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Resources: For Accreditation - Evaluation Instrument

Evaluation Instrument for Accreditation

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Latest Update: May 15, 2022

Table of Contents

INTRODUCTION DOMAIN I: ORGANIZATION DOMAIN II: INSTITUTIONAL REVIEW BOARD OR ETHICS COMMITTEE DOMAIN III: RESEARCHER AND RESEARCH STAFF TABLES

ELEMENT II.4.A.

ELEMENT II.4.A.: The IRB or EC has and follows written policies and procedures for determining the risks to prospective participants who are vulnerable to coercion or undue influence and ensuring that additional protections are provided as required by applicable laws, regulations, codes, and guidance.
The IRB or EC should evaluate research to judge whether the research involves participants who are vulnerable to coercion or undue influence. When some or all of the participants are likely to be vulnerable, the IRB or EC should ensure that additional safeguards are included in the research design to protect the rights and welfare of these participants. If the IRB or EC reviews research that involves children; pregnant women, fetuses, or neonates; prisoners; or adults who lack the ability to consent, or the IRB or EC regularly reviews research that involves other vulnerable individuals (for example, students, employees, or economically or educationally disadvantaged persons, or homeless persons), the IRB or EC should have written policies and procedures regarding additional protections for these categories.
 
It is impractical to have specific policies for every vulnerable population that might be involved in research. Therefore, when a research study involves vulnerable populations not otherwise covered by specific policies and procedures, policies and procedures should describe in general the steps followed by the IRB or EC to evaluate such research to determine the need for additional protections.
In research involving no more than minimal risk and vulnerable populations, the IRB or EC may decide that existing protections are sufficient and no additional protections are warranted.  Conversely, sometimes when research involves no more than minimal risk, additional protections for vulnerable populations might be appropriate.

If additional protections for vulnerable populations are not required under laws, regulations, codes, and guidance, then policies and procedures should describe equivalent protections.  Equivalent protections ensure safeguards are in place to protect vulnerable populations, while allowing flexibility in review. 

