonates.
2. Each individual providing consent under paragraph
(b)(2) or (c)(5) of this section is fully informed
regarding the reasonably foreseeable impact of the
research on the neonate.
3. Individuals engaged in the research will have no
part in determining the viability of a neonate.
4. The requirements of paragraph (b) or (c) of this
section have been met as applicable.
According to 45 CFR46 §205(c),
if the neonate is nonviable after delivery, all of the following additional conditions must be met:
1. Vital functions of the neonate will not be
artificially maintained;
2. The research will not terminate the heartbeat or
respiration of the neonate;
3. There will be no added risk to the neonate
resulting from the research;
4. The purpose of the research is the development of
important biomedical knowledge that cannot be obtained
by other means; and
5. The legally effective informed consent of both
parents of the neonate is obtained in accord with
subpart A of this part, except that the waiver and
alteration provisions of 45 CFR 46 §116(c)
and (d) do not apply. However, if either parent is
unable to consent because of unavailability,
incompetence, or temporary incapacity, the informed
consent of one parent of a nonviable neonate will
suffice to meet the requirements of this paragraph
(c)(5), except that the consent of the father need not
be obtained if the pregnancy resulted from rape or
incest. The consent of a legally authorized
representative of either or both of the parents of a
nonviable neonate will not suffice to meet the
requirements of this paragraph (c)(5).
According to 45 CFR 46 §207(b),
research not otherwise approvable which presents an
opportunity to understand, prevent, or alleviate a
serious problem affecting the health or welfare of
pregnant women, fetuses, or neonates will be sent to the
Secretary of the Department of Health and Human Services
for review. The Secretary will determine the
approvability of the research based on the conditions
stated in 45 CFR 46 §207(b).
Back to Table of
Contents
8.2 Inclusion of Prisoners
in Research
Definition:
Prisoner: any person
involuntarily confined or detained in a penal
institution. The term also includes persons detained in
other facilities (e.g., group homes, work release
centers) by statute or commitment procedures which
provide alternatives to criminal prosecution or
incarceration in a penal institution, as well as persons
detained pending arraignment, trial, or sentencing.
45 CFR 46 Subpart C is applicable to all biomedical and behavioral research
involving prisoners as subjects. The use of prisoners as
subjects is severely limited since such subjects'
ability to voluntarily consent is limited by the
"coercive nature of the environment." All research
involving prisoners will require full committee review.
If a subject in an ongoing research study subsequently
becomes a prisoner, the researcher must report this to
the IRB immediately so that the IRB can review the
protocol again with a prisoner representative present,
to adequately assess the special conditions that the
prisoner will face with respect to continued
participation in the study while incarcerated.
DHHS funded research involving
prisoners must be approved by both the local IRB and the
federal funding department/agency head. The research
must be limited to 'minimal risk' studies of criminal
behavior and incarceration, penal institutions and
prisoners as a social class; research on conditions
affecting prisoners--including social and psychological
problems--only if approved by the department/agency head
after expert consultation; and therapeutic research,
with control groups also requiring the department/agency
head's approval. Unfunded and non-HHS supported research
does not require approval by the federal agency.
A majority of the IRB (exclusive of
prisoner members) must have no association with the
prison(s) involved, apart from their membership on the
IRB. At least one member of the IRB must be either a
prisoner or a prisoner representative/advocate with
appropriate background and experience to serve in that
capacity. The IRB can approve research involving
prisoners only if it finds that:
1. The research under review represents one of the
categories of research permissible under 45 CFR 46 §306(a)(2); AND
2. Any possible advantages accruing to the prisoner
through his or her participation in the research, when
compared to the general living conditions, medical care,
quality of food, amenities and opportunity for earnings
in the prison, are not of such a magnitude that his or
her ability to weigh the risks of the research against
the value of such advantages in the limited choice
environment of the prison is impaired; AND
3. The risks involved in the research are
commensurate with risks that would be accepted by
nonprisoner volunteers; AND
4. Procedures for the selection of subjects within
the prison are fair to all prisoners and immune from
arbitrary intervention by prison authorities or
prisoners. Unless the principal investigator provides to
the IRB justification in writing for following some
other procedures, control subjects must be selected
randomly from the group of available prisoners who meet
the characteristics needed for that particular research
project; AND
5. The information is presented in language which is
understandable to the subject population; AND
6. Adequate assurance exists that parole boards will
not take into account a prisoner's participation in the
research in making decisions regarding parole, and each
prisoner is clearly informed in advance that
participation in the research will have no effect on his
or her parole; AND
7. Where the IRB finds there may be a need for
follow-up examination or care of participants after the
end of their participation, adequate provision has been
made for such examination or care, taking into account
the varying lengths of individual prisoners' sentences,
and for informing participants of this fact.
