Patient Information Sheet on Research Procedures in IMH

Volunteer Patients Participating in Clinical Research

The Institute of Mental Health (IMH) is one of the nation's foremost centers for psychiatric research. Studies involving volunteer subjects (patients and clinical research volunteers) are carried out in IMH. Volunteer subjects at IMH become partners in a special relationship with members of the research teams in the search for better understanding of mental illnesses and for better ways to treat these illnesses.

What does it mean to be a volunteer?

The health of millions has been improved because of advances in science and technology, and the altruism and willingness of thousands of individuals like you who take part in clinical research. Without your help, the research studies at IMH cannot be accomplished. This information is prepared to help you understand what is involved in participating in clinical research.

What is clinical research?

Volunteers who have a particular illness or condition, can help research doctors and scientists better understand, diagnose, prevent, treat, or cure it. These studies may involve drugs, devices, interventions or tests designed to prevent, treat, cure or diagnose diseases. The research is planned to help others and may not benefit any one individual directly.

What is a clinical trial?

Clinical trials are a means of developing new treatments and medications for diseases and conditions. There are strict rules for clinical trials, which are monitored by the National Healthcare Group- Domain Specific Review Board (NHG-DSRB) and the drug regulating body of the country, where applicable, especially when research involves new drugs.

Are there risks involved in participating in clinical research?

There are risks inherent in any clinical research. The type and seriousness of the risk depend on the individual study. The specific risks associated with any research protocol are described in detail in the consent document, which you will be asked to sign before participating in the research. The consent document is translated in a language understood by the research subject. In addition, the risks of participating in a study and other questions that you may have about the study will be explained to you by a member of the research team. Before deciding to participate, you should carefully weigh these risks. You will also be informed of alternative treatment if they are available. You may also ask your attending physician or the Princial Investigator of the study about the same. Although you may not receive any direct benefit as a result of participating in research, the knowledge gained from the study may help others. The following section describes safeguards to protect the safety and rights of volunteer subjects.

Protocol review

All new protocols proposeded at IMH must be approved by IMH Clinical Research Committee (CRC) and NHG-DSRB before they can recruit subjects for the study. At the level of IMH, all protocols are reviewed by CRC mainly on their scientific merit and advice of the Chairman Medical Board (CMB) is sought where necessary. The protocols are then reviewed by the NHG-DSRB, which reviews the ethical aspects of the protocol. Clinical drug trials that involve drugs/devices also need a certificate from the Health Services Authority (HSA) of Singapore.

The Committees, which consist of medical specialists, statisticians, nurses, social workers, patient representatives and medical ethicists, are the advocate of the volunteer subject. CRC and DSRB will only approve protocols that address medically important questions in a scientific and ethical manner.

Informed Consent

Your participation in any Clinical Center research protocol is entirely voluntary. For every study in which you intend to participate, you will receive a document called "Consent to Participate in a Clinical Research Study" that explains the study in simple language. A member of the research team will discuss the protocol with you, explain its details, and answer your questions.

You are free to change your mind and withdraw from the study at any time after signing the consent document. This means that you are free to withdraw from the study completely, or to refuse particular tests or treatments; this will not affect your current treatment or your relationship with the physician in theInstitution in anyway.