Gatekeeper Letter Guidelines

If you will recruit participants from an external organization and/or perform data collection at a site outside of Central, you typically must obtain written permission to do so from the relevant “gatekeeper”(s). A gatekeeper is the head (or designee) of the organization or site at which your research activities will take place--such as a school principal, clinic director, department manager, club leader or program administrator. It is customary for the Principal Investigator (PI) to request a letter directly from the gatekeeper. Besides providing necessary documentation for your project’s review by the Institutional Review Board (IRB), personal communication with the gatekeeper will pave the way for executing your project once IRB approval is in hand.

If the gatekeeper supports and approves your project, they may not be sure what exactly to write in the letter to the IRB. Therefore, the IRB encourages you to provide them with a guideline or draft of the content. The IRB is interested in a gatekeeper acknowledging the following: 1) familiarity with the methodology of your study including an understanding of how the investigator will directly interface with participants and/or participant data; 2) support and approval of your project, 3) if relevant, verification that the activities to be undertaken are in line with organizational activities. The latter is most applicable to the field of education in which action research projects involve comparisons among normal classroom activities. Normal classroom practice consists of any and all activities that occur during research that would be done in a regular classroom setting despite the research being carried out. If you are only implementing these activities as part of the research and they would not be carried out if not for the research, then it is not normal classroom practice.

* PLEASE NOTE: if a study involves ONLY normal classroom activities, the IRB defers to the gatekeeper to determine if student assent and/or parental consent must be obtained. If the study goes beyond traditional class content, parental consent IS required by the IRB.

The gatekeeper will likely want to know the details of your study. In your request to a gatekeeper, you should make reference to the same kind of information that you provide in your IRB protocol, including the information in the informed consent document. At minimum you will share: who are you, what the project is about, its purpose and timeframe, how participants will be involved, how participants’ identity and responses will be protected, and what the gatekeeper is being asked to provide--for example, permission to recruit study participants, and/or existing data. If you are planning to post or distribute recruitment flyers, distribute questionnaires or use other data collection techniques, you should clearly describe the method and provide relevant documents (e.g., questionnaires). This information should be provided to the gatekeeper before you ask them to agree to support the project. This is essential to ensure that the gatekeeper is able to make an informed decision.

A gatekeeper may want to know that the IRB has reviewed and approved your project before agreeing to support it. Yet, IRB approval is contingent upon gatekeeper support. What to do? The IRB recommends that you 1) advise the gatekeeper that the IRB requires that the gatekeeper supports the study prior to approval, 2) assure them that the IRB will thoroughly review the study to ensure that participants are protected and potential risks are minimized, and 3) suggest the gatekeeper add to the letter a contingency statement such as, “I commit my full support to this project provided that [PIs Name] obtains the approval of the Central Institutional Review Board.” You may also invite the gatekeeper to contact the IRB Chair or Administrator at IRB@ccsu.edu to discuss any concerns.

Please note that gatekeeper letters from external agencies must:

  • Include an original signature (faxed or scanned copies are acceptable, as long as the signature is legible)
  • Include the signees title
  • Be addressed to the IRB
  • Be printed on official letter head
  • Electronic copies of gatekeeper letters may be submitted to IRB@ccsu.edu with the New Protocol Submission Form as an appendix.