The Human Research Protection Program at the Icahn School of Medicine at Mount Sinai (ISMMS) is a comprehensive system to ensure the protection of the rights and welfare of subjects in human research. The Program for the Protection of Human Subjects (PPHS) is a key component of ISMMS’ efforts to ensure human subject protections. It supports our researchers in assuring the ethical conduct of research and compliance with federal, state, and institutional regulations, and provides a professional office staff to assist both investigators, participants, and five Institutional Review Boards (IRBs).
In addition, the overall Human Research Protection Program at ISMMS includes additional organizational, administrative, and investigator components, and is based on all individuals fulfilling their roles and responsibilities. Essential aspects of the overall mission of human subjects protection are provided by the organized interaction of the PPHS with the Financial Conflict of Interest Committee, the Clinical Trial Office, the Office of Research Compliance, the Biosafety Program, and the Radiation Safety Committee.
Our Human Research Protection Plan describes Mount Sinai’s plan to comply with ethical and legal requirements for the conduct and oversight of human research.
News and Announcements
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Effective October 1, 2025, the Program for the Protection of Human Subjects (PPHS) will implement an updated fee schedule for all industry-sponsored human subjects research projects submitted for review.
PPHS has not adjusted IRB-related fees since 2019. However, with increasing costs tied to regulatory compliance, operational support, and the growing administrative complexity of industry-sponsored and externally funded research, a revised fee structure will take effect on October 1, 2025. As part of this process, we reviewed the posted rates of our regional peers as well as those of comparable academic institutions across the country. The revised structure reflects the services, expertise, and institutional resources required to support high-quality research and to ensure compliance with evolving regulatory standards.
As part of this change, PPHS will no longer invoice industry sponsors directly. Instead, researchers will be required to provide an unrestricted fund number at the time of their submission in RUTH and will be billed once IRB approval has been granted.
Additional details are outlined in the attached document.
Please note the new IRB Fee Schedule will be updated under the For Researchers section of the PPHS website before October 1, 2025.
- Click here to access RUTH, the IRB Electronic Submission System
- Click here to access the Research Roadmap, Central Hub for Navigation of the Mount Sinai Health System Research Enterprise
- To access previous PPHS/RUTH listserv messages, please click here.