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

General Guidance

National Institutes of Health

Screening and Recruitment

Obtaining Informed Consent

Enrolling Non-English Speaking Subjects

Future Use Data Sharing and Genetic Research

Data Security