WHO IS ELIGIBLE FOR A RESEARCH STUDY?

Every research study has strict inclusion and exclusion criteria. Your medical history and medications will be reviewed after signing an informed consent form. Laboratory tests, ECG’s, and cognitive tests are examples of assessments that are done to determine eligibility for a research study.

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WHAT INFORMATION WILL I BE GIVEN ABOUT A STUDY?

You will be informed of why the research is being done, how many volunteers are expected to be enrolled (locally and globally), where assessments will be done, and how often they are done. In addition, you will told about the treatment arms in the study, and how volunteers will be assigned to the treatment arms. You will be advised of the risks and benefits of participating in a research study, as well as the alternatives that are available. You will be asked to sign an informed consent form that gives details about the study, including possible side effects of the medication under study. The informed consent document, which you will be asked to sign before any study related procedures are done, will also describe what will occur at each visit.

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WHAT IS INFORMED CONSENT?

Informed consent for a research study is more than reading the document and signing a piece of paper. Informed consent is a process that relies on the following principles: that adequate information is provided to a potential volunteer to make an informed and autonomous decision; that the potential volunteer understands the information provided; and that consent is given voluntarily. Informed consent is an ongoing process. Research volunteers are encouraged to ask questions at any time during their participation.

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IS A RESEARCH VOLUNTEER ALLOWED TO CHANGE THEIR MIND ABOUT PARTICIPATING IN A STUDY?

Yes, all research study volunteers are allowed to stop participating in a study at any time, for any reason. Participation in research studies is voluntary. Volunteers have no obligation to continue in a study if they do not wish to.

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WHY SHOULD I OR A FAMILY MEMBER PARTICIPATE IN A RESEARCH STUDY?

Research studies provide volunteers with the opportunity to receive investigational drugs or devices that are not yet available to the public. Volunteers have said that they want to participate, not for themselves, but for the benefit of future generations.

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DO I HAVE TO STOP MY MEDICATIONS IN ORDER TO PARTICIPATE IN A RESEARCH STUDY?

Most studies allow participants to continue on all of their current medications. There are some studies that require participants to stop a particular medication in order to participate. You would not be asked to stop taking a medication that could jeopardize your health. You would not be asked to stop taking a medication without the knowledge, and agreement of your Primary Care Physician

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WHAT HAPPENS WHEN THE STUDY ENDS?

All research study volunteers need to be aware that their participation in a study may be stopped by the study sponsor, study doctor, Institutional Review Board (IRB), or the US Food & Drug Administration (FDA). Some reasons for stopping include non-compliance by the research volunteer, unforeseen side effects, and lack of treatment efficacy. Sometimes research volunteers are offered the opportunity to participate in an open-label extension study. What this means is that when the main study is completed all volunteers receive active study medication for an extended period of time which might be up to the time that the medication becomes commercially available.

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WILL MY PRIMARY CARE DOCTOR (PCP) BE NOTIFIED OF MY PARTICIPATION IN A RESEARCH STUDY?

There are many individuals that do not want their PCP notified that they are participating in a research study. We encourage volunteers to notify their PCP’s. If desired, Principal Investigator Robert J. Thomas, MD and Sub-Investigator Martha Gilpatrick, MD are available to speak with a volunteer's PCP.

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ARE RESEARCH STUDY VOLUNTEERS PAID?

Most studies do offer a stipend for time and travel.

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WHAT IF I CAN'T GET TO THE STUDY SITE BECAUSE I DON'T DRIVE?

Some sponsors will agree to pay for the cost of transportation to and from the site. Transportation should not be a barrier to participating in a research study.

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IS IT OK TO ASK QUESTIONS OVER THE COURSE OF THE STUDY?

The informed consent process begins at the time of your first visit. You are encouraged to ask questions at any time during the study.

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WILL THE INVESTIGATIONAL MEDICATION BE AVAILABLE AT MY LOCAL PHARMACY AT THE END OF THE STUDY?

Investigational medications are not available at the end of a study. An investigational medication is not available commercially until after it has been approved by the Food & Drug Administration (FDA).