SOP 007: IRB Approval Criteria

Purpose

This SOP describes the criteria for WVU IRB approval of protocols. Although it is not a requirement for an IRB member to complete the Criteria for Approval Checklist in the electronic system upon his or her review, the checklist is available for the IRB member to use as a guide while making determinations on any research under which these criteria must be satisfied.

General Considerations

1. These criteria must be satisfied for each review (initial, continuing, and amendments) for both expedited review and review by the convened IRB.
2. Risks to participants are minimized:
   • By using procedures that are consistent with sound research design and which do not unnecessarily expose participants to risk; and
   • Whenever appropriate, by using procedures already being performed on the participantsfor diagnostic or treatment purposes
3. Risks to participants are reasonable in relation to anticipated benefits, if any, to participants and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies the participant(s) would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (e.g., the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.
4. Selection of participants 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 involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.
5. Informed consent will be sought from each prospective participant  or the participant’s legally authorized representative, in accordance with and  to the extent required by the Federal Regulations.
   
6. When appropriate, the research plan makes adequate provisions for monitoring the data collected to ensure the safety of participants.
7. When appropriate, there are adequate provisions to protect the privacy of participants and to maintain the confidentiality of data.
   
8. When some or all of the participants 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 have been included in the protocol to protect the rights and welfare of these participants.
   
9. Risk/Benefit assessment: The goal of the assessment is to ensure that the risks to research participants posed by participation in the research are justified by the anticipated benefits to the participants or society.
   
10. Identify the risks associated with the research, as distinguished from the risks of standard procedures the participants would receive even if not participating in research.
    
11. Determine whether the risks are reasonable in relation to the benefits to participants, if any, and assess the importance of the knowledge to be gained.
    
12. Ensure that potential participants will be provided with an accurate and fair description of the risks or discomforts and the anticipated benefits.
    
13. To assess the risk and benefits of the proposed research, the IRB must determine that:
    • The research uses procedures consistent with sound research design;
    • The research design is sound enough to reasonably expect the research to answer its proposed question; and
    • The knowledge expected to result from this research is sufficiently important to justify the risk

    In making this determination, the IRB may draw on its knowledge and disciplinary expertise, or the IRB may draw on the knowledge and disciplinary expertise of others, such as reviews by a funding agency, or departmental review. When scientific review is conducted by an individual or entity external to the IRB, documentation that the above questions were considered must be provided to the IRB for review and consideration. Departmental scientific review is initiated when the electronic system sends notification to the administrative official responsible for the investigator’s research unit that a new protocol was submitted. The administrative official then reviews and acknowledges the new protocol application and alerts WVU OHRP staff or the investigator listed as PI on the protocol if any issues are identified.

14. To approve research, the IRB determines that research studies have the resources necessary to protect participants, such as:
    • Adequate time for the researchers to conduct and complete the research
    • Adequate number of qualified staff
    • Adequate facilities
    • Access to a population that will allow recruitment of the necessary number of participants
    • Availability of medical or psychosocial resources that participants might need as a consequence of the research
15. The IRB determines that the selection of participants is equitable with respect to gender, age, class, etc. by viewing the submitted protocol, and/or other research project materials. The IRB will not approve a protocol that does not provide adequately for the equitable selection of participants or has not provided an appropriate scientific and ethical justification for excluding classes of persons who might benefit from the research. In making this determination, the IRB evaluate:
    • The purpose of the research;
    • The setting in which the research occurs;
    • The scientific and ethical justification for including vulnerable populations such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons;
    • The scientific and ethical justification for excluding classes of persons who might benefit from the research; and
    • The inclusion and exclusion criteria.
16. At the time of the continuing review the IRB will determine that the PI has followed the participant selection criteria that he/she originally set forth at the time of the initial IRB review and approval (See SOP 030: Continuing Review of Approved Research).
17. The IRB will ensure that informed consent will be sought from each prospective participant or the participant’s legally authorized representative, in accordance with and to the extent required by 45 CFR 46.116 and 21 CFR 50.20. In addition, the IRB will ensure that informed consent will be appropriately documented in accordance with, and to the extent required by 45 CFR 46.117 and 21 CFR 60.27 (See also SOP 012: Informed Consent Requirements and SOP 016: Documentation of the Informed Consent Process).
    
