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:
- School Districts typically have a form for researchers to submit.
- Community leaders, non-governmental organizations (NGOs), and local organizations can write letters attesting to feasibility or cultural appropriateness when local context is an important component in assessing the research plan.
- Clinic or hospital administration may write an email or provide a formal document related to access or release of records.
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:
- Name, title or role, and contact information of the person providing permission
- Name of the PI and brief description of the activities to be conducted at the site
- Confirmation that the approach to recruitment, the method and timing for obtaining consent, and data collection activities are appropriate for the setting and the study participants
- Confirmation that additional local review is not required and any other local requirements have been met
- Confirmation that the research plan does not expose study participants to unnecessary risk
Depending on the site and the study population, additional information may be required.