The Program for the Protection of Human Subjects (PPHS) Office reports the following updates to the integration of IRB operations across the Mount Sinai Health System (MSHS), and the ongoing implementation of IDEATE, Mount Sinai’s new electronic system for research application submissions. Together, these policy changes and the establishment of IDEATE will create a more uniform and efficient process for starting a human subject research project.
- The 229R Reliance form is no longer required for multisite research. For research occurring at more than one Mount Sinai Health System site, the PPHS Office will accept the System Chair’s signature as approval for all sites. The System Chair can designate this signing authority, and only one signature will be required regardless. This signature is currently affixed to the HRP-211 form, but this will change as the PPHS further integrates our processes into IDEATE.
- All federally funded projects will be submitted through the PPHS Office, regardless of the project’s Health System site of origin. This change will support a more streamlined submission process and allow for better coordination of grant approvals with federal agencies.
- All new multisite projects involving Icahn School of Medicine at Mount Sinai and/or The Mount Sinai Hospital will be submitted to the PPHS Office, either through the current process or IDEATE, when applicable. Applications for these multisite projects should not be submitted to another Health System site for review. Initial expedited projects will be submitted through IDEATE as the new system is rolled out to each department. The PPHS Office has already made this change with select departments, whose investigators will now submit all initial expedited projects through IDEATE, regardless of the project’s Health System site of origin. As more departments begin using IDEATE for project submissions, they will also use the new system for research at all Health System sites. As the IDEATE rollout schedule accelerates, the PPHS Office will work closely with each department as they adopt the IDEATE submission process for initial expedited projects.
- All Exempt projects to be conducted at any site within the Health System will be submitted through IDEATE.
- Full Board projects will be submitted through IDEATE on a pilot basis over the next several weeks to ensure a smooth transition process. It is anticipated that all Full Board projects will be submitted through IDEATE beginning Q3 2016. If you are interested in using your Full Board project for the IDEATE pilot, please contact me at email@example.com or (212) 824-8203.
Projects not impacted by the changes above at this time:
- Multisite projects that do not involve Icahn School of Medicine at Mount Sinai and/or The Mount Sinai Hospital should be submitted to the IRB of the Health System site where the majority of human subject interventions will take place (e.g., Mount Sinai Beth Israel).
- Single site, non-federally funded Full Board projects should continue to be submitted to that Health System site’s IRB.