Most frequently asked questions regarding the review process of human subjects protocol applications.
1. What is the Human Subjects Institutional Review Board (IRB)?
The IRB is a diverse group of scientific and non-scientific individuals who conduct the initial and ongoing review of research studies in order to ensure the protection of the rights, safety and well-being of human subjects participating in those studies. The membership of the IRB at Davidson College changes from year to year, but most years, the committee is composed of ten members: five faculty, two staff, two students and one member of the community who is not an employee of the college. All members are administrative appointments. The Federal Code of Regulations (Title 45 Part 46: Protection of Human Subjects) governs the composition and conduct of the IRB.
2. How often does the IRB conduct committee meetings?
The IRB meets monthly during the academic year (September through May) and as needed during the summer months of June, July and August. Other meetings may be called at the discretion of the chair.
3. Who reviews my application after it is submitted to the IRB?
It depends on the type of review you are requesting. If you are requesting exemption from further IRB review, in most (but not necessarily all) cases only the chair or vice chair will review your application and protocol. For most other applications, however, the chair and two other selected members of the committee will carry out the review. In the case of an application requiring full board review, the entire committee reviews the protocol application and makes a decision at its monthly meeting.
4. What if the chair or vice chair of the IRB is also my faculty sponsor? Would this person also review and approve my application?
No. In such a case the vice chair (in the instance of the chair being the sponsor) or the chair (in the instance of the vice chair being the sponsor) of the IRB would oversee the review process.
5. What if there is a disagreement among the three individuals who have reviewed a non-exempt protocol?
In most cases any such disagreements are quickly and informally resolved by discussion. The chair may contact the investigator (as well as the faculty sponsor, in the case of astudent protocol) to resolve any questions and ambiguities. On rare occasions, however, agreement may not be reached, and in such a case the chair will place the protocol on the agenda of the next scheduled IRB meeting for discussion and decision by the Full Board.
6. What is the average turn-around time for a protocol to be reviewed?
The review of a protocol application typically takes a week to ten days. If revisions are required, the process may require more time. On rare occasions, the entire membership of the IRB may need to discuss a protocol at its monthly meeting before making a final decision.
7. What are the most common reasons a protocol must be revised?
Missing or incomplete information is the most common reason, so please make certain that you have answered every required question thoroughly and have provided enough information about your project so that your protocol will make sense to someone else who is reading about your project for the first time.
Another common problem is that the consent form does not clearly describe the research project, the risks to the participants, or the rights of the participants to refuse to participate or withdraw from the study. Similarly, the consent form may have errors in syntax and style, may be written in unclear language, may use an inconsistent point-of-view, or may be written at a level that is not appropriate for the age and educational level of the participants. Consulting the consent and assent form templates will help you avoid these problems.
8. If I make any changes in my protocol does the IRB have to review and approve it again?
Yes. Any changes to your protocol must be reviewed and approved by the IRB prior to the implementation of those changes. In many cases this can be done quickly. Please contact the IRB Chair (Dr. Meghan Griffith, 704-894-2403) or Vice Chair (Ms. Sharon Byrd, 704-894-2158) regarding any changes made to your protocol.
9. Do I need IRB approval if my work will be conducted outside of Davidson's campus?
Yes. To ensure that researchers comply with federal and College regulations it is important that the College, through the IRB, approve of all research conducted by any investigator working as an agent of the College (even if it is in a foreign country).
10. Can I begin my research before I receive IRB approval?
No. The IRB cannot approve a protocol submitted after the research is initiated, nor can the IRB sanction any human subjects data collected prior to approval.
11. What happens if I conduct human subject research without IRB approval?
You will be out of compliance with Federal requirements for human subject research. This can result in Federal or College actions that will prevent you from conducting human subject research and will jeopardize the Davidson College human research certification.