Link 1. Tools for determining the regulatory and institutional requirements

Link 2. Guidance: The Lead PI is from Miami or Miami is the Lead Institution for a multi-site funded project.

Link 3. The PI is from another institution and the research is conducted at Miami
(a formal agreement may or may not be required)

Link 4. Registering a collaboration with an externally reviewed and IRB approved or exempted project

Link 5. Information for External Researchers without a Miami research collaborator

Agreement Requirements

Determining the regulatory and institutional requirements. You may use the online form utility to determine what actions may be required when collaborating. You may also download a PDF version in a one page decision tree format.

Occasionally a multi-site project comes along that puts the institutions involved at significant risk of liability and the protocol suggests a common responsibility. But if the activities are parsed, the activities of Miami have a different level of risk. So, we may wish to separate the activities. For example, there have been a couple of projects where the activities of the external researchers were conducting some sort of clinical trial (cancer treatment/pediatric etc) that includes significant opportunities for harm when the activity of the Miami researchers is interviewing family members. This is why we do not sign agreements until there is a protocol approved. If necessary, the Provost's Office, mediated by the Miami Research Ethics and Integrity Office (MREI) may decide that Miami should conduct a separate review that covers only the Miami activities.

Definitions:

IAA (Interinstitutinoal IRB Authorization Agreement) or sometimes termed "Reliance Agreement": A formal agreement between instituitions to designate oversight authority and mutual responsibilities related to human subjects research. These agreements are required when federal funds are expended by both institutions. To be binding, the agreements must be countersigned by persons who can commit the institutions legally and contractually. This is typically a vice-president or assigned designee.

"Engaged in Research": A regulatory distinction. In practical terms, a person is engaged in human subjects research when they are in a position that could be perceived to risk harm to the subjects. Typically this role is obtaining consent, interacting with subjects, collecting data, or having access to data with identifiers. If the role of an investigator for a project is to analyze truly anonymous data (information that coud in no way be linked to the subject), then they are not "engaged in regulated research."

Guidance: 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 MREI may accept the review of the external collaborator's (PI's) IRB. The externally approved protocol will be examined to determine if the review process meets Miami standards or incurs a potential liability for which Miami should be aware of and manage. Note: 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 incut 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

PI's 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 MREI at sullivnh@miamioh.edu.

(a) 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.

(b) 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.

(c) If no Miami personnel will be obtaining consent of subjects, collecting data or having access to data with identifiers, then Miami is not by definition engaged in regulated research therefore Miami IRB approval or MREI exemption are 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 d, below). Copies of the research description and the approval letter should be sent to MREI for our records.

(d) 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, Provost's Office etc.). The IRB and the MREI do not have the authority to grant or deny access to Miami facilities, staff, or students. Rather, the IRB or the MREI reviews and approves procedures.

Note: Unless the Miami IRB has conducted a review and issued an approval letter, Miami University or the Miami IRB cannot be referenced as approving of the research. MREI acceptance of external review does not constitute Miami IRB approval. You can refer subjects to the MREI for questions or concerns about the procedures (per our policy, we will have a copy of the protocol on file).