The role of the Research Subject Advocate is to promote clinical research and the safety of research subjects involved in research conducted through the General Clinical Research Center.

Who are the Research Subject Advocates?

Robert Betts, MD and Nancy Needler, BS, CCRC are the Research Subject Advocates (RSAs) for the University of Rochester General Clinical Research Center (GCRC). Nancy Needler has an office located on the GCRC.

The Research Subject Advocate is a position created to assure the safety of human research subjects participating in clinical trials and other health care research. We strongly support participation in research studies, while making sure that research is done as safely as possible.

Who do I contact?

If you have a question about the details of the study you are participating in (such as number of visits, procedures, etc.), contact the study coordinator or investigator.

If you have questions or concerns about your rights as a research subject, contact the RSA at the number provided in this brochure.

What can the Research Subject Advocates do for you?

One of our roles is to act as an advocate for your rights as a research participant. This includes some of the following:

• Providing information about research in general or helping you obtain information about the particular study in which you may be participating;
• Making sure that communication between you and the study investigator or other research personnel goes smoothly;
• Serving as an objective witness to the consent process if requested by you;
• To discuss and resolve your questions, concerns, or complaints.

How can I contact a Research Subject Advocate?

One of the Research Subject Advocates is usually available Monday through Friday, from approximately 8:30 AM to 4:30 PM.

Nancy Needler (585) 275-1020
Robert Betts (585) 275-1952

You may ask one of the GCRC nurses to help you contact one of us.

How will my confidentiality be maintained?

The RSAs will maintain the confidentiality of all communication provided by a research subject. Subjects are encouraged to be honest about their concerns – we are here to protect YOU, the research subject.

General Information about Participating in a Research Study

Participating in a research study is your choice. Make sure you have been given enough information to make your decision. You should have the answers to the following questions:

1. Why is this research study being done?
2. What tests or procedures are involved? How much of my time will the visits take? How long will I be in the study?
3. What types of risks, discomforts, or side effects can I expect?
4. What benefits, if any, can I expect?
5. What other choices do I have if I do not want to volunteer?
6. How will my records be protected?

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