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:

• New Specimen Banking Questions for Continuation Applications
• Case Reports and Case Series Guidance
  • Authorization fro Release of Protected Health Information (PHI) for Media Relations
• NIH Human Genomic Data Sharing (GDS) Policy and Guidelines
  • GDS Extramural Institutional Certification
  • GDS Provisional Institutional Certification
  • Data Use Limitation record for biospecimens collected beforeJanuary 25, 2015
  • Data Use Limitation record for biospecimens collected on or afterJanuary 25, 2015
  • Cover letter to request DULR

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

• Click to read the NIH policy change notification.
• Notification to Investigators
• Letter to Subjects
• Letter to Subjects - Spanish
• Investigator's CoC Notification Plan - form to be completed and submitted to PPHS
  
• CoC language for consent documents that need revision due to this change
• CoC language for consent documents that need revision due to this change (Spanish)
• Guide to CoCs - for non-NIH funded projects only
• NIH CoC website (Updated 10/1/17)

Research Personnel Information

• Investigator Manual
• Study Personnel Changes Process

Screening and Recruitment

• Screening Guidelines
• Recruitment Guidelines
• Recruitment Resources
• For Guidelines for Human Research Advertisements, please review Worksheet HRP-312
• Phone consent for minimal risk research

Consenting Non-English Speaking Participants

• Policy on translated consents & short forms
• Short Form Consent Languages

Future Use Data Sharing and Genetic Research

• Guidance on Research Involving Genetic Testing Under NYS Law
• Guidance on Future Use and GWAS
• Guidance and Best Practice on Depositing Data Into Large Databases
• Consent language for blood/tissue banking
• Consent language for database repositories

Data Security

• Medical Center Data Security Policies
• PPHS Data Security Standards
• Information Security Team (InfoSec) Risk Assessment Process (sign-in using school email and network password required)