Letters of Cooperation for Non-UW Institutions/Organizations

March 2019

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:

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:

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 Language

A letter or email of cooperation can be brief and should include the following elements:

See Also: