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

• 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

• HRP-901-Guidance-Human Subjects Research Determinations (updated 12.15.2021)
• HRP-905-Guidance-HIV Testing in Research (updated 12.08.2022)
  
  • Mount Sinai Health System Policy (updates to this institutional policy, GPP-415, will be posted on the intranet)
• *HRP-902-Guidance-Case Reports and Case Series (posted 06.2021)
  
  • Authorization for Release of PHI for Scientific Publication rev.1.18
  • Authorization for Release of Protected Health Information (PHI) for Media Relations
• HRP-906-Guidance-Research File Scanning (posted 11.04.2019)
• HRP-907-Guidance-Research MRI (posted 12.21.2020)
• HRP-904-Guidance-Changing a Study PI (updated 07.11.2023)
• HRP-922-Guidance-RNI Reporting (updated 07.11.2023)
• HRP-923-Guidance-RNI Reporting for R2Rs (updated 10.26.2023)
• HRP-925-Guidance-Emergency Use-Compassionate Use (posted 02.08.2024)
• HRP-926-Guidance-Exempt Modification (posted 02.22.2024)

National Institutes of Health

• PPHS NIH Human Genomic Data Sharing (GDS) Policy and Guidelines
• Guidance on NIH Scientific Data Management and Sharing Policy
  • NIH GDS Extramural Institutional Certification
  • NIH GDS Provisional Institutional Certification
  • PPHS Data Use Limitation Form for Biospecimens collected before January 25, 2015 (updated 09.01.2021)
  • PPHS Data Use Limitation Form for Biospecimens collected after January 25, 2015 (updated 09.01.2021)
  • Optional PPHS Cover Letter to Request Data Use from Another Institution
• Single IRB Policy for Multi-site Research (01.25.2018)
  • 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)
  
  • Visit here for more information on CoCs. If after reviewing the NIH guidance you have questions, please feel free to contact the PPHS office at IRB@mssm.edu.
  • For Non-NIH Funded Studies: You must contact the PPHS office at IRB@mssm.edu to discuss obtaining a CoC for a Non-NIH Funded Study. See HRP-910-Guidance-Certificates of Confidentiality (CoC) – NIH Process for Non-NIH Funded Studies (revised 09.22.2023).

Screening and Recruitment

• Screening Guidelines
• Recruitment Guidelines (updated 09.21.2022)
• Recruitment Resources
• For Guidelines for Human Research Advertisements, please review Worksheet HRP-315 (revised 09.22.2023)

Obtaining Informed Consent

• HRP-090 - SOP - Informed Consent Process for Research (updated 12.09.2022)
• HRP-091 - SOP - Written Documentation of Consent (updated 12.09.2022)
• HRP-093-SOP-Consent at a Distance (updated 06.05.2023) (supercedes prior Phone Consent for Minimal Risk Research Policy)
• HRP-095-SOP-Obtaining Informed Consent when a Minor Enrolled in Research Attains 18 years of age (updated 08.20.2019)

Enrolling Non-English Speaking Subjects

• Policy on translated consents & short forms
• Short Form Consent Languages
• Information on finding instruments in multiple languages – Levy Library

Future Use Data Sharing and Genetic Research

• HRP-097-SOP-Future Use of Research Data and/or Specimens (updated 04.27.2023)
• HRP-909-Guidance-Research Involving Genetic Testing Under NYS Law (updated 01.01.2015)
• Guidance on Future Use and GWAS
• HRP-912-Guidance-Best Practice on Depositing Data Into Large Databases (updated 12.22.2022)
• HRP-913-Guidance-Consent Language for Banking Samples-Data (updated 12.22.2022)

Data Security

• Medical Center Data Security Policies
• HRP-915-Guidance-PPHS Data Security Standards (posted 02.2009)