Back to Table of
Contents
8.3 Inclusion of Children
in Research
Definitions:
Children: persons who have
not attained the legal age for consent, or not
classified as an emancipated minor, to treatments or
procedures involved in research or clinical
investigations, under the applicable laws of the
jurisdiction in which the research or clinical
investigations will occur.
Assent: the child’s
affirmative agreement to participate in research. Mere
failure to object may not, absent affirmative agreement,
be construed as assent.
Permission: the agreement of
parent(s) or guardian(s) to the participation of the
child in research.
Parent: the child’s
biological or adoptive parent
Guardian: an individual who
is authorized under state or local law to consent on
behalf of a child to general medical care when general
medical care includes participation in research.
Children are recognized as
vulnerable under the federal regulations and as such
have additional protections codified under Subpart D to 45 CFR 46 . For studies involving children, the IRB
may approve only the categories of research listed below
provided all applicable criteria are met:
1. Research not involving greater than minimal
risk (45
CFR 46 §404), if the IRB finds that no
greater than minimal risk to children is presented, the
approval may be given only if adequate provisions are
made for soliciting the assent of the children and the
permission of at least one (1) parent/guardian. Minimal
risk means “ the probability and magnitude of harm or
discomfort anticipated in the research are not greater
in and of themselves than those ordinarily encountered
in daily activities or during the performance of routine
physical or psychological examinations or tests.” 45 CFR 46 §102(i)
2. Research involving greater than minimal risk
but presenting the prospect of direct benefit to the
individual subjects (45
CFR 46 §405), if the IRB finds that
more than minimal risk to children has been presented by
the intervention or procedure that holds out the
prospect of direct benefit for the individual subject,
or by a monitoring procedure that is likely to
contribute to the subject’s well-being, approval may
be given only if the IRB finds:
A. The risk is
justified by the anticipated benefit to the subjects, and
B. The relation of the anticipated benefit to the
risk is at least as favorable to the subjects as
that presented by
available alternative
approaches and
C. Adequate provisions are made for soliciting
the assent of the children and at least one (1)
parent/guardian.
3. Research involving greater than minimal risk
and no prospect of direct benefit to individual
subject’s, but likely to yield generalizable knowledge
about the subject's disorder or condition (45
CFR 46 §406), if the IRB finds that
more than minimal risk to children is presented by an
intervention or procedure that does not hold out the
prospect of direct benefit for the individual subject,
or by a monitoring procedure which is not likely to
contribute to the well-being of the subject, approval
may be given only if the IRB finds that:
A. The risk represents a minor increase over
minimal risk, AND
B. The intervention or procedure presents
experiences to subjects that are reasonably commensurate with
those
inherent in their actual or
expected medical, dental, psychological, social, or
educational
situations, AND
C. The intervention or procedure is likely to
yield generalizable knowledge about the subjects'
disorder or condition
which is of
vital importance for the understanding or amelioration
of the
subjects' disorder or condition, AND
D. Adequate provisions are made for soliciting
assent of the children and permission of BOTH parents/
guardians.
4. Research not otherwise approvable which
presents an opportunity to understand, prevent, or
alleviate a serious problem affecting the health or
welfare of children (45
CFR 46 §407), if the IRB does not
believe the research meets the requirement of §404, §405 or §406, approval may be given if:
A.
The IRB finds that the research presents a reasonable
opportunity to further the understanding, prevention, or
alleviation
of a serious problem
affecting the health or welfare of children; and
B.
The Secretary of the Department of Health and Human
Services, after consultation with a panel of experts in
pertinent
disciplines (for example: science,
medicine, education, ethics, law) and following
opportunity for
public review
and
comment, has determined either:
1. That the research in fact satisfies the
conditions of §404, §405,
and/or §406 as
applicable, or
2. The following:
(i) The research presents a reasonable opportunity to
further the understanding, prevention, or alleviation of
a serious
problem affecting the health or welfare of
children;
(ii) The research will be conducted in accordance with
sound ethical principles;
(iii) Adequate provisions are made for soliciting the
assent of children and the permission of their parents or
guardians.
