Institutional Review Board

Protocol Element Checklist

Use this checklist as a guide to ensure that you have included all the required elements in your protocol.

  • Study Design
    1. Protocol methodology is scientifically sound an adequately designed.
    2. Hypotheses, clinical objectives and planned analyses are clearly stated.
    3. Planned interventions and their timing are clearly stated.
    4. Primary and Secondary outcome measures are defined.
    5. Sample size is projected on the basis of statistical calculation.
    6. Statistical Analyses of outcome measures are appropriate.
    7. Randomization method is described and appropriate (if applicable).
  • Study Population
    1. Study population is defined, including inclusion/exclusion criteria.
    2. Appropriate justification is given for the exclusion of population groups (e.g. Minors, Women, Ethnic groups, Non-English Speaking people, etc.) NOTE: Acceptable justifications for exclusion of minors include:
      1. the research topic to be studied is irrelevant to children;
      2. there are laws or regulations barring the inclusion of children in the research. For example, the regulations for protection of human subjects allow consenting adults to accept a higher level of risk than is permitted for children;
      3. the knowledge being sought in the research is already available for children or will be obtained from another ongoing study, and an additional study will be redundant. NIH program staff can be contacted for guidance on this issue if the information is not readily available;
      4. a separate, age-specific study in children is warranted and preferable (consult NIH Policy for specific example of such studies).
      5. Insufficient data are available in adults to judge potential risk in children (in which case one of the research objectives could be to obtain sufficient adult data to make this judgment). While children usually should not be the initial group to be involved in research studies, in some instances, the nature and seriousness of the illness may warrant their participation earlier based on careful risk and benefit analysis.
      6. Study designs aimed at collecting additional data on pre-enrolled adult study participants (e.g., longitudinal follow-up studies that did not include data on children).
      7. Other special cases justified by the investigator and found acceptable to the review group and the Institute Director.
    3. If subjects who do not have the capacity to consent will be enrolled in this study, justification for their inclusion is provided.
  • Risk/Benefit
    1. Potential risks have been identified and minimized as far as possible.
    2. The potential benefits to participants or others justify the risks, including medical, social, and psychological risks.
    3. Data storage has been clearly outlined, including how subjects' confidentiality will be ensured.
    4. If subjects will be video or audio-taped, the following has been addressed: What will be taped, how the tapes will be used, If subjects will be compensated for allowing themselves to be taped, and when the tapes will be destroyed.
  • Participant Recruitment
    1. Anticipated enrollment numbers are stated.
    2. Recruitment sources for both subjects and controls are clearly outlined.
    3. Methods for subject/control recruitment are clearly outlined.
    4. Methods for ensuring voluntariness of participation are clearly outlined.
    5. Patient Privacy protections are clearly outlined.
  • Informed Consent
    1. The informed consent process is clearly outlined.
    2. If a waiver or alteration of the informed consent process is requested, clear justification is provided.
    3. If subjects who might lack the ability to give informed consent will be enrolled, a description of how, and from whom, informed consent will be sought is provided.
  • Costs and Remuneration
    1. Any reimbursement or remuneration is clearly outlined, including the pro-rating scale if multiple visits are required. 
    2. All tests and procedures are outlined and identified as for Research Purposes or Standard Clinical Care.
    3. A listing of the costs to subjects (tests/procedures/supplies which are the responsibility of the subject) is provided.
  • Collaborations
    1. All collaborations are clearly defined, including the aspect(s) of research to be carried out by the collaborator(s). 
    2. Any sharing of specimens is detailed including who will provide/receive the specimens, where the specimens will be stored, and when the specimens will be destroyed, if at all.
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