Study Site Cooperation
Investigators often work with organizations that are not affiliated with the University (e.g. school districts, businesses, health agencies, etc.) to conduct their research. In this case, the UNI IRB requires that investigators provide a letter (or email) of cooperation (LOC) from the organization to indicate 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).
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 organizational representative’s name, title, organization, and contact information. If by email, the email must show the date sent and 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 obtain acceptable documentation.
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 supervisors 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 typically 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.
Investigators may solicit the cooperation of research sites prior to submission of their IRB application, since IRB approval is not typically required for such 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.
Research may not commence at any given research site until documentation of cooperation has been received and accepted by the IRB. If there are multiple study sites, at least one letter/email must be on file before the IRB application will be approved, and the rest are typically accepted after IRB approval, as additional research sites are brought on board. 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 currently under review, the reviewer will be informed that the letter/email has been received.
When the research is being carried out at UNI, documentation is 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 Office of Institutional Research, may 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.
It is not uncommon for a cooperating organization to request IRB approval before the organization will provide an LOC. If an organization requires IRB approval prior to agreeing to cooperate with your study, please inform the IRB Administrator and your study may be approved contingent on later submission of the necessary documentation.
- For further detail, download this Letters of Cooperation procedural document (DOC) which is used by the IRB in determining when documentation of cooperation is necessary.