All adults (including those with cognitive impairments) are presumed competent to consent unless legally judged to be incompetent.
Cognitively impaired persons are considered a vulnerable research population because their mental disability may compromise their capacity to make a reasoned decision about participation in a study.
People with Alzheimer's disease, dementia, mental illness and developmental disabilities may be considered cognitively impaired and may not be able to provide informed consent for participation in research.
In certain circumstances, when it is determined that a potential research participant is cognitively impaired, federal regulations and state statute permit researchers to obtain consent from a legally-authorized representative via surrogate consent.
For research protocols involving subjects who have fluctuating or limited decision-making capacity or prospective incapacity, Principal Investigators should establish and maintain ongoing communication with involved caregivers, consistent with the subjects' autonomy and with medical confidentiality.
The National Bioethics Advisory Commission issued a report on Research Involving Persons with Mental Disorders That May Affect Decision-making Capacity (December 1998). The recommendations set forth in that report should be carefully reviewed by Principal Investigators considering research involving such a population. Some of the requirements or considerations discussed in the report include:
A primary consideration when recruiting subjects with severe cognitive or psychiatric disorders is to establish procedures for determining which individuals are able to provide legally valid consent, and which are not.
The protocol reviewed by the IRB must detail a specific plan for the assessment of the decision-making capacity of the subject. The assessment will be conducted by the investigator for any subject who may qualify for Surrogate Consent. While there are no standardized measures for determining capacity to consent, subjects may be assessed on their ability to understand and to express a reasoned choice concerning the:
The capacity to understand all of these concepts may not be necessary in order to consent to participate in a particular research protocol -- greater capacity is required for higher-risk protocols. This assessment should be used for determining the capacity of the surrogate as well, if necessary.
In protocols in which surrogate consent has been approved by the IRB, assessment of the decision-making capacity of the surrogate should be implemented only when the investigator has reason to believe that the subject's decision-making capacity may be impaired.
To have the option to obtain consent from a subject's legally-authorized representative, the investigator must request the use of surrogate consent.
When consent will be obtained from a legally-authorized representative (surrogate), the IRB usually will require that the assent of the subject be obtained.
Assent is defined as affirmative agreement to participate in research. Failure to object does not qualify as assent.
For more information on the use of a legally-authorized representative, see Surrogate Consenrt.
"LAR means an individual, or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research." 45CFR.46.102( c) and 21CFR50.3(l).
An LAR is required in order to conduct human research in the Commonwealth of Virginia with a person who is an adult incapable of making an informed decision, as defined in Virginia Code 54.1-2982, at the time consent is required.
When such conditions are met:
Minor. In Virginia, an individual below the age of 18 who is unemancipated is considered a "minor" for research purposes and must have a parent(s) or a legal guardian (either of which are considered Legally Authorized Representatives in Virginia) give permission for participation in research. The minor provides assent according to his or her capabilities. In cases where the child is under court-appointed or state custody a Legally-Authorized Representative, who is not the parent or legal guardian, provides consent on behalf of the child.
The list below indicates who may serve as LAR for an incapable adult in Virginia, in the following specified decreasing order of priority:
If a higher ranking LAR is identified after consent has been obtained, the higher ranking LAR must be contacted and informed of the study. He/she should be given a copy of the signed consent form and any communications with him/her should be documented in a note to file. A decision by a higher-ranking LAR to withdraw the subject from the research should be handled the same way one would handle a decision by the subject to withdraw if he/she becomes able to give consent for themselves. LARs and subjects considering withdrawal from a study should be fully informed about any clinical risks of withdrawing, such as feasibility, risks of removing inserted devices.
Federal regulations (HHS and FDA) offer the following broad definitions to which the above Virginia LAR list applies:
In the federal regulations, the terms 'parent' and 'guardian' specifically apply to those who are legally authorized to consent on behalf of a child. Note that in the case of a legal guardian, the child usually, but not always, lives with the guardian. Additionally, not every sibling in a family may have the same legal guardian.
Conditions Limiting LAR Use in Virginia:
A legally authorized representative may not consent or give permission:
Use of LARs for research being conducted outside of Virginia
Different states may vary how they define:
Determinations about who can serve as an LAR, that is, consent on behalf of someone else's participation in research, are based on the jurisdiction in which the research is being conducted. The PI must understand the implications of state laws for the proposed research and describe how differing state requirements will be met in the research. Also note that research being conducted in foreign countries is subject to applicable laws for designating a legally authorized representative for the region or country in which the research is being conducted.
For research in which one or more eligible participants may require an LAR (as described in the protocol), the PI should cite, or provide an excerpt of, the relevant law regarding which individuals may serve as LARs for research being conducted outside of Virginia. The IRB reviewer may consult with the IRB Chair regarding the appropriateness of LAR eligibility for such research. General Counsel may also be asked to provide an opinion in this regard.
IRB Considerations for Allowing an LAR to Provide Informed Consent on Behalf of a Decisionally Impaired Adult:
Last Modified: Monday, 26-Jun-2017 11:16:29 EDT