Guidance on the Use of Recruitment Letters
Mailed letters can be a useful tool for study teams recruiting participants for a research project. The purpose of the recruitment letter is to inform potential subjects about a study and provide them a way to contact the study team for more information and to indicate interest.
Version date: April 8, 2015
The following list describes the most common situations in which recruitment letters are appropriate and indicates elements that may be required for each situation.
- Recruitment of patients from a clinic population: Letter should come from the clinic and/or be signed by the patient’s physician, someone else who the patient would recognize as being involved in their care, or have access to their private health information. Because mailed letters are considered a secure form of communication (as opposed to, for example, recruitment emails), limited Protected Health Information (PHI) can be included in the recruitment letter, as long as the letter is coming from someone the patient would recognize as having access to their PHI.
- Recruitment of subjects from a previous study for a follow-up or other related study: Letter should refer to the study in which the individual has already participated and state how the new study is related to it.
- Recruitment of children through their school: Letter should be addressed to parents/guardians; it can be provided in a packet that children take home with them.
- 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 s/he decides to participate. This must also include a statement that participation is voluntary.
- If the study team intends to follow up with recipients of the letters, usually 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 an self-addressed stamped envelope that allows them to opt-out. NOTE: Anopt-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, etc.