Study Site Cooperation
Investigators should feel free to begin soliciting the cooperation of research sites prior to submission of their IRB application, since IRB approval is not typically required for communications with study sites. However, when the individual whose cooperation is being sought is also likely to be a potential participant in the study (e.g., a school principal in a study about school administrators), then the contact with the study site must be approved by the IRB in advance, either informally by email or via the regular review process. 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. The best approach may be to use a dual purpose communication to those individuals, but this must be approved prior to contact.
A letter (or email) of cooperation serves as documentation from the research site that the investigator has permission to conduct the research at that location, or that the site is providing the necessary assistance in implementing research activities (e.g., providing access to participants). Letters/emails may be submitted with the IRB application or following IRB review/approval, but at least one letter/email must be on file with the IRB before the application can be approved, unless the reviewer approves the study contingent on its receipt. Regardless, research may not commence at any given research site until documentation of cooperation has been received and accepted by the IRB. Unless attached to the IRB application, letters/email should be directed to the IRB Administrator, who will determine if the letter is sufficient as documentation and send the PI an acknowledgement. If the study is still under review, the reviewer will be informed that the letter/email has been received.
A letter of cooperation may be submitted as a formal signed hard copy letter or as an informal email or fax from the organization. A simple signature form created by the PI may be acceptable as well. When the study is taking place in a school, a district approval form may be submitted in lieu of a letter or email from the principal or superintendent. 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.
The letter or email 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 and directors of student clubs. Please note that some units, 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.
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.
For a detailed list of when a letter/email of cooperation is required, you can download this procedural document, which is used by the IRB in assessing when documentation of cooperation is necessary.