Regulatory and guidance references


Required written materials

  1. Essential requirements for IRB or EC review:
    1. Policies and procedures describe the process to evaluate risks to vulnerable participants and ensure additional protections are provided:
      1. Applications include whether some or all of the participants are likely to be vulnerable to coercion or undue influence.
      2. When some or all of the participants are likely to be vulnerable, applications include a description of additional safeguards included in the protocol to protect their rights and welfare.
      3. In order to approve research where some or all of the participants are likely to be vulnerable, policies and procedures have the IRB or EC determine whether additional safeguards have been included in the protocol to protect their rights and welfare.
      4. If research involves pregnant women, fetuses, or neonates, policies and procedures have the IRB or EC follow Subpart B of the DHHS regulations or equivalent protections as allowed by law.
        1. If the organization chooses not to apply Subpart B to all research regardless of funding, policies and procedures include equivalent protections for participants in non-funded research.
      5. If research involves prisoners as participants, policies and procedures have the IRB follow Subpart C of the DHHS or equivalent protections as allowed by law.
        1. If the organization chooses not to apply Subpart C to all research regardless of funding, procedures include equivalent protections for participants in non-funded research.
        2. If the convened IRB or EC reviews research that involves prisoners, policies and procedures indicate that one or more individuals who are prisoners or prisoner representatives have to be present at the meeting.
      6. If research involves children as participants, policies and procedures have the IRB or EC follow Subpart D of the DHHS or equivalent protections as allowed by law.
        1. If the organization chooses not to apply Subpart D to all research regardless of funding, procedures include equivalent protections for participants in non-funded research.
      7. If research involves adults unable to consent, policies and procedures have the IRB or EC consider specific criteria for approval of such research that provides additional safeguards to protect their rights and welfare.
      8. If the IRB or EC regularly reviews research that involves other vulnerable populations, policies and procedures describe the steps the IRB or EC follows to evaluate whether additional safeguards are included in research to protect the rights and welfare of these participants.
  2. When following DHHS regulations:
    1. Policies and procedures have the IRB or EC follow the requirements specified in Subpart B for research involving pregnant women, fetuses, or neonates; Subpart C for research involving prisoners; and Subpart D for research involving children.
  3. When following DoD requirements organizations must comply with all requirements in Subparts B, C, and D, with the qualifications below:
    1. Research involving pregnant women, prisoners, and children are subject to the DHHS Subparts B, C, and D, except where modified by DoDI 3216.02.
    2. For purposes of applying Subpart B, the phrase “biomedical knowledge” is replaced with “generalizable knowledge.”
      1. The applicability of Subpart B is limited to research involving pregnant women as participants in research that is more than minimal risk and included interventions or invasive procedures to the woman or the fetus or involving fetuses or neonates as participants.
      2. Fetal research must comply with the US Code Title 42, Chapter 6A, Subchapter III, Part H, 289g.
        1. Research or experimentation may not be conducted, in the United States or in any other country, on a nonviable living human fetus ex utero or a living human fetus ex utero for whom viability has not been ascertained unless the research or experimentation:
          1. May enhance the well-being or meet the health needs of the fetus or enhance the probability of its survival to viability; or
          2. Will pose no added risk of suffering, injury, or death to the fetus and the purpose of the research or experimentation is the development of important biomedical knowledge which cannot be obtained by other means.
        2. The risk standard must be the same for fetuses which are intended to be aborted and fetuses which are intended to be carried to term.
    3. For human participant research that would not otherwise be approved but presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of pregnant women, fetuses, or neonates, written approval from the DOHRP must be obtained through the COHPR prior to research starting.
    4. In addition to the categories of permissible human participant research involving prisoners identified in DHHS regulations Subpart C, two additional categories are permissible:
      1. Epidemiological research is permitted under the following conditions:
        1. Where the sole purpose of the research is to describe the prevalence or incidence of a disease by identifying all cases, or study potential risk factor associations for a disease.
        2. The research presents no more than minimal risk.
        3. The research presents no more than an inconvenience to the participant.
        4. Prisoners are not a particular focus of the research.
      2. Human participant research involving prisoners that would otherwise meet exemption criteria may be conducted, but must first be approved by an IRB and meet the requirements of Subpart C and DoDI 3216.02.
    5. DoD organizations conducting research involving prisoners must demonstrate to the senior designated official that the IRB has fulfilled its duties in accordance with Subpart C.
    6. When a previously enrolled human participant becomes a prisoner, and the protocol has not been reviewed and approved by the IRB in accordance with Subpart C, the researcher must promptly notify the IRB.
      1. For DoD-conducted research, the human protections director must notify the COHRP.
