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When is a letter of support needed?
In the absence of documentation from an ethics committee at the site of recruitment or research, a letter of support or other documentation of permission may be needed. The IRB may request that researchers provide this documentation to ensure that appropriate safeguards are in place, that the study is feasible, or the research plan is culturally appropriate.
What is the purpose of a letter of support?
The purpose of a letter of support is to provide the IRB with documentation that the site is aware of the study activities and has agreed to the plan for carrying out those activities.
Who writes and signs letters of support?
Documentation of support should come from an individual in a position to provide permission for that site. The letter of support cannot come from a member of the study team.
What is the format for a letter of support?
Documentation of support or permission can come in a variety of forms. Examples include:
The specific format is not dictated by the IRB and should be left to the discretion of the organization or person providing permission.
What should be in a letter of support?
The letter should contain enough information to enable the IRB to assess whether the site understands and supports the study plan. As applicable, common elements include:
Depending on the site and the study population, additional information may be required.