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Protocol Review Worksheet

SUGGESTED APPROACH FOR REVIEWING A NEW IRB APPLICATION AT BELMONT UNIVERSITY

Adapted from:  IRB Member Handbook – Robert Amdur, M.D.  Every Committee member has this handbook.

Pages 43-46 for second edition (red cover)

Pages 49-52 for third edition (gray cover) 

  1. First read the consent form or document (such as invitation letter) but don’t take notes or make revisions.
    The purpose of the consent document is to explain the purpose of the study in lay language. Reading it first should orient to the reviewer to the protocol.
  2. Then read the full application and supporting materials for approval criteria.
    Read the entire application, protocol and supporting documentation, taking notes as needed.  You are looking to see if it meets the following criteria or conditions of approval:

    INCLUSION/EXCLUSION CRITERIA FOR PARTICIPANTS

    • Are inclusion and exclusion criteria clearly specified, appropriate, and consistent throughout the application?
    • If women, minorities, or children are included or excluded, is this justified?
    • Is the choice of participants appropriate for the question being asked?
    • Is the principle of distributive justice adequately incorporated in the inclusion and exclusion criteria for the research protocol? Is participant selection equitable?

     

    RECRUITMENT OF PARTICIPANTS

    • Are the recruitment procedures clearly described?
    • Are the location and timing of the recruitment procedures appropriate considering the proposed populations?
    • Are the recruitment procedures appropriate (ensure that they do not violate an individual's right to privacy)?
    • Is the individual performing recruitment appropriate for the process?
    • Are all recruitment materials present and appropriate?
    • Are there acceptable methods for screening participants prior to recruitment?

     

    COMPENSATION AND COSTS FOR PARTICIPANTS

    • Is the amount or type of compensation or reimbursement reasonable, or does it seem coercive?
    • Are there adequate provisions to avoid out-of-pocket expenses for the research participant, or is there sufficient justification to allow participants to pay?
    • If children or adolescents are involved, who received the compensation and is this appropriate?

     

    SPECIFIC AIMS AND BACKGROUND

    • Are the aims or purpose clearly specified?
    • Are there adequate preliminary data to justify the research?
    • Is there appropriate justification for this specific protocol?

     

    SCIENTIFIC DESIGN

    • Is the scientific design or protocol (e.g., controls) adequate to answer the question?
    • Are the objectives likely to be achievable within the proposed time period?
    • Is the protocol described and adequately justified?

    RESEARCH PROCEDURES

    • Are the rationale and details of the research procedures accurately described and acceptable?
    • Where applicable, is there a clear differentiation between research procedures and standard of care or normal procedures?
    • Are the individuals performing the procedures appropriately educated and/or trained?
    • Is the location where the procedure will be performed acceptable?
    • Where applicable, are there adequate plans to inform participants about specific research results if necessary? Examples include clinically relevant results, risk of depression, incidental findings.

     

    DATA ANALYSIS AND STATISTICAL ANALYSIS

    • Is the rationale for the proposed number of participants reasonable?
    • Where applicable, are the plans for data and statistical analysis defined and justified, including the use of stopping rules and end points?

     

    POTENTIAL RISKS, DISCOMFORTS, AND BENEFITS FOR PARTICIPANTS

    • Are the risks and benefits adequately identified, evaluated, and described?
    • Are the potential risks minimized and the likelihood of benefits maximized?
    • Is the risk/benefit ratio acceptable for proceeding with the research?
    • If children are involved, does the protocol pose no greater than minimal risk? If it does pose greater than minimal risk, is it a “minor increase over minimal risk”? If yes, do the potential benefits to the children outweigh the minor increase over minimal risk?

     

    PRIVACY AND CONFIDENTIALITY

    • Are there adequate provisions to protect the privacy of participants?
    • Are there adequate provisions to protect the confidentiality of the participants and their data?
    • Are there adequate plans to store and de-identify (code) the data?
    • Is the use of identifiers or links to identifiers necessary, and how is this information protected?

     

    INFORMED CONSENT/ASSENT

    • Are all the elements of informed consent in the consent document? A consent document can be the official form, or in some cases, within a letter of invitation to participate.
    • Is the process of obtaining consent adequately described in the protocol?
    • Is assent required for children?
    • Is waiver or modification of full informed consent possible?
  3. Reread the consent document again.
    Reread the consent document and make note of suggested corrections or questions for the investigator.

 

Federal Definitions Used in this Document 

  1. Minimal risk: at 45 CFR 46.102(i) when applied to subpart D should be interpreted as “those risks encountered during daily life by normal, average, healthy children living in safe environments or during the performance of routine physical or psychological examinations or tests.”
  2. Minor increase over minimal risk:  at 45 CFR 46.406: Criteria for "minor increase over minimal risk" should include the following (a) the procedure does not meet minimal risk criteria, and (b) the investigator has presented sufficient evidence about the procedures, population, and the qualifications of research personnel to assure the IRB that:
    1. The increase in the probability and magnitude of harm is only slightly more than minimal risk.
    2. Any potential harms associated with the procedure will be transient and reversible in consideration of the nature of the harm (restricted to time of procedure or short post-experimental period).
    3. There is no or an extremely small probability that participants will experience as severe the potential pain, discomfort, stress, or harm associated with the procedure.
  3. Privacy:  Having control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others. Example: an interview in front of other people would not provide privacy for a participant. Defined in OHRP IRB Guidebook, 1993, Chapter III.
  4. Confidentiality:  Pertains to the treatment of information that an individual has disclosed in a relationship of trust with the expectation that it will not be divulged to others in ways that are inconsistent with the understanding of the original disclosure without permission. Example: choosing not to identify an interviewee with his or her responses is keeping the interview data confidential. Defined in OHRP IRB Guidebook, 1993, Chapter III.
  5. Assent:  At 46.402(b): means a child’s affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent.