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
- Updated Guidance on Research MRIs (Dec 21, 2020)
- Beginning February 1, 2021, the Program for the Protection of Human Subjects (PPHS) will require the use of a new 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
- Quick Guide for R2R Initial Submissions in RUTH
- Quick Guide for R2R Continuing Review in RUTH
- Quick Guide for R2R Modification Submissions in RUTH
- CV/PI Proxy/PC Quick Guide
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. Visit the RUTH Portal Library for all templates.
- Projects approved prior to 1/21/19 will remain under the Pre-2018 Common 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
- Research File Scanning Guidance
- Guidance on Research MRI
National Institutes of Health
- NIH Human Genomic Data Sharing (GDS) Policy and Guidelines
- NIH Institutional Certifications
- GDS Extramural Institutional Certification
- GDS Provisional Institutional Certification
- Data Use Limitation record for biospecimens collected before January 25, 2015 (updated 9.1.2021)
- Data Use Limitation record for biospecimens collected on or after January 25, 2015 (updated 9.1.2021)
- 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)
- See guidance. Visit here for more information on applying for a CoC. If after reviewing the NIH guidance you have questions, please feel free to contact the PPHS office at IRB@mssm.edu.
Screening and Recruitment
- Screening Guidelines
- Recruitment Guidelines
- Recruitment Resources
- For Guidelines for Human Research Advertisements, please review Worksheet HRP-315
Obtaining Consent
- 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