David Callejo Pérez
November 15, 2013
Submission deadline: November 1, 2013
Cooperative research projects are those projects which involve more than one institution. The official relationship between the two institutions is not relevant. Each institution is responsible for safeguarding the rights and welfare of human participants and for complying with federal regulations and institutional policies. See 45 CFR 46.114 for more information.
PIs' at Saginaw Valley State University (SVSU) who are conducting research at another institution are required to abide by SVSU requirements, as well as the requirements of the other institution. For studies funded by DHHS the PI is responsible for ensuring all data collection sites within the cooperative research protocol have an approved DHHS assurance (e.g., federalwide assurance), and each will review the research protocol separately.
When SVSU is considered to be “engaged in research” (see OHRP guidance document “Engagement of Institutions in Research,” January 26, 1999) but the PI is not associated with SVSU (that is, for instance, when an outside group desires to collect data at SVSU and has a local contact for doing so), the PI must submit the following for review by the IRB: an application cover sheet and completed protocol; a letter of support from the involved faculty member at SVSU who will sponsor the project, and a letter of approval from the PI’s IRB, unless the PI’s institution does not have an IRB. If the PI’s institution does not have an IRB, then they will be required to submit a full application to the IRB at SVSU. The IRB will then complete the appropriate review process, based on the nature of the research project. SVSU may choose to rely more heavily on the review of the PI’s Institutional IRB. However, this does not relieve SVSU’s IRB from reviewing the project as outlined above, although an authorization agreement may facilitate projects. When SVSU is not “engaged in the research,” the unaffiliated PI needs to obtain IRB approval at his or her institution and secure permission from an SVSU official (e.g., department Chairperson, dean, supervisor, or other appropriate Administrative official) to conduct the study at SVSU.