21 CFR Part 56 Flashcards
What is 21 CFR Part 56 about?
IRBs
IRB authority
- Approve research
- Conduct continuing reviews
- Require modifications (to secure approval)
- Verify no material changes occurred since previous review
- Disapprove research
- Observe, or have a third party observe, the consent process and research
- Suspend or terminate approval.
How many members must an IRB have?
at least 5
What types of members must an IRB have?
- Members from various backgrounds and professions (must be qualified and knowledgeable)
- non-scientist member (mandatory to be part of a voting quorum per 45 cfr 46)
- scientist member - (Orgs conducting FDA regulated clinical trials should include at least one physician as a scientific member)
- unaffiliated member (not affiliated w/the org operating the IRB)
- IRB must consider inclusion of someone who has knowledge &experience with vulnerable populations if the research involves that pop.
- Members w/conflict of interest cannot be present / vote
Minimum info to be included on an IRB app?
- Risk/anticipated benefit analysis
- Informed consent
- Assent
- Selection of Subjects
- Privacy/Confidentiality
- Research Plan for Collection, Storage, and Analysis of Data (including DSMC plan)
- Research Design/Methods
- Additional Info (re: special populations)
- Additional items IRB must review (qualifications of PI if FDA regulated, Description of research, Provision for protection of rights and welfare of subjects, compliance with laws/regulations/policies, IB & protocol)
Responsibilities of investigators
- Protects rights/welfare of subjects
- Understand ethical standards and reg requirements
- Personally conduct or supervise the research
- Ensure staff is properly trained
- Ensure all IRB and other required approvals - Initial, updates & continuing review (& maintain records)
- Obtain & document informed consent
- Comply with IRB requirements for timely reporting of unanticipated problems, safety reports, or data safety & monitoring reports.
- Secured retention & confidentiality of research records
- Notify IRB of new info that may impact subject safety/security
What is the reporting timeline to the IRB for emergency use of an investigational drug or device?
5 working days (or sooner if required by IRB) of administration
What are the three possible IRB review procedures?
- Expedited Review (no more than minimal risk)
- Exempt - Limited IRB Review of Select Exemption Categories (4 of the 8 exemption categories - 2 and 3 because of PHI, 7 & 8 because broad consent is/has been obtained).
- Convened Committee Review
What are the requirements for a convened IRB review?
- A majority of IRB members ( a quorum) must be present
- At least 1 member whose primary concerns are non-scientific must be present
- All requirements of 45 CFR 46.111 are satisfied
- Majority of members approve the research
- Members with a COI in the research project cannot participate in plan review or be present for voting.
- IRB must notify the researchers & organization of the outcome in writing
- IRBs must keep detailed documentation of meeting activities
What is a primary reviewer system?
A “primary reviewer system” uses one person with experience or expertise in the study area to conduct a thorough review of the IRB application and accompanying documents and present findings at the meeting. The rest of the IRB members receive basic information.
Which things can (or can’t) an expedited reviewer do?
They can: approve research, require modification, defer review to the convened IRB, review minor changes in previously approved research, conduct limited IRB review if it is a condition of exemption status.
They cannot: disapprove research.
What are the two main categories for expedited review as determined by federal regulations?
1) The research does not involve more than minimal risk
2) The entire research project must be consistent with one or more of the federally defined categories:
- IND is not required and an IDE is not required or the medical device is cleared/approved for marking and used in according to that labeling
- Collection of blood draw via finger stick, heel stick, ear stick, or venipuncture.
- Prospective collection of biological specimens for research via noninvasive means
- Collection of data through non-invasive procedures routinely employed in clinical practice
- Research with data, documents, records or specimens that have been collected or will be collected solely for non-research purposes
- Collection of data from voice, video, digital or image recordings made for research
- Research on individual or group characteristics or behavior
- Continuing review (previously reviewed by convened IRB) where research is permanently closed & all research activities are complete (only LTFU left), or no subjects have been enrolled and no new risks identified, or the remaining research activities are data analysis.
- Continuing review for research that doesn’t meet any of the above but the full/convened IRB determines research is minimal risk and no additional risks ID’d
Which part of 21 CFR 56 matches another CFR, and which CFR does it match?
21 CFR 56.111 matches 45 CFR 46.111 (Criteria for IRB approval of research)
When must the exempt status be determined for a human subjects research project?
Prior to initiation of the research or of the activity. It cannot be made retroactively.
What does the NIH Genomic Data Sharing Policy dictate?
If the investigator wants to provide data to the database or use data from the NIH Database of Genotypes and Phenotypes the research must be reviewed by the IRB.
