IRB & Human Subjects Research Compliance

Evaluate compliance with 45 CFR Part 46 (Common Rule) requirements for Institutional Review Boards and human subjects research protection

BiotechHealthcareResearch22 minutes21 questions

1. IRB Establishment & Composition

Does your IRB have at least five members with varying backgrounds and expertise?*

§46.107: IRB membership requirements including diversity

Does the IRB include at least one member whose primary concerns are in scientific areas and one in nonscientific areas?*

§46.107(b): Required diversity of professional competence

Does the IRB include at least one member who is not otherwise affiliated with the institution?*

§46.107(d): Community representative requirement

Are written IRB procedures established covering review, approval, and reporting?*

§46.103(b)(4): Written procedures required for IRB operations

2. IRB Review & Approval Process

Does the IRB review research at convened meetings with quorum present?*

§46.108: Quorum requires majority of members including one nonscientist

Are IRB members with conflicting interests excused from deliberation and voting?*

§46.107(e): Conflict of interest management

Does the IRB conduct initial review of all research before commencement?*

§46.109: No research may begin without IRB approval

Are IRB meeting minutes documented with attendance, actions taken, and vote counts?*

§46.115: Documentation requirements for all IRB activities

3. Informed Consent

Do informed consent documents include all eight required elements per §46.116?*

Research purpose, procedures, risks, benefits, alternatives, confidentiality, compensation, contacts

Is informed consent obtained before any research procedures begin?*

§46.116: Consent required prior to involvement in research

Are consent forms written in language understandable to the subject?*

§46.116(a)(3): Information must be in terms subjects can comprehend

Are signed informed consent documents retained for at least 3 years after study completion?*

§46.115(b): Record retention requirements

4. Risk Assessment & Minimization

Does the IRB determine that risks to subjects are minimized?*

§46.111(a)(1): Risk minimization is a criterion for approval

Does the IRB determine that risks are reasonable in relation to anticipated benefits?*

§46.111(a)(2): Risk-benefit assessment required

Are provisions adequate for monitoring data to ensure safety of subjects?*

§46.111(a)(6): Data and safety monitoring requirements

5. Vulnerable Populations

If research involves pregnant women, fetuses, or neonates, are Subpart B requirements met?

§46.201-§46.207: Additional protections for pregnant women

If research involves prisoners, are Subpart C requirements met including DHHS consultation?

§46.301-§46.306: Additional protections and OHRP review for prisoner research

If research involves children, are Subpart D requirements met including parental permission?

§46.401-§46.409: Additional protections and assent requirements for children

6. Continuing Review & Monitoring

Does the IRB conduct continuing review at intervals appropriate to the degree of risk (at least annually)?*

§46.109(e): Continuing review required at least once per year

Are modifications to approved research reviewed and approved by the IRB before implementation?*

§46.103(b)(4)(iii): Amendment review procedures

Are unanticipated problems and adverse events reported to the IRB in a timely manner?*

§46.103(b)(5): Prompt reporting of unanticipated problems

Please answer all required questions to see your results