Researchers must satisfy the requirements all of the institutions involved. It is the responsibility of the principal researcher and external collaborators to meet the requirements. As a means for reducing regulatory burden, federal regulations and Miami policy allow for single IRB oversight for multi-institution projects. The procedures for establishing responsibilities are dependent on the nature of the research and funding sources. Miami’s requirements for documentation and approval are summarized in a decision tree.
The following describes the two most common situations. (“Principal investigator [PI]” refers to the person who has overall responsibility for the administration of the project).
The researcher is at Miami and the PI for the project is at another institution
It would be very unusual for a university or college not to have policies related to human subjects research oversight and an IRB. Miami researchers who are the PI on a project must seek Miami IRB approval. If Miami personnel are not the PI on a project and are not receiving external funds in support of the research, the Miami Research Ethics & Integrity program (MREI) may accept the review of the external collaborator’s (PI’s) IRB. This form may be used to register external IRB approval. The externally approved protocol will be examined to determine if the review process meets Miami standards or incurs a potential liability of which Miami should be aware of and manage.
Occasionally, a Miami researcher will propose a collaboration where Miami will wish to retain oversight for just the activities of Miami personnel. For example, the overall project is a biomedical clinical trial to be conducted at a medical center that could incur significant liability, but the activities of the Miami researcher are limited to data collection and analysis related to an anonymous online survey related to the study.
The PI is from another institution and the research is conducted at Miami
PIs who desire to conduct human subjects research at Miami University must have IRB approval from their home institution (or in the absence of such an IRB, a request can be made for the Miami IRB to conduct a review). To document adequate IRB oversight to Miami, external researchers must submit a copy of their protocol and a copy of the approval letter to the MREI program.
Miami’s IRB and the MREI program consider only the protection of human subjects; they do not grant authority for the PI to conduct the research at Miami. Therefore, the authority to conduct research must be obtained from the appropriate university official relative to the research to be conducted (e.g. Dean of the College, Dean of Students, Director of Clinical Training, Department Chair). It would be wise to reference this authorization when submitting your IRB approval materials to your home institution.
- It is Miami policy that all human subjects research being conducted on a Miami campus be reviewed by an Institutional Review Board. That IRB review or exemption could be provided by the home institution of the researcher.
- If the outside researcher is collaborating with a Miami employee and the Miami employee is functioning as a researcher, the Miami researcher must be listed as personnel on the external collaborator’s IRB-approved protocol or the Miami IRB must conduct a review of the protocol using the Miami procedures.
- If no Miami personnel will be obtaining consent of subjects, collecting data, or have access to data with identifiers, then Miami is not engaged in research; therefore, Miami IRB approval or MREI program exemption is not required. However, we ask that external researchers send us a copy of the protocol and approval letter because we may be contacted about the project by potential subjects or the university administration granting access (see bullet below). Copies of the research description and the approval letter should be sent to the MREI program for our records.
- Researchers must still obtain permission to use Miami facilities from the appropriate official (e.g. Dean of Student Affairs, Dean of a College, Department Chairs, Provosts Office). The IRB and the MREI program do not have the authority to grant or deny access to Miami facilities, staff, or students. Rather, the IRB or MREI program reviews and approves procedures.
Unless the Miami IRB has conducted a review and issued an approval letter, neither Miami University nor the Miami IRB can be referenced as approving of the research. MREI program’s acceptance of external review does not constitute Miami IRB approval.
Written by Neal Sullivan, Director, Miami University Research Ethics & Integrity Program.
Photos by Jeff Sabo, Miami University Photo Services.