Research Subject Advocates

The Research Subject Advocates (RSA) are experienced in study methodology and research ethics. Their mandate is to advocate for study participants and to represent the views of research participants to CRU staff and the investigative team when appropriate.

The RSA role includes:

• Patient advocacy: The RSA should be informed of all issues related to human subject protection on the CRU.
• Resource for participants: Advise study participants who may have questions about study participation
• Informed consent: The RSAs are available to be an impartial observer of the consent process
• Protocol compliance monitoring
• Data and safety monitoring: Advise investigators on data safety and monitoring plan development and assist in resolution of compliance questions.
• Education of study personnel: Training / guidance in the informed consent process

The RSAs are available to help during the study planning phase as you develop your Data and Safety Monitoring Plan. Please feel free to contact Meg Smirnoff RN, FNP, MPH at margaret.smirnoff@mountsinai.org.