ELEMENT II.4.B.

ELEMENT II.4.B.: The IRB or EC has and follows written policies and procedures requiring appropriate protections for prospective participants who cannot give consent or whose decision-making capacity is in question.

The IRB or EC should determine whether the research involves participants whose decision-making capacity is in question. When some or all of the participants are likely to have diminished decision-making capacity, the IRB or EC should consider whether additional safeguards are needed as part of the consent process. The IRB or EC should evaluate whether research submitted for review satisfies this criterion. If the IRB or EC reviews research that involves children, fetuses, neonates, prisoners, or adults who lack the ability to consent, or the IRB or EC regularly reviews research involving other populations who have diminished decision-making capacity, the IRB or EC should have written policies and procedures regarding the consent process for these individuals. When a research study involves a population that has a diminished decision-making capacity not otherwise covered by specific policies and procedures, policies and procedures should describe in general the steps the IRB or EC uses to evaluate the consent process in this population.

Regulatory and guidance references

DHHS: 45 CFR 46.204, 45 CFR 46.205, 45 CFR 46.305, 45 CFR 46.402(a)-(c), 45 CFR 46.408
DOD: Instruction 3216.02 9
ED: 34 CFR 98.4
FDA: 21 CFR 50.3(l), 21 CFR 50.3(n), 21 CFR 50.55
ICH-GCP: 3.1.6, 4.8,12, 4.8.13, Public Law 107-110 Jan. 8, 2002 Part E
VA: VHA Handbook 1200.05, 36, 45, 46, 47, 48, 49
AAHRPP Tip Sheet: Following the Guideline of the International Conference on Harmonisation – Good Clinical Practice (E6)
AAHRPP Tip Sheet: Reviewing Research Involving Adult Participants with Diminished Functional Abilities Related to Capacity to Consent
AAHRPP Tip Sheet: Review of Research involving Prisoners and the Role of the Prisoner Representative
AAHRPP Tip Sheet: Sufficient Information to Determine Whether the Criteria for Approval are Met

