Research that includes dementia patients who lack capacity to give informed consent always requires surrogate decision makers to provide proxy consent. Surrogates also frequently serve as study partners for participants in dementia research to help them comply with study procedures and oversee patients'welfare. The involvement of surrogates and study partners in research raises unique ethical issues that should be addressed by researchers and institutional review boards, but little is known about the experiences of surrogates and their potential conflicts of interest in the research setting. Surrogates are usually family members and dementia patients'primary caregivers. While research has demonstrated that care giving to persons with dementia can be highly burdensome, the experience of caregivers who also participate in research is unexamined. Participation of caregivers in dementia research can involve a significant commitment of time and considerable effort to enable patients to undergo multiple study procedures and return for repeated study visits. Empirical studies to date that are often based on hypothetical scenarios have focused primarily on surrogates'decisions to enroll persons with dementia in research and show that their decisions are often motivated by altruism, trust in the investigators, hope for benefits to the patient, caregiver or the patient's descendents, or desperation to stop or slow the progression of dementia. Enrollment decisions can also reflect an expectation that there is an interdependence of the potential risks and benefits of research for both the patient and caregiver-what affects one can affect the other. How such hopes and expectations play out over the course of research participation is unknown. In addition, little is known about the conflicts of interest that may arise for surrogates in their multiple roles as family member, caregiver, proxy decision maker, and study partner. This prospective study has three specific aims: (1) describe the roles and responsibilities of surrogate decision makers and study partners for dementia research participants who lack consent capacity, (2) describe the experiences of and potential conflicts for caregivers, who are serving as surrogates and study partners, and how their conflicts of interest are managed over the course of their involvement in research, and (3) delineate and analyze the common ethical issues raised in dementia research involving surrogates and study partners in light of the ethical perspectives of the Principlist and Relational paradigms. Qualitative research methods will be used to achieve these aims by interviewing individuals who are actively involved in dementia studies, including investigators, dementia study coordinators, and caregivers who are serving as surrogates and study partners. At a time when research into the causes, cures, and treatment of dementia is crucial to help relieve suffering in millions of affected citizens and reduce health care costs, results of this project will inform the work of researchers and institutional review boards to ensure that the interests of dementia patients and their study partners are protected in research.

Public Health Relevance

This study examines the experiences of caregivers who are serving as surrogate decision makers and study partners for individuals with dementia who are participating in research and lack the capacity to give their own informed consent. The multifaceted roles and interests that caregivers have as family members, proxy decision makers, and study partners may pose ethical concerns and conflicts of interest for them over the course of their involvement in research. This project will use qualitative research methods to identify common ethical issues raised for caregivers in their role as surrogate decision maker and/or study partner and conduct an ethical analysis of these issues to help inform investigators and institutional review boards who are concerned with the protection of dementia patients and their study partners in research.

Agency
National Institute of Health (NIH)
Type
Research Project (R01)
Project #
5R01AG038440-04
Application #
8721297
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Silverberg, Nina B
Project Start
Project End
Budget Start
Budget End
Support Year
4
Fiscal Year
2014
Total Cost
Indirect Cost
Name
Johns Hopkins University
Department
Psychiatry
Type
Schools of Medicine
DUNS #
City
Baltimore
State
MD
Country
United States
Zip Code
21218
Black, Betty S; Taylor, Holly; Rabins, Peter V et al. (2014) Researchers' perspectives on the role of study partners in dementia research. Int Psychogeriatr 26:1649-57