Back to Table of
Contents
8.3.1 Requirements for
Consent and Assent Involving Children
In addition to the determinations
required under other applicable sections of 45 CFR 46 Subpart D,
the IRB shall determine that adequate provisions are
made for soliciting the assent of the children, when in
the judgment of the IRB the children are capable of
providing assent. In determining whether children are
capable of assenting, the IRB shall take into account
the ages, maturity, and psychological state of the
children involved. This judgment may be made for all
children to be involved in research under a particular
protocol, or for each child, as the IRB deems
appropriate. If the IRB determines that the capability
of some or all of the children is so limited that they
cannot reasonably be consulted or that the intervention
or procedure involved in the research holds out a
prospect of direct benefit that is important to the
health or well-being of the children and is available
only in the context of the research, the assent of the
children is not a necessary condition for proceeding
with the research. Even where the IRB determines that
the subjects are capable of assenting, the IRB may still
waive the assent requirement under circumstances in
which consent may be waived in accordance with 45 CFR 46 §116(d):
1. The research involves no more than minimal risk
to the subjects, AND
2. The waiver or alteration will not adversely
affect the rights and welfare of the subjects, AND
3. The research could not practicably be carried out
without the waiver or alteration; AND
4. Whenever appropriate, the subjects will be
provided with additional pertinent information after
participation.
In addition to the minor’s assent,
researchers are also responsible for obtaining the
permission of the child’s parent or guardian as set
forth in the Code of Virginia, §32.1-162.18, 45 CFR 46 §116 and any additional elements the Radford University IRB
deems necessary. One parent’s signature is sufficient
for research that is minimal risk or greater than
minimal risk with prospect for direct benefit to the
participants (§8.3,
Radford IRB Manual, 45 CFR 46 §404- 405).
For research conducted under 45 CFR 46 §406 and §407,
consent is required from both parents/guardians
unless:
1. One parent is deceased, unknown, incompetent, or
not reasonably available OR
2. Only one parent/guardian has legal responsibility
for the care and custody of the child.
Parental consent must be documented
according toe 45 CFR 46 §117.
Minors who are wards of the state
as defined in §4.5.7 of
this document, require the addition of a participant
advocate to the IRB. One individual may act as an
advocate for more than one minor. The Radford
University IRB requires the advocate to disclose any
conflicts of interest. Only those persons without
conflicts of interest can be appointed as advocates.
Back to Table of
Contents
8.4 Inclusion of Adults
Who Lack Decision Making Capability
Special procedures for IRB review
and approval are necessary for research projects
involving incapacitated adults. The term incapacitated
refers to diminished or absent decision making
capabilities. Impaired capacity is not limited to
individuals with neurological, psychiatric, or under the
influence of a substance diagnoses. Conversely,
individuals with these problems should not be presumed
to be cognitively impaired.
Generally, cognitively impaired
potential or actual research subjects may not understand
the difference between research and treatment or the
dual role of the researcher. Therefore, when
appropriate, it is essential that the assent process
clearly indicate the differences between individualized
treatment (e.g., special education in the classroom
setting) and research. PIs may want to consider using
an independent expert to assess the participant’s
capacity to consent or assent. State of Virginia law
requires the presence of a legally authorized
representative and an adult witness during the
consent process of any adult that has been judged to
have a diminished decision making capability. The RU
IRB will only approve research involving adults that
cannot consent provided the following criteria are met:
1. The research question cannot be answered by using
adults able to consent, AND
2. The research is of minimal risk or more than
minimal risk with the prospect of direct benefit to each
individual participant, AND
3. The assent of the adult will be a requirement for
participation, unless the adult is incapable of
providing assent, AND
4. When assent is obtained, the PI will document the
assent by noting on the consent or assent form that the
subject assented to participate in the research
Back to Table of
Contents
8.5 Inclusion of Radford
University Staff and Students in Research
In addition to pregnant women,
children, prisoners and incapacitated adults, the RU IRB
considers students and staff a vulnerable population.
Students and staff are likely to be in subordinate or
collegial relationships with researchers that make it
difficult to consent freely, without undue influence, to
participate in research. Therefore, the RU IRB follows
special procedures designed to safeguard these
subjects. The IRB will approve research that includes
RU staff and students provided all of the following
conditions exist:
1.