Required written materials

Essential requirements:
1. Policies and procedures have the IRB or EC evaluate whether the research involves participants who have diminished decision-making capacity and, if so, provide additional safeguards to ensure an appropriate consent process.
  1. When a research study involves populations with diminished decision-making capacity not covered by specific policies and procedures, policies and procedures describe, in general, the steps followed by the IRB or EC to evaluate the consent process for these populations.
  2. When research involves pregnant women, fetuses, or neonates, policies and procedures have the IRB or EC follow Subpart B of the DHHS regulations or equivalent laws or regulations to approve an appropriate consent process.
  3. When research involves prisoners as participants, policies and procedures have the IRB or EC follow Subpart C of the DHHS regulations or equivalent laws or regulations to approve an appropriate consent process that includes a determination that:
    1. The information will be presented in language that is understandable to prisoners.
    2. Each prisoner will be informed in advance that participation in the research will have no effect on his or her parole.
  4. When research involves children as participants, policies and procedures have the IRB or EC follow Subpart D of the DHHS or FDA regulations or equivalent laws or regulations to approve an appropriate assent process for children and consent process for parents or guardians.
  5. When researchers are likely to approach adults who lack the ability to consent, policies and procedures have the IRB evaluate whether:
    1. The proposed plan for the assessment of the capacity to consent is adequate.
    2. Assent of the participants is a requirement, and, if so, whether the plan for assent is adequate.
When following DHHS regulations:
1. When research involves pregnant women, policies and procedures have the IRB or EC determine that the consent of the pregnant women is required if the research holds out:
  1. The prospect of direct benefit to the pregnant woman.
  2. The prospect of direct benefit both to the pregnant woman and the fetus.
  3. No prospect of benefit for the woman or the fetus when risk to the fetus is not greater than minimal and the purpose of the research is the development of important biomedical knowledge that cannot be obtained by any other means.
  4. When research involves pregnant women and holds out the prospect of direct benefit solely to the fetus, policies and procedures have the IRB or EC determine that the consent of the pregnant woman and the father is required, except that the father’s consent need not be obtained if he is unable to consent because of unavailability, incompetence, or temporary incapacity or the pregnancy resulted from rape or incest if the research holds out the prospect of direct benefit solely to the fetus.
  5. When the research involves neonates of uncertain viability, policies and procedures have the IRB or EC determine that the consent of either parent of the neonate is required or, if neither parent is able to consent because of unavailability, incompetence, or temporary incapacity, the legally effective consent of either parent’s legally authorized representative is required, except that the consent of the father or his legally authorized representative need not be obtained if the pregnancy resulted from rape or incest.
2. When the research involves non-viable neonates, policies and procedures have the IRB or EC determine that the consent of both parents is required, except:
  1. If either parent is unable to consent because of unavailability, incompetence, or temporary incapacity, the consent of one parent is required.
  2. If the pregnancy resulted from rape or incest the consent of the father need not be obtained.
  3. When the research involves non-viable neonates, policies and procedures did not allow the IRB or EC to approve the consent of a legally authorized representative.
When following DHHS or FDA regulations:
1. When research involves children, policies and procedures have the IRB or EC following the requirements in Subpart D pertaining to obtaining assent of children and permission of the parents or guardian.
2. For research that involves no more than minimal risk or more than minimal risk with the prospect of direct benefit to the individual children, policies and procedures have the IRB or EC determine whether:
  1. The permission of both parents is required unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child, or the permission of one parent is sufficient.
  2. For research that involves more than minimal risk without the prospect of direct benefit to the individual children, policies and procedures have the IRB or EC determine that the permission of both parents is required unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.
3. Policies and procedures have the IRB or EC determine and document that assent is a requirement of:
  1. All children.
  2. Some children.
  3. None of the children.
4. When the IRB or EC determines that assent is not a requirement of some children, policies and procedures have the IRB or EC determine and document which children are not required to assent.
5. When the IRB or EC determines that assent is not a requirement for some or all children, policies and procedures have the IRB or EC determine and document one or more of the following:
  1. The children are not capable of providing assent based on the age, maturity, or psychological state.
  2. The capability of the children is so limited that they cannot reasonably be consulted.
  3. The intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the child and is available only in the context of the research.
  4. Assent can be waived using the criteria for waiver of the consent process.
6. When the IRB or EC determines that assent is a requirement, policies and procedures have the IRB determine whether:
  1. Assent will be documented.
  2. If so, the process to document assent.
When following DoD requirements:
1. If consent is to be obtained from the legal representative of the experimental subjects as defined in DODI 3216.02, the research must intend to benefit each participant enrolled in the study.
When following ED requirements:
1. Policies and procedures include a process to comply with the Protection of Pupil Rights Amendment. This process may occur outside the IRB or EC:
2. For certain types of research projects directly funded by the U.S. Department of Education: No student will be required, as part of any research project, to submit without prior consent to surveys, psychiatric examination, testing, or treatment, or psychological examination, testing, or treatment, in which the primary purpose is to reveal information concerning one or more of the following:
  1. Political affiliations or beliefs of the student or the student’s parent.
  2. Mental or psychological problems of the student or the student’s family.
  3. Sex behavior or attitudes.
