Program for the Protection of Human Subjects

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

  • As of November 11, 2022, study teams will have the option to create and submit a combined Modification and Continuing review submission (MODCR combo) in RUTH. The steps to access this option are the same steps you currently follow to create a Continuing review submission or a Modification submission. Click HERE to read the MOD CR Combo ListServ message from 11/11/22 for:
    • Considerations for choosing the MODCR Combo submission.
    • Steps to follow to submit a MODCR combo submission.
  • Beginning February 1, 2021, the Program for the Protection of Human Subjects (PPHS) will require the use of a new PPHS Naming Convention to be used with the RUTH application submission system. Changes to document names for migrated projects is not required unless a change to the document is submitted for review. The effective start date is 2/1/2021, however study teams can begin immediately.
  • Click here to access RUTH, the IRB Electronic Submission System
  • All COVID-19 research-related guidance can be accessed via the Research Roadmap ORANGE LINE
  • To access previous PPHS/RUTH listserv messages, please click here.