2.5 Criteria for IRB Approval

Last Revised: 1/24/20188/5/2026

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 and procedure is to describe the Organization’s criteria for IRB approval forof human subject research, reviewed both by the full convened IRB or thorough an expedited review process.

---

2.0 Policy

It is the policy of the Organization that human subject research must satisfy certain 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 for IRB approval must be satisfied in full accordance with applicable federal regulations and HRPP policies which contain greater detail about how the IRB interprets and applies these criteria. The criteria must be met before the IRBIRB/ORA can grant approval of any submission by expedited review or full IRB review.approval.

• 3.1.

  Risks to subjects are minimized: (i) Byby 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.purposes (45 CFR 46.111(a)(1); 21 CFR 56.111(a)(1)).
  • 3.1.1. The IRB will:
    • 3.1.1.1. EnsureDetermine that the PI and other study personnel have the necessary qualifications, experience (and medical licensure
      if
    • 3.1.1.1.1. The credentialing processes at Nebraska Medicine, BMC or CHMC in advance of IRB review will facilitate IRB assessment that investigators and study staff are qualified
  appropriate).
• 3.1.1.2. EvaluateDetermine that the study design is adequate to achieve the aims of the research design in order to ensure that it is both sound and does not unnecessarily expose subjects to risk.
• 3.1.1.3. EnsuringDetermine thatthat, as appropriate, the research usesutilizes procedures already being performed on the subjects for diagnostic or treatment purposes
• 3.1.1.4. AssessDetermine whetherthat risks arehave 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. UtilizeAssure reviewersthat (orthe otherprotocol is reviewed by IRB members or consultants)consultants to the IRB who have familiarity with the procedures being performed, and who therefore canare moreable ablyto 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.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 carefullyonly evaluateconsider therisks protocol in order to identify all risks. A risk is a potential harm (injury) associated withof 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 reasonable person in the subject positionparticipant would likelyfind considerthem significant.meaningful Riskswhen candeciding bewhether generallyto categorizedconsent. as physical, psychological, sociological, economic, and legal.

• 3.2.4.

  InWhen evaluatingconsidering thepotential risk(s)benefits ofassociated with the research, the IRB will use the criteria that the risk(s) must be “reasonably foreseeable“. This means data exists which indicate there is a reasonable possibility that the subject could experience the harm described. It does not mean that every known risk associated with each research intervention must be addressed. It is also important to consider when a harm may be irreversible.

3.2.5. The IRB will assess thedirect anticipated benefits to subjects (if any) and the importance of the knowledge that may be reasonably expected to result from the research. In

Note: making this assessment, theThe IRB will consider the background section, the literature citations, and other sections of the IRB application and other related materials (for example, the detailed protocol or the published literature) which support the PI’s statement of anticipated benefits. The IRB doesgenerally not classifyconsider financial compensation to the subject as a “benefit” in the context of the risk-benefit relationship.

3.2.6.5. 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 as(that opposedis, toby not choosing available alternatives which may be more advantageous.advantageous).

3.2.7.6. TheAs part of its analysis of the risk-benefit relationship, the IRB will assessconsider thatwhether the researchresearchers hashave the necessary resources to protect subjects:subjects,

as described 3.2.7.in HRPP policy 1.9 Adequate(Resources time for the researchersNecessary to conductProtect and complete the research. 3.2.7.2. Adequate number of qualified staff. 3.2.7.3. Adequate facilities. 3.2.7.4. Access to a population that will allow recruitment of the necessary number of participants. 3.2.7.5. Availability of medical or psychosocial resources that participants may need as a consequence of the research. 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.persons (45 CFR 46.111(a)(3); 21 CFR 56.111(a)(3)).

• 3.3.1. The IRB will assess the IRB application and other related materials (for example, recruitment materials) in order to ensure that the selection of subjects is equitable with respect to age, gender, reproductive status, ethnicity, inclusion of vulnerable populations and any other factors that affect the equitable selection of subjects. No group should receive a disproportionate share of the benefits of the research or bear a disproportionate burden.

3.3.2. In making this assessment the IRB will evaluate at least the following:

• 3.3.2.1. PurposeStudy of the research.population
• 3.3.2.2. SettingInclusion inand which the research occurs

3.3.2.3. Whether prospective subjects will be vulnerable to coercion or undue influence 3.3.2.4. The selection (inclusion/exclusion)exclusion criteria 3.3.2.5.3. Scientific and ethical justification for inclusion of vulnerable populationssubjects (see HRPP policy 4.1 [Additional Protections for Vulnerable Persons]) 3.3.2.6.4. Scientific and ethical justification for excluding classes of persons who might benefit from the research. 3.3.2.7.5. Subject recruitmentidentification and enrollmentrecruitment procedures 3.3.2.8. The influence of compensation to participants 3.3.3. The IRB’s assessment of equitable subject selection will be made at the time of initial review, continuing review, and changes in protocol.

