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.