53. DHHS Regulations - Criteria for w88 slot Approval

Updated June 23, 2021

For research that is conducted, supported or otherwise subject to regulation by a federal department or agency, the University w88 slot complies with Department of Health and Human Services (DHHS) criteria for w88 slot approval of human research at 45 CFR 46.111.

NOTE: Under the University's w88 slot Flexibility Policy (w88 slot-Flex), these DHHS criteria may be adapted for minimal risk research that is not conducted, supported, or otherwise regulated by a federal agency. w88 slot-Flex applies to type of review, requirements for informed consent and documentation of consent, and additional protections for vulnerable populations. For information about w88 slot-Flex, use "flex" to search the w88 slot policy manual.

DHHS Criteria for w88 slot Approval for Federally-funded Research

1. Risks to w88 slot are minimized by using procedures:
   • that are consistent with sound w88 slot design (as confirmed by responsible officials),
   • that do not unnecessarily expose w88 slot to risk, and
   • (whenever appropriate) which are already being performed on the w88 slot for diagnostic or treatment purposes.
2. Risks to w88 slot are reasonable in relation to anticipated benefits, if any, to w88 slot; and the importance of the knowledge that may reasonably be expected to result.
   • In evaluating risks and benefits, the w88 slot 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 w88 slot 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 w88 slot will consider the following:
   • the purposes of the w88 slot;
   • the settings in which the w88 slot will be conducted;
   • recruitment and w88 slot processes; and
   • any special problems for w88 slot 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 w88 slot 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 w88 slot policy manual for waivers of documentation of consent provisions).
6. When appropriate, the w88 slot 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 w88 slot and to maintain the confidentiality of data.

Additional DHHS Criteria for w88 slot 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 w88 slot 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 w88 slot-Flex with concomitant adjustments to additional protections for vulnerable populations.