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.
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.
- 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
- Research File Scanning Guidance
National Institutes of Health
- NIH Human Genomic Data Sharing (GDS) Policy and Guidelines
- 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) - Updates coming soon.
- Contact the PPHS at IRB@mssm.edu if you have any questions.
Screening and Recruitment
- Screening Guidelines
- Recruitment Guidelines
- Recruitment Resources
- For Guidelines for Human Research Advertisements, please review Worksheet HRP-315
- Consent at a Distance Policy (supercedes prior Phone Consent for Minimal Risk Research Policy)
- Obtaining Informed Consent when a Minor Enrolled in Research Attains 18 years of age
- Policy on translated consents & short forms
- Short Form Consent Languages
Future Use Data Sharing and Genetic Research
- Future Use of Research Data and/or Specimens
- 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
- 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)