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

Vulnerable subject populations in human subjects research Developed by: U-MIC University of Michigan IRB Collaborative

45 CFR 46, subpart A Vulnerable subjects Common Rule HHS regulations governing human subjects research 45 CFR 46.111 refers to five vulnerable populations children prisoners pregnant women mentally disabled persons economically or educationally disadvantaged persons may face increased susceptibility to coercion undue influence Developed by: U-MIC

45 CFR 46, subparts B, C, and D Vulnerable subjects additional requirements for the protection of three populations pregnant women, fetuses, and neonates prisoners children Developed by: U-MIC

45 CFR 46, subpart B Vulnerable subjects pregnant women, fetuses, and nonviable neonates or neonates of uncertain viability defines these populations presents IRB approval criteria IRB must consider risk level benefit type direct indirect Developed by: U-MIC

45 CFR 46, subpart C Vulnerable subjects prisoners IRB membership requirements for the review and approval of research involving prisoners additional IRB duties circumstances in which prisoners may participate U-MIC: Prisoners as Research Subjects Part One: Federal Regulations Part Two: Certification and IRB Review Developed by: U-MIC

45 CFR 46, subpart D Vulnerable subjects children persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted IRB responsibilities circumstances in which children may participate risk/benefit assent/parental permission Developed by: U-MIC

FDA regulations (21 CFR 50 and 56) Vulnerable subjects FDA regulations (21 CFR 50 and 56) also address vulnerable populations 21 CFR 50, subpart D research involving children differences from 45 CFR 46 (examples) FDA does not permit waivers of parental permission. FDA regulations do not address research involving pregnant women, fetuses, and neonates prisoners Developed by: U-MIC

UM HRPP Operations Manual Vulnerable subjects UM HRPP Operations Manual Part 7 institutional policy governing the IRB review and approval of research involving pregnant women, fetuses, and nonviable neonates or neonates of uncertain viability prisoners children adults with cognitive impairment or otherwise impaired decision-making capacity Developed by: U-MIC

eResearch Vulnerable subjects Researchers must consider whether study is designed to include/allow vulnerable populations select appropriate vulnerable populations from the following list: children (including viable neonates) neonates of uncertain viability and/or nonviable neonates individuals and/or products involving human in vitro fertilization, pregnant women and/or fetuses lactating women women of childbearing potential prisoners cognitively impaired adults college students economically or educationally disadvantaged persons patients of the study team employees, students or trainees of the study team family members of the study team Based on populations selected, IRB applies appropriate federal regulations, institutional policies, and special considerations in its review. Developed by: U-MIC

Common Rule changes Vulnerable subjects 45 CFR 46, subpart A effective January 19, 2018 modifications to vulnerable population categories UM policies/procedures Updates forthcoming Developed by: U-MIC

Vulnerable subject populations in human subjects research Vulnerable subjects Vulnerable subject populations in human subjects research Developed by: U-MIC

Thank you. Brian Seabolt IRBMED Developed by: U-MIC