Office of Research & Sponsored Programs

IRB Manual Study Site Cooperation

Study Site Cooperation

 

Letters of Cooperation

Letters (or emails) documenting the permission and/or cooperation from any external research site or cooperating organization are required. These may be submitted with the IRB application or following review/approval, but at least one must be on file with the IRB before the application can be approved.  Research may not commence at any given research site until documentation of cooperation has been received and accepted by the IRB. 

Study site letters should not be confused with consent documents from individuals who may later decide to participate in the research. 

A letter of cooperation serves as documentation from the research site that the investigator has permission to conduct the research at that location. The letter typically must be from someone in authority at the organization, not a group counselor or teacher. Although the PI is encouraged to likewise have contact with others in the organization whose cooperation will be needed to carry out the research (e.g.., teachers who will be distributing consent forms to students), only documentation from the top official should be submitted to the IRB. An exception to this rule is that letters are occasionally permitted from coaches or professors in large or international institutions, when it makes more sense to seek the permission of someone closer to the research rather a central administrator. PIs are cautioned to check with central administration at colleges and universities, however, because they often have their own rules about oversight of research conducted at their institutions, and may require documentation of IRB review from UNI or require IRB review at that institution. 

When the research is being carried out at UNI, letters are only required from special departments or areas, primarily coaches of sports teams, directors of student clubs, and individual faculty or departments who are providing a dataset to the PI for analysis. Please note that some departments, such as the Registrar, may themselves require documentation of IRB review (or that IRB review is not needed) prior to providing a mailing list or contact information for potential participants. 

A letter of cooperation may be submitted to the IRB as a formal signed hard copy letter or as an informal email or fax from the organization. Regardless of format, the letter must show the individual’s name, title, organization, and contact information. If by email, the email must show the originator’s email address (in the case of forwarded emails). The letter should also say something about what is being permitted (e.g., to allow the investigator access to recruit participants, to allow the investigator to carry out the data collection on site, to allow posting of a flyer, or to serve as a “conduit” for distributing recruitment materials). If the letters do not contain the required contact information or are not from a person in authority, the IRB will request that the PI seek another or updated letter or email. 

If the study requires multiple sites, the PI has the option to draft the “letter” of cooperation as a form and simply request signatures from the research sites. Also, the study may be approved as a multi-site project with only one letter of cooperation on file. The PI is then required to ensure that letters from each additional site are provided to the IRB Administrator before initiating any research at those locations. When an additional letter is received for a multi-site study, the IRB Administrator will send a confirmatory email to the PI authorizing the research to begin at that location. 

If the individual in authority at the prospective site is also a possible participant in the study, investigators should be careful not to confuse requesting permission to conduct the study at that site with inviting the individual’s participation as a possible subject in the study.  Under those circumstances, the PI should review Recruitment of Research Sites and contact the IRB Administrator with any questions.

If the study procedures involve recruitment on Facebook, other social media sites, or email listservs, it is essential that the PI review the site's policies on research and privacy before proceeding with the study.  Among other things, it may be necessary to request permission of a group page or listserv administrator before posting information about the study.  The IRB does not require a letter of cooperation (documentation of permission) in these cases, with one exception:  in the event that the PI is employed by the organization or otherwise already has access to the mailing list or page through that professional position, the PI must provide documentation of permission/cooperation to use it for UNI research purposes.  Contact the IRB Administrator with any questions about this.  

 
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