When studies are conducted in whole or in part at sites external to UW-Madison or UW Health, study teams may be asked to provide letters (or emails) of cooperation from those sites. The purpose of a letter of cooperation is to provide documentation to the HS IRBs that the site is aware of the study activities that will be conducted at that site and it supports participation in the study. This guidance describes when such letters may be needed, who should provide the letter, and suggestions for template language to include in the letter.
For What Types of Sites May Letters of Cooperation Be Needed?Letters of cooperation typically need to be submitted to the IRB for the following types of sites when study activities beyond recruitment and/or consenting of subjects 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
- The HS IRBs are not serving as IRB of record for the sites. NOTE: If the HS IRBs are serving as IRB of record for an individual (not the site as a whole) then a letter of cooperation may still be needed.
When Is a Letter of Cooperation Needed for These Types of Sites?Letters of cooperation for sites that meet the above criteria 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.
Are Letters of Cooperation Needed for Other Types of Sites or Studies?Even if a letter of cooperation is not required to be submitted to the IRB, the HS IRBs recommend that study teams obtain permission from external sites at which study activities such as recruitment and consenting will be conducted, to be sure that the site is aware and supportive of the research. Study teams should still obtain appropriate permission from sites before conducting any recruitment or consent activities. These permissions do not need to be provided to the HS IRBs, except as described above.
Who Should Write the Letter of Cooperation?A letter or email of cooperation should be signed by someone at the site who is in a position to provide permission for that site to be involved in the proposed study activities (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 LanguageA 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.