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
2023 Informed Consent Template
After a process lasting many months with input from the research community, research subjects and experts in the fields of communication and research ethics, we are happy to roll out our revised informed consent form (ICF) template. The text has been modified to use language that is more inclusive, uses gender-neutral language to promote equitable research and modified text to acknowledge subject diversity and sensitivity to differences and personal preference. You will find that the sections involving pregnancy and birth control have been notably updated as well as the future use and withdrawal language.
We are aiming for a transition that is as stress-free as possible. We are publishing the templates December 6, 2022, BUT they are not mandated for use for another 2 months, beginning February 14, 2023. Any new project approved by the PPHS, as the IRB of Record, after February 14, 2023 will be required to use the new 2023 ICF template. We strongly urge researchers to incorporate the new template promptly but understand there may be work in progress where the transition would be too disruptive. The choice is the researchers' up until February 14th!
Refer to the HRP-921 below for detailed information on the use and migration of the 2023 ICF template. Consent templates are also available in the RUTH Library > Templates.
- HRP-921 Guidance 2023 ICF Template Roll Out (12.05.2022)
- HRP-502a MSHS Template Consent for Adults (11.11.2022)
- HRP-502a MSHS Template Consent for Adults Spanish (11.11.2022)
- HRP-502c MSHS Template Parental Permission for Child Participants (11.11.2022)
- HRP-502c MSHS Template Parental Permission for Child Participants Spanish (11.11.2022)
- HRP-502p MSHS Template Permission for Incapacitated Adults (11.11.2022)
- HRP-502p MSHS Template Permission for Incapacitated Adults Spanish (11.11.2022)
- HRP-502f MSHS R2S Template Consent for Adults (11.11.2022)
- HRP-502a3 MSHS Template Consent for Adults-No HIPAA (11.11.2022)
- HRP-502a1 EHC-MSHS Template Consent for Adults (11.11.2022)
- HRP-502a2 QHC-MSHS Template Consent for Adults (11.11.2022)
- HRP-508 MSHS Exempt Research Information Sheet (11.11.2022)
- HRP-509 Standalone Research HIPAA Authorization (11.11.2022)
- HRP-509 Standalone Research HIPAA Authorization Spanish (11.11.2022)
- HRP-502 Compare 2019-2022 (no instructions)
- Instructional Guidance for 2023 ICF (11.11.2022)
- HRP-232R – Request to Rely on an External IRB
- 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.