  4. Illegal, anti-social, self-incriminating, or demeaning behavior.
  5. Critical appraisals of other individuals with whom respondents have close family relationships.
  6. Legally recognized privileged or analogous relationships, such as those of lawyers, physicians, and ministers.
  7. Religious practices, affiliations, or beliefs of the student or student’s parent.
  8. Income (other than that required by law to determine eligibility for participation in a program or for receiving financial assistance under such program).
3. Prior consent means:
  1. Prior consent of the student, if the student is an adult or emancipated minor.
  2. Prior written consent of the parent or guardian, if the student is not an emancipated minor.
4. For certain types of research projects not directly funded by the U.S. Department of Education and conducted in a school that receives funding from the U.S. Department of Education: Policies and procedures include a process to verify compliance with U.S. Department of Education regulations that schools are required to develop and adopt policies in conjunction with parents regarding the following:
  1. The right of a parent of a student to inspect, upon the request of the parent, a survey created by a third party before the survey is administered or distributed by a school to a student.
    1. Any applicable procedures for granting a request by a parent for reasonable access to such survey within a reasonable period of time after the request is received.
  2. Arrangements to protect student privacy that are provided by the agency in the event of the administration or distribution of a survey to a student containing one or more of the following items (including the right of a parent of a student to inspect, upon the request of the parent, any survey containing one or more of such items):
    1. Political affiliations or beliefs of the student or the student’s parent.
    2. Mental or psychological problems of the student or the student’s family.
    3. Sex behavior or attitudes.
    4. Illegal, anti-social, self-incriminating, or demeaning behavior.
    5. Critical appraisals of other individuals with whom respondents have close family relationships.
    6. Legally recognized privileged or analogous relationships, such as those of lawyers, physicians, and ministers.
    7. Religious practices, affiliations, or beliefs of the student or the student’s parent.
    8. Income (other than that required by law to determine eligibility for participation in a program or for receiving financial assistance under such program).
  3. The right of a parent of a student to inspect, upon the request of the parent, any instructional material used as part of the educational curriculum for the student.
  4. Any applicable procedures for granting a request by a parent for reasonable access to instructional material received.
  5. The administration of physical examinations or screenings that the school or agency may administer to a student.
  6. The collection, disclosure, or use of personal information collected from students for the purpose of marketing or for selling that information (or otherwise providing that information to others for that purpose), including arrangements to protect student privacy that are provided by the agency in the event of such collection, disclosure, or use.
  7. The right of a parent of a student to inspect, upon the request of the parent, any instrument used in the collection of personal information before the instrument is administered or distributed to a student.
  8. Any applicable procedures for granting a request by a parent for reasonable access to such instrument within a reasonable period of time after the request is received.
When following VA requirements:
1. Policies and procedures indicate:
  1. Consent by a legally authorized representative is limited to situations where the prospective participant is incompetent or has impaired decision-making capacity, as determined and documented in the person’s medical record in a signed and dated progress note.
  2. Consent from the legally authorized representative of the participant can only be obtained from the following: a healthcare agent (i.e., an individual named by an individual in a durable power of attorney for health care); legal guardian or special guardian; next of kin in this order: a close relative of the patient 18 years of age or older, in the following priority: spouse, child, parent, sibling, grandparent, or grandchild; or close friend, unless otherwise specified by applicable state law.
  3. If there is any question as to whether a potential adult participant has decision-making capacity, and there is no documentation in the medical record that the individual lacks decision-making capacity, and the individual has not been ruled incompetent by a court of law, the researcher must consult with a qualified practitioner (who may be a member of the research team) about the individual’s decision-making capacity before proceeding with the consent process.
  4. Individuals, who because of a known condition, are at high risk to temporary or fluctuating lack of decision-making capacity must be evaluated by a qualified practitioner to determine the individual’s ability to provide consent. This evaluation must be performed as described in the IRB-approved protocol.
  5. If the individual is deemed to lack decision-making capacity at the time of their participation in the study, a legally authorized representative must provide consent.
  6. If the participant regains decision-making capacity, the researcher must repeat the consent process with the participant, and obtain the participant’s permission to continue with the study.
  7. Disclosures to be made to the participant must be made to the participant’s legally authorized representative.
  8. The participant’s legally authorized representative must be told that that his or her obligation is to try to determine what the participant would do if able to make an informed decision. If the prospective participant’s wishes cannot be determined, the legally authorized representative must be told that he or she is responsible for determining what is in the participant’s best interest.
  9. Have the researcher explain the proposed research to the prospective participant when feasible even when the participant’s legally authorized representative gives consent.
  10. Have the practitioner explain the proposed research to the prospective participant when feasible.
  11. Ensure the study includes appropriate procedures for respecting dissent. Prohibit participants from being forced or coerced to participate in a research study.

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

Application form
Reviewer checklist
Consent template

Outcomes

IRB or EC members approve research involving participants with diminished decision-making capacity that includes additional safeguards for seeking their consent.

Proceed To: ELEMENT II.4.C.

Resources: For Accreditation - Evaluation Instrument

Evaluation Instrument for Accreditation

Table of Contents

ELEMENT II.4.B.