_Research | �þ�ˮ��

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 �þ�ˮ�� 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. �þ�ˮ��'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 �þ�ˮ�� 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 �þ�ˮ�� 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 �þ�ˮ�� Research Ethics and Integrity Program (REI) may decide that �þ�ˮ�� should conduct a separate review that covers only the �þ�ˮ�� 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 �þ�ˮ�� 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. �þ�ˮ�� researchers who are the PI on a project must seek �þ�ˮ�� IRB approval. If �þ�ˮ�� 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 �þ�ˮ�� standards or incurs a potential liability for which �þ�ˮ�� should be aware of and manage. Note: occasionally a �þ�ˮ�� researcher will propose a collaboration where �þ�ˮ�� will wish to retain oversight for just the activities of �þ�ˮ�� 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 �þ�ˮ�� 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 �þ�ˮ�� .

PI's who desire to conduct human subjects research at �þ�ˮ�� must have IRB approval from their home institution (or in the absence of such an IRB, a request can be made for the �þ�ˮ�� IRB to conduct a review). To document adequate IRB oversight to �þ�ˮ��, 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 �þ�ˮ��. 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 �þ�ˮ�� Policy that all human subjects research being conducted on a �þ�ˮ�� 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 �þ�ˮ�� employee and the �þ�ˮ�� employee is functioning as a researcher, the �þ�ˮ�� researcher must be listed as personnel on the external collaborator's IRB approved protocol or the �þ�ˮ�� IRB must conduct a review of the protocol using the �þ�ˮ�� procedures.

(c) If no �þ�ˮ�� personnel will be obtaining consent of subjects, collecting data or having access to data with identifiers, then �þ�ˮ�� is not by definition engaged in regulated research therefore �þ�ˮ�� 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 �þ�ˮ�� 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 �þ�ˮ�� facilities, staff, or students. Rather, the IRB or the REI reviews and approves procedures.

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

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