Maryland looks at laws to define surrogate rights
Maryland looks at laws to define surrogate rights
A working group of bioethics, legal, and health care professionals in Maryland issued draft recommendations late last year allowing a surrogate to enroll an incapacitated patient in clinical research trials. If approved, these guidelines would become the first to address the thorny issue of placing cognitively impaired individuals in a research protocol.
The preliminary proposal announced by the Maryland Attorney General’s Office in Baltimore, will provide the state’s legislators with a recommendation for amending the Health Care Decisions Act of 1993. The leader of the group, Assistant Attorney General Jack Schwarz, JD, says he hopes to provide "an inclusive, nonadversarial process that focuses squarely on sound ethical practice."
Schwarz emphasizes that the draft recommendations are preliminary and that a decision to seek legislative sponsorship of a proposal to amend the current law will come only after interested members of the public "have a full opportunity to express their views."
Five categories covered
According to Schwarz, the group sought to protect vulnerable individuals against possible abuse, honor the autonomous choice of those people who expressed a desire to contribute to research, and encourage research on ailments affecting cognitively impaired people with ecessary safeguards as a matter of social justice.
The group’s preliminary recommendations are divided into five specific advance-directive-related categories, as follows:
1. Consent by a health care agent when the patient has executed a research-specific advance directive. Under this authority the agent would have the authority listed below:
• If there is no greater than minimal risk to the patient, the agent would be authorized to consent if the agent concludes that the individual would have wanted to participate in the particular protocol, even if the investigator can identify no reasonable prospect of direct medical benefit to the individual.
• If there is greater than minimal risk but a reasonable prospect of direct medical benefit to the individual, the agent would be authorized to consent if the agent concludes either that the individual’s preference is unknown, or that participation can be considered in the individual’s best medical interest.
• If there is greater than minimal risk and no reasonable prospect of direct medical benefit to the individual, the agent would be authorized to consent if the agent concludes that the individual would have wanted to participate in the particular protocol and either of these conditions is met:
the protocol involves no more than a minor increase over minimal risk;
if the protocol involves a significant increase over minimal risk, a knowledgeable person from outside the research team (for example, a member of the institution’s ethics committee) confirms that the agent understands the goals and risks of the protocol.
2. Consent by a health care agent when the patient has executed a general advance directive. Under this authority, the agent would have the authority listed below:
• If there is no greater than minimal risk, the agent would be authorized to consent if the agent concludes that the individual would have wanted to participate in the particular protocol, even if the investigator can identify no reasonable prospect of direct medical benefit to the individual.
• If there is greater than minimal risk and a reasonable prospect of direct medical benefit to the individual, the agent would be authorized to consent if the agent concludes either that the individual would have wanted to participate in the particular protocol, or, if the individual’s preference is unknown, that participation could be in the individual’s medical best interest.
The agent would be expected to apply a statutory definition of "best interest," not a personal hunch.
• If there is greater than minimal risk and no reasonable prospect of direct medical benefit to the individual, the agent would be authorized to consent if the agent concludes that the individual would have wanted to participate in the particular protocol and the agent’s conclusion is based on direct and explicit evidence of the individual’s wish to participate, as documented in accordance with standards and procedures set by the institutional review board, and the protocol involves no more than a minor increase over minimal risk, or the protocol is substantially identical to prior protocols in which the individual chose to participate when he or she was able to provide informed consent.
3. Consent by a family member or friend when the patient did not execute an advance directive. Under this presumed authority, the surrogate would have the authority listed below:
• If there is no greater than minimal risk, the surrogate would be authorized to consent if the surrogate concludes that the individual would have wanted to participate in the particular protocol even if the investigator can identify no reasonable prospect of direct medical benefit to the individual.
• If there is greater than minimal risk and reasonable prospect of direct medical benefit to the individual, the surrogate would be authorized to consent if the protocol does not involve experimental treatment of a mental disorder and the surrogate concludes that the individual would have wanted to participate in the protocol, or if the individual’s preference is unknown, the surrogate concludes that participation can be considered to be in the individual’s best medical interest.
• If there is greater than minimal risk and no reasonable prospect of direct medical benefit to the individual, participation in the research would not be authorized.
4. Consent by a "monitor" when the patient executed an advance directive related to research but did not name an agent and a surrogate is not available. Under this authority, the following would be authorized:
• If there is no greater than minimal risk, the individual’s participation in research may be authorized by a monitor who would make an informed and objective decision about enrollment and continuing participation in the protocol. The monitor would decide on the basis of an advance directive, other relevant information, and the specific nature of the protocol.
• If there is greater than minimal risk and reasonable prospect of direct medical benefit to the individual, an independent monitor may consent to participation if the monitor concludes either that the individual would have wanted to participate in the protocol or if the individual’s presumed preference cannot be determined from the advance directive or relevant information, that participation can be considered to be in the individual’s medical best interest. The monitor would have responsibility for the individual’s continued participation, as well.
• If there is greater than minimal risk and no reasonable prospect of direct medical benefit to the individual, participation in the research would not be authorized.
5. Consent when there is no relevant advance directive and no one who qualifies as a surrogate is available to make decisions. The following authorization would apply:
• If there is no greater than minimal risk, participation in the research would not be authorized unless the protocol represented a reasonable prospect of direct medical benefit to the individual and the individual’s participation is authorized by a court pursuant to existing guardianship procedures.
• If there is greater than minimal risk and reasonable prospect of direct medical benefit to the individual, the participation in the research may be authorized by a court pursuant to existing guardianship procedures.
• If there is greater than minimal risk and no reasonable prospect of direct medical benefit to the individual, participation in the research would not be authorized.
[Editor’s note: Readers who would like to question or comment on these proposed guidelines are invited to contact: Assistant Attorney General Jack Schwarz, Chief Counsel for Opinions and Advice, Maryland Attorney General’s Office, 200 Saint Paul Place, Baltimore, MD 21202. Telephone: (410) 576-6344. Fax: (410) 576-7003. E-mail: jaschwar@umab net.ab.umd.edu.]
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