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HRPP Policy - Individuals Lacking Capacity
About This Policy
- Effective date:
- Last updated:
- Policy Contact:
IU Human Subjects Office
This policy applies to the conduct of all non-exempt human subjects research under the oversight of the IU IRBs involving adults who may lack consent capacity, or may lose capacity during the course of the research.
Research involving adults who may lack consent capacity, or may lose capacity during the course of the research, for which IU or its affiliates are relying on an external IRB for oversight must comply with Section 2.1 of this policy.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 by an appropriate individual for the potential subject's participation in the research. 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 law IC 16-36-1-5, the following individuals may serve as a 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.
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 (e.g., subject loses capacity or gains capacity), the previous consent is no longer valid for continued participation.
- All 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
IU HRPP Policies
Related Policy Documents
IU HRPP Guidance
Related Guidance Documents
- AAHRPP Standards
- Element II.4.A
- Element II.4.B
- Element III.1.F
- DoD Instruction 3216.02 – Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research, section 9b
- Indiana Code 16-36-1-5
- NIH Guidance on Research Involving Individuals with Questionable Capacity to Consent: Points to Consider
- VHA Handbook 1200.05 - Requirements for the Protection of Human Subjects in Research, especially section 20
adult An individual who has reached age of majority in the relevant state. In Indiana, a person at least eighteen (18) years of age.
adult indivdiuals lacking consent capacity Individuals who, for various reasons, lack the ability to understand the research, appreciate the consequences of their participation, consider alternatives, and/or make reasoned choices, such that they cannot provide informed consent for themselves.
assent An individual's affirmative agreement to participate in research obtained in conjunction with permission of the individual's parents, guardian, or legally authorized representative. Mere failure to object should not, absent affirmative agreement, be construed as assent.
audit (see also for-cause (directed) audit, internal audit, and not-for-cause (scheduled) audit) A systematic and independent examination of study-related activities and documents to determine whether the evaluated study-related activities were conducted, and the data were recorded, analyzed, and accurately reported, according to applicable federal regulations, state laws, and institutional policies. Includes audits, monitoring visits, and compliance inspections.
children (minor) Persons who have not attained the legal age for consent to treatments or procedures involved in the research or clinical investigation, under the applicable law of the jurisdiction in which the research or clinical investigation will be conducted. In Indiana, persons less than 18 years of age.
generalizable knowledge Information that expands the knowledge base of a scientific discipline or other scholarly field of study.
identifiable private information Private information for which the identity of the subject is or may readily be ascertained by the research personnel or associated with the information.
informed consent An ongoing process by which a subject (or, his or her legal representative) voluntarily confirms his or her willingness to participate in a particular research project in accordance with the IU HRPP Policy on Informed Consent.
legally authorized representative (LAR) An individual or judicial or other body authorized under applicable law to consent on behalf of a prospective participant to the participant's participation in the procedure(s) involved in the research. For definition of LAR in Indiana, see the IU HRPP Policy on Adult Individuals Lacking Consent Capacity.
minimal risk The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
parent A child's biological or adoptive parent.
private information Includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., medical records).
representative As defined by Indiana Code 16-36-1, an individual delegated to consent to health care of another who for a time will not be reasonably available to exercise the authority. The delegation: (1) must be in writing; (2) must be signed by the delegate; (3) must be witnessed by an adult; and (4) may specify conditions on the authority delegated. Unless the writing expressly provides otherwise, the delegate may not delegate the authority to another individual.
research A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge (Synonymous with clinical investigation For research subject to FDA regulations, any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the FDA under §505(i), §507(d), or §520(g) of the Food, Drug & Cosmetic Act, or need not meet the requirements for prior submission to the FDA under these sections of the act, but the results of which are intended to be later submitted to, or held for inspection by, the FDA as part of an application for a research or marketing permit. The term does not include experiments that must meet the provisions of part 58 regarding nonclinical laboratory studies (21 CFR 50.3(c)).) The following activities are deemed not to be research under this definition: Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information that focus directly on the individuals about whom the information is collected; Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters); Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for the activities authorized by law or court order solely for criminal justice or criminal investigative purposes; Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.
research personnel Individuals engaged in human subjects research; specifically, individuals who interact or intervene with human subjects or access identifiable information for research purposes. May also be called investigators.Back to top