Doctor, should I (or my family member) enroll in a research study on Alzheimer’s disease?
Currently, any of us can go to the Web site from the National Institute of Health and find a list of over 100 (as of today, 141) research projects that are underway, and these projects need people who have Alzheimer’s disease or a related disorder. For our scientific knowledge to advance, people need to enter these research studies. However, many of us may have significant misgivings about being part in such projects.
In order for a research project to enroll a person, that person must give what is called “informed consent.” How can anyone, especially a person with Alzheimer’s disease truly give informed consent? Although this can be considered an extremely difficult philosophical question, it is a practical question that is addressed daily.
First, let us consider, how is the question brought up? Perhaps someone in the family of the person with Alzheimer’s disease sees something about a research study. Perhaps, after a visit to a specialist, the specialist suggests entry into a research study. Perhaps someone with Alzheimer’s disease sees an advertisement for entrance into a research project. The person who may be entered into the study can always consider the motivation of that person who recommends the research study. If the person making the recommendation is considering the interests of the person who may enter the research study, then such a recommendation might be considered. However, the formal entry into the research project is ultimately arranged by someone involved in the project.
Therefore, it is obvious that this person will have some vested interest in having people enter into the research study. Consequently, at this point it is very important for everyone concerned to carefully read what is known as the "consent form." In addition, this form should be explained in detail to everyone. If there is any concern of any type at this point, then don't enter the study.
Certainly, we can all ask our primary care doctor for his or her opinion. However, with so many research studies available, our primary care doctors are probably not in a situation to be able to say very much about any specific research project. Therefore, the decision is going to be made primarily on the level of comfort with the consent. Hospital committees approve these consent forms with the primary goal of protecting the potential research subjects, including people with Alzheimer's disease from risk.
Such protection, however, does not eliminate risk and anyone thinking of being involved in a research project should make sure that they discuss all possible risks with the researcher. If, after discussion about risks and other concerns, the potential research subject needs also to consider their own motivation and why he or she personally wants to be a research subject. Even after all available information is considered and discussed, it may still not be an easy answer as to whether one should be part of a research project or not.
As someone who treats Alzheimer's disease, does research in Alzheimer's disease and has family members with Alzheimer's disease, I can tell you that none of what I have written here fully answers the initial question raised at the beginning, "Should I enroll in a research study?" Only the person considering such enrollment can answer it. All of the areas of discussion above can be discussed in more detail. We will probably return to this discussion in the future.