by Rebecca Logsdon, Ph.D.
Research on Alzheimer’s disease and dementia is proceeding at a rapid pace, and research volunteers (subjects) are essential to the success of this work. However, individuals with AD and their advocates must evaluate each project before deciding to volunteer. It is particularly important that researchers communicate information in a way that is both thorough and understandable, so that volunteers can make informed choices about participating in research. One way to ensure that research volunteers are adequately informed and protected is through an Institutional Review Board (IRB).
The University of Washington has an IRB that reviews all research projects to ensure that projects and investigators are ethical, that participants are adequately informed and protected, and that procedures are in place to monitor any problems that occur during the project. All research staff members are trained to follow the rules established by the National Institutes of Health (NIH), which is the government agency that oversees federally funded health-related research.
One important rule of research is that before enrolling in a study, each potential participant must be given adequate information to provide “informed consent.” An important aspect of informed consent is that participants receive a description of the study procedures, purpose, possible risks, and potential benefits. The information should be presented clearly, using language that participants can understand, and any questions about the study should be addressed before consent is given. For individuals with no memory or cognitive problems, researchers strive to provide complete information so participants can make an informed choice whether or not to volunteer for a research study.
For individuals with dementia, the informed consent process is also essential, but may require special adaptations, particularly as memory and cognitive problems become progressively worse. It is important to provide participants with an opportunity to evaluate the potential risks and benefits of a research study and to respect their choices about participation. If they are unable to express a choice, a proxy decision- maker (usually a family member or other person designated as power of attorney or guardian) may make some decisions on the participant’s behalf. In making decisions about how informed consent is to be obtained for individuals with dementia, researchers and IRBs consider the risks and potential benefits of the research study, whether the participant has the ability to make an informed decision about being in the study, whether they have documented their preferences about research participation in advance, and whether there is a suitable proxy available to act in the par-ticipant’s best interests.
For studies that involve no risk or minimal risk, a proxy decision-maker may consent for a person with dementia to participate, provided that the person with dementia does not object. Whether or not the proxy agrees, if the person with dementia objects or refuses to participate, he or she may not be forced to be involved in the research.
When the risks of the project are judged to be greater than minimal and there is no potential benefit to the participant, there are more restrictions on who can participate--usually only individuals who are capable of giving their own informed consent or who have an advance directive specifying their desire to participate in this type of research can be allowed to participate. This ensures that individuals will not be enrolled in research that could potentially harm them unless they explicitly have expressed their desire to participate.
Individuals volunteer to participate in research for a number of different reasons: some expect to benefit directly from the research, others do it for "future generations," and still others view research as an opportunity to participate in the fight against AD. Whatever the reason, all volunteers have the right to know what the research involves and to make an informed and free choice whether to participate. To all those who have chosen to participate, we give our heartfelt thanks; to those who have chosen not to volunteer, we respect your decision as well.
Possible questions to ask when considering participating in research: