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

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

Foreword

Introduction

Why Do Patients Participate in Research on Mental Disorders?

What Is Mental Health Clinical Research?

How Will Treatment in a Clinical Research Study Differ from Treatment Your Own Doctor Provides?

How Are Clinical Studies of Mental Disorders Designed?

What Is a "Placebo Control" in a Medication Trial?

What Is the Investigator's Responsibility if a Patient Has a Clinical Crisis?

What Protections Exist for Research Subjects?

Does Research Involve Special Risk?

What Is Informed Consent?

Involvement of Family Members and Others

Will You Have Access to Those Drugs That Work After a Trial Is Complete?

Obtaining Care After a Research Project Has Ended

Learning About the Results of Research

Checklist of Questions

For More Information on Research into the Brain, Behavior, and Mental Disorders

Foreword

Through the ages, disorders of the mind have been among the most devastating and feared illnesses of humanity. Today, thanks to ambitious and productive research on mental illnesses and to the willingness of many persons to participate in research, highly effective treatments for mental illnesses exist. As a result of these treatments, many thousands of persons who have brain diseases such as depression, manic-depressive illness, schizophrenia, and anxiety disorders lead fulfilling and productive lives.

Just as the pace of progress to date would not have been possible without the participation in research of patients with mental illness and other volunteers, neither will the advances of tomorrow be realized without their continued participation. It is important to note that just as research on treatments has evolved and become more effective, so too has our society's attentiveness to the well-being of research volunteers grown. Procedures now in place to protect volunteers are more effective than ever before.

The National Institute of Mental Health (NIMH) recognizes the Nation's debt of gratitude to research participants, and is striving to maintain the trust that human subjects place in the excellence of the research enterprise. Thus, we prepared this booklet to highlight some of the questions a person may have in thinking about joining a research study. We hope that by anticipating some questions and helping persons better understand why they might consider participating in mental illness research, all Americans will benefit in the years ahead.

Introduction

In research on mental illness, as in other areas of medical science, volunteers are all-important. Thanks in large part to their help, clinical researchers are learning more and more about the causes of mental disorders and are finding new and better treatments.

If you wonder whether to take part in a mental illness-related research study, this booklet may help. (It also may be useful as you help a family member or friend with this decision.) Anything you decide will, of course, be personal and will depend upon your interests, needs, and expectations about research. In coming to your decision, you need to understand your rights as a research volunteer. Because your rights and well-being as a subject in research come first, this booklet will review the safeguards designed to protect you.

You also should know how scientists study mental illness. Research volunteers are not merely "subjects" of research, but actively take part in the search for knowledge. When you do participate, you deserve to understand a few of the most important requirements for good clinical research.

We encourage you to review the information in this booklet and discuss it with others whom you trust. The topics are in a question-and-answer format. As you read, make notes of any additional questions you have for the director of the research project you are considering. We hope this will help you to get the facts, raise your concerns knowledgeably, and decide then about taking part in a research study.

Why Do Patients Participate in Research on Mental Disorders?

Although remarkable progress has been made in defining and treating mental illnesses, some treatments are not effective for all persons or may have significant side effects. Thus, most people who agree to take part in studies of mental illness hope the research will produce knowledge about the disease itself -- for example, the role of genetics in illness -- or about treatments that will benefit them directly.

Research may allow you to try a new treatment before it is widely available. Even if the aim of a study is not to test the effectiveness of a new treatment, the research may offer a degree of care that you might not get otherwise. Such care may allow the investigators to monitor your symptoms very closely to be sure of your diagnosis.

Medical, psychological, and behavioral research are our best hope for better understanding of and treatments for mental illnesses. Although most who take part in research hope to benefit themselves, they may also simply wish to help others, which is a reward in itself.

What Is Mental Health Clinical Research?

Scientists study and try different ways to diagnose, treat, and prevent human disease more effectively. The needed research may take place in a basic science laboratory, a clinic, or in the community.