The Virginia Commonwealth University IRB office created the IRB Member Handbook for training new members and to serve as a resource to all members.
The following are some highlights from the 67-page handbook:
• Reviewing a submission. This section covers various types of reviews, including initial review, expedited review, full board, continuing review, and amendment.
The handbook notes that when an IRB member is a primary or secondary reviewer for an initial submission to the full board, they should use the Guiding Your Review template, and do the following:
- read the consent document, but do not take notes or make revisions,
- read the protocol summary,
- read the full protocol and supporting material carefully, taking notes as needed,
- re-read the consent document and make suggested changes or corrections, and
- re-read other submitted documents and make suggested changes or corrections.
The Guiding Your Review template has 53 questions, including the following:
- Introduction, Background, Aims: “Are there adequate preliminary data to justify the research?”
- Scientific Design: “Are the objectives likely to be achievable within a given period of time?”
- Inclusion/Exclusion Criteria: “Is the choice of subjects appropriate to the question being asked?”
- Recruitment of Subjects: “Are there acceptable methods for screening subjects before recruitment?”
- Research Procedures: “Is there a clear differentiation between research procedures and standard care?”
- Drugs, Biologics, Devices: “Are the drug or device safety and efficacy data sufficient to warrant the proposed phase of testing?”
- Data Analysis and Statistical Analysis: “Are the plans for data and analysis defined and justified, including stopping rules and end points?”
- Potential Risks, Discomforts and Benefits for Subject: “If there is no direct benefit to participants, is there mention of the benefits to future subjects of knowledge to be gained?”
- Privacy and Confidentiality: “Are there adequate provisions to protect the privacy and ensure the confidentiality of the research subjects?”
• Reports: This section covers unanticipated problems (UPs) and how to review reports of UPs, as well as protocol deviations and violations, noncompliance. The following is a sample item:
- Protocol Deviation is any change to the IRB-approved protocol taken without prior IRB review to eliminate an apparent immediate hazard to research participants;
- Protocol Violation is an accidental or unintentional change to the IRB-approved protocol that harmed participants or others, or that indicates participants or others may be at increased risk of harm.
The Virginia Commonwealth University IRB office created the IRB Member Handbook for training new members and to serve as a resource to all members.
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