Frequently Asked Questions (FAQs) About Participating in Research Studies

1. What is the purpose of these studies? Doctors and researchers use medical research studies to better understand the causes of Parkinson’s disease and to improve treatment. These studies include laboratory-based experiments, studies of disease heredity, studies of “biomarkers” in blood or spinal fluid, and medication trials.  Ultimately, the research is aimed at finding ways to improve the lives of those with Parkinson’s disease and their loved ones.
2. Why do people take part in research studies? One reason people take part in research studies is to help understand the cause of Parkinson’s disease and related disorders. Even though these people may not always directly benefit from participating in the research studies, their participation advances knowledge about their illness, which could lead to a treatment or cure for others. Another reason for taking part in studies is to test potential new treatments. These studies usually compare a new treatment with either a currently used treatment or with placebo, an inactive substance. These studies are designed so that neither the participants nor the researchers know who is taking the new treatment and who is taking the placebo. This is called a “double-blind” study and is the most reliable way to test new treatments. Because no one involved with the study knows what the participants are taking, there is no bias of the data. This is how all new medications are tested before they are approved by the U.S. Food and Drug Administration (FDA) for prescription use.
3. How is participating in a research study different from visiting my regular doctor? Our research studies are looking at a specific medical problem, Parkinson’s disease and related disorders. Although we do some of the same medical tests that your regular doctor will do, we do not provide complete medical care.  You must continue to see your doctor on a regular basis to make sure all of your health needs are being taken care of.
4. What will my responsibilities be if I participate in a research study? Volunteers’ responsibilities vary within the Pacific Udall Center.  Some study participants will be seen either at home or in their doctor’s office, and some will come to our research clinic for an evaluation. The volunteers, along with caregivers or other family members, will first have the study explained to them and will sign a consent form. The consent form will be a written explanation of the study procedures, risks and benefits of participation, and other information about the study. Study participants will be asked about their medical history, what medications they are currently taking, and will have a physical exam, an electrocardiogram (EKG), and a small amount of blood drawn to look for any relevant blood chemistry problems. Study participants in medication treatment trials will be asked to keep track of their medication during the study, to keep a daily diary of medication which has been taken, and to note any changes in their health. Participants in other research studies will often be asked to spend one or more mornings at our research clinic. Procedures that will occur during this time vary greatly depending on which study is involved; these will be explained in detail before a volunteer participates.
5. How do I decide if study participation is right for me? Study participation is not for everyone. Some studies place a substantial burden on the participant’s time as well as the time of their caregivers. Some studies involve extensive memory testing, which can cause fatigue or stress to the study participants. On the other hand, some people find study participation to be quite rewarding. They get the most up-to-date information on the state of the research into their disease, as well as having the opportunity to meet others in similar circumstances. Study participation can also be a way to find other support resources. Deciding to participate in a study is a personal decision, to be made with the help of family, friends, and your personal physician. When deciding whether to enter a study, the possible benefits and drawbacks should be carefully considered. Possible benefits to participation include access to new treatments, expert diagnostic evaluation and recommendations for care, the opportunity to learn more about your condition, and a chance to help others who may have the same illness. Possible drawbacks to consider are side effects of treatments or procedures, no guaranteed treatment benefit, and the chance of receiving placebo instead of the new treatment being tested
6. What are my rights as a study volunteer? Study volunteers have the right to decide whether to participate in a study and when to leave a study. You have the right to decide you want to stop your participation at any time. We will usually ask a participant to come to the clinic for a final follow-up visit in order to terminate participation in an orderly fashion. Study volunteers have the right to Informed Consent. This means that all of the study procedures, as well as the risks and benefits of study participation, are explained before you decide to participate. You will also be informed of alternatives to participating in the research study. You have the right and the responsibility to know all the facts before you participate in a study. After your questions are answered, if you still wish to participate you will be asked to sign a form, which is a written explanation of the study. Even after you have signed the form, you should feel free to ask members of the research team any questions that you might have during your study participation. Study volunteers have a right to have their health protected. Research staff and investigators will monitor your health during the study to make sure that you are not experiencing serious side effects from any treatment or procedure. If you do develop any health problems during the course of the study, we will ask to share your results with your regular doctor. You should continue to see your doctor on a regular basis while you are in any research study.