Creative suggestions for getting consent from decisionally impaired

Study with schizophrenia patients yields best practices

A trial studying antipsychotic drugs provides best practices for handling ethical issues involving decisionally impaired persons. The Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) schizophrenia study was an 18-month study in which it was anticipated that some participants would lose decision-making capacity during the course of the study.

Decisional impairment concerns a person's potential inability to protect his or her own interests, and it encompasses both the capacity to provide consent and how voluntary the consent is, says Susan J. Delano, CIP, deputy managing director of the Research Foundation for Mental Hygiene Inc. of Menands, NY. The Research Foundation is a nonprofit corporation that administers grants and contracts for research conducted in facilities operated by the New York State Department of Mental Hygiene.

"This was a study where they thought carefully about building in additional protection for subjects and created a subject advocate mechanism," Delano says. Delano has an oversight role relative to IRBs that function in all of the department's facilities.

"The CATIE study brought in this subject advocate who participated in the consent process and had the authority to withdraw subjects from the study under certain circumstances," Delano says.

For example, if the original risk-benefit ratio changed substantially, the subject advocate could withdraw the subject from the study, she says. "They were careful about assessments of capacity up front and processes to make sure the consent process was informative for subjects," she says. "This was quite a step forward in terms of providing a protective mechanism for subjects."

Even with the added protection of a subject advocate, there needed to be an analysis to see whether the subject advocate mechanism was sufficiently protective, Delano notes. "Decisional impairment creates vulnerability, and there's a potential inability for a person to adequately protect his or her own interest," Delano explains. "They might be unable to evaluate how their own participation is affecting them or to look at any changes in their own situation."

IRB considerations might include the following, Delano says:

  • capacity assessment;
  • decisional impairment versus diagnosis;
  • decisional impairment that is not related to mental illness, and this could include substance abuse, stress, and medical conditions;
  • other factors creating vulnerability, including incarceration, stigma, lack of health insurance, and educational level.

A further step ethically would be to allow capable participants to appoint someone who can act as a surrogate decision maker should the participant lose decision-making capacity, Delano suggests.

"Within our system we do allow this," she adds. "The surrogates have a broad range of authority to withdraw subjects from research, and they have the ability to make amendments in the study."

For example, if new information becomes available about side effects, and these need to be communicated back to participants, who will then need to provide consent, the surrogate decision maker could say that the participant could continue in the study, Delano says.

Surrogates are used sparingly. "They are usually a family member," Delano says. Typically the surrogate is selected by a participant who has full decision-making capacity at the beginning of a study. If the participant loses decision-making capacity, the surrogate would provide consent within the limitations determined by the participant when the surrogate was chosen, she explains.

"The subject would say, 'This person has authority to act as my surrogate, but if the risk level increases significantly, then I must withdraw from the study," Delano says.

There are other protections that could be used, including:

  • Using different methods, timing, locations in the consent process;
  • involving family members or friends of participants;
  • educating the surrogate;
  • making consent an ongoing process;
  • limiting or excluding participation of vulnerable populations;
  • providing a consent auditor who assesses the quality of the consent process and procedures;
  • providing a medical monitor who has the authority to withdraw the subject;
  • using a data safety monitoring board.

It's important to note the decisional impairment can occur in situations other than mental health research, she adds.

"People need to understand that just because they aren't reviewing psychiatric research doesn't mean these issues aren't relevant to them," Delano says. "There are other situations in which lack of capacity is clearly an issue."

Another issue to consider is that states have different laws regarding decision-making capacity, and these must be a part of any policy regarding providing greater ethical safeguards for subjects with limited decision making capacity, Delano says.

The CATIE study's use of participant advocates is a good model for IRBs and institutions that desire to improve their ethical oversight for vulnerable populations, she notes.

"The CATIE study was a very thoughtful and well-planned protective mechanism, and it's one that, while we could tweak, it really went a great distance toward providing additional protections," Delano says.