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Published by the Institutional Review Board (IRB) at North Georgia College & State University
February, 2001
The Institutional Review Board (IRB) at North Georgia College & State University is responsible for reviewing and approving all research involving human participants, including faculty and staff projects, theses, and all student projects. The main function of IRB is to ensure, to the best of its ability, that all research with human participants is conducted in accordance with certain ethical principles. The three major concerns of the IRB are: (1) whether legally informed consent is obtained from research participants; (2) whether the benefits of the research outweigh the risks to the participant; and (3) whether the participants are deceived.
To obtain information relevant to these concerns, the IRB asks that those wishing to use human research participants complete an application form for each study they intend to perform (this form is titled "Application for Approval of Research with Human Research Participants" and is available on this site and from IRB committee members). Since the review process typically requires the review of the full IRB committee, you should allow two to three weeks for approval of projects that do not raise major ethical concerns. If serious ethical concerns are involved, the process may take longer. After your research is approved, it is your responsibility to report immediately to the IRB any significant changes or unanticipated problems in your project, including but not limited to the addition of other treatment groups, or the introduction of new instruments or materials into the project.
What Must Be Reviewed?
Most research involving human participants at NGCSU will require a full IRB review, but there are two categories of exceptions.
First, some research is exempt from review (see Appendix A). If you believe your research qualifies as exempt, please identify the basis for your exemption, but you should still complete the application if you want IRB to endorse your exemption. The IRB would need to know something about the study in order to assess whether or not the exemption applied, and if it does not, the complete application will be needed anyway. If you believe you qualify for exemption, submit your application directly to the IRB chairperson.
Second, some research qualifies for expedited review (see Appendix B). Again, the best strategy is to submit a completed application, noting the basis for expedited review. Expedited reviews will be carried out either by the IRB chairperson or by one or more experienced reviewers designated by the chairperson. If you believe you qualify for an expedited review, submit your application directly to the IRB chairperson. If you do not qualify for an exemption or an expedited review, you should complete the entire application and submit it to the chairperson or one of the other IRB members.
What Do I Need to Report on the Application?
We need to know who you are and how to reach you, what question(s) your proposed research intends to answer, what risks are possible for participants, what is being done to minimize those risks, and what benefits participants will receive. We will need for you to submit a copy of the consent form(s) you will be using in the study. Please follow the general format in the IRB sample consent form.
What Does it Take to Get Approval?
In reviewing applications, the IRB seeks to determine that: (a) risks to participants are minimized; (b) risks to participants are reasonable in relation to expected benefits, if any, to the participants, and the importance of the knowledge that may be reasonably expected to result; (c) selection of participants is equitable, meaning that vulnerable populations are not being used unnecessarily; (d) informed consent will be sought from each prospective participant or the participant's legally authorized representative; (e) informed consent will be appropriately documented, and (f) when appropriate, the research plan makes adequate provision to protect the privacy of participants and to maintain confidentiality of data.
The IRB meets approximately every three weeks. To have a proposal reviewed at a given meeting, your materials should be received at least four business days prior to the meeting date. Meeting dates for the current term are available by clicking here. You will receive both written and e-mail notification of the IRB's decision within a few days of the meeting.
For more information on Human Subjects Research Guidelines, see the 1993 IRB Guidebook on the National Institutes of Health web site.
The IRB is guided by the Federal Code of Regulations, Title 45, Part 46 (Protection of Human Subjects), which is available online.
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