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

May 29, 2019:

The PPHS has issued new guidance explaining the criteria for determining whether or not an activity is Human Subjects Research (HSR). If you are a principal investigator of a research activity, or in charge of a program or project designed to generate data, you can make this determination independently of the PPHS. Please visit the Guidance and Policies page to review the guidance.

May 17, 2019:

In order to better collect and document the appropriate local context for international research studies being conducted by ISMMS researchers, the PPHS has created a new form: HRP-231 - FORM - International Research. If you are conducting international research, you are now required to include this in your application.

May 8, 2019:

All requests for the ISMMS IRB to serve as the Reviewing IRB for an NIH grant submission must be submitted for consideration well in advance of the grant deadline. Please review the criteria for when ISMMS is willing to be the Reviewing IRB, and follow the instructions for submitting an HRP-230 form on the Request to Serve (R2S) page of the PPHS website, under Grant Submissions.

April 25, 2019

The January 21, 2019 announcement below ONLY applies to new studies. Studies approved prior to 1/21/19 should not transition their consent forms to the new consent template.

February 1, 2019:

New IRB Fee Schedule goes into effect on February 1st. Please see the Information for Sponsored Research section of the For Researchers page for more details.

January 21, 2019

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 (revised 1/16/19).
    • New projects submitted using an old version of the consent template will be rejected.
    • 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.