A Guide to the Informed Consent Process

Are You Thinking About Taking Part in a Research Study?

If you are, you should know that all research done here at the Department of Psychiatry at Columbia University and the New York State Psychiatric Institute has been reviewed and approved by an Institutional Review Board (the "IRB"). Our IRB is a committee of professionals and lay members with expertise in science, medicine, patient care, law, religion, and ethics. We are responsible for assuring that research with patients or other individuals meets the highest ethical and safety standards and follows all Federal and State rules and requirements for research. We are of diverse background and include members of the community, members of patient advocacy organizations, and people who have personal experience with mental illness.

The New York State Psychiatric Institute ("PI") is the oldest and one of the most highly regarded psychiatry research centers in the United States. Members of the IRB volunteer their time to support PI’s efforts to improve the understanding and treatment of mental illness and related problems by helping ensure that your participation in research respects your rights, needs and expectations.

As you consider taking part in research, you should understand the following:

1. All research participation is voluntary–you do not have to take part in research and you may change your mind about your decision to take part in research at any time, even once the research has begun. People who take part in research are sometimes called research participants, research subjects, or research volunteers.

2. You can take part in research only after you give your informed consent. Informed consent means that you have been given all the information about the research that you need to make the decision to participate, that you understand the information, and that you can freely and without pressure agree to participate in the research. For research with children, a parent or guardian must give permission and the child must be willing to take part (to "assent" to the research). Since research often involves unfamiliar or complicated procedures, take time to discuss the study with the researchers before you make your decision.

3. In most studies, you will be asked to sign a written consent form which summarizes the study’s purpose, procedures, benefits, risks, alternatives, and your rights as a participant in research. A round dated stamp on each page of the consent form shows that the study’s IRB approval is current. If you agree to participate in research, the IRB requires that you and the researcher sign and date the form before the research can begin. You will be given a copy of the form to keep for future reference. This form includes important phone numbers to call if you have questions about the research or questions about your rights as a research subject. In limited circumstances, a written and/or signed consent form is not required by the IRB. When this happens, all the required information is discussed with you, and all of your rights as a research participant remain the same.

4. The research team determines if you are eligible for a study. Only people who can safely participate and who can help the research achieve its goals are included. For this reason, it is important that you provide the researcher with complete and correct information about your medical and psychiatric history.

5. If you are considering taking part in research which provides treatment (a treatment study), talk to the researcher so that you understand what the research will offer you, whether this treatment differs from what you might get if you were not participating in research, and what your treatment alternatives are.

6. The consent form describes a research study’s main risks and benefits. Treatment studies, just like regular treatment, involve some risks and benefits. Take the time to learn about what these risks and benefits mean for you as you discuss the study with members of the research team.

7. Most research studies involve some procedures or tests which are not part of your care or treatment and are done to help answer scientific questions.

8. Other types of research studies do not provide any treatment and all procedures are done to answer important scientific questions.

9. Some research studies provide payment for your time and effort or reimbursement for expenses related to research participation (such as transportation costs.) The consent form describes this in the compensation section.

10. Research often involves collecting private or personal information about you. Under the confidentiality section, a consent form describes the steps the researcher and Institute will to take to protect your privacy, and any limits to that protection.

If you have any questions about research participation, or if you simply want to give us feedback, please feel free to contact us at 212-543-2062 or by e-mail at irbmail@pi.cpmc.columbia.edu.

Thank you.

David H. Strauss, M.D.

Chairman, Institutional Review Board

New York State Psychiatric Institute