Student researchers may seek guidance from their research mentor or dissertation chair if uncertain about expedited review requirements. Independent researchers who may require clarification concerning expedited review requirements may contact the Calhoun IRB chair directly at email@example.com .
As per the U.S. Department of Health and Human Services Title 45, Part 46, “In order to approve research covered by this policy the IRB shall determine that all of the following requirements are satisfied.”
- Risks to subjects are minimized:
- By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and
- whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
- 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). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.
- 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, in accordance with, and to the extent required by §46.116.
- Informed consent will be appropriately documented, in accordance with, and to the extent required by §46.117.
- 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 and to maintain the confidentiality of data.
U.S. Department of Health and Human Services (2009, January 15). Protection of human subjects. Code of Federal Regulations, Title 45, Part 46. Retrieved from https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html#46.102