Studies are often conducted at multiple sites, and/or sites that are not part of the Office of Mental Health (OMH) that may or may not have their own IRB. How do you know when to and how to go about securing the necessary approvals for conducting research at these sites? Apply the following procedures (separated by category, outlined in the next paragraph) when PI/CU/RFMH staff is responsible for the research conducted at the other sites or when CU or RFMH is the grantee. If either is true, then establish that the facility is engaged in research. In short, an institution is 'engaged in research' if their employees/agents interact/intervene with or obtain individually identifiable information about living individuals, or if the research is supported by a direct US Health and Human Services (HHS) grant to the institution. If the facility is engaged in research, next determine if there is a local or affiliated IRB. Also, consult the OMH website to determine if the facility is part of the OMH.
You will find step-by-step guidance, separated into three categories by type of collaborating site:
the site is an OMH facility
the site is a non-OMH facility that has an IRB
the site is a non-OMH facility that does not have an IRB
The NYSPI-IRB may be willing to serve as the IRB for another site. At the end of this approval process for conducting research at multiple sites, the NYSPI-IRB requires that all collaborating sites are covered by a Federal Wide Assurance (FWA), have their site's research reviewed by an IRB that has formally agreed to do so, and follow all local, state, and federal regulations concerning research: including those related to initial, continuing, amendment, and adverse event review.