53. DHHS Regulations - Criteria for IRB Approval

Updated June 23, 2021

For research that is conducted, supported or otherwise subject to regulation by a federal department or agency, the University IRB complies with Department of Health and Human Services (DHHS) criteria for IRB approval of human research at 45 CFR 46.111.

NOTE: Under the University's IRB Flexibility Policy (IRB-Flex), these DHHS criteria may be adapted for minimal risk research that is not conducted, supported, or otherwise regulated by a federal agency. IRB-Flex applies to type of review, requirements for informed consent and documentation of consent, and additional protections for vulnerable populations. For information about IRB-Flex, use "flex" to search the IRB policy manual.

DHHS Criteria for IRB Approval for Federally-funded Research

1. Risks to subjects are minimized by using procedures:
   • that are consistent with sound research design (as confirmed by responsible officials),
   • that do not unnecessarily expose subjects to risk, and
   • (whenever appropriate) which are already being performed on the subjects for diagnostic or treatment purposes.
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 considers 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 does 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 assessing this criterion, the IRB will consider the following:
   • the purposes of the research;
   • the settings in which the research will be conducted;
   • recruitment and consent processes; and
   • any special problems for 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 by §46.116 (see the online IRB policy manual for information about informed consent requirements),
5. Informed consent will be appropriately documented, in accordance with, and to the extent required by §46.117 (for information about waivers of documentation of consent, see the online IRB policy manual for waivers of documentation of consent provisions).
6. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
7. When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

Additional DHHS Criteria for IRB Approval of Federally-funded Research Involving Vulnerable Populations:

When some or all of the participants are likely to be vulnerable to coercion or undue influence, additional safeguards must be included in the study to protect the rights and welfare of these participants. See IRB policy for research involving pregnant women/fetuses; prisoners; children; adults with impaired decision-making capacity; economically/educationally disadvantaged persons; persons who do not speak English.

As noted above, minimal risk research that is not conducted, supported, or regulated by a federal agency, may qualify for consideration under IRB-Flex with concomitant adjustments to additional protections for vulnerable populations.