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2.5 Criteria for IRB Approval

Last Revised: 8/5/2026

For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: IRB Approval Criteria

1.0 Purpose

The purpose of this policy is to describe the Organization’s criteria for approval of human subject research, reviewed both by the convened IRB or thorough an expedited review process.

2.0 Policy

It is the policy of the Organization that human subject research must satisfy basic ethical and regulatory requirements, including those described in 45 CFR 46.111 and 21 CFR 56.111.

3.0 Criteria for IRB Approval

Each of the following criteria must be satisfied in accordance with applicable federal regulations and HRPP policies before IRB/ORA can grant approval.

  • 3.1. Risks to subjects are minimized: (i) by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures, already being performed on the subjects for diagnostic or treatment purposes (45 CFR 46.111(a)(1); 21 CFR 56.111(a)(1)).

    • 3.1.1. The IRB will:
      • 3.1.1.1. Determine that the PI and other study personnel have the necessary qualifications, experience (and licensure if appropriate).
      • 3.1.1.2. Determine that the study design is adequate to achieve the aims of the research and does not unnecessarily expose subjects to risk.
      • 3.1.1.3. Determine that, as appropriate, the research utilizes procedures already being performed on the subjects for diagnostic or treatment purposes
      • 3.1.1.4. Determine that risks have been minimized by using alternative procedures that have less risk, precautions to decrease the likelihood that harms will occur, and contingencies to deal with harms if they occur.
      • 3.1.1.5. Assure that the protocol is reviewed by IRB members or consultants to the IRB who have familiarity with the procedures being performed, and who therefore are able to assess whether risks are minimized.

  • 3.2. 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 (45 CFR 46.111(a)(2); 21 CFR 56.111(a)(2)).

    Note: A risk is a potential harm (injury) associated with the research. Risks can be generally categorized as physical, psychological, sociological, economic, and legal.

    • 3.2.1. The IRB will only consider those risks and benefits that may result from the research as distinguished from risks and benefits of therapies (or other interventions) the subjects would receive if not participating in the research.

    • 3.2.2. The IRB will not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) in determining whether the risk-benefit relationship is acceptable.

    • 3.2.3. The IRB will only consider risks of the research that are “reasonably foreseeable“. "Reasonably foreseeable risks" are potential harms that have enough credible evidence—from past experience, scientific principles, or previous studies—that a participant would find them meaningful when deciding whether to consent.

    • 3.2.4. When considering potential benefits associated with the research, the IRB will consider direct anticipated benefits to subjects (if any) and the importance of the knowledge that may be reasonably expected to result from the research.

      Note: The IRB will generally not consider financial compensation to the subject as a “benefit” in the context of the risk-benefit relationship.

    • 3.2.5. The IRB will assess the risk/benefit relationship of the research and ensure that it is both acceptable and that subjects are not disadvantaged by participating in research (that is, by not choosing available alternatives which may be more advantageous).

    • 3.2.6. As part of its analysis of the risk-benefit relationship, the IRB will consider whether the researchers have the necessary resources to protect subjects, as described in HRPP policy 1.9 (Resources Necessary to Protect Subjects).

  • 3.3. 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 that involves a category of subjects who are vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons (45 CFR 46.111(a)(3); 21 CFR 56.111(a)(3)).

    • 3.3.2. In making this assessment the IRB will evaluate at least the following:
      • 3.3.2.1. Study population
      • 3.3.2.2. Inclusion and exclusion criteria
      • 3.3.2.3. Scientific and ethical justification for inclusion of vulnerable subjects (see HRPP policy 4.1 [Additional Protections for Vulnerable Persons])
      • 3.3.2.4. Scientific and ethical justification for excluding classes of persons who might benefit from the research.
      • 3.3.2.5. Subject identification and recruitment procedures

  • 3.4. 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 the federal regulations (45 CFR 46.111(a)(4); 21 CFR 56.111(a)(4)).

    • 3.4.1. The IRB will review the process of informed consent as described in the IRB application to determine that Legally effective informed consent will be sought from each prospective subject or the subject’s Legally Authorized Representative (LAR) and will be sought only under circumstances that provide sufficient opportunity to discuss and consider whether or not to participate and that minimize the possibility of coercion or undue influence The information that is given to the subject or the legally authorized representative will be in language understandable to the subject or the legally authorized representative. The prospective subject or the legally authorized representative will be provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information. Informed consent will begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research Informed consent as a whole will present information in sufficient detail relating to the research, and will be organized and presented in a way that does not merely provide lists of isolated facts, but rather facilitates the prospective subject's or legally authorized representative's understanding of the reasons why one might or might not want to participate. The informed consent process and documents will include no exculpatory language through which the subject or the legally authorized representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence
    • 3.4.2. The IRB will review the process of informed to consent to assure that the requirements of HRPP policies 5.1 (Obtaining Informed Consent from Research Subjects), 5.2 (Waiver or Alteration of Informed Consent and HIPAA Authorization) and other relevant polies are satisfied.

  • 3.5. Informed consent will be appropriately documented or appropriately waived, in accordance with federal regulations (45 CFR 46.111(a)(5); 21 CFR 56.111(a)(5)).

    • 3.5.1. The IRB will review the informed consent documents (and request for waiver of documentation of informed consent) to assure that the requirements of HRPP policies 5.1 (Obtaining Informed Consent from Research Subjects), 5.4 (Waiver of Requirement to Obtain Signed Consent Form) and other relevant policies are satisfied.

  • 3.6. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects (45 CFR 46.111(a)(6); 21 CFR 56.111(a)(6)).

    • 3.6.1. The IRB will review the IRB application and other related materials to assure that the requirements of HRPP policy 3.2 (Data and Safety Monitoring) are satisfied.
    • 3.6.2. The IRB will review the IRB application and other related materials to assure that the requirements of HRPP policy 3.1 (Assessing the Need for Increased Monitoring, Interim Continuing Review, and Verification from Sources Other than the PI) are satisfied.

  • 3.7. When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data (45 CFR 46.111(a)(7); 21 CFR 56.111(a)(7)).

    • 3.7.1. The IRB will review the IRB application and other related materials to assure that the requirements of HRPP policies 3.3 (Privacy Interests and Confidentiality of Research Data), 3.4 (Use of Protected Health Information in Research) and 3.12 (Ethical Access) and are satisfied.

  • 3.8. When some or all of the subjects are likely to be vulnerable to coercion or undue influence, additional safeguards have been included in the study to protect the rights and welfare of these subjects (45 CFR 46.111(b); 21 CFR 56.111(b)).

    • 3.8.1. The IRB will review the IRB application and other related materials to assure that the requirements of HRPP policy 4.1 (Additional Protections for Vulnerable Persons) are satisfied.

4.0 Additional Considerations

In addition to the specific criteria described above, the IRB will consider other applicable federal, state and local law and regulations, Organization policies, and ethical principles (including those described in the Belmont Report, and the World Medical Association Declaration of Helsinki) when deciding whether a research proposal is approvable.

DOCUMENT HISTORY:

 Written: 1/11/2016 (Approved: 1/11/2016) - original author not recorded

 Revised: 1/24/2018 - revision not documented

 Revised 8/5/2026 - Added regulatory citations; removed some superfluous and/or redundant text; stylistic changes

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