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1.    To determine if you need IRB review of your research, you must first answer these questions:

            Does it involve human subjects and is it research?

2.    If you have answered YES to both questions, you will need IRB review of your research.  The IRB review process has been streamlined to better facilitate faculty submission of research protocols.  However, there are a couple of important items:

            A.    All faculty submitting research protocols, both individual and course related,  must ensure that all personnel involved with the study design, data collection, or analysis have completed RU Human Subjects Training.

To complete the RU Human Subjects Training, go to http://phrp.nihtraining.com/users/login.php

                 B.    Adjunct Faculty must be sponsored by the appropriate Department Chair before any protocols   will be reviewed by the RU IRB.

3.    Determine what you need to submit and when you need to submit.  Be sure to submit the proper forms and documents to ensure timely review of your IRB submission.  Research protocols are reviewed on a first- come, first-served basis.

4.    If your research protocol is approved, then you are ready to conduct research involving human subjects research!  However, remember that you must get proper consent (documented unless waived by the IRB) and abide by the RU IRB policies.  Below are the RU IRB's requirements of investigators:

Investigators play a crucial role in protecting the rights and welfare of human subjects and are responsible for carrying out sound ethical research consistent with research plans approved by an IRB. Along with meeting the specific requirements of a particular research study, investigators are responsible for ongoing requirements in the conduct of approved research that include, in summary:

• obtaining and documenting informed consent of subjects or subjects’ legally authorized representatives prior to the subjects’ participation in the research, unless these requirements have been waived by the IRB (45 CFR 46.116; 45 CFR 46.117);
• obtaining prior approval from the IRB for any modifications of the previously approved research, including modifications to the informed consent process and document, except those necessary to eliminate apparent immediate hazards to subjects (45 CFR 46.103(b)(4)) ; and
• ensuring that progress reports and requests for continuing review and approval are submitted to the IRB in accordance with the policies, procedures, and actions of the IRB as referenced in the institution’s OHRP-approved Federalwide Assurance (45 CFR 46.103(b)(4), 45 CFR 46.109(e), 45 CFR 46.115(a)(1)) .

In addition, investigators at Radford University are also responsible for meeting the following requirements:

• providing to the IRB prompt reports of any unanticipated problems involving risks to subjects or others (45 CFR 46.103(b)(5);
• providing to the IRB prompt reports of serious or continuing noncompliance with the regulations or the requirements or determinations of the IRB (45 CFR 46.103(b)(5)); and
• keeping consent documents for at least three years after completion of the study (45 CFR 46.115(b)).

Important:  Any informed consent documents, except for those under the EXEMPT review, must have an RU IRB approval stamp.  You must give a copy of the consent form with the stamp visible to study participants.  Failure to do so is a violation of IRB policies and procedures.

5.    Your IRB protocol is approved for a maximum of 1 year.  If you wish to continue the approved research, or if you are conducting initial data analysis, you must submit a Request for Continuation to the IRB Administrator no later than 10 days before your protocol expires.  If your protocol expires, you must cease all research with human subjects until further approval is conferred by the RU IRB.

6.    If you have concluded all research under your IRB protocol, or if you have surpassed the 1-year time limit and do not wish to continue the study, you must submit a Study Closure Report to the IRB Administrator.

7.    Failure to follow the RU IRB Policies and Procedures can result in suspension of your research, suspension of future IRB privileges, termination of your research at Radford University, and/or suspension of research funding.

8.    If you have any questions about the IRB, please contact the RU IRB Administrator at 831- 5290 or irb-iacuc@radford.edu