When studies are conducted in whole or in part at sites external to the institution, study teams may need to provide a letter of cooperation from those sites. The purpose of a letter of cooperation is to document that the site is aware of the research and supports its participation in the study. NOTE: This does not apply to studies conducted in K-12 settings. See the Investigator Manual for details.
- When and For What Types of Sites May Letters of Cooperation Be Needed?
Letters of cooperation typically need to be submitted for the following types of sites when study activities beyond recruitment and/or consenting of participants will occur at that site:- Sites that do not have an IRB or other committee or group (e.g., ethics committee, research review committee, etc.) reviewing the study; AND
- For which UW-Madison is not serving as the reviewing IRB.
- For sites that meet the above criteria, letters are needed for studies that are:
- Federally funded;
- FDA-regulated; and/or
- Involve the access or disclosure of protected health information held by the external site.
- For sites that meet the above criteria, letters are needed for studies that are:
- Are Letters of Cooperation Needed for Other Types of Sites or Studies?
Even if not required, we recommend that you obtain permission from sites at which study activities will be conducted (including recruitment), to ensure the site is aware and supportive of the research. These kinds of permissions do not need to be provided to the IRB. - Who Should Write the Letter of Cooperation?
A letter of cooperation should be signed by someone at the site who can provide permission for that site to be involved in the study (e.g., director or head of community center or organization, manager of a pharmacy). The letter of cooperation should not be signed by a member of the study team conducting research at the site.- Template Language
- A letter or email of cooperation can be brief and should include the following elements:
- Study title
- A brief description of the research and/or activities to be conducted at the site
- Person or entity providing permission (including title, contact information, and confirmation of appropriate authority to provide permission)
- For studies involving access to or disclosure of protected health information held by that site, the following statement should be included: I also understand that if the IRB has granted a waiver of authorization, [name of entity] may rely on that waiver in using or disclosing PHI. If any PHI will be disclosed pursuant to the waiver, [name of entity] must account for such disclosures.
- A letter or email of cooperation can be brief and should include the following elements:
- Template Language