      2. For DoD-supported research, the non-DoD organization must notify the DOHRPO and other federal agencies.
      3. The DOHRP must concur with the IRB before the participant can continue to participate while a prisoner.
    7. Research involving a detainee or a prisoner of war as a human participant is prohibited.
      1. This prohibition does not apply to activities covered by investigational new drug or investigational device provisions of FDA regulations, when the purpose is for diagnosis or treatment of a medical condition in a patient.
      2. Such treatment may be offered to detainees or prisoners of war with their informed consent when the medical products are subject to FDA regulations, and only when the same product may be available to DoD-affiliated personnel consistent with established medical practices.
    8. Service members and DoD-affiliated personnel are considered to be vulnerable to coercion and undue influence by the DoD due to the nature of the command structure of the organization. Therefore, additional protections for DoD-affiliated personnel are required, as follows (DoDI 3216.02 section 3.9 (f)):
      1. If the research involves DoD-affiliated personnel as participants and if the research includes any risks to their fitness for duty (e.g., health, availability to perform job, data breach), the informed consent document must inform DoD-affiliated personnel about these risks and that they should seek command or component guidance before participating.
      2. If the research involves DoD-affiliated personnel, the researcher must receive command or component approval to execute the research.
      3. Military and civilian supervisors, officers, and others in the chain of command are prohibited from influencing their subordinates to participate in research.
      4. Military and civilian supervisors, officers, and others in the chain of command must not be present at any participant recruitment sessions or during the consent process for DoD-affiliated personnel. Excluded supervisors or those in the chain of command may participate in separate recruitment sessions, if applicable.
      5. Service members and all Reserve component and National Guard members in a federal duty status are considered to be adults. If a Service member, Reserve component or National Guard member in federal duty status, student at a Service Academy, or trainee is under 18 years of age, the IRB must carefully consider the HSR recruitment process and the necessity of including such member as a human participant.
      6. In order to approve research involving DoD-affiliated personnel, the IRB or component HRPO must determine whether the following requirements have been satisfied:
        1. The consent documentation must include, if applicable, potential risks for revocation of clearance, credentials, or other privileged access or duty.
        2. For research involving recruitment of DoD-affiliated personnel in research determined to be greater than minimal risk, and when recruitment occurs in a group setting, the IRB must appoint an ombudsperson. The ombudsperson:
          1. Must not have a conflict of interest with the research or be a part of the research team.
          2. Must be present during the recruitment, monitoring that the recruitment and informed consent explain that participation is voluntary and that the information provided about the research is consistent with the IRB-approved script and materials, including digitally provided materials.
          3. Should be available to address DoD-affiliated personnel’s concerns about participation.
      7. Compensation to DoD-affiliated personnel for participation in research while on duty is prohibited in accordance with 5 USC, with particular reference to Subparts G and H, with some exceptions for purposes consistent with 24 USC 30.
    9. Research involving large-scale genomic data from DoD-affiliated personal is subject to additional requirements (DoDI 3216.02 section 3.10):
      1. The disclosure of DoD-affiliated personnel’s genomic data may pose a risk to national security; accordingly, written materials must describe administrative, technical, and physical safeguards commensurate with risk, including the secondary use or sharing of de-identified data or specimens.
      2. All research involving large-scale genomic data collected from DoD-affiliated personnel must have a certificate of confidentiality from DHHS (Title 42, U.S.C., and Public Law 114-255).
      3. Research involving large-scale genomic data collected from DoD-affiliated personnel is subject to DoD component security review to ensure the adequacy of the proposed administrative, technical, and physical safeguards, including the secondary use or sharing of de-identified data or specimens.
    10. DoD organizations must demonstrate to the senior designated official that the IRB has fulfilled its duties in accordance with DHHS Subpart D, 45 CFR 46. 407 and 21 CFR 50.54.
  4. When following DOE requirements:
    1. DOE and DOE site employees are considered vulnerable subjects when participating in research and additional care must be taken to ensure their participation is truly voluntary (e.g., by ensuring they do not report to members of the research team) and that data collected about them is kept confidential.
    2. Policies must include direction for the IRB to consider if additional protections are required for research involving employees and contractors.
  5. When following EPA regulations:
    1. Policies and procedures include that for research conducted or supported by the EPA, research involving intentional exposure of pregnant women or children to any substance is prohibited and not approved by the IRB or EC.
    2. Policies and procedures include that for research intended for submission to the EPA, research involving intentional exposure of pregnant women or children to any substance is prohibited and not approved by the IRB or EC.
    3. Policies and procedures have the IRB review observational research involving pregnant women and fetuses using 40 CFR 26 and 45 CFR 46 Subpart B.
