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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 . IRB MEMBERSHIP REQUIREMENTS AND QUORUM. IRB membership requirements and quorum. requirements for IRB membership
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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. Developed by: U-MIC
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 Developed by: U-MIC
IRB membership requirements and quorum IRB membership requirements • at least five members • varying backgrounds • must be qualified through • expertise • diversity 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 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.” Developed by: U-MIC
IRB membership requirements and quorum IRB membership requirements • FDA-regulated research • at least one physician 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 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. 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: • part-time employees • current students • members of any governing panel or board of the University • paid and unpaid consultants of the University • healthcare providers with medical staff membership or other credentials to practice at University clinical sites • volunteers working at the University on business unrelated to the University 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: 14members total 8 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: 14members total 8= (14 ÷ 2) + 1 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 Developed by: U-MIC
IRB membership requirements and quorum IRB membership requirements and quorum Developed by: U-MIC
Brian Seabolt IRBMED thank you. Developed by: U-MIC