Office of the Institutional Review Board

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Overview

The Office of the Institutional Review Board’s (IRB) mission is to ensure that Shaw University complies with all federal and university mandated criteria for human subjects’ protection and to ensure that the rights, welfare, and safety of volunteer participants are protected at all times.

The role of the IRB is to:

Review all study requests (internal and external).
Approve, disapprove, or ask for modifications to planned research.
Continue to review protocols for the duration of each study.
Terminate any research activities that are in violation of University or Federal regulations.

IRB review and approval is required prior to initiating any research involving human participants. Research participants will not be exposed to unreasonable risks and will be ensured that a properly informed consent process has occurred.

Research is defined by the Department of Health and Human Services as a “systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge” (45 CFR 46.102(d)). Link for citation: https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46/subpart-A/section-46.102
Per Federal regulations (45 CFR 46.102(f)), a human subject is defined as 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. Link for citation: https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46/subpart-A/section-46.102

IRB Review Process

All investigators who wish to submit an application to the IRB must familiarize themselves with the policy and procedure manual prior to submission.

If you are collaborating with another institution, email the IRB office for additional information prior to initiating the application process.

All research involving human subjects must be submitted to the IRB for review prior to initiation. In order to determine if your proposed work must be submitted for review please read the following:

The federal definition of research is “a systematic investigation including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”
A systematic investigation usually attempts to answer a question or attempts to prove or disprove a hypothesis.
The statement applies to sharing the information/data/results that you obtain in your investigation with others in the classroom setting, at a poster presentation, in a publication, or at a conference. If you are unsure about your plans to share your results at a time in the future you should submit an IRB application for review.

Review Timeline

The IRB meets on the first Thursday of each month, with some exceptions for holidays. IRB applications that require full IRB review should be submitted by the 15th of the prior month for review at the next IRB meeting.

Please note that the IRB office accepts applications throughout the month. If you suspect that your application may be exempt from review or requires expedited review, please submit the application at any time during the month.

Required Training

The program provides training for IRB and other required compliance topics. Contact IRB@shawu.edu to register for training.
Office for Human Research Protections, and

U.S. National Institutes of Health , and

Human Participant Protections Education for Research Teams
Attendance at a seminar where the main purpose is to discuss the responsible conduct of research involving human subjects.

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Office of the Institutional Review Board

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Overview

IRB Review Process

Review Timeline

Required Training

Resources

Shaw University Researchers

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