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 Policies:

• Obtaining Informed Consent when a Minor Enrolled in Research Attains 18 years of age

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 (found on the Forms page, under For Researchers). Projects approved prior to 1/21/19 will remain under the old rule and should not transfer the consent documents to the new template. 

General Guidance:

• Human Subjects Research Determinations Guidance
• HIV Testing in Research
  
  • Mount Sinai Health System Policy (updates to this institutional policy, GPP-415, will be posted on the intranet)
• New Specimen Banking Questions for Continuation Applications
• Case Reports and Case Series Guidance
  • Authorization fro Release of Protected Health Information (PHI) for Media Relations

National Institutes of Health

• 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 - effective 1/25/18

• Information from the NIH, including the full policy.

• For more information on the PPHS practice related to this policy, and information for grant applications, please visit the Request to Rely (R2R) or Request to Serve (R2S) subpages depending on whether ISMMS will be a relying institution or will serve as the reviewing IRB, respectively.

• 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)