The research must not bestow upon participating RU
subjects any competitive academic or occupational
advantage over other
RU students or staff who do not volunteer
2.
No penalty can be levied against any student or staff
member who do not volunteer, AND
3.
Any participating RU staff or students should not be
treated differently from other non-affiliated
study participants
Due to the potential for perceived
or real coercion to participate, RU students and staff
who desire to participate in the research must not be
under the direct supervision of the PI or listed as
research collaborators except as necessitated by
scientific merit or overwhelming benefit to subjects
unless approved by the IRB.
The RU IRB will review all studies
involving the participation of RU students and staff
(exempt, expedited and full board). The IRB may waive
any and/or all of the above conditions provided the
study demonstrates either of the following:
1. Overwhelming benefit to the subject, OR
2. Reasonable scientific merit
Back to Table of Contents
8.6 Student Subject Pools
Subject pools are undergraduate
students enrolled in particular departmental courses
encouraging participation in one or more research
projects. All student participation in subject pool
research must be completely voluntary. Reimbursement
for participation must not jeopardize the student’s
confidentiality or anonymity. Alternatives must be
provided for classes that require research
participation, and these alternatives should be of equal
time burden. It is up to the student to decide whether
to participate in a particular study; instructors cannot
require or mandate student participation. Instructors
are strongly discouraged from recruiting subjects they
directly supervise or selecting subjects on such basis.
Back to Table of
Contents
8.7 Elderly and Aged
Individuals
It is generally agreed that the
elderly are, as a group, heterogeneous and not usually
in need of special protections, except in two
circumstances: cognitive impairment and
institutionalization. Under those conditions, the same
considerations are applicable as with any other
nonelderly subject in the same circumstances. In the
past, persons in nursing homes or other institutions
have been selected as subjects because of their easy
accessibility. It is now recognized, however, that
conditions in institutional settings increase the
chances for coercion and undue influence because of the
lack of freedom inherent in such situations. Research in
these settings should therefore be avoided, unless the
involvement of the institutional population is necessary
to the conduct of the research.
Points to consider:
1. Does the proposed consent process provide
mechanisms for determining the adequacy of prospective
subjects' comprehension and recall?
2. How will subjects' capacity to consent be
determined?
3. Will the research take place in an institutional
setting? Has the possibility of coercion and undue
influence been sufficiently minimized?
Back to Table of
Contents
45 CFR 46
Code of Federal Regulations
TITLE 45
PUBLIC WELFARE
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
PART 46
PROTECTION OF HUMAN SUBJECTS
* * *
Revised June 23, 2005
Effective June 23, 2005
* * *
Subpart A -- |
Basic HHS Policy
for Protection of Human Research
Subjects
|
Sec. |
|
46.101 |
To what does this
policy apply? |
46.102 |
Definitions. |
46.103 |
Assuring compliance
with this policy--research conducted or
supported by any Federal Department or
Agency. |
46.104-
46.106 |
[Reserved] |
46.107 |
IRB membership. |
46.108 |
IRB functions and
operations. |
46.109 |
IRB review of
research. |
46.110 |
Expedited review
procedures for certain kinds of research
involving no more than minimal risk, and
for minor changes in approved research. |
46.111 |
Criteria for IRB
approval of research. |
46.112 |
Review by
institution. |
46.113 |
Suspension or
termination of IRB approval of research. |
46.114 |
Cooperative
research. |
46.115 |
IRB records. |
46.116 |
General
requirements for informed consent. |
46.117 |
Documentation of
informed consent. |
46.118 |
Applications and
proposals lacking definite plans for
involvement of human subjects. |
46.119 |
Research undertaken
without the intention of involving human
subjects. |
46.120 |
Evaluation and
disposition of applications and
proposals for research to be conducted
or supported by a Federal Department or
Agency. |
46.121 |
[Reserved] |
46.122 |
Use of Federal
funds. |
46.123 |
Early termination
of research support: Evaluation of
applications and proposals. |
46.124 |
Conditions. |
Subpart B -- |
Additional
Protections for Pregnant Women, Human
Fetuses and Neonates Involved in
Research |
Sec. |
|
46.201 |
To what do these
regulations apply? |
46.202 |
Definitions. |
46.203 |
