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

December 5, 2018

Winter is Coming! 

Read the PPHS announcement regarding the revised Common Rule, which goes into effect January 21, 2019.

  • ALL new studies approved after January 21, 2019, are required to use the new consent template.
    • Friday, December 7, 2018 is the last Full Board deadline for meetings prior to the implementation of the new rule.
    • Projects not granted FULL approval prior to January 21, 2019 will require a full review under the new regulations after January 21, 2019, regardless of what stage of the review process they have completed.

 

October 25, 2018

The PPHS has posted guidance for the use of external IRBs:

  • For Requests to RELY on an external IRB, please review the new R2R page under Guidance and Policies.
  • For Requests for ISMMS to SERVE as the reviewing IRB, please review the new R2S page under Guidance and Policies.