All recruitment letters also should include the following basic information:

• An introduction that gives the title of the study, the name and affiliation of the Principal Investigator and study team, and a clear statement that it is about a research study. The introduction should also state why that particular individual is receiving a letter about the study.
• A brief description of the purpose of the study and what the potential subject would need to do if they decide to participate.
• A statement that participation is voluntary.
• If the study team intends to follow up with recipients of the letters (e.g., with a phone call) the letter must include that information. The IRB typically expects the letter to include instructions on how to opt out of this follow-up, usually by providing a name and contact information or enclosing a self-addressed stamped envelope that allows them to opt-out. NOTE: An opt-out postcard could be used if it does not include details that would suggest the presence of a health condition or other information generally thought of as private. For example, the postcard should not have the title of the study.
• A closing section. This should include instructions for the next step, e.g., contacting the study team to indicate interest, returning a signed consent form.

In addition to the above information, recruitment letters may need to include other specific details depending on the recruitment process for a particular study. Study teams should contact the IRBs Office with any questions about recruitment letter content.