Researcher’s Palette

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

Data Security
Links and information about Mount Sinai data security policies and procedures.

How to:

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.

Consent
Information on the informed consent process, form, and documentation

InfoEd/eRAP Portal
More information about data management.

Basic Definitions
Terms you need to understand.

Research Affiliates
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