The PPHS and the IRB offices at the Mount Sinai Health System sites have been successfully integrating policies, practices, and forms this year. Below are some key policies and processes that have been adopted by all sites:
- Consent process, policies, and template:
- In April 2015, a system-wide consent template was introduced and became mandatory throughout the system on May 1, 2015. All informed consent documents should be on the 4/1/15 template version.
- In October, 2015:
- The HIV in Research Consent must be used when HIV testing will occur within the research setting, including as part of screening for a research study.
- Consent documents for storing data/specimens will use the same future use language boilerplate.
- Consent documents when depositing data/specimens in large repositories will use the same boilerplate language. (See Guidance on Future Use and GWAS)
- In August, 2015:
- all sites adopted the ISMMS/MSH Phone consent process for minimal risk research when collecting PHI.
- Short Form Consent Policy. In August, all sites adopted the ISMMS/MSH Short Form Consent Policy. All requests must be made in advance to IRB@mssm.edu. Each request is evaluated on a case-by-case basis. (It is rare that a fully translated consent document is not required; ad hoc translation is not allowed).
- Policy on use of external IRBs. In July, all sites agreed to allow for the use of commercial IRBs. These remain limited to specific types of projects and are evaluated on a case-by-case basis. All requests to use a commercial IRB must be sent to IRB@mssm.edu using HRP-229A. There is a one-time administrative set up fee of $575 for industry sponsored research permitted to use a commercial IRB for the official IRB review of the study. For additional information, please review the Use of Commercial IRBs under Guidelines and Policies
- Guidance documents:
- Recruitment methods (revised 10/7/15)
- Screening guidance
As always, we appreciate all you do to protect the research volunteers who agree to take part in the research conducted by Investigators working within the Mount Sinai Health System.