18. For all research that is more than minimal risk, the researcher must submit a data safety monitoring plan. The initial plan submitted to the IRB should describe the procedures for safety monitoring, reporting of unanticipated problems involving risks to participants or others, descriptions of interim safety reviews and the procedures planned for transmitting the results to the IRB. This description should include information regarding an independent Data and Safety Monitoring Board (DSMB) if one exists, or an explanation of why an independent data safety monitor is not necessary. (See SOP 036: Research Data Protection and HIPAA for more information.)
    
19. The IRB must determine whether the activities in the research constitute an invasion of privacy. To make that determination, the IRB must obtain information regarding how the researchers are getting access to participants or their private, identifiable information and the participant's expectations of privacy in the situation. Researchers must have appropriate authorization to access the participants or their information. In developing strategies for the protection of participants’ privacy, consideration should be given to:
    • Methods used to identify and contact potential participantsSettings in which an individual will be interacting with a researcher
    • Appropriateness of all personnel present for research activities
    • Methods used to obtain information about participants and the nature of the requested information
    • Information that is obtained about individuals other than the “target participants” and whether such individuals meet the regulatory definition of “human participant” (i.e., a participant provides information about a family member for a survey)
20. At the time of initial review, the IRB ensures that the privacy and confidentiality of research participants is protected. The IRB assesses whether there are adequate provisions to protect participant privacy and maintain confidentiality. The IRB does this through the evaluation of the methods used to obtain information:
    • About participants;
    • About individuals who may be recruited to participate in the research;
    • The use of personally identifiable records; and
    • The methods to protect the confidentiality of the research data.

    The IRB will review all information received from the researcher(s) and determine whether the privacy and confidentiality of research participants is sufficiently protected. In some cases, the IRB may also require that a Certificate of Confidentiality be obtained to provide additional protection for the participant.

    In reviewing confidentiality protections, the IRB shall consider the nature, probability, and magnitude of harms that would likely result from disclosure of collected information outside the research. It shall evaluate the effectiveness of proposed de-identification techniques, coding systems, encryption methods, storage facilities, access limitations, and other relevant factors in determining the adequacy of confidentiality protections.

21. At the time of initial review, the IRB will consider the scientific and ethical reasons for including vulnerable subjects in research (if applicable). The IRB may determine and require that, when appropriate, additional safeguards be put into place for vulnerable participants, such as those with impaired decision-making capacity

Additional Considerations

1. At the time of initial and continuing review, the IRB will make a determination regarding the risks associated with the research protocols. Risks associated with the research will be classified as either “minimal” or “greater than minimal.” The meeting minutes should reflect the IRB’s determination regarding risk levels.
2. At the time of initial review and at continuing review, the IRB will make a determination regarding the frequency of review of the research protocols. All protocols will be reviewed by the IRB at intervals appropriate to the degree of risk and based on SOP 021: Approval Period and Determination of Expiration. In some circumstances, a shorter review interval (i.e. biannually, quarterly, or after accrual of a specific number of participants) may be required (see 4.3). The meeting minutes will reflect the IRB’s determination regarding review frequency.
3. Research that meets any of the following criteria could require review more than annually:
   • Significant risk to research participants (i.e. death, permanent or long-lasting disability or morbidity, severe toxicity) without the possibility of direct benefit to the participants.
   • Involvement of especially vulnerable populations likely to be participants to coercion (i.e. terminally ill).
   • History of serious or continuing non-compliance on the part of the PI.

   Please note: This is not an exhaustive list. At any time, the IRB may determine that research meets criteria to require review more than annually.

