Institutional Review Boards

Institutional Review Boards (IRBs) are supervisory bodies that ensure compliance with ethics law.

Definition

The Common Rule sets out requirements for IRBs.

An IRB must have the expertise and professional competence required to review a research proposal.

An IRB must include 5 people at minimum, and must satisfy these characteristics with at least 1 person:

1. A person not otherwise affiliated with the institution
2. A scientist
3. A non-scientist

The board must be diverse (race, gender, culture, etc.).

The board must have the power to disapprove of a research proposal, conduct continuing review of research, and discontinue research based on results of continuing review.

Subpart C

For IRBs implementing subpart C (for prisoners), they are additionally required to have...

• A majority of members that are not otherwise affiliated with the prison
• A prisoner or prisoner representative

The prisoner or prisoner representative member must have a vote on any components of the research proposal relevant to subpart C, but can be deprived of that vote and excluded from quorum on all other components.

Applications

The Common Rule also specifies when an application must be made for IRB review.

An application for initial review for IRB review must cover:

• a risk/benefit analysis
• the informed consent process and informed consent documentation process
• the assent process and assent documentation process, if necessary
• the identification and selection processes for subjects
• safeguards for vulnerable populations, if necessary
• the privacy and confidentiality process
• the data governance process
• the qualifications of involved researchers, especially with regard to data governance and analysis
• the research design
• compliance with laws, regulations, and policies, if necessary

Applications for continuing review may be necessary as well. These must cover:

• the number of subjects
• a summary of unanticipated problems, adverse events, subject withdrawals, and complaints encountered
• any new relevant information
• a copy of the informed consent document

Any changes to the research protocol or other processes must similarly be submitted to IRB review.

Reviewing Risk

While an application must include a risk/benefit analysis, the IRB is responsible for assessing the reasonability of risks given the benefits.

Furthermore, regardless of the benefits, the IRB must ensure that risks are minimized to the greatest extent.

Risks for behavioral research generally fall into one of these categories:

• invasion of privacy
• breach of confidentiality
• study procedures themselves

Risks need to considered in a variety of dimensions. Degree of risk is generally understood as a function of the severity of risked outcomes and the likelihood of risked outcomes. Risks are also often dependent on situations, such as legality and cultural norms.

Reviewing Equity

The IRB is responsible for ensuring that subject selection is equitable in terms of the burdens of research protocols as well as in terms of the possible yields of benefits. Both should be spread across groups.

Generally, vulnerable populations can only be selected if research is specific to that group, or if there are expected benefits specific to that group, or if there are significant direct benefits to selected individuals.

Expedited Review

Some research proposals and continuing reviews are eligible for expedited review. The alternative is called convened review.

Reports of Unanticipated Problems

An unanticipated problem is any event that is:

• unexpected
• related or possibly related to the research protocols
• increases risk to subjects

The IRB must promptly recieve a report for any unanticipated problems, adverse events, or noncompliance to the IRB.

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