Criteria for Approval
The HRRC evaluates human subject research proposals for approval based on the criteria outlined in the federal regulations: 45 CFR 46.111. Tabling decisions that require information or modifications from researchers in order to obtain approval are related to one of these criteria, otherwise the notes are included as advisory comments for consideration by the researcher.
In order to approve research the HRRC must determine that all of the following requirements are met:
1. 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 benefits
2. 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.
3. 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.
4. Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required (see the Elements of Informed Consent).
Documentation of informed consent
5. Informed consent will be appropriately documented, in accordance with, and to the extent required (see Documentation of Informed Consent).
6. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
Privacy and confidentiality
7. When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
Vulnerable population considerations
***When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.