Illustration from Jimmy’s Cambridge, UK. jimmyscambridge.net
Excerpted from The Memory Clinic, this is Appendix 2.
Whether you have dementia, think you’ll get it, or feel like you will live on as a healthy control, we need you to participate in research! And now that I work at a coordinating center for Alzheimer’s clinical trials, it’s my bailiwick to get you informed and motivated to consider volunteering.
To locate clinical trials, I always recommend http://www.clinicaltrials.gov. The entries onto this government-sponsored website are vetted to a small extent, in that proof of an ethics review board approval is required for all studies listed. However, some of the entries may be outdated (e.g., the study stopped recruiting a year ago) or the ethics review board that approved the study may not have the same high standards as others. As you pursue participation in a study, be VERY suspicious if:
- there is no mechanism for someone to answer your questions about the study (and there is NO such thing as a stupid question)
- you have not been informed equally well about benefits and risks of participating
- there are penalties for withdrawing from the study
- the patient with dementia can give consent in the absence of someone holding power of attorney
It is important to ask if you must stop medications the patient is already taking in order to participate. Depending upon whether you and your doctor think those medications are actively benefiting the patient, having to stop them for the study may be a deal-breaker.
Inquire after the number of visits entailed and the locations (not always a one-stop protocol!). We try not to design studies that require a swarm of visits, but there may be a lot of activity to get you rolling in the study (several visits, including imaging), then a slower visit schedule for the remainder of the study. Know what to expect.
Rights of the participant in a study should be stated on the informed consent form. These include:
- a written explanation of all study procedures, purposes, risks, and benefits
- the opportunity to ask questions and to feel that all questions have been answered satisfactorily before consenting to the study
- ample time to consider the risks and benefits before consenting to the study
- the ability to withdraw at any point in the study without penalties or adverse consequences to the patient’s clinical care
- assurance of confidentiality
It is the researcher’s responsibility to help patients and their families feel comfortable enough with the study procedures that they will be inclined to complete participation. We are disappointed if you have to leave the study early, but we know that your participation is voluntary. We do value your contribution of time and energy and especially your trust that we will act in your best interest in all events.
Do ask whether a placebo-controlled study will conduct an extension for study-completers. In the extension, all participants will typically have the opportunity to use the study drug (or Investigational Product, IP). This may offset your concerns about being assigned to the placebo group during the main study.