Duties of IRBs in
connection with research involving
pregnant women, fetuses, and neonates. |
46.204 |
Research involving
pregnant women or fetuses. |
46.205 |
Research involving
neonates. |
46.206 |
Research involving,
after delivery, the placenta, the dead
fetus or fetal material. |
46.207 |
Research not
otherwise approvable which presents an
opportunity to understand, prevent, or
alleviate a serious problem affecting
the health or welfare of pregnant women,
fetuses, or neonates. |
Subpart C -- |
Additional
Protections Pertaining to Biomedical and
Behavioral Research Involving Prisoners
as Subjects |
Sec. |
|
46.301 |
Applicability. |
46.302 |
Purpose. |
46.303 |
Definitions. |
46.304 |
Composition of
Institutional Review Boards where
prisoners are involved. |
46.305 |
Additional duties
of the Institutional Review Boards where
prisoners are involved. |
46.306 |
Permitted research
involving prisoners. |
Subpart D -- |
Additional
Protections for Children Involved as
Subjects in Research |
Sec. |
|
46.401 |
To what do these
regulations apply? |
46.402 |
Definitions. |
46.403 |
IRB duties. |
46.404 |
Research not
involving greater than minimal risk. |
46.405 |
Research involving
greater than minimal risk but presenting
the prospect of direct benefit to the
individual subjects. |
46.406 |
Research involving
greater than minimal risk and no
prospect of direct benefit to individual
subjects, but likely to yield
generalizable knowledge about the
subject's disorder or condition. |
46.407 |
Research not
otherwise approvable which presents an
opportunity to understand, prevent, or
alleviate a serious problem affecting
the health or welfare of children. |
46.408 |
Requirements for
permission by parents or guardians and
for assent by children. |
46.409 |
Wards. |
Authority: 5 U.S.C. 301; 42
U.S.C. 289(a).
Editorial Note: The
Department of Health and Human Services issued a
notice of waiver regarding the requirements set
forth in part 46, relating to protection of
human subjects, as they pertain to demonstration
projects, approved under section 1115 of the
Social Security Act, which test the use of
cost--sharing, such as deductibles, copayment
and coinsurance, in the Medicaid program. For
further information see 47 FR 9208, Mar. 4,
1982.
Note: As revised, Subpart A
of the HHS regulations incorporates the Federal
Policy for the Protection of Human Subjects (56
FR 28003). Subpart D of the HHS regulations has
been amended at Section 46.401(b) to reference
the revised Subpart A.
The Federal Policy for the
Protection of Human Subjects is also codified at
7 CFR Part 1c |
Department of
Agriculture |
10 CFR Part 745 |
Department of
Energy |
14 CFR Part 1230 |
National
Aeronautics and Space Administration |
15 CFR Part 27 |
Department of
Commerce |
16 CFR Part 1028 |
Consumer Product
Safety Commission |
22 CFR Part 225 |
International
Development Cooperation Agency,Agency
for International Development |
24 CFR Part 60 |
Department of
Housing and Urban Development |
28 CFR Part 46 |
Department of
Justice |
32 CFR Part 219 |
Department of
Defense |
34 CFR Part 97 |
Department of
Education |
38 CFR Part 16 |
Department of
Veterans Affairs |
40 CFR Part 26 |
Environmental
Protection Agency |
45 CFR Part 690 |
National Science
Foundation |
49 CFR Part 11 |
Department of
Transportation |
* * *
Subpart A |
Basic HHS Policy
for Protection of Human Research
Subjects |
|
Authority: 5 U.S.C.
301; 42 U.S.C. 289(a); 42 U.S.C.
300v-1(b). |
|
Source: 56 FR
28003, June 18, 1991; 70 FR 36325, June
23, 2005. |
�46.101
To what does this policy apply?
(a) Except as provided in
paragraph (b) of this section, this policy
applies to all research involving human subjects
conducted, supported, or otherwise subject to
regulation by any federal department or agency
which takes appropriate administrative action to
make the policy applicable to such research.
This includes research conducted by federal
civilian employees or military personnel, except
that each department or agency head may adopt
such procedural modifications as may be
appropriate from an administrative standpoint.
It also includes research conducted, supported,
or otherwise subject to regulation by the
federal government outside the United States.
(1) Research that is
conducted or supported by a federal department
or agency, whether or not it is regulated as
defined in �46.102(e),
must comply with all sections of this policy.
(2) Research that is
neither conducted nor supported by a federal
department or agency but is subject to
regulation as defined in �46.102(e)
must be reviewed and approved, in compliance
with �46.101, �46.102,
and �46.107 through �46.117 of this policy, by an institutional review board
(IRB) that operates in accordance with the
pertinent requirements of this policy.
