All adults (including those with cognitive impairments) are presumed competent to consent unless legally judged to be incompetent. In most cases, minors are presumed to not be competent to consent form themselves.
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 (LAR) 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.
Who/What is a Legally Authorized Representative?
“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).
When is an LAR required?
Adult. 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:
It is important to note that even though verbal consent, obtained over the phone may be obtained from the LAR for clinical care, verbal consent from the LAR is not allowed for research if written consent is required for the study.
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.
Definition of Children
The definition of “children” also takes into account the particular treatments or procedures involved in the proposed research; for example, in some places individuals who are sixteen years of age may legally consent to certain medical treatments, and so if the involvement of human subjects in a proposed research activity consists of these treatments, then they may be considered as adults for that purpose. If a proposed activity includes something for which the subject has not yet reached the legal age of consent, however, that person must be considered a child.
An FAQ from OHRP states
If by law a child is able to consent to treatment without parental permission, can they also consent to participate in research related to that treatment?
HHS regulations at 45 CFR 46.402(a) define “children” as “persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.” If research on a specific treatment involves solely treatments or procedures for which minors can give consent outside the research context (under applicable state** and local laws, for example, research on sexually transmitted diseases or pregnancy), such individuals would not meet the definition of children as defined at 45 CFR 46.402(a). Thus, subpart D would not apply to the research and parental permission (or waiver thereof) is not a consideration for these minors. Under these circumstances, minors may provide their own informed consent.
**Virginia Code § 54.1-2969. Authority to consent to surgical and medical treatment of certain minors.
For information on emancipated minors see: Emancipated Minors
Who may be an LAR?
Adult. 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.
Minor. 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:
1) The age of children and/or minors, including emancipated minors,
2) Which individuals can give permission for their participation in research and for the participation of children who are in court-appointed custody, and
3) Which individuals are qualified to serve as legally authorized representatives.
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: