The General Clinical Research Center

Here at NYU School of Medicine General Clinical Research Center (NYU SOM GCRC) many of our faculty lead research programs aimed at developing new treatments for diseases and conditions which cause great human suffering.

To be successful, however, our researchers need state-of-the-art facilities and support. The NYU SOM GCRC provides an environment that allows clinical researchers to work safely with patients to learn about diseases and to devise new ways to prevent or cure them.

The NYU SOM GCRC is one of over 75 such Centers throughout the US. They are supported by special grants from the National Center for Research Resources of the NIH to each institution and must meet exacting standards for research quality and clinical safety. Each center is reviewed every five years by a team of experts to be sure that high standards are maintained.

How does it work?

A researcher at NYU who has an interest in a new clinical trial prepares a detailed plan explaining exactly how the work will be done: this is called a research protocol. For example, the basis of the plan may be the researcher's own idea, it may be a study from a national center such as the National Cancer Institute or it may be a test of a new drug or device that a pharmaceutical company wishes to market. The plan is presented to several committees for review to be sure that it is a good and worthwhile research study, and that participants will be safe. Specifically, every GCRC study must be reviewed and approved by the New York University SOM Institutional Review Board, the GCRC Advisory Committee and the Research Review Committee of the facility where the study is to take place.

A study can start only after it has been approved by all of these committees.

Why would I want to participate in a clinical study?

Research studies on a GCRC target different diseases or conditions. You might be interested in participating in a study because you suffer from that disease or condition and you would like to help advance knowledge that will lead to a cure or an improved therapy. On the other hand, you might be interested in participating as a normal volunteer.

It is important to be aware that research studies of new drugs or treatments, even if successful, may bring no personal benefit to you, but may be of value to others in the future.

Are there restrictions on my participation?

Individuals participating in a study must meet certain requirements, such as physical condition, age, or stage of disease and must be willing to sign an informed consent. Informed consent is defined as voluntary consent given by a person (or a responsible proxy) to participate in a study after being informed of the purpose, methods, procedures, risks and benefits. Consent must be given freely without undue influence.

Participants must also provide permission for the use of their health information so that it can be used and shared with those involved in the current research project, and possibly for research studies in the future.

Subjects have a right to withdraw from a study at any time without jeopardizing their medical care.