(b) Unless otherwise
required by department or agency heads, research
activities in which the only involvement of
human subjects will be in one or more of the
following categories are exempt from this
policy:
(1) Research conducted in
established or commonly accepted educational
settings, involving normal educational
practices, such as (i) research on regular and
special education instructional strategies, or
(ii) research on the effectiveness of or the
comparison among instructional techniques,
curricula, or classroom management methods.
(2) Research involving the
use of educational tests (cognitive, diagnostic,
aptitude, achievement), survey procedures,
interview procedures, or observation of public
behavior, unless:
(i) information obtained is recorded in such a
manner that human subjects can be identified,
directly or through identifiers linked to the
subjects; and (ii) any disclosure of the human
subjects' responses outside the research could
reasonably place the subjects at risk of
criminal or civil liability or be damaging to
the subjects' financial standing, employability,
or reputation.
(3) Research involving the
use of educational tests (cognitive, diagnostic,
aptitude, achievement), survey procedures,
interview procedures, or observation of public
behavior that is not exempt under paragraph
(b)(2) of this section, if:
(i) the human subjects are elected or appointed
public officials or candidates for public
office; or (ii) federal statute(s) require(s)
without exception that the confidentiality of
the personally identifiable information will be
maintained throughout the research and
thereafter.
(4) Research involving the
collection or study of existing data, documents,
records, pathological specimens, or diagnostic
specimens, if these sources are publicly
available or if the information is recorded by
the investigator in such a manner that subjects
cannot be identified, directly or through
identifiers linked to the subjects.
(5) Research and
demonstration projects which are conducted by or
subject to the approval of department or agency
heads, and which are designed to study,
evaluate, or otherwise examine:
(i) Public benefit or service programs; (ii)
procedures for obtaining benefits or services
under those programs; (iii) possible changes in
or alternatives to those programs or procedures;
or (iv) possible changes in methods or levels of
payment for benefits or services under those
programs.
(6) Taste and food quality
evaluation and consumer acceptance studies, (i)
if wholesome foods without additives are
consumed or (ii) if a food is consumed that
contains a food ingredient at or below the level
and for a use found to be safe, or agricultural
chemical or environmental contaminant at or
below the level found to be safe, by the Food
and Drug Administration or approved by the
Environmental Protection Agency or the Food
Safety and Inspection Service of the U.S.
Department of Agriculture.
(c) Department or agency
heads retain final judgment as to whether a
particular activity is covered by this policy.
(d) Department or agency
heads may require that specific research
activities or classes of research activities
conducted, supported, or otherwise subject to
regulation by the department or agency but not
otherwise covered by this policy, comply with
some or all of the requirements of this policy.
(e) Compliance with this
policy requires compliance with pertinent
federal laws or regulations which provide
additional protections for human subjects.
(f) This policy does not
affect any state or local laws or regulations
which may otherwise be applicable and which
provide additional protections for human
subjects.
(g) This policy does not
affect any foreign laws or regulations which may
otherwise be applicable and which provide
additional protections to human subjects of
research.
(h) When research covered
by this policy takes place in foreign countries,
procedures normally followed in the foreign
countries to protect human subjects may differ
from those set forth in this policy. [An example
is a foreign institution which complies with
guidelines consistent with the World Medical
Assembly Declaration (Declaration of Helsinki
amended 1989) issued either by sovereign states
or by an organization whose function for the
protection of human research subjects is
internationally recognized.] In these
circumstances, if a department or agency head
determines that the procedures prescribed by the
institution afford protections that are at least
equivalent to those provided in this policy, the
department or agency head may approve the
substitution of the foreign procedures in lieu
of the procedural requirements provided in this
policy. Except when otherwise required by
statute, Executive Order, or the department or
agency head, notices of these actions as they
occur will be published in the FEDERAL REGISTER
or will be otherwise published as provided in
department or agency procedures.
