Email Recruitment Guidance
Version Date: August 22, 2016The purpose of this document is to provide guidance for study teams using email to recruit human subjects for research studies. The University of Wisconsin Health Sciences IRBs recognize email to be an effective means to recruit potential research subjects, as long as specific guidelines are adhered to when using email as a recruitment method.
Recruitment of UW-Madison Faculty, Staff and StudentsThe University of Wisconsin-Madison allows researchers use email to send its faculty, staff, and student information about research opportunities as part of its research mission. Many research teams use a mass email service provided by the University of Wisconsin-Madison’s Division of Information Technology (DoIT). Information about this service and the requirements for its use are available at: Mass Email - Getting Started.
Recruitment of Non-UW-Madison IndividualsEmail recruitment may also be used to approach potential subjects who are not UW-Madison faculty, staff or students. In this case, study teams must adhere to the requirements described on this page, with the exception of the requirements for sending mass emails out through DoIT. Study teams must describe who is sending out the emails, i.e. the researchers themselves or another entity on behalf of the researchers. If the study team will send the emails, a description of how they will obtain the potential subjects’ email addresses must be included in the application.
Emails and Protected Health Information (PHI)Study teams who wish to recruit patients through use of emails must ensure HIPAA privacy and security protections are adequately addressed. Some guidelines to follow include:
- Use encrypted email whenever possible
- Send de-identified information in the email whenever possible (e.g., the subject line of the email should not read "Seeking participants for an Irritable Bowel Syndrome Study" instead, it should read "Seeking participants for a UW-Madison Research Study")
- Do not send emails containing a social security number or sensitive protected health information (PHI)
- Do not include multiple recipients on an email (recipients should never see another potential subject's email address)
- Forms containing protected health information, such as consent forms that describe specific subject conditions, should not be included in emails. Subjects should also not be asked to complete and return forms through email when PHI is included.
What to Provide in the IRB ApplicationAs with any other recruitment materials, the script of email advertisements must be reviewed by an IRB prior to its use. Research teams are expected to specifically describe use of email solicitation as a recruitment method in all applications submitted to the IRB. If email is not a recruitment method originally approved by the IRB, research teams are required to submit a change of protocol to add this method and obtain approval from the IRB before implementing it. Along with a copy of the email, the IRB application should describe:
- The source of the email list
- The targeted population of the email
- How frequently the email will be sent and the total number of emails that may be sent to subjects
- In cases when an email will be sent more than once regarding a specific study:
- Include a method for individuals who do not wish to receive additional emails to be taken off the list or
- If it is not possible to remove individuals from the list, include a statement that they cannot be removed and if they are not interested in participation they should delete future emails. Note: this option will only apply when emails are sent using a program that does not allow for subjects to be removed from the mailing list, such as DoIT’s Mass Email. If emails are sent directly by the study team an option to be removed from future mailings must be provided.
What to Include in the Email ScriptOutlined below are specific recommendations regarding the content of email messages:
- The subject line of the email should clearly state that it is an advertisement for a research study, such as: "Seeking participants for a research study" or "Information about a Research Opportunity".
- The text of the email should clearly identify the source of the email list, such as “You are receiving this email because you are a student at UW-Madison. Your email address was obtained from the UW-Madison Division of Information Technology (DoIT).”
- The email message should contain a brief description of the main study interventions. If the study involves testing experimental drugs or devices, identify them as such. In addition, if some subjects will receive placebo, ensure that this is mentioned in the email as well.
- If a DoIT email list will be used, include a statement that the UW-Madison allows researchers to send emails to its faculty, staff, and students as part of its research mission. See the Sample Recruitment Email for specific language.
- Include a statement that that the email has been approved by a UW-Madison Institutional Review Board. Note: this statement is not necessary in the case of studies that qualify for exemption.
- Adhere to the other requirements outlined in UW-Madison’s guidelines and policy for Recruitment of Research Participants Guidance.