Federally supported research projects involving human subjects that do not fit any of the exceptions, or is not eligible for expedited review will receive full-board review. Primary investigators should complete the appropriate sections of a Research Project Form.
Approval of the proposed project will be based on the following:
- Risks to subjects are minimized: (i) By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk (i.e., adequacy of measures for minimizing of risk and the protection of the health, safety, comfort, and legal rights of the subject).
- Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research).
- Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.
- Informed consent will be sought from each prospective subject or the subject's legally authorized representative as defined in this document.
- Informed consent will be appropriately documented.
- When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
- When appropriate, there are adequate provisions to protect the privacy of subjects.
All types of IRB review:
- Exemptions— only statutorily defined exempted research. Read more...
- Expedited — list of certain kinds of research involving no more than minimal risk, or for minor changes in already-approved research. Read more...
- Full-Board Review — all other federally supported research involving human subjects. Read more...