(i) Unless otherwise
required by law, department or agency heads may
waive the applicability of some or all of the
provisions of this policy to specific research
activities or classes or research activities
otherwise covered by this policy. Except when
otherwise required by statute or Executive
Order, the department or agency head shall
forward advance notices of these actions to the
Office for Human Research Protections,
Department of Health and Human Services (HHS),
or any successor office, and shall also publish
them in the FEDERAL REGISTER or in such other
manner as provided in Department or Agency
procedures.1
1 Institutions
with HHS-approved assurances on file will abide
by provisions of Title 45 CFR part 46 subparts
A-D. Some of the other departments and agencies
have incorporated all provisions of Title 45 CFR
Part 46 into their policies and procedures as
well. However, the exemptions at 45 CFR
46.101(b) do not apply to research involving
prisoners, subpart C. The exemption at 45 CFR
46.101(b)(2), for research involving survey or
interview procedures or observation of public
behavior, does not apply to research with
children, subpart D, except for research
involving observations of public behavior when
the investigator(s) do not participate in the
activities being observed.
[56 FR 38012, 28022, June
18, 1991; 56 FR 29756, June 28, 1991; 70 FR
36325, June 23, 2005]
�46.102
Definitions.
(a) Department or agency
head means the head of any federal
department or agency and any other officer or
employee of any department or agency to whom
authority has been delegated.
(b) Institution means any public or private entity or agency
(including federal, state, and other agencies).
(c) Legally authorized
representative means an individual or
judicial or other body authorized under
applicable law to consent on behalf of a
prospective subject to the subject's
participation in the procedure(s) involved in
the research.
(d) Research means a
systematic investigation, including research
development, testing and evaluation, designed to
develop or contribute to generalizable
knowledge. Activities which meet this definition
constitute research for purposes of this policy,
whether or not they are conducted or supported
under a program which is considered research for
other purposes. For example, some demonstration
and service programs may include research
activities.
(e) Research subject to
regulation, and similar terms are intended
to encompass those research activities for which
a federal department or agency has specific
responsibility for regulating as a research
activity, (for example, Investigational New Drug
requirements administered by the Food and Drug
Administration). It does not include research
activities which are incidentally regulated by a
federal department or agency solely as part of
the department's or agency's broader
responsibility to regulate certain types of
activities whether research or non-research in
nature (for example, Wage and Hour requirements
administered by the Department of Labor).
(f) Human subject means a living individual about whom an
investigator (whether professional or student)
conducting research obtains
(1) Data through
intervention or interaction with the individual,
or
(2) Identifiable private information.
Intervention includes both physical procedures by which data
are gathered (for example, venipuncture) and
manipulations of the subject or the subject's
environment that are performed for research
purposes. Interaction includes communication or
interpersonal contact between investigator and
subject. Private information includes
information about behavior that occurs in a
context in which an individual can reasonably
expect that no observation or recording is
taking place, and information which has been
provided for specific purposes by an individual
and which the individual can reasonably expect
will not be made public (for example, a medical
record). Private information must be
individually identifiable (i.e., the identity of
the subject is or may readily be ascertained by
the investigator or associated with the
information) in order for obtaining the
information to constitute research involving
human subjects.
(g) IRB means an
institutional review board established in accord
with and for the purposes expressed in this
policy.
(h) IRB approval means the determination of the IRB that the
research has been reviewed and may be conducted
at an institution within the constraints set
forth by the IRB and by other institutional and
federal requirements.
(i) Minimal risk means that the probability and magnitude of harm
or discomfort anticipated in the research are
not greater in and of themselves than those
ordinarily encountered in daily life or during
the performance of routine physical or
psychological examinations or tests.
(j) Certification means the official notification by the
institution to the supporting department or
agency, in accordance with the requirements of
this policy, that a research project or activity
involving human subjects has been reviewed and
approved by an IRB in accordance with an
approved assurance.
�46.103
Assuring compliance with this policy -- research
conducted or supported by any Federal Department
or Agency.
(a) Each institution
engaged in research which is covered by this
policy and which is conducted or supported by a
federal department or agency shall provide
written assurance satisfactory to the department
or agency head that it will comply with the
requirements set forth in this policy. In lieu
of requiring submission of an assurance,
individual department or agency heads shall
accept the existence of a current assurance,
appropriate for the research in question, on
file with the Office for Human Research
Protections, HHS, or any successor office, and
approved for federalwide use by that office.
When the existence of an HHS-approved assurance
is accepted in lieu of requiring submission of
an assurance, reports (except certification)
required by this policy to be made to department
and agency heads shall also be made to the
Office for Human Research Protections, HHS, or
any successor office.
(b) Departments and
agencies will conduct or support research
covered by this policy only if the institution
has an assurance approved as provided in this
section, and only if the institution has
certified to the department or agency head that
the research has been reviewed and approved by
an IRB provided for in the assurance, and will
be subject to continuing review by the IRB.
