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IRB MEMBERSHIP REQUIREMENTS AND QUORUMDeveloped by:U-MICUniversity of Michigan IRB Collaborative

IRB membership requirements and quorum

requirements forIRB membershipapproval of research at convened IRB meetings

federal regulationsHHSFDAHuman Research Protection Program (HRPP)Operations Manual3Developed by:U-MICIRB membership requirements and quorum

IRB membership requirements

at least five membersvarying backgroundsmust be qualified throughexpertisediversity4Developed by:U-MICIRB membership requirements and quorum

IRB membership requirements

IRB must determine acceptability of research in terms ofinstitutional commitments and policiesapplicable laws and regulationsstandards of professional conduct and practice5Developed by:U-MICIRB membership requirements and quorum

IRB membership requirements

at least one scientist memberat 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.

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IRB membership requirements

FDA-regulated researchat least one physician7Developed by:U-MICIRB membership requirements and quorum

IRB membership requirements

research involving vulnerable subjectschildrenprisonerspregnant womenhandicapped or mentally disabled personsconsider including member(s)knowledgeable about populationexperienced in working with population8Developed by:U-MICIRB 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.9Developed by:U-MICIRB membership requirements and quorum

IRB membership requirements

at least one member not affiliated with institutionnot part of the immediate family of an affiliated person

OHRP considers the following affiliated:part-time employeescurrent studentsmembers of any governing panel or board of the Universitypaid and unpaid consultants of the Universityhealthcare providers with medical staff membership or other credentials to practice at University clinical sitesvolunteers working at the University on business unrelated to the University10Developed by:U-MICIRB membership requirements and quorum

quorum

minimum number of voters required for valid IRB votemajority of voting membersif regular voter is not present, an alternate with comparable qualifications

Example:14 members total811Developed by:U-MICIRB membership requirements and quorum

quorum

minimum number of voters required for valid IRB votemajority of voting membersif regular voter is not present, an alternate with comparable qualifications

Example:14 members total8 = (14 2) + 112Developed by:U-MICIRB membership requirements and quorum

quorum

All required members must be present.e.g., at least one nonscientistrecorded in minutesno vote untilall required members are presentquorum is met13Developed by:U-MICIRB membership requirements and quorum

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thank you.Brian SeaboltIRBMED15Developed by:U-MICOther284075.4