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.
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 here 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.
What is Clinical Mental Health 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.
In mental health clinical research, the term “clinical” means that the research involves persons in actual patient care settings. These may be inpatient settings (for patients whose illness requires hospitalization) and outpatient settings (for those who live in the community).
Some clinical research may examine how well a new treatment works?perhaps a drug or other type of therapy. In other instances, a clinical study might explore factors that affect mental disorders. These factors might include the role of genes and their interactions with life experiences in ways that might alter the chemistry of the brain and lead to illness.
In making your decision to participate in a research study, you should discuss the purpose of the research with the study director. Ask where the research will take place and how long it will last. What does the research involve? What are the potential benefits of participation? What are the risks? Does the research involve treatment of your illness? You will probably have many other questions for the researcher. Again, it may be helpful to write them down.
In the search for new knowledge, both you and the researcher will be trying out new things. If you do not know about the many safeguards that exist to protect research subjects, you may overestimate the risks of research. On the other hand, if you expect to receive only the most advanced new treatments, you may become disappointed.