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What is Human Subjects Research?
It can be very difficult to determine what constitutes human
subjects research. Unfortunately, there is no clear line in the
sand. The Common Rule offers the following definitions as guidance
for determining human subjects research. The definitions are
intentionally broad to include a wide range of research in hopes of
capturing both the biomedical and humanities spectrums. These
definitions are the starting point for anyone attempting to
determine whether their research requires IRB review.
The first question to ask is if your project
involves human subjects:
Human Subject
means a living individual about whom the investigator conducting
research obtains (a) data through intervention or interaction with
the individual or (b) identifiable private information (45
CFR 46.102f). 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.
The second question is if your project is actually
research as defined by the Common Rule:
Research means a
systematic investigation, including research development, testing
and evaluation, designed to develop or contribute to
generalizable knowledge. Activities meeting 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 (45 CFR 46.102d).
For more information see the
Office for Human Research Protections.
If the answer to both questions is YES, then
you need to submit your research protocol to the IRB Office. Otherwise, you need to
ask these questions:
- Does the activity involve the use of a drug (including an
approved drug or an over-the-counter drug), other than the use
of an approved drug in the course of medical practice?
- Does the activity involve the use of a medical device
(including an approved medical device), other than the use of an
approved medical device in the course of medical practice? (Note
that medical devices generally include devices intended for the
use in the diagnosis of disease or other conditions, or in the
cure, mitigation, treatment, or prevention of disease, in humans
or other animals, and devices intended to affect the structure
or any function of the body of humans or other animals.
- Will data be submitted to the FDA or held for their
inspection?
If the answer to one of the above questions is "YES," then you
will need IRB review before proceeding with your research.
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