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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 . 

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 Program (REI) may decide that Miami should conduct a separate review that covers only the Miami activities.

Definitions:

IAA (Interinstitutional IRB Authorization Agreement) or sometimes termed "Reliance Agreement '': A formal agreement between institutions 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 could 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 REI 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 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 .

PI's who desire to conduct human subjects research at ºÚÁÏÉçÇø 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 REI.

Note: REI only considers the protection of human subjects; it does 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 etc.). It would be wise to reference this authorization when submitting your IRB approval materials to your home institution.

(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 REI 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 REI 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 REI do not have the authority to grant or deny access to Miami facilities, staff, or ºÚÁÏÉçÇøs. Rather, the IRB or the REI reviews and approves procedures.

Note: Unless the Miami IRB has conducted a review and issued an approval letter, ºÚÁÏÉçÇø or the Miami IRB cannot be referenced as approving of the research. REI acceptance of external review does not constitute Miami IRB approval.

You can refer subjects to the REI for questions or concerns about the procedures (per our policy, we will have a copy of the protocol on file).