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

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

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

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

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

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

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

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

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

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

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) Developed by: U-MIC

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

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

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