As of Friday, May 1, 2015, the Program for the Protection of Human Subjects (PPHS) began requiring the use of new consent templates, version date 4/1/2015, for IRB submissions. Version date 4/1/2015 templates highlight the ongoing efforts of the PPHS team to implement the usage of Mount Sinai Health System documents, replacing different site specific boilerplate language with a unified template. In addition, the HIPAA section of the templates has been revised to incorporate all hospitals within the Health System and eliminates the need for stand-alone HIPAA documents for each hospital engaged in the research.
The updated consent forms are now mandatory for the following submissions:
- initial submissions to the PPHS,
- continuation submissions still active to future enrollment (Note, the currently approved consent document must be transferred over to the latest version even if there are no other changes being requested.), and
- modification submissions affecting the consent template.
Research teams can obtain the latest document templates on the PPHS website, in the Forms and Documents Kiosk under “Consent Templates.” For a detailed account of the changes made to these documents, the PPHS has made “tracked changes” versions of the documents available at the top of the page, along with a PDF history of changes, entitled “PPHS Forms and Documents Version Revision History.”
For more information about PPHS templates, procedures, and policies, or if you have questions about these changes, contact the PPHS Office at email@example.com or 212-824-8200.