Mailed Recruitment Letter Guidance
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. This document provides guidance on the information required by the Health Sciences (HS) IRBs for studies that use recruitment letters, as well as the information that must be provided to potential subjects when mailed recruitment letters are used.
Version date: November 15, 2017
Who Can Make First ContactIf a study team is recruiting potential subjects through a clinical setting, the initial contact, whether in-person or via telephone or letter, should come from someone who, by virtue of his/her position, would have access to the potential subject’s confidential health-related information. Based on this principle, the following list of individuals who may be the first to contact potential subjects is provided for example purposes only and is not meant to be exhaustive:
- A member of the potential subject’s clinical team, and those individuals working on behalf of members of the clinical team (e.g., nurses, PAs, pharmacists);
- An administrator from the clinic, department or center where the potential subject receives care;
- An individual, such as a study nurse, investigator, or research coordinator, acting as an agent of a clinical researcher involved in the potential subjects’ care;
- An individual, such as a study nurse, investigator, or research coordinator, who works within a clinic, department or center where a potential subject has or will receive care (e.g., from the Department of Surgery for a potential subject who has an upcoming surgery scheduled);
- The administrator of a database housed within a clinic, department or center where a potential subject has or will receive care (e.g., from a recruitment database or registry within the department or clinic where the potential subject has been seen for clinical care).
Mailed Recruitment Letter Information Required in ARROW Application
Contact via Mailed Letter
Mailed recruitment letters, whether or not they precede a telephone call, should be clear regarding why the potential subjects are being contacted and how the individual(s) sending the letter have identified the potential subjects. The Health Sciences IRBs recommend including the following template language in letters to potential subjects to help clarify why patients are being contacted:
- The University of Wisconsin-Madison and UW Health collaborate on research studies and provide research opportunities as part of their core missions. You are receiving this letter because you [are/were] a patient at a UW Health Clinic [NAME OF CLINIC] and we think you might qualify for a research study [I am conducting/conducted by NAME OF RESEARCHER]. The purpose of this study is to…
Common Uses for Recruitment Letters
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 someone who, by virtue of his/her position, would have access to the potential subject’s confidential health-related information. See above for examples.
- 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.
Basic Elements to Include in Recruitment Letters
All recruitment letters 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 s/he decides 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.