IRB members are selected to ensure a diverse set of perspectives and expertise appropriate to the many kinds of research under review. Our IRB members are physicians, researchers, clinicians, nurses, pharmacists, physical therapists (among other members of the medical community), engineers, lawyers, non-scientists and community members all contributing their knowledge, viewpoints, and hard work.
As an IRB member you are required to read the DUHS IRB Member Manual. A few key sections of the manual have been reproduced below. Please refer to your Member Manual for instruction on how to prepare and present a protocol review at an IRB meeting. The Member Manual also contains general information on the organization, purpose and function of the IRB.
Required Training for IRB Members
All DUHS IRB members are required to complete the following training:
- Complete the required ethics credentialing (CITI modules)
- Observe two IRB meetings
- Meet in person for an hour's orientation session, before your first & second IRB meetings
- Read the DUHS IRB Member Manual
Ethics Credentialing (CITI Modules) For IRB Members
All IRB Members must complete the same ethics training required of Duke researchers, which is a set of online CITI modules.
Additionally, IRB Members and staff are required to complete the 3 CITI modules as named below on the CITI website:
Vulnerable Subjects - Research Involving Prisoners
Vulnerable Subjects - Research Involving Children
Vulnerable Subjects - Research Involving Pregnant Women, Human Fetuses, and Neonates
These must be completed before you can be granted access to iRIS as an IRB member.
IRB Primary Reviewer Checklists
For your convenience, we have attached the IRB Primary Reviewer Checklists below. However, please note these reviewer checklists are now embedded into iRIS and should be filled out in this electronic system.
- IRB Primary Reviewer Checklist-Amendment
- IRB Primary Reviewer Checklist-Continuing Review
- IRB Primary Reviewer Checklist-New Protocol
- IRB Primary Reviewer Checklist-UPIRTSO
Tools Available to IRB Members
This website contains:
Housekeeping Notes for IRB Members
1. Communicate with your IRB Chair prior to the IRB meeting if you find that a protocol has significant problems that could cause the protocol to be deferred at the IRB meeting.
2. Communicate with the PI and study team prior to the IRB meeting to answer questions you have about the study, clarify issues, ask about study enrollment and progress, or ask for documentation you may be missing.
3. Complete your review in iRIS by 1:00 PM on the day of the IRB meeting.
4. If you find you cannot attend a meeting, please find a replacement from your Department (another IRB Member) to attend the meeting in your place. Notify the IRB Board Specialist for your meeting immediately, so protocol assignments can be sent to another reviewer. NOTE: If no one from your department attends the IRB meeting, then all protocols from your department may have to be pulled from the agenda. Federal Regulations require the appropriate expertise present at the meeting in order to review the items on the agenda.
5. Lunch: Please tell your Board Specialist if you have special dietary needs.
6. The Board Specialist maintains quorum in the room and records the vote count for each vote. If you have to leave an IRB meeting temporarily to respond to a page, make a phone call, or visit the restroom, please catch the eye of the Board Specialist so she/he knows you are leaving.
7. Tell your Board Specialist if you have to leave an IRB meeting early, or if you have to arrive late.
8. Visitors: Visitors are welcome at our IRB meetings. If you would like to bring a visitor with you to observe the meeting, please tell the Board Specialist as soon as possible, so that she/he can make appropriate arrangements for a visitor. All visitors must sign a confidentiality agreement prior to the start of the IRB meeting.
9. If you can’t find something in iRIS, or need help navigating through iRIS, call your Board Specialist.
10. Parking: The IRB will supply you with a Hock Plaza parking permit only if you are unable to attend the IRB meeting any other way. There are only a few parking places designated for the IRB in Hock Plaza. The board specialist will ask when sending you the meeting agenda if you need a parking permit. If you do, a parking pass will be emailed to you to print and use. These passes are only good for one meeting and for the day stipulated. Wave the barcode that is in the upper right corner near the red light to ENTER and EXIT the gates. Please place the pass on the dashboard of your vehicle while parked.