Assurances applicable to federally supported or
conducted research shall at a minimum include:
(1) A statement of
principles governing the institution in the
discharge of its responsibilities for protecting
the rights and welfare of human subjects of
research conducted at or sponsored by the
institution, regardless of whether the research
is subject to Federal regulation. This may
include an appropriate existing code,
declaration, or statement of ethical principles,
or a statement formulated by the institution
itself. This requirement does not preempt
provisions of this policy applicable to
department- or agency-supported or regulated
research and need not be applicable to any
research exempted or waived under �46.101 (b) or (i).
(2) Designation of one or
more IRBs established in accordance with the
requirements of this policy, and for which
provisions are made for meeting space and
sufficient staff to support the IRB's review and
recordkeeping duties.
(3) A list of IRB members
identified by name; earned degrees;
representative capacity; indications of
experience such as board certifications,
licenses, etc., sufficient to describe each
member's chief anticipated contributions to IRB
deliberations; and any employment or other
relationship between each member and the
institution; for example: full-time employee,
part-time employee, member of governing panel or
board, stockholder, paid or unpaid consultant.
Changes in IRB membership shall be reported to
the department or agency head, unless in accord
with �46.103(a) of this policy, the existence
of an HHS-approved assurance is accepted. In
this case, change in IRB membership shall be
reported to the Office for Human Research
Protections, HHS, or any successor office.
(4) Written procedures
which the IRB will follow (i) for conducting its
initial and continuing review of research and
for reporting its findings and actions to the
investigator and the institution; (ii) for
determining which projects require review more
often than annually and which projects need
verification from sources other than the
investigators that no material changes have
occurred since previous IRB review; and (iii)
for ensuring prompt reporting to the IRB of
proposed changes in a research activity, and for
ensuring that such changes in approved research,
during the period for which IRB approval has
already been given, may not be initiated without
IRB review and approval except when necessary to
eliminate apparent immediate hazards to the
subject.
(5) Written procedures for
ensuring prompt reporting to the IRB,
appropriate institutional officials, and the
department or agency head of (i) any
unanticipated problems involving risks to
subjects or others or any serious or continuing
noncompliance with this policy or the
requirements or determinations of the IRB; and
(ii) any suspension or termination of IRB
approval.
(c) The assurance shall be
executed by an individual authorized to act for
the institution and to assume on behalf of the
institution the obligations imposed by this
policy and shall be filed in such form and
manner as the department or agency head
prescribes.
(d) The Department or
Agency head will evaluate all assurances
submitted in accordance with this policy through
such officers and employees of the department or
agency and such experts or consultants engaged
for this purpose as the department or agency
head determines to be appropriate. The
department or agency head's evaluation will take
into consideration the adequacy of the proposed
IRB in light of the anticipated scope of the
institution's research activities and the types
of subject populations likely to be involved,
the appropriateness of the proposed initial and
continuing review procedures in light of the
probable risks, and the size and complexity of
the institution.
(e) On the basis of this
evaluation, the department or agency head may
approve or disapprove the assurance, or enter
into negotiations to develop an approvable one.
The department or agency head may limit the
period during which any particular approved
assurance or class of approved assurances shall
remain effective or otherwise condition or
restrict approval.
(f) Certification is
required when the research is supported by a
federal department or agency and not otherwise
exempted or waived under �46.101 (b) or (i). An institution with an approved
assurance shall certify that each application or
proposal for research covered by the assurance
and by �46.103 of this Policy has been reviewed and approved by
the IRB. Such certification must be submitted
with the application or proposal or by such
later date as may be prescribed by the
department or agency to which the application or
proposal is submitted. Under no condition shall
research covered by �46.103 of the Policy be supported prior to receipt of
the certification that the research has been
reviewed and approved by the IRB. Institutions
without an approved assurance covering the
research shall certify within 30 days after
receipt of a request for such a certification
from the department or agency, that the
application or proposal has been approved by the
IRB. If the certification is not submitted
within these time limits, the application or
proposal may be returned to the institution.
(Approved by the Office of Management and Budget
under control number 0990-0260.)
[56 FR 38012, 28022, June
18, 1991; 56 FR 29756, June 28, 1991; 70 FR
36325, June 23, 2005]
��46.104--46.106
[Reserved]
| | 