Why You or a Family Member Should Join an Alzheimer's Study
Why should you or a family member join an Alzheimer study? Or, what do you need to know about the research study process?
I work at a university or teaching hospital. One of the roles of a university or teaching hospital is conducting research. Research on Alzheimer’s disease commonly requires patients with Alzheimer’s disease to be part of a study. Most people who are not involved with health care have very little idea what research is or means. Therefore, it is difficult to understand what being a “subject” in a research study means. In this and my next blog, I will try to teach “Research 101”, a brief overview of medical research and how it pertains to Alzheimer’s disease. When we are done, I hope that you, my readers, may be more informed consumers of Alzheimer’s disease research.
We can generally divide medical research into two types, bench or basic research and clinical research. Basic research is what we typically think of when we see people in white coats with test tubes and chemicals. There is much more to basic research than this. However, in this discussion I want to address clinical research. This is the type of research that involves people, frequently patients with a disorder. The people involved are called subjects.
We can think of clinical research as dating back to antiquity. In the middle ages when a hole was drilled in the skull to let out the demons that caused headache, and the surgeon who did the drilling paid attention as to whether the patient died or got cured, he was a doing a crude form of clinical research. Research should however involve a theory, measurement and analysis. Most importantly, it should include ethics. All current research in the U.S. has ethical safeguards. Not only do we have safeguards for our human subjects, but we have safeguards for animal subjects. Much has been and is being written about the use of animal subjects. That is not our topic, ours is the inclusion of human subjects in research. It is difficult to envision how we could perform studies on the potential benefit of medications on the outcome of Alzheimer’s disease without eventually studying the medications in human subjects, patients with Alzheimer’s disease.
In studies of human subjects, there are obvious extremes of risk and anyone entering into a study needs to be aware of them. Some research may be as safe as answering questions or having blood drawn. Other studies may involve the use of unproven medications that have potentially serious side effects. How can the average person, who has no training in this area, fully interpret the potential risks? Also, there must be potential benefits, otherwise why would the study be done? The potential risks and benefits must be explained to the subject and any other significant persons, such as family members. After this explanation comes an important step. The human subject of a study, (or as is sometimes the case in dementia when the patient cannot understand the issues involved, a family member or companion) must give informed consent. Informed consent is exactly what the terms imply. The subject needs to have the proper information about the study. Only then can he or she give consent to be in the study.
Giving informed consent may be as simple as verbally agreeing to answer some questions. More commonly, especially if the study involves any significant risk, the subject is asked to sign a consent form. A consent form is a document that is designed to explain the research study, inform the subject of his or her role in the study (things such as time commitments), inform the subject about the potential risks and benefits of the study, inform the subject about who the researchers are that are responsible for the study, and inform the subject how to contact someone from the study and inform the subject as to who oversees the research, including its potential risks and benefits.
Only after giving informed consent can a subject enter into a study. But, you ask, how can you know if you want to be in a study to get to the point of asking about the risks and benefits? Getting to the point of asking is an individualistic thing. Some people are aware of research from friends, support groups, newspapers, the internet or some other source. If, for their personal reasons, they desire to be involved in the research, they will commonly seek out the research opportunities. They might do this out of interest in science; desire to possibly help themselves or others. These people then seek out opportunities for being in research. Other possible subjects may to be in a medical situation, such as at our university, that offers to include them (the potential subjects) the opportunity to join the research. No matter which situation, the patients still have the same opportunity for and quality of medical care whether they enter the study or not.
Therefore, patients enter into a research studies because they are informed about them; have the opportunities to enter them and the desire to be a part of this medical research process.
In my next blog I will cover another important aspect of this process. What are the safeguards that are in place to protect the subjects? Although the consent form is supposed to be written at an eighth grade level, it frequently many pages in length and not always as clear as we might like. Therefore, it is important for you to know that the researcher does not just “whip out a consent form” for potential subject to sign. Instead there is a complex process that occurs before, during and after the consent is signed. This process helps ensure that the research is being done safely and ethically. We will cover this next time.