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.

New Guidance:

Single IRB Policy for Multi-site Research - NIH Policy Change effective 1/25/18

For applications with due dates on or after January 25, 2018, and contract solicitations published on or after January 25, 2018, NIH expects that all sites participating in multi-site studies, which involve non-exempt human subjects research funded by the NIH, will use a single Institutional Review Board (sIRB) to conduct the ethical review required for the protection of human subjects.

This policy applies to the domestic sites of NIH-funded multi-site studies where each site will conduct the same protocol involving non-exempt human subjects research. It does not apply to career development, research training or fellowship awards. Click here for more information from the NIH, including the full policy.

The PPHS has issued a statement confirming our understanding of the policy and agreeing to rely on external institutions serving as the sIRB using the SMART IRB Reliance agreement.

The full statement is available for download here and may be included in grant applications meeting this criteria: ISMMS PPHS Statement on NIH sIRB Policy

* This notice does not apply to projects where ISMMS will serve as the Reviewing IRB nor does it apply when the SMART IRB Agreement, or existing master agreement, is not being used. Please contact the PPHS office directly in these instances. 

Certificates of Confidentiality (CoC) - NIH Policy Change effective 10/1/17

Research Personnel Information

Screening and Recruitment

Consenting Non-English Speaking Participants

Future Use Data Sharing and Genetic Research

Data Security