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Objective

To describe the requirements for the use of a legally authorized representative (LAR) in the informed consent process. The investigator must specify the circumstances in which an LAR’s consent/permission will be sought in order to enroll a subject(s) into the research protocol. For purposes of VCU IRB review, the term “LAR” will be associated with research involving adult subjects OR where parents or guardians give permission for research involving children who are less than 18 years of age and not legally emancipated OR where an agent represents a child in court-appointed or state custody. The IRB must specifically approve the use of an LAR for adults or children in court-appointed or state custody.

Description

1. 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).

1. When is an LAR required?

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 described in § 54.1-2982, at the time consent is required.  When such conditions are met:

1. The person's legally authorized representative shall issue informed consent/permission and the signature shall be witnessed. 
2. The research participant should be invited to participate in the informed consent discussion and provide his/her signature (as assent).

In Virginia, an individual below the age of 18 who is unemancipated is considered a ‘child’ 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.  (See IRB WPP  XV-2: Assent and Parental/Guardian Permission Considerations).  The ‘child’ 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, refer to the VCU IRB WPP XV-3: Children in Court-Appointed or State Custody and Emancipated Minors for further information.

NOTE:  In Virginia, an individual below the age of 18 years of age who is legally emancipated (with legal documentation to verify such status) is permitted to make all decisions concerning research participation as would someone 18 and older who is also decisionally capable. 

The list below indicates who may serve as LAR in Virginia, in the following specified decreasing order of priority:

1. the parent or parents having custody of a prospective subject who is a minor,
2. the agent appointed under an advance directive, as defined in § 54.1-2982, executed by the prospective subject, provided the advance directive authorizes the agent to make decisions regarding the prospective subject's participation in human research,
3. the legal guardian of a prospective subject,
4. the spouse of the prospective subject, except where a suit for divorce has been filed and the divorce decree is not yet final,
5. an adult child of the prospective subject,
6. a parent of the prospective subject when the subject is an adult,
7. an adult brother or sister of the prospective subject, or
8. any person or judicial or other body authorized by law or regulation to consent on behalf of a prospective subject to such subject's participation in the particular human research.

Federal regulations (HHS and FDA) offer the following broad definitions to which the above Virginia LAR list applies:

1. “Parent” means a child’s biological or adoptive parent.
2. “Guardian” is “an individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care.”  (45CFR46.402) 
3. FDA regulations further qualify the definition by adding that “for the purposes of subpart D of this Part, a guardian also means an individual who is authorized to consent on behalf of a child to participate in research.” (21CFR50.3).

In the federal regulations, the terms ‘parent’ and ‘guardian’ specifically apply to those who are legally authorized to consent on behalf of a child.  Virginia law broadly views all individuals described in the LAR list above to be Legally Authorized Representatives, including reference to a ‘legal guardian.’ (#3 above).  For the decisionally incapable adult (including emancipated minors, as relevant), the applicable LAR designations to be drawn from the above list are #’s 2, 3, 4, 5, 6, 7, or 8.   For purposes of research with children, a parent or guardian acts on behalf of a child (items # 1 and 3 above) or #8 applies if the child is in court-appointed or state custody.  Examples of individuals who may have the formal designation of legal guardian for a child include: an adult family member of the child, an adult friend of the family.  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.  

3. Conditions Limiting LAR Use in Virginia:

A legally authorized representative may not consent or give permission:

1. to non-therapeutic research unless it is determined by the human research committee (IRB) that such non-therapeutic research will present no more than a minor increase over minimal risk to the human subject.
2. to participation in human research on behalf of a prospective subject if the legally authorized representative knows, or upon reasonable inquiry ought to know, that any aspect of the human research protocol is contrary to the religious beliefs or basic values of the prospective subject, whether expressed orally or in writing.
3. to participation in human research involving non-therapeutic sterilization, abortion, psychosurgery or admission for research purposes to a facility or hospital as defined by the Code of Virginia at § 37.1-1.

4. Use of LARs for research being conducted outside of Virginia

Different states may have variation in defining 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 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, is based on the jurisdiction in which the research is being conducted. For further guidance on these and other considerations, please refer to WPP IRB WPP # II-5: State Law Applicability for Research Conducted In- and Outside of Virginia.   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 or OECO regarding the appropriateness of LAR eligibility for such research.  General Counsel may also be asked to provide an opinion in this regard.

5. Additional Considerations/Conditions:
   1. If two or more persons who qualify as legally authorized representatives and have equal decision-making priority inform the principal investigator or attending physician that they disagree (with each other) as to participation of the prospective subject in human research, the subject shall not be enrolled in the human research that is the subject of the consent.
      
   2. No informed consent form shall include any language through which the person who is to be the human subject waives or appears to waive any of his legal rights, including any release of any individual, institution, or agency or any agents thereof from liability for negligence.
   3. Notwithstanding consent by a legally authorized representative, no person shall be forced to participate in any human research if the investigator conducting the human research knows that participation in the research is protested by the prospective subject.
   4. In the case of persons suffering from organic brain diseases causing progressive deterioration of cognition for which there is no known cure or medically accepted treatment, the implementation of experimental courses of therapeutic treatment to which a legally authorized representative has given informed consent shall not constitute the use of force, unless prior knowledge of participant refusal is known.
   5. Unless the research constitutes the best medical interests for the prospective participant and is not available outside of the research context, dissent or objection on the part of the participant ought to be respected regardless of the LAR's wishes.

6. IRB Considerations for Allowing an LAR to Provide Informed Consent on Behalf of a Decisionally Impaired Adult:
   1. The PI plans to/has requested to enroll adults who are not capable of providing consent.
   2. The PI indicates that an appropriate Legally Authorized Representative will be asked to give consent on behalf of the incapacitated adult. 
   3. The PI indicates that all eligible subjects will require an LAR OR that some subjects may be able to provide assent or even consent for themselves
   4. The PI describes a plan and includes documents to assess capacity and solicit the consent for continued participation for adult subjects who will or may regain decision making capacity.  Consider use or revision of the VCU Informed Consent Evaluation Tool at http://www.research.vcu.edu/forms/ICEval.doc, as appropriate
   5. A written or script-supported consent document (or other information relevant to the research) will be provided to the research participant accompanied by a consent conversation, as applicable.
   6. The circumstances of the consent process provide the prospective participant or the LAR sufficient opportunity to consider whether to participate.
   7. The circumstances of the consent process minimize the possibility of coercion or undue influence. 
   8. The person communicating information to the participant or the LAR during the consent process will provide that information in language understandable to the participant or the representative.

Responsibility

It is the responsibility of the principal investigator to indicate a plan and justification for enrolling subjects who are not capable of providing legally recognized informed consent. The IRB is responsible for approving the enrollment of individuals unable to provide consent, as well as the use of an LAR in protocol-specific circumstances according to this policy.  

References

Code of Virginia 32.1-162.16. Definitions

Code of Virginia 32.1-162.18. Informed consent