   The following factors will also be considered when determining which studies require review more frequently than on an annual basis:

   • The probability and magnitude of anticipated risks to participants.
   • The likely medical condition of the proposed participants.
   • The overall qualifications of the PI and other members of the research team.
   • The specific experience of the responsible researcher and other members of the research team in conducting similar research.
   • The nature and frequency of adverse events observed in similar research at this and other institutions
   • The novelty of the research making unanticipated adverse events more likely.
   • Any other factors that the IRB deems relevant.
4. The IRB recognizes that protecting the rights and welfare of participants sometimes requires that the IRB verify independently, utilizing sources other than the researcher that no material changes occurred during the IRB-designated approval period. Independent verification from sources other than the researcher may be necessary at times, for example, in cooperative studies or other multi-center research.

   The IRB will determine the need for verification from outside sources on a case-by-case basis and according to the following criteria:

   • Protocols where concern about possible material changes occurring without IRB approval have been raised based on information provided in continuing review reports or from other sources.
   • Protocols conducted by researchers who have previously failed to comply with federal regulations and/or the requirements or determinations of the IRB.
   • Protocols subject to internal audit.
   • Whenever else the IRB deems verification from outside sources is relevant.

   The following factors will also be considered when determining which studies require independent verification:

   • The probability and magnitude of anticipated risks to participants.
   • The likely medical condition of the proposed participants.
   • The probable nature and frequency of changes that may ordinarily be expected in the type of research proposed.

   In making determinations about independent verification, the IRB may prospectively require that such verification take place at predetermined intervals during the approval period or may retrospectively require such verification at the time of continuing review, review of amendments, and/or unanticipated problems.

   If any material changes have occurred without IRB review and approval, the IRB will decide on the corrective action to be taken.

5. In reviewing the adequacy of informed consent procedures for proposed research, the IRB may on occasion determine that special monitoring of the consent process by an impartial observer (consent monitor) is required to reduce the possibility of coercion and undue influence. Such monitoring may be particularly warranted where the research presents significant risks to participants, or if participants are likely to have difficulty understanding the information to be provided. Monitoring may also be appropriate as a corrective action where the IRB has identified problems associated with a particular researcher or a research project.
6. The IRB follows and must adhere to applicable state and local laws in the jurisdictions where the research is taking place. The WVU OHRP and the IRB will rely on the WVU General Counsel for the interpretation and application of West Virginia State law and the laws of any other jurisdiction where research is conducted as they apply to human subject research. All consent forms must be consistent with applicable state and local laws.
   
7. Deception occurs when researchers provide false or incomplete information to participants. The IRB accepts the need for certain types of behavioral and social science studies (and in rare cases, biomedical research) to employ strategies that include deception. Employment of such strategies must, however, be justified. In general, deception is not acceptable if, in the judgment of the IRB, the participant may have declined to participate had they been informed of the true purpose of the research. Studies that use deception as part of their experimental design must meet all the requirements of 45 CFR §46.116(d), described below, and include a post-project debriefing unless an exception is granted by the IRB. If such an exception is requested, this will require full board review. If the research includes the use of deception, the investigator must:
   • Provide justification for the deception (e.g., why the research could not be conducted without deception);
   • Describe the manner of deception (e.g., the participants are not informed of the true intent of the research) and/or how the deception will take place (e.g., an associate will simulate an accident);
   • Note whether the deception results in an increased risk to participants (e.g., associates engage in a staged altercation, which could result in emotional upset) or the effect of the deception on a subject’s willingness to participate in research;
   • Describe how any additional risks would be minimized; and
   • Offer the participant the option to withdraw their data from the research project in the debriefing script

References

WVU Policies:

• SOP 012: Informed Consent Requirements

Federal Regulations:

• 21 CFR 56.111
• 21 CFR 812
• 45 CFR 46.111

AAHRPP:

• Standard II-2