Please read the following before submitting to the PPHS office for human research review. All submissions must be sent to the IRB Inbox at IRB@mssm.edu.
Submissions that have not met the prerequisites listed below will not move forward in the review process and will be returned to the submitter. Returns may result in delays. Please have these requirements completed prior to submission.
- All study personnel listed on the HRP 211 form or any new personnel being added to a project must complete their FCOIC disclosures in Sinai Central.
- All study personnel must complete the PPHS education requirements (please see PPHS Ed Reqs for more information on the requirements). To see the completed courses, review the Investigators Form for the project in Sinai Central.
- Submit to the GCO via InfoEd. Generally, you should time your submissions to the GCO and the PPHS closely to ensure that back office cross-checking requirements are satisfied so that processing is not delayed at either office.
The following links provide access to the most common tasks required for interaction with the PPHS.
PPHS Forms and Documents
Go directly to access our forms, manuals, and templates
Training and Education
Addresses mandatory requirements for the conduct of human research at MSSM and educational offerings of interest to human subjects researchers.
HIPAA for Research
The Health Insurance Portability and Protection act created specific requirements for researchers; this page provides links to fulfilling these obligations.
Data and Safety Monitoring
Information on appropriate plans to fulfill investigator responsibilities for monitoring
Links and information about Mount Sinai data security policies and procedures.
Request to Start New Study
Detailed explanation of how to submit a new study for review by the PPHS
Request to Modify a Study
Process for changing a study that is currently approved by the PPHS
Request to Continue a Study
All human subject research must be reviewed at least once a year. Submission deadlines are important to avoid project interruption.
Report Important Information to the IRB (Reportable New Information)
This form defines what kind of information should be reported to the IRB, and replaces all previous forms of conveying reportable information.
Request to Advertise for Subjects
Procedures for PPHS approval of advertisements. Links to advertising opportunities
Request to Close a Study
Once a study is completed, you must notify the PPHS using the following process
Respond to Formal IRB Communication
Detailed explanation of how to respond to the PPHS
Guidance and Policies
Guidance, policies, and standard operating procedures regarding the conduct of human research at Mount Sinai
Meeting Dates and Deadlines
Calendars showing deadlines for various meetings; also describes the time frame for human subjects review
IRB Review Fees
The MSSM PPHS charges fees for some IRB reviews. See this page to see details.
Emergency Use of A Test Article
Methods for using test articles, for example investigational drugs and devices, on an emergency basis for a single patient
Other Helpful Topics:
Develop Your Study
Basic and Advanced instructions on generating research proposals. Includes links to other sites.
Information on the informed consent process, form, and documentation
More information about data management.
Terms you need to understand.
If you are conducting Mount Sinai research at Elmhurst Hospital Center, Queens Hospital Center, the Jewish Home and Hospital, or the Bronx VA, you should review this information.
Review of Coordinating Center Activities
If you are the coordinating center for a multi-centered study, there are specific requirements to fulfill.
Embryonic Stem Cell Research Oversight Committee (ESCRO)
All embryonic stem cell research requires ESCRO oversight in addition to human subjects protections review, if needed.
Contact Information for Related Offices
Researchers must work in certain circumstances with other offices and committees
Program for the Protection of Human Subjects
Office Hours: Monday-Friday 8AM - 5PM
For general inquiries, call or send e-mail to: IRB@mssm.edu
For submissions to the PPHS, send e-mail to: IRB@mssm.edu
PPHS Physical Location & Overnight Delivery Address
345 East 102nd Street
Suite 200 - 2nd Floor
New York, NY 10029
Icahn School of Medicine
One Gustave L. Levy Place
New York, NY 10029-65749