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.