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, serving as a resource for research volunteers and UR research personnel.
Health Research Participants
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.
Support for Data & Safety Monitoring Plan (DSMP) Compliance
All clinical research protocols must include provisions for monitoring the safety of participants. The details of a DSMP are dependent upon many 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 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. Click here for more about the Data and Safety Monitoring Plan Policy.
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.
- Research Protocol Templates - RSRB protocol templates that contain elements of a research protocol and guidance on information for different types of research.
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 Office of Human Subject Protection provides a presentation on the every-day task of carrying out informed consent, titled “Informed Consent: Federal Regulations, Institutional Policy and Good Practice.” Click here to access the presentation.
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.