Review Process
How do I know if my project needs IRB review?
Bentley University relies on OHRP Guidance OHRP Chart 1: Is An Activity Research Involving Human Subjects Covered by 45 CFR46 to determine when an IRB review is required. Once you consult the OHRP Chart and determine that project meets the definition of research and qualifies for research with human subjects, your project will fall into one of three categories of IRB review: exempt, expedited or full board (more than minimal risk). The determination of level of IRB review required is made by the IRB Chair.
If you have any questions about making a valid human research determination or which level of review your project qualifies for, please contact Susan Richman, IRB Chair at srichman@bentley.edu. Kindly note that you must submit the funding proposal for all federally sponsored research with your protocol application.
Exemption Review
Some research may be eligible for an exemption from IRB review according to the rules stated in
45 CFR 46.101(b) and for FDA governed research in 21 CFR 50 and 56. Only IRB administration can exempt research from review, not the investigator.
Only minimal risk research qualifies for exemption from IRB review. Research that is officially exempted from IRB review requires no further interaction with the IRB unless the PI would like to change study procedures or adverse events occur.
What is required for exempt review?
- Complete the IRB application, marking the “exempt” category.
- Submit the application and any supporting documents (informed consent, surveys, recruitment materials, instruments, site permission letters, IRB approvals from other institutions, etc.) via email to the IRB Chair, Susan Richman, at srichman@bentley.edu.
- Complete the Collaborative Institutional Training Initiative (CITI) training course on human research subjects protection and submit your certificate of completion with your application.
- All research staff interacting with data must also complete the training and submit certificates.
Expedited Review
All research studies submitted for IRB review are screened for the level of IRB review required. Minimal risk research that includes procedures outlined in the Expedited Categories, will be reviewed by one or two IRB members.
What is required for expedited review?
- Complete the IRB application, marking the “expedited” category.
- Submit the application and any supporting documents (informed consent, surveys, recruitment materials, instruments, site permission letters, IRB approvals from other institutions, etc.) via email to the IRB Chair, Susan Richman, at srichman@bentley.edu.
- Complete the Collaborative Institutional Training Initiative (CITI) training course on human research subjects protection and submit your certificate of completion with your application.
- All research staff interacting with data must also complete the training and submit certificates.
Full Committee Review
Any research activities that pose greater than minimal risk to participants must be reviewed at a convened IRB meeting. These reviews are referred to as Full Board reviews. In some cases, these studies require additional procedures to reduce risk. If you are planning a research study that may be of greater than minimal risk, you may contact the IRB Chair for guidance.
Full board materials should be submitted to the IRB Chair. You should follow the procedures required for an expedited review. Once your IRB application has been submitted, you will work closely with the IRB on the next steps. No research may begin until final IRB approval has been granted.