Office of Research & Sponsored Programs

IRB Manual Unaffiliated Researchers

Research Involving Other Institutions and Unaffiliated Researchers

 

Research Involving More than One Institution

The University will ensure that all collaborating institutions (including subcontractors and subgrantees) engaged in the conduct of research involving human participants will have mechanisms to protect human subjects that are at least equivalent to those procedures provided for in the ethical principles to which this institution is committed.  Collaborating institutions are those engaged in human participants research by virtue of subject accrual, transfer of identifiable information, and/or in exchange of something of value, such as material support (e.g., money or identifiable materials), co-authorship, intellectual property, or credits. 

The University will comply with the requirements set forth in 45 CFR 46.114 regarding cooperative research projects.  When research covered by this institution’s Federal Wide Assurance (FWA) is conducted at or in cooperation with another entity, all provisions remain in effect for that research.

The UNI IRB may, at its discretion, enter into a joint review arrangement, rely upon the review of another qualified IRB that adheres to similar standards of human participant protections, or make similar arrangements for the purpose of meeting the IRB review requirements and avoiding duplication of effort.  These arrangements may be entered into on a case-by-case basis, if arrangement is needed for the review of a single research project.  Or, for ongoing cooperative research, a more formal arrangement may be entered into, such as a memorandum of understanding detailing the joint review mechanism(s).  Use of a single, consolidated informed consent form for such studies is strongly encouraged.  In addition, copies of all correlative protocols and consent documents required at collaborating institutions must be kept on file at the University of Northern Iowa. 

Researchers planning a project in collaboration with investigators from another institution should contact the IRB Administrator for guidance on pursuing an inter-institutional agreement before submitting the application for review at either institution.

Research at UNI by Researchers Not Affiliated with UNI

When individuals from other institutions or organizations conduct research involving participants who are UNI students, staff, or faculty, or research that makes use of UNI facilities or records, the UNI IRB does not provide formal oversight for that research unless the study is more than minimal risk.  In minimal risk research, external investigators are expected to seek the permission of the unit or administrative head that provides the closest oversight for the study sample (e.g., coach or department head), as appropriate, and provide the UNI IRB with documentation of their own IRB's approval.  Contact the UNI IRB Administrator with questions.

If someone affiliated with UNI serves as a co-investigator, or otherwise performs study tasks (beyond simply forwarding or collecting anonymous study materials, or providing mailing lists), then the study must be reviewed at UNI as well, unless an inter-institutional agreement is signed. 

Research Begun Prior to Affiliation with UNI

When a faculty member, staff, or student comes to UNI with a research project already underway, the study must be reviewed by the UNI IRB prior to any further activities taking place on the project.  In some circumstances, the IRB may agree to allow the study to continue under the oversight of the prior IRB, but most often the oversight should be "transferred" here.  If all data collection is completed, and data analysis is the only activity still planned, then the review will be accomplished using the Application for Use of Existing Data.  If the only remaining activity is to write up the results of analysis already completed, then UNI IRB review is not necessary.

An exception to this general rule is that if the study was reviewed by an IRB at a prior institution and was found Exempt, the only requirement for transferring the study to UNI is that the Exempt approval/determination be provided to and accepted by the UNI IRB office.  In the event changes are subsequently needed in study procedures or other details, the investigator must request approval of the modifications from the IRB prior to implementing the changes (see Modifications).

 

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