Research Subject Advocacy (RSA) Program

The Research Subject Advocacy (RSA) Program complements the University of Rochester Human Subject Protection Program in support of ensuring the safety of people participating in health research. In addition to serving as a resource for volunteers who have questions or concerns regarding participation in research, the RSA Program provides assistance to investigators and all members of research teams in the following areas:

Creating a compliant Data and Safety Monitor Plan to include in the study protocol
Establishing an Informed Consent Process
Human Subject Protection concerns

Health Research Participants

Health Research Personnel

Health Research Participants
Your comfort and safety are important to us.

All trials and studies are approved by a committee to make sure your safety is protected. You can withdraw from a clinical trial or study at any time, for any reason.

Participating as a volunteer (also known as a research subject) in a clinical trial or study may benefit you and may help others in the future. People participate for a variety of reasons, and it is important to be aware of the potential benefits and the risks.

For information about Health Research at the University of Rochester, including opportunities to volunteer, please visit the Health Research Website.

What can our Research Subject Advocate do for you?

Help you to find information about a study.
Help you to communicate with the study team.
Join you when the study team explains the details and asks you to participate, at your request.
Listen to your questions, concerns and complaints and help you to find answers.

If you or someone you know is participating in a study, we encourage you to ask these questions:

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

If you have been asked to participate in a trial or study and you have questions or concerns, our Research Subject Advocate can help you.

Health Research Personnel
Consult with the RSA Program to receive support in developing a Data and Safety Monitoring Plan and the informed consent process for your studies.
- Data and Safety Monitoring
- Informed Consent Process
- Informed Consent Observation
  
  Support for Data & Safety Monitoring Plan (DSMP) Compliance
  All clinical research protocols must include provisions for monitoring the safety of participants. Specific monitoring requirements, identifying the required structure and the focus of monitoring, depend upon several factors, including:
  - The level of risk presented by the study design;
  - Regulations that govern the object of the study;
  - Requirements associated with sponsor funding.
  Examples of governing requirements include:
  - NIH/FDA: NIH Guidelines specify that all clinical trials should have a system in place for appropriate oversight and monitoring to ensure the safety of subjects and validity of the data. Monitoring should be appropriate to the nature, size, and complexity of the trial. There are additional administrative considerations if the clinical trial requires compliance with FDA regulations. Monitoring should conform to Good Clinical Practice (GCP) and International Committee on Harmonization (ICH) guidelines.
  - The Research Subjects Review Board (RSRB): RSRB requires a DSMP for all research studies involving greater than minimal risk. The plan must be described in the protocol/application.
  - Clinical Research Center (CRC): Every protocol evaluated by the CRC Advisory Committee must have a DSMP. To assist the Committee in completing their evaluations, please include all of the required elements, outlined in the CRC policy “Safety Monitoring Requirements.” CRC policies and forms are found on the CRC Website. Please note that studies conducted on the CRC must have a physician on the study team who monitors for safety.
  NOTE: A unified policy to provide one integrated framework for UR DSMPs is under development. Until this unified DSMP Policy is adopted, the RSA Program will help researchers to identify the appropriate structure of a monitoring plan for specific studies.
  
  The following documents may assist researchers:
  - Guidance for Investigators This RSRB document contains details for data monitoring. The RSRB application itself contains a DSMP section for completion.
  - Guidelines for Writing a Research Protocol An RSRB document that includes elements of a research protocol.
  If you require assistance in developing your DSMP or wish to have your DSMP reviewed prior to IRB submission, request a consultation with the Research Subject Advocate.
  
  Support for Developing an Informed Consent Process
  The RSA Program can provide researchers with training on conducting and documenting the informed consent process.
  
  The following resource may assist researchers:
  - The Medical College of Wisconsin has an introductory video on Eliciting Truly Informed Consent informed consent. Click Here for access.
  Observation of Informed Consent Process
  The RSA is available to observe the informed consent process, at the request of participants and/or research study personnel.
  
  If you require assistance in developing your Informed Consent Process, or have a request for the RSA to observe the administration of an informed consent, request a consultation with the Research Subject Advocate.
  
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Contact

Nancy Needler, BS, CCRC
Research Subject Advocate
(585) 275-1020
Email Nancy

Eric P. Rubinstein, JD, MPH
Director
(585) 758-7802
Email Eric

General Inquiries
Email Regulatory Support