Institutional Review Board Manual
Required Protocol Information
The Institutional Review Board (IRB) requires specific information to ensure the protection of research subjects and has developed a Project Application Form to capture this information. Researchers are requested to complete and submit this Project Application Form along with a full copy of any research protocol that exists.
The minimal requested information includes:
- A description of, and scientific rationale for, the proposed research activity; and
- A discussion of the human subject protection issues which address, at a minimum:
- Risks to subjects;
- All experimental procedures;
- Anticipated benefits to subjects, if any;
- Anticipated number of subjects;
- Subject selection, recruitment procedures, and subject inclusion/exclusion criteria:
- Informed consent document and process to be used; and
- Appropriate additional safeguards if potentially vulnerable subjects are to be enrolled, i.e., the elderly, prisoners, children, cognitively impaired people, or people who are economically or educationally disadvantaged.
The information should be in sufficient detail to allow the IRB to address the following areas:
- Proposed research design is scientifically sound & will not unnecessarily expose subjects to risk.
- Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of knowledge that may reasonably be expected to result.
- Risks to subjects are minimized.
- Subject selection is equitable.
- Informed consent is obtained from research subjects or their legally authorized representative(s).
- Additional safeguards required for subjects likely to be vulnerable to coercion or undue influence.
- Subject privacy & confidentiality are maximized.