skip to main content

53. DHHS Regulations: Criteria for IRB Approval (45 CFR 46.111)

The University IRBs comply with the DHHS criteria for IRB approval of human subject research when that research is conducted, supported or otherwise subject to regulation by a federal department or agency.

NOTE: These criteria may be adapted for minimal risk research that does not receive federal funds or support or require compliance with FDA regulation, in accordance with the University IRB Flexibility Policy. For details about the IRB-Flex policy, see the relevant policy sections of for exempt research, expedited reviews, informed consent, and vulnerable populations.

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,

·        that do not unnecessarily expose subjects to risk, and

·        (whenever appropriate) which are already being performed on the subjects for diagnostic or treatment purposes.

  1. 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 IRBs 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 IRBs do 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.

  1. Selection of subjects is equitable. In assessing this criterion, the IRBs will consider the following:

·        the purposes of the research;

·        the settings in which the research will be conducted; and

·        any special problems for research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.

  1. 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 (for information about DHHS consent requirements and waivers or alterations of the consent process, see the consent policies).
  2. 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 relevant policy).

NOTE: The University does not authorize use of a "short form written consent document" or short form consent process as referenced in §46.117(b)(2).

  1. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
  2. 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 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 must be included in the study to protect the rights and welfare of these subjects. (For more information, see the population-specific policy sections.)

As noted above, for minimal risk research that does not receive federal funds or support, and does not invoke FDA regulations, the IRB may consider additional protections for vulnerable populations under the IRB-Flex policy.

Take the next step...