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HRPP Policy - Individuals Lacking Capacity
About This Policy
- Effective date:
- Last updated:
- Policy Contact:
IU Human Research Protection Program (HRPP)
This policy applies to non-exempt human subjects research under the oversight of the Indiana University Institutional Review Boards (IRBs) involving adults who may lack consent capacity, or may lose capacity during the course of the research.Back to top
Since adult individuals lacking consent capacity are likely to be vulnerable to coercion or undue influence, additional protections must be applied to protect the rights and welfare of these subjects. Specifically, in order to approve research involving adults who may lack the capacity to provide consent for themselves, or may lose capacity during the course of the research, the IRB must find that the research plan includes appropriate mechanisms for:
- Assessing potential subjects' capacity to consent and reassessing that capacity on an ongoing basis, if applicable
- Identifying and obtaining consent from an appropriate legally authorized representative (LAR) if the potential subject lacks capacity, unless consent has been waived
- Obtaining assent from the potential subjects, when appropriate
Adult Individuals who lack consent capacity may be enrolled in research where the IRB finds:
- That the proposed research presents at least one of the following:
- No greater than minimal risk to subjects
- Greater probability of direct benefit to subjects than harm to subjects
- Greater than minimal risk and no prospect of direct benefit to individual subjects, but is likely to yield generalizable knowledge about subjects' disorder or condition that is of vital importance for the understanding or amelioration of the disorder or condition
- That one of the following are also met:
- The research cannot be performed solely with persons who possess consent capacity and the focus of the research is the disorder leading to the subjects' lack of consent capacity, whether or not the lack of consent capacity itself is being evaluated.
- The research is not directly related to the subjects' lack of consent capacity but research personnel have presented a compelling argument for including such subjects.
Informed consent must be obtained from an appropriate individual for the potential subject’s participation in the research in compliance with state laws in which the research is taking place. Identification of the appropriate individual is based on the subject’s individual circumstances.
- If the potential subject has a court-appointed guardian who has been charged with making medical decisions for the potential subject, the potential subject cannot legally provide informed consent for him/herself, regardless of the subject's capacity to understand the research.
- If there is not a relevant court-appointed guardian and the study team determines the subject has consent capacity pursuant to the IRB-approved assessment procedures, the subject should consent/authorize for him or herself.
- If the study team determines and documents that the subject does not have consent capacity pursuant to the IRB-approved assessment procedures, a LAR must provide consent for the subject's participation.
Pursuant to Indiana Code 16-36-1-5, the following individuals may serve as an LAR, in the following order of priority:
- Health care representative
- Adult child
- Adult sibling
- Adult grandchild
- The nearest other relative in the next degree of kinship not listed in items 3-7*
- The individual's religious superior, if the individual is a member of a religious order*
If none of the above are reasonably available, the IRB may approve, on a case-by-case basis, that a friend may serve as LAR if the friend is an adult, has maintained regular contact with the potential subject, and is familiar with the potential subject's activities, health, and religious or moral beliefs.
*Individuals listed at priority #8 and #9 may not serve as LAR if the research is subject to VA regulations.
The following individuals may NOT serve as a LAR under this policy:
- A spouse who is legally separated or has a petition for dissolution, legal separation, or annulment of marriage pending in a court from the potential subject
- An individual who is subject to a protective order or other court order that directs that individual to avoid contact with the potential subject
- An individual who is subject to a pending criminal charge in which the potential subject was the alleged victim
The IRB may waive consent requirements pursuant to the IU HRPP Policy on Informed Consent.
Responsibilities of LARs
LARs are acting on behalf of the potential subjects, therefore:
- LARs must be told that their obligation is to try to determine what the subjects would do if able to make an informed decision.
- If the potential subjects' wishes cannot be determined, the LARs must be told they are responsible for determining what is in the subjects' best interest.
If feasible, research personnel must make adequate provisions for obtaining assent from subjects who cannot consent for themselves.
For research involving a human being as an experimental subject, if consent is to be obtained from a subject's LAR, the IRB must determine that the research is intended to be beneficial to the individual subject.
For studies proposing to enroll subjects who lack consent capacity, the study team completes the human subject application and provides protocol-specific information about the study-specific mechanisms for assessing subjects' consent capacity, identifying and obtaining consent from an appropriate LAR if subjects cannot consent for themselves, and obtaining assent from subjects. The IRB considers the information in the IRB application and documents its determinations, as appropriate.
The study team must conduct due diligence to identify the appropriate LAR based on the priority defined in section 2.1. Specifically, the individual with the highest priority who is reasonably available must serve as the LAR and the study team must do due diligence to ensure and document that an individual with higher priority is not reasonably available.
A study team can find that an individual is not reasonably available after the study team has made and documented repeated attempts to contact the individual over a reasonable time period with no response. The expectation is that study teams will make at least 3 attempts over at least 48 hours, unless the IRB has reviewed and approved a protocol-specific standard for finding that individuals are not reasonably available.
If there are multiple individuals at the same priority level who are reasonably available, those individuals shall make a reasonable effort to reach a consensus as to participation of the potential subject in the research. If the individuals at the same priority level disagree, a majority of the available individuals at the same priority level controls.
If a study team believes that allowing a friend to serve as the LAR for an adult lacking consent capacity would provide reasonable protections for a potential subject, the study team may submit a subject-specific request that the friend serve as LAR for the particular subject and provide appropriate justification.
When a subject’s consent capacity changes after initial consent is obtained, the following applies for continued subject participation,
- When a subject loses capacity,
- Research procedures with the subject, including interactions and interventions and collection of identifiable private information, may continue as the subject’s consent to participate should be honored.
- However, if re-consent is required by the IRB, for example, due to an increase in risks, re-assessment of consent capacity should be conducted, and if the subject is determined to lack capacity to provide consent, research personnel must seek and obtain informed consent, from the appropriate individual per this policy.
- When a subject gains capacity,
- Research procedures with the subject, including interactions and interventions and collection of identifiable private information, must immediately cease.
- Research personnel must seek and obtain informed consent for ongoing procedures from the appropriate individual per this policy, or request a waiver of informed consent per the IU HRPP Policy on Informed Consent.
- Research personnel must seek and obtain HIPAA authorization, if applicable, for ongoing procedures from the appropriate individual per this policy, or request a waiver of authorization, per the IU HRPP Policy on Use of PHI in Research.
Individuals found to be in violation of this policy may be subject to sanctions relating to their participation in research with human subjects, up to and including permanent suspension or debarment from engaging in research with human subjects at Indiana University.Back to top
- AAHRPP Standards
- Element I.1.G
- Standard II-4, Elements II.4.A, II.4.B
- 10 USC 980 - DoD Limitation on use of humans as experimental subjects
- Indiana Code 16-36-1-5
- NIH Guidance on Research Involving Individuals with Questionable Capacity to Consent: Points to Consider
- VHA Directive 1200.05 - Requirements for the Protection of Human Subjects in Research
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