WHO CAN SERVE AS A LEGALLY AUTHORIZED REPRESENTATIVE?

The federal regulations governing research clearly allow an Investigator to rely on a participant's legally authorized representative ("LAR") to provide informed consent for that individual's participation in a clinical trial.i However, the regulations leave the issue of who can serve as an LAR up to the states.

Quorum Review may approve the use of an LAR for certain trials when the protocol design maintains appropriate safeguards. In addition, when a trial requires the enrollment of incapacitated adults the sponsor or the investigator sometimes may mandate that each participant have an LAR to provide informed consent on behalf of that participant.

Before you as an Investigator rely on the consent provided by an LAR, Quorum Review strongly encourages you to learn how an individual can qualify to serve as an LAR in your state. The discussion below sets forth several concerns for you to consider. You might want to consult legal counsel. As this area of law is complex and unsettled,ii however, Quorum Review cannot counsel you as to the appropriate course of action.

As an initial matter, it is important to note the distinction between the following two concepts:

  • The legal authority to consent to health care treatment for another person, and
  • The legal authority to consent on behalf of another person to that person's participation in the procedure(s) involved in the research, especially when that study may pose risks and offers no benefit for the prospective enrollee.

Most states have established some parameters for identifying LARs for health care treatment. Broadly speaking, there are several ways in which an individual can be authorized to make health care decisions on behalf of another person for treatment:

  • By court order;
  • By a written instrument, such as a power of attorney for health care decisions;
  • By a statute that describes who can act as a proxy for health care decisions; or
  • Under the legal theories declared by the courts of the state.

However, Quorum Review is aware of very few states that have established parameters for identifying LARs or proxy decision makers specifically for research. Although a small number of states have established statutory guidelines,iii it is most common for state statutes and court decisions to be silent or inconsistent when declaring that the legal authority for treatment decision-making extends to decision-making about research participation.

In the absence of state law, a researcher should not assume that an LAR for treatment decisionmaking automatically can act as an LAR for research participation. When a guardian is appointed to act on behalf of an incapacitated adult, for example, the guardian generally is authorized to act only in the ward's best interests. A court-appointed guardian thus might not be able to consent for the ward to participate in a study that involves no direct benefit for the ward. Many states also specifically prohibit a court-appointed guardian from consenting to research without explicit court approval.

As a researcher, you have at least three approaches to consider:

  1. First, you could insist that an LAR provide documentation of having been appointed specifically to consent to research participation. Examples of such documentation may include a court order or a durable power of attorney specifying that the LAR can consent to participation in research. A durable power of attorney must have been signed by the participant while the participant was competent.
  2. As it is unlikely that many participants have obtained or executed such instruments, another approach would be to determine whether under the laws of your state an LAR for health care purposes can consent to participation in the procedures involved in the research. We encourage you to seek assistance from an attorney for this analysis.
  3. A final approach would be to ask the LAR to provide a letter from his or her attorney certifying that the LAR has authority to consent on behalf of the potential participant to participate in the research. If you have any question about the documentation provided by the LAR you should consult your attorney.

Please note that the consenting process continues even after an LAR is identified and the consent of the LAR is obtained. Quorum Review expects researchers to obtain continuing assent from adult participants who lack the decisional capacity to consent to research. Even if an LAR has authorized an individual's participation, a researcher has an ongoing obligation to discontinue that individual's participation should the individual express fear, discomfort or any disagreement with study procedures at any time.

You can contact Quorum Review for more information at (206) 448-4082, or through our website at www.quorumreview.com.

i 21 CFR § 50.20.
ii See, for example, Thompson Publishing Guide to Good Clinical Practice, "States Offer Myriad of Options for Legally Authorized Representative" (February 2005 Newsletter).
iii As of August, 2007 Quorum is aware of such laws in the states of Virginia, California and Arkansas. There may be additional state laws, however, of which Quorum is not aware and this memorandum should not be relied upon as legal advice. Virginia law allows for proxy consent where the research holds the prospect of direct benefit to the participant and, if no direct benefit, then only where the IRB determines the research less than minimal risk. The Code of Virginia §§ 32.1-162.16-18. California allows proxy consent for research that maintains or improves the participant's health or holds the prospect of obtaining information about the participant's condition. California Health & Safety Code §§ 24170–24179.5. Arkansas has a provision limiting the use of an LAR stating "No guardian appointed prior to October 1, 2001 shall make any of the following decisions without filing a petition and receiving express court approval... Authorize experimental medical procedures." Arkansas Code Annotated s 28-65-302(c).