External Research Site Approvals

Table of Contents

Format

Documentation of research site approvals is necessary to ensure that the study is feasible and is appropriate for the culture and the target population. The documentation provides the IRB with confirmation that the site is aware of the activities and has agreed to research activities administered on site. Researchers can request this documentation concurrently or after IRB submission. Sites like public schools require IRB approval before documentation of approval.

Format

Documentation must be written on letterhead where possible and contain the following information:

• 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 the research plan does not expose study participants to unnecessary risk
• Depending on the site and the study population, additional information may be required.