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 Federalfederal Regulations.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 and ICFs in order to determine that legallyLegally 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,influence andThe whichinformation includesthat 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.participate, Inand additionan opportunity to ensuringdiscuss that theinformation. ICFInformed containsconsent allwill requiredbegin elementswith a concise and focused presentation of informedthe consent,key information that is most likely to assist a prospective subject or legally authorized representative in understanding the Boardreasons mustwhy alsoone determinemight thereor 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 anmade appropriateto 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 into considerationassure that the requirements of theHRPP naturepolicies 5.1 (Obtaining Informed Consent from Research Subjects), 5.2 (Waiver or Alteration of theInformed research, risks associated with the research,Consent and theHIPAA characteristicsAuthorization) ofand theother subjectrelevant population.polies are 3.4.2. The IRB will determine which projects should have a third party observe the consent process.satisfied.

3.5.

Informed consent will be appropriately documented,documented or appropriately waived, in accordance with,with andfederal toregulations the(45 extentCFR required46.111(a)(5); by21 theCFR Federal Regulations.56.111(a)(5)).

• 3.5.1. The IRB will review the IRBinformed applicationconsent documents (and ICFsrequest infor orderwaiver to determine that all individuals involved in the obtainment andof documentation of informed consentconsent) haveto assure that the necessaryrequirements expertiseof asHRPP wellpolicies as5.1 sufficient(Obtaining knowledgeInformed aboutConsent thefrom protocolResearch Subjects), 5.4 (Waiver of Requirement to Obtain Signed Consent Form) and IRBother consentrelevant requirements.

policies are 3.5.2. Under certain circumstances, the IRB may determine that obtainment and documentation of informed consent by a physician or dentist will be required for some trials.satisfied.

3.6.

When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.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 (e.g., detailed protocol) in order to determineassure that the safety monitoring plan makes adequate provision for monitoring the involvementrequirements of subjectsHRPP policy 3.2 (Data and theSafety collectionMonitoring) ofare data to ensure the safety of subjects.satisfied.
• 3.6.2. The overall elements of the monitoring plan will vary depending on the potential risks, complexity, and nature of the research. These may vary from monitoring by the PI in a small, low risk study to the establishment of an independent data and safety monitoring board (DSMB).

3.6.3. The IRB will also determine whetherreview the researchIRB requiresapplication reviewand moreother oftenrelated thanmaterials annually,to asassure describedthat inthe requirements of HRPP policy 3.1 (Assessing the Need for Increased Monitoring, Interim Continuing Review, and Verification from Sources Other than the PI). are 3.6.4. The approval period will be documented in the IRB records and conveyed to the PI. 3.6.5. The IRB will determine which projects need verification from sources other than the PI that no material changes have occurred in the research since the previous IRB review. 3.6.6. The IRB will determine which projects require an audit of research records.satisfied.

3.7.

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

• 3.7.1. PrivacyThe refersIRB towill persons and their interest in controlling access to themselves. In order to ensure protection of subject’s privacy,review the IRB willapplication applyand other related materials to assure that the followingrequirements criteria:of
  HRPP
• policies 3.7.1.1.

3 The(Privacy methods used to identifyInterests and contactConfidentiality prospectiveof subjectsResearch isData), acceptable.3.4 (Use 3.7.1.2.of TheProtected settingsHealth Information in whichResearch) theand individual3.12 will(Ethical participateAccess) in the consent process as well as the research adequately protect privacy. 3.7.1.3. The personnel involved in the researchand are appropriate in consideration of their responsibilities. 3.7.1.4. All necessary procedures are in place during the research to protect privacy.satisfied. 3.7.2. Confidentiality refers to protecting data. In order to ensure there is an appropriate plan to maintain confidentiality and minimize the possibility that information will be inappropriately disclosed, the IRB will apply the following criteria:

3.7.2.1. The reason(s) for disclosing data to individuals, sponsors or other organizations is justified. 3.7.2.2. The procedures for securing and transmitting data are acceptable. 3.7.2.3. The potential harm that may result from inappropriate disclosure of research data is minimized.

3.8. When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.subjects (45 CFR 46.111(b); 21 CFR 56.111(b)).

• 3.8.1. The IRB will review the characteristicsIRB ofapplication and other related materials to assure that the proposed subject population in consideration of:
• 3.8.1.1. The nature and risksrequirements of the research.

3.8.1.2. Whether the subjects are likely to be vulnerable to coercion, undue influence, or more susceptible to risk. 3.8.2. The IRB will ensure that additional safeguards are included in the protocol in order to fully protect the rights and welfare of vulnerable subjects in accordance with HRPP policy 4.1 (Additional Protections for Vulnerable Populations).Persons) are satisfied.

---

4.0 Additional Considerations

In addition to the specific criteria described in section 3.0,above, the IRB will consider other applicable federal, state and local law and regulations, Organization policies, and basic ethical principles (asincluding those described in the Belmont Report, orand 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