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.

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

As of 10/1/17, the National Institutes of Health (NIH) has radically changed its policy regarding issuing CoCs. This policy effects any research involving human subjects, their information or samples or projects that generate genomic information. Click to read the NIH policy change notification.

This requires the attention of the Investigator and impacted research subjects must be notified. Projects that already have a CoC are not impacted by this change. Projects that are not funded by the NIH are not impacted by this change and the process for obtaining a CoC is unchanged.

It is the responsibility of the PI to implement a mechanism to notify impacted research subjects who have already consented for involved research.Letter, emails and phone calls can be used. In person notification is also acceptable.

Please complete the Investigator's CoC Notification Plan (found below) and return to the PPHS at IRB@mssm.edu. The PPHS will not be sending out routine acknowledgements of receipt. We will contact you if we have any questions. If a receipt is required please contact the PPHS with your request and justification.

For those choosing to notify in writing, the research team will be responsible for preparing the “stuffed” addressed envelopes. The mailroom has graciously agreed to do mailing of up to 50 subjects at no direct cost to the project. Above 50 letters postage will be charge back at $0.46 per hand addressed envelope. The charge drops to $0.40 if addressed by machine. For further details please contact the mail room directly.

 Research Personnel Information

Screening and Recruitment

Consenting Non-English Speaking Participants

Future Use Data Sharing and Genetic Research

Data Security