The U.S. Department of Health and Human Services (HHS) and fifteen other Federal Departments and Agencies have issued final revisions to the Common Rule, which is the Federal Policy for the Protection of Human Subjects. The changes will go into effect on January 19, 2018. These changes to the federal policy will result in a number of changes to CUNY HRPP policies and procedures. The impact of Common Rule changes on CUNY HRPP policies and procedures is summarized here. Related information from the HHS Office for Human Research Protections (OHRP) is available here. Updated CUNY policies and procedural documents will be available on the CUNY HRPP website on January 19.
The SPH HRPP office will be providing ongoing support and resources to SPH researchers regarding these changes in the coming months.
The CUNY Central HRPP Office has issued a revised SOP on IRB Authorization Agreements (IAA) (also known as a Reliance Agreement, Cooperative Agreement, or IRB Memorandum of Understanding (MOU)). An IAA is formal document that provides a mechanism for an institution engaged in human subjects research to designate the institutional review board (IRB) of another institution as the IRB
of Record for one or more human subject research protocols. An IAA is an agreement between the institution(s) that 1) Specifies which institution’s IRB will be the IRB of Record for some or all components of a study; and 2) Defines the responsibilities for the IRB and for each institution.
The CUNY Office of Research, in collaboration with the CUNY Office of General Counsel and the CUNY Office of Institutional Research, has revised the guidance and procedures document to assist researchers (e.g., CUNY faculty, staff, post-doctoral associates, students) in ensuring compliance with Family Educational Rights and Privacy Act (FERPA) when using CUNY’s educational records for research purposes. Please familiarize yourself with this updated guidance.
In response to the increasing number of requests for inclusion of independent researchers (i.e., volunteer researchers) in CUNY research, the Office of Research, in collaboration with the Office of General Counsel, has developed procedures and an application to allow for the involvement of independent researchers in CUNY research. Please note that the authority to approve the involvement of independent researchers resides with the CUNY college or school where the research will take place. The procedures and application are available on the Research Agreements web page.
Welcome to the new SPH HRPP website! Along with developing a more user-friendly site, our Office has created a variety of resources and tools to aid SPH researchers in understanding and meeting regulatory requirements surrounding human subjects research. We hope you’ll find this information useful. As always, please feel free to contact us with questions, comments, or feedback.