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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
• Health 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:

1. Why is this research study being done?
2. What tests or procedures are involved?
3. How long will I be in the study?
4. What types of risks, discomforts or side effects can I expect?
5. What benefits, if any, can I expect?
6. What other choices do I have if I do not want to volunteer?
7. 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/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.

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 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.

Contact

For a consultation, contact the Research Subject Advocate.

 

NIH Funding Acknowledgement ** Important ** All publications resulting from the utilization of CTSI resources are required to credit the CTSI grant by including the NIH FUNDING ACKNOWLEDGEMENT and must comply with the NIH Public Access Policy.