A Participant's Guide To Mental Health Clinical Research - Pamphlet

Pamphlet by: National Institute of Mental Health, June 8, 1999 by Steven E. Hyman

You and any family members interested in your well-being should discuss with the director of the research your questions about compassionate plea use. Each case is different, so the agreement has to be between the drug manufacturer and your own doctor.

Obtaining Care After a Research Project Has Ended

If you decide to take part in a research study -- and, especially one that takes place in a hospital -- you may find that you will have to stop, or interrupt, the care you now are getting for a mental disorder. Doing that, even temporarily, may result in your losing access to a program of personal care that had been expensive and hard to come by. The director of research on your study often will help you to get back into a program of care when the study is finished. The investigator?s institution may assist in arranging for follow-up care.

Learning About the Results of Research

In most informed consent forms, the researcher promises to share what is learned from the study with you. These results will sum up the responses of everyone who took part in the study. In addition, the researcher will discuss with you any results that relate to your diagnosis or that may be useful in deciding on the best treatment for your disorder.

Be sure to ask the director of research when you can expect to hear about the results. Ask how you will get this information. Will the researcher write an article describing the study, or will those who took part be invited to a meeting with the study director when all the results are in? If you have questions about the results when you receive them, ask the researcher who can help you to understand what they mean.

A frustrating thing about research is that it often takes years before the results of a study are available. This is because of the time it takes to conduct the study, including getting enough people in the study to make the results meaningful. Be patient, but remember to ask for the results if you have not received them when you expected them.

Checklist of Questions

So you have been asked to take part in a research study! This can be a very satisfying experience, allowing you to help yourself now and to help others in the future. After all, without research, treatment cannot improve, and without those who take part, there would be no research! You are the one who makes research possible.

But how you do know if you want to take part? What questions should you ask? The researcher should answer these basic questions clearly for you. Others undoubtedly will arise during the discussion.

Q: Why do you want me in your study?

Q: What is the research about? How will this research help in treating or understanding my disorder?

Q: What do I need to do and how much time will this take?

Q: How might this study help me, my relatives, or other people with my disorder?

Q: What possible risks are there to me or my relatives if I take part?

Q: How will this be different from the care I am getting now, and do I have other options or choices?

Q: Could my illness become worse during the study? What will happen if it does?