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What Should You Ask Before Agreeing to Participate in a Research Study?

The decision to participate in a research study should be made after careful consideration of the risks, benefits, and alternatives, and should involve input from a variety of sources including friends, family members, and health care providers. The series of questions that follow are meant to serve as a guide to help with this decision-making process. Note that most of these questions are relevant to clinical trials as opposed to survey or services research. Many of the following questions also do not apply to studies that involve routine testing procedures that are conducted for the purpose of evaluating the causes and consequences of mental illness.

What is the purpose of the study?

What are the risks?

Will I have to stop my current treatment (particularly medications)?

Is there a possibility that I will be given a placebo?

Is the study being conducted as a single- or double-blind procedure?

What follow-up care can I expect when my participation in the study terminates (even if this occurs before the trial is completed)?

How will this affect my daily life?

Will I have to be hospitalized as part of the study?

What are the benefits I can expect to receive from participation in this study?

How will informed consent be assured?

What information will I be given about the research personnel?

Are there any conflicts of interest for the personnel associated with this research?

Will my medical information be kept confidential?

Will a sample of my DNA be collected?

Rights of All Research Participants

You have the right to:

Prepared for the National Mental Health Association Annual Conference (June, 2001) by:
E. Anne Riley, Ph.D., Research Associate, Clinical Brain Disorders Branch/NIMH
Shannon Flynn, Research Assistant, Clinical Brain Disorders Branch/NIMH
Susan R.B. Weiss, Ph.D., Senior Director, Research, National Mental Health Association


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