Institutional Review Board

Protocol


For all research involving human subjects, the principal investigator will be responsible for completing the Submission Form and the Research Protocol.

The IRB protocol is the formal design or plan for the proposed experiment or research activity; specifically, it is the plan submitted to the IRB for review and subsequently, to an agency for research support. The protocol includes a description of the research design or methodology to be employed, the eligibility requirements for prospective subjects and controls, the treatment regimen(s), and the proposed methods of analysis that will be performed on the collected data. The following format should be used in developing the research protocol.

Description of Study

Purpose and Potential Benefits

Summarize the background, rationale, nature, and significance of the proposed research.

Location of Study

Identify all sites at which research will be conducted.

Dates of study

Include month/day/year of start and end dates of study.

Subjects

Include estimated number and description of types of subjects (e.g., normal volunteers, pregnant women, students), age, sex, inclusion and exclusion criteria, and source of subjects (e.g., referral sources).

Methods and Procedures

Provide details on subject recruitment, nature and type of evaluation, subject's time commitment, proposed follow-up, debriefings when indicated, and any other information necessary to evaluate the involvement of subjects in the research.

Participant Payments or Costs

Indicate whether the subjects will be offered an incentive to participate in the study and if so, in what form (e.g., cash, meals, taxi fare, etc.) and in what amount.

Subject Confidentiality

Indicate the extent to which confidentiality of records identifying subjects will be maintained. Be specific where will the records be maintained? Who will have access to the records? etc.

Potential Risks to Subjects

Specify any risks (physical, social, psychological, legal), indicate precautions instituted to minimize risks, and describe procedures to be followed in the event of problems. Specify the results of pilot work or the work of others with similar procedures.

Risk/Benefit Ratio

Specify the level of risk in relation to anticipated benefits.

Informed Consent

A copy of all proposed informed consent forms must be attached to the research protocol. Refer to the instructions for developing the informed consent form(s).


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