2. 1 Developed by: U-MIC To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you press enter.

3. IRB MEMBERSHIP REQUIREMENTS AND QUORUM Developed by: U-MIC University of Michigan IRB Collaborative

4. IRB membership requirements and quorum requirements for IRB membership approval of research at convened IRB meetings federal regulations  HHS  FDA Human Research Protection Program (HRPP)  Operations Manual 3 Developed by: U-MIC

5. IRB membership requirements and quorum IRB membership requirements  at least five members  varying backgrounds  must be qualified through  expertise  diversity 4 Developed by: U-MIC

6. IRB membership requirements and quorum IRB membership requirements  IRB must determine acceptability of research in terms of  institutional commitments and policies  applicable laws and regulations  standards of professional conduct and practice 5 Developed by: U-MIC

7. IRB membership requirements and quorum IRB membership requirements  at least one scientist member  at least one nonscientist member OHRP: “…members whose training, background, and occupation would incline them to view scientific activities from the standpoint of someone within a behavioral or biomedical research discipline should be considered a scientist, while members whose training, background, and occupation would incline them to view research activities from a standpoint outside of any biomedical or behavioral scientific discipline should be considered a nonscientist. In addition, the IRB must have members with sufficient knowledge of the specific scientific discipline(s) relevant to the research that it reviews.” 6 Developed by: U-MIC

8. IRB membership requirements and quorum IRB membership requirements  FDA-regulated research  at least one physician 7 Developed by: U-MIC

9. IRB membership requirements and quorum IRB membership requirements  research involving vulnerable subjects  children  prisoners  pregnant women  handicapped or mentally disabled persons  consider including member(s)  knowledgeable about population  experienced in working with population 8 Developed by: U-MIC

10. IRB membership requirements and quorum IRB membership requirements  Ensure that no IRB consists solely of men or solely of women.  No selections may be made solely on the basis of gender. No IRB may consist entirely of members of one profession. 9 Developed by: U-MIC

11. IRB membership requirements and quorum IRB membership requirements  at least one member not affiliated with institution  not part of the immediate family of an affiliated person OHRP considers the following affiliated: o part-time employees o current students o members of any governing panel or board of the University o paid and unpaid consultants of the University o healthcare providers with medical staff membership or other credentials to practice at University clinical sites o volunteers working at the University on business unrelated to the University 10 Developed by: U-MIC

12. IRB membership requirements and quorum quorum  minimum number of voters required for valid IRB vote majority of voting members if regular voter is not present, an alternate with comparable qualifications Example: 14 members total 8 11 Developed by: U-MIC

13. IRB membership requirements and quorum quorum  minimum number of voters required for valid IRB vote majority of voting members if regular voter is not present, an alternate with comparable qualifications Example: 14 members total 8 = (14 ÷ 2) + 1 12 Developed by: U-MIC

14. IRB membership requirements and quorum quorum  All required members must be present.  e.g., at least one nonscientist  recorded in minutes  no vote until  all required members are present  quorum is met 13 Developed by: U-MIC

15. IRB membership requirements and quorum 14 Developed by: U-MIC IRB membership requirements and quorum

16. THANK YOU. Brian Seabolt IRBMED 15 Developed by: U-MIC