21 CRF 56: IRB Flashcards
Which circumstance requires IRB review for a study?
IRB review, approval and continuous review is required for all clinical investigations that need to be submitted to the FDA
What are the implications and potential challenges that a researcher might face if they choose not to seek approval from an Institutional Review Board (IRB) before conducting a clinical investigation? How does it affect their ability to obtain a permit from the FDA?
The FDA may not provision a permit and consider the data from an investigational that was not approved or reviewed by the IRB.
What are the four exemptions from an IRB requirement?
- Administration of an emergency test article (you must submit to the IRB within 5 days of administration. Subsequent uses must be approved by the IRB)
- The investigation started before 1981 and it did not require IRB review per the FDA regulations at the time
- The investigation started before 1981 and it required IRB review per the FDA regulations at the time. But it doesn’t need to follow current FDA regulations.
- Taste, food quality and consumer acceptance studies that are already approved
Is there any situation where the IRB requirement could be waived? What types of studies can this be done for?
The FDA can waive regulations, including the requirement for IRB review, for specific research activities or classes of research.
The FDA can do this for applications for sponsor or sponsor-investigator studies
What qualifications and characteristics should the members of an Institutional Review Board (IRB) possess to ensure the effective review of research activities? What are the minimum number of people and requirements that must make up and IRB?
- You need at least 5 individuals to make up an IRB
- Members should have varying expertise and diversity (cultural, gender, ethnicities)
- No IRBs should be made up of the same gender or profession
- IRBs should have at least 1 person from a scientific field and 1 from a non science field
- IRBs should have at least 1 person that is not affiliated with the institution and is not immediate family to someone who is affiliated
What steps does the regulation suggest for IRBs that regularly review research involving categories like children, prisoners, pregnant women, or mentally disabled persons?
An IRB can invite experts to provide their expertise in the review of a complex issues of vulnerable populations. They do not have a vote with the IRB to approve/disapprove applications.
When is it prohibited for an IRB member to be part of the initial or continuing review of an investigation?
An IRB member that has a conflict of interest (i.e. they are affiliated with the investigation) cannot be part of the review.
Describe the conditions under which an IRB must review proposed research?
The majority of the IRB board must be present and at least 1 member of the non scientific community must be present. The majority of the IRB must vote to approved an proposed study.
Per the CFR, what are the specific instances that an IRB must promptly report to ensure human subjects’ protection, and to which entities should these reports be submitted?
- Suspension or termination of approval by the IRB
- Unanticipated risks to participants and others
- Continuous noncompliance to regulations and IRB requirements
Reporting to IRB, institution officials and the FDA
What are the key written procedures that an Institutional Review Board (IRB) is required to follow to fulfill the operational requirements of CFR part 56? (5)
- Conduct initial and continuous review of studies and communicate findings to investigators and institutions
- Assess frequency of renewal and if studies need to be reviewed more than once a year
- Assess if IRB needs to verify that no changes have occurred in a study since their last review
- Require studies to report changes to research activities (reportable events)
- Mandate that studies first obtain IRB approval before implementing changes, unless it is to reduce the immediate risk/harm to subjects/others
The IRB is granted certain decision-making authority over research activities. Explain the options available to an IRB during the review process. What authority does the IRB have over research studies per the CFR?
The IRB has authority to review all research activities covered by the CFR and has the ability to approve, request modifications or disapprove requests/applications
What role does the IRB play in ensuring the adequacy of information provided to subjects during the informed consent process? When might the IRB require additional information beyond what is specified in §50.25?
The IRB requires that information given to participants as part of the informed consent adheres to part 50 of the CRF. The IRB might require that studies provide additional information to participants if it believes it will add to the protection of the rights and welfare of participants
Under what circumstances can an IRB waive the requirement for subjects to sign a written consent form? Describe the conditions that need to be met for this waiver. (Per CFR 50)
- If the research activities post no more than a minimal risk to the participants and that the procedures involved do not normally need written consent in non-research contexts.
- The exception in part 50 of emergency research not needing informed consent is met
In cases where the documentation requirement is waived, what authority might the IRB have to impose additional requirements on the investigator, and what purpose would these additional requirements serve?
The IRB may request the investigator to provide a statement to affected individuals to inform them about the research. The purpose is to inform people of the research and explain why they are not being required to consent.
What steps must an IRB take when notifying investigators and institutions of its decision on a research activity? How does the IRB handle the notification process if it decides to disapprove a research activity?
The IRB must provide written notification of their decision to the investigators and institutions.
If it disapproves the research activity, the IRB must provide a written reason for their decision and an opportunity for the investigation to respond.
