Guidance and Policies

Policies define how the Icahn School of Medicine at Mount Sinai Program for the Protection of Human Subjects (PPHS) operates in the pursuit of human subjects' protection. Policies apply to all ISMMS research staff. Guidance is designed to assist the researcher and Institutional Review Board (IRB) member in understanding, interpreting, and applying the regulations and policies. Standard Operating Procedures describe the expectations for what and how a task should be accomplished.


  • Beginning February 1, 2021, the Program for the Protection of Human Subjects (PPHS) will require the use of a new HRP-903-Guidance-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.
    • Format for the Structured File Name should be: File Type > Study Number >Study teams can add any wording (title, etc.) next, but should be somewhat descriptive including versions/dates, etc.
    • For dates use format: mm.dd.yyyy 

RUTH Quick Guides

Revised Common Rule

  • PPHS Announcement (11.28.19)
  • All new project submitted after January 21, 2019 are subject to the Revised Common Rule and should use the most recent version of the PPHS HRP-502 template. Visit the RUTH Portal Library for all templates.
  • Projects approved prior to 1/21/19 will remain under the Pre-2018 Common Rule and should not transfer the consent documents to the new template.

General Guidance

National Institutes of Health

Screening and Recruitment

Obtaining Consent

Future Use Data Sharing and Genetic Research

Data Security