    4. Policies and procedures allow the IRB to review and approve observational research involving children that does not involve greater than minimal risk only if the IRB finds that adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians, as set forth in 26.406.
    5. Policies and procedures allow the IRB to review and approve observational research involving children that involves greater than minimal risk but presenting the prospect of direct benefit to the individual participants if the IRB finds and documents that:
      1. The intervention or procedure holds out the prospect of direct benefit to the individual participant or is likely to contribute to the participant's well-being.
      2. The risk is justified by the anticipated benefit to the participants.
      3. The relation of the anticipated benefit to the risk is at least as favorable to the participants as that presented by available alternative approaches.
      4. Adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians, as set forth in 26.406.
  6. When following FDA regulations:
    1. Policies and procedures have the IRB or EC follow the requirements specified in Subpart D for research involving children.
  7. When following the ICH-GCP (E6) guideline:
    1. When adults are unable to consent, policies and procedures have the IRB or EC determine:
      1. A non-therapeutic clinical trial (i.e., a trial in which there is no anticipated direct clinical benefit to the participant) should be conducted in participants who personally give consent and who sign and date the written consent document.
      2. Non-therapeutic clinical trials may be conducted in participants with consent of a legally acceptable representative provided the following conditions are fulfilled:
        1. The objectives of the clinical trial cannot be met by means of a trial in participants who can give consent personally
        2. The foreseeable risks to the participants are low
        3. The negative impact on the participant’s well-being is minimized and low
        4. The clinical trial is not prohibited by law; and
        5. The opinion of the IRB or EC is expressly sought on the inclusion of such participants, and the written opinion covers this aspect. Such trials, unless an exception is justified, should be conducted in patients having a disease or condition for which the investigational product is intended. Participants in these trials should be particularly closely monitored and should be withdrawn if they appear to be unduly distressed.
  8. When following VA requirements:
    1. Policies and procedures have the IRB find and document in the minutes or IRB records specific findings in accordance with VA requirements.
    2. Policies and procedures indicate:
      1. Research that involves provision of in vitro fertilization services is permitted and can be conducted by VA researchers while on official VA duty, or at VA facilities, or at VA-approved off-site facilities.
        1. This includes prospective and retrospective research involving provision of or the enhancement of FDA-approved methods of in vitro fertilization for studies involving consenting participants, both male and female, undergoing or who have undergone in vitro fertilization for the treatment of certain forms of human infertility. In vitro fertilization is any fertilization of human ova that occurs outside the body of a female, either through a mixture of donor human sperm and ova or by any other means.
      2. Prospective and retrospective studies that enroll or include pregnant participants who conceived through in vitro fertilization or other artificial reproductive technologies are permitted.
      3. Research in which the focus is either a fetus, either in-utero or ex-utero, can be conducted by VA researchers while on official VA duty, at VA facilities, or at VA-approved off-site facilities. Use of human fetal tissue and human stem cells shall be governed by the policy set by NIH for recipients of NIH research funding. 
      4. Research involving the creation of a human embryo or embryos solely for research purposes or research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR 46.208(a)(2) and Section 498B of the Public Health Service Act (42 U.S.C. 289g(b)) cannot be conducted by VA researchers, at VA facilities, or at VA-approved off-site facilities. 
      5. VA researchers cannot conduct interventions in research that include neonates while on official VA duty, at VA facilities, or at VA-approved off-site facilities. VA researchers may conduct research involving noninvasive monitoring of neonates if the research is determined by the IRB to be minimal risk. Prospective observational and retrospective record review studies that involve neonates or neonatal outcomes are permitted.
      6. Research involving prisoners cannot be conducted by VA researchers while on official VA duty, at VA facilities, or at VA-approved off-site facilities unless a waiver has been granted by the CRADO.
      7. Research involving children as participants is not allowed unless a waiver has been granted by the VA medical facility director. Research involving children may not pose greater than minimal risk to the child.
        1. Biological specimens and data obtained from children is considered research involving children even if deidentified.
      8. Before approving international research involving human participants research, the IRB must ensure that human participants outside of the U.S. who participate in research projects in which VA is a collaborator receive equivalent protections as research participants inside the U.S.
        1. If the activity involves research involving human participants requiring IRB approval or limited IRB review, the VA medical facility director must approve participation in the proposed international research.

    Common types of materials that may be used to meet the element

    • Application form
    • Reviewer checklist

    Outcomes

    • IRB or EC members determine whether additional safeguards are required in research that involves vulnerable individuals in order to protect their rights and welfare.
    • The IRB or EC documents required determinations and provides protocol-specific findings justifying the determinations.

    Proceed To: ELEMENT II.4.B.