Use of Email for Research Purposes Guidance
Version Date: April 24, 2017
The purpose of this document is to provide guidance for study teams that will use email to communicate with human subjects during research studies. The University of Wisconsin Health Sciences IRBs recognize email to be an effective means to communicate with research subjects, as long as specific guidelines are adhered to in order to ensure the privacy and confidentiality of subjects.
Email may be used in a variety of ways during a study, including for recruitment, scheduling study visits, or as part of general study participation. The following guidelines apply to all uses of email for research purposes. Additional information on situation specific use of emails is provided below.
Health Information within Emails
- Only secure, university-issued or approved email accounts should be used, such as @wisc.edu, @medicine.wisc.edu or @uwhealth.org accounts. Personal email accounts, such as @gmail.com, may not be used. Use encrypted email if possible.
- Email addresses that include health related information should not be used. This includes addresses that directly reference health status (e.g., ParkinsonsDiseaseResearch@wisc.edu) or that indirectly imply health status (e.g., email@example.com).
- Use of a custom email account is suggested for studies that will enroll large numbers of subjects or that will communicate with subjects often (e.g., firstname.lastname@example.org). This is preferred over providing contact information for a member of the study team in order to ensure active monitoring of the account. Auto-reply messages should be set in advance whenever email is used to communicate for research purposes and the inbox will not be monitored for more than a day.
- Prior to using email to convey information about subjects’ health or which will elicit information about subjects’ health, permission for email must be obtained from subjects. Such permission may be obtained orally or in writing. If permission is obtained orally, the study team must document subjects’ oral agreement to use email. Prior to obtaining permission, subjects must be informed that use of unencrypted email is not a secure method of communication and that there are many ways for unauthorized users to get access to email.
- Subjects should never be asked to provide sensitive information such as social security numbers or discuss stigmatizing health information (e.g. communicable disease status or sensitive laboratory test results) through email. This includes sending information such as inclusion and exclusion criteria to subjects to confirm eligibility, when such information is sensitive or stigmatizing.
- Email scripts sent to the general public may contain limited information about the conditions being researched. For example, the subject line of the email could state “Seeking participants for an Irritable Bowel Syndrome Study.” However, when subjects are being targeted by email specifically because they have a condition, the email should not reference the health conditions of the potential subjects. For example, the subject line of an email to individuals known to have IBS should read "Seeking participants for a UW-Madison Research Study” instead of "Seeking participants for an Irritable Bowel Syndrome Study."
- Absent prior permission from the recipient, attachments that contain health information – such as informed consent forms and information sheets – cannot be sent by email.
- If detailed or sensitive health information needs to be obtained from subjects through methods other than in-person communication – such as through a health questionnaire document – the study team should investigate the use of alternative, more secure mechanisms for collecting information. As an example, an email to subjects could include a link to a questionnaire in Qualtrics.
- Do not include multiple recipients on an email. Recipients should never see another subject’s or potential subject's email address. The blind copy (bc:) function should be used to protect subject privacy.
The following disclosure language should also be included at the end of all email communications with subjects (the language in brackets should be revised to be study-specific).
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- Email is generally not a secure way to communicate sensitive or health related information as there are many ways for unauthorized users to access email. You should avoid sending sensitive, detailed personal information by email. Email should also not be used to convey information of an urgent nature. If you need to talk to someone immediately or would prefer not to receive study communication by email, please contact [Name, Title, Phone Number].
Email can be used both directly and indirectly as a recruitment tool. Direct email recruitment includes obtaining potential subjects’ email addresses and sending IRB approved recruitment material to the subject by email. Indirect email recruitment includes listing a study-related email address in recruitment flyers, brochures, or study information sheets for subjects to use to contact the study team.
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- Indirect recruitment: As with any other recruitment materials, a description of how email will be used to communicate with potential subjects for recruitment purposes should be included in the IRB application along with any recruitment materials, including email templates that will be used to respond to initial inquiries about the study. Remember that the subject line and content of these emails should not contain any references to health information or request health information from the subject through email.
- Direct recruitment of UW-Madison Faculty, Staff, and Students: The University of Wisconsin-Madison allows researchers to use email to send its faculty, staff, and students 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.
- Direct recruitment of Non-UW-Madison Individuals: Email 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 in this guidance, with the exception of the requirements for sending mass emails via DoIT.
- Information to include in the application for direct recruitment: Study teams must describe who will send the emails, i.e. the researchers themselves or another entity on behalf of the researchers. Additionally, study teams should provide:
In addition, a copy of the proposed email text should be included with the IRB application. The following guidelines should be followed when drafting the email template (a sample recruitment email is included at the end of this guidance):
- 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
- 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 in the email 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.
If a research team receives complaints from a recipient of a recruitment email, the individual can be referred to these email recruitment guidelines. If the recipient does not accept these guidelines, the complaint should be reported to the IRB that approved the research study.
- Include the email address from which the email will be sent, the subject line, and any graphics used.
- 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 (below) for specific language.
- Include a statement that that the email has been approved by a UW-Madison Institutional Review Board. Note: If using a DoIT list, this information is embedded in the addendum (see below) and it is not necessary to replicate it. In addition, 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.
Study teams may want to use email to schedule or confirm initial study visits. The HS IRBs office realizes that this is an easy and effective way to coordinate with subjects, but it also presents issues with privacy and confidentiality. If email will be used to schedule initial study visits the following guidelines should be followed:
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- A copy of the email script(s) and a description of how the email script(s) will be used should be included in the recruitment section of the application for review by the IRB. Included in the description should be an explanation of how permission will be obtained from subjects to use email for this purpose. Permission may be obtained through email by asking subjects if they agree to set up an appointment by email before sending scheduling information. If subjects are contacted by phone, the phone recruitment script should include a description of how email will be used along with the request for subjects to provide their email address.
- The email to schedule an initial study visit may not convey any information about subject’s health unless the subject has first given permission to use email for this purpose (see General Requirements for Email Use above for more information on this required permission). Absent such permission, care should be taken not to indirectly include health information in any appointment reminder; for example, by indicating that subjects should come to a specific clinic such as the Carbone Cancer Center or the Infectious Disease Clinic. Even with subject permission, the email should contain as little health information as is necessary to convey the intended message.
- Obtaining permission from subjects to use email as part of recruitment and to schedule initial study visits does not authorize the study team to use email to communicate with subjects generally. Permission to use email for purposes other than recruitment or scheduling of initial study visits is required as described below.
Study teams may want to communicate with subjects by email during the course of a study for purposes such as scheduling additional study visits, sending study reminders, and providing links to complete online surveys. Study teams are allowed to use email to communicate with subjects during the course of the study in accordance with the following guidelines:
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- The “Research Design General” section of the IRB application should describe how email will be used for the research. Templates of emails that will be sent to subjects after informed consent is obtained do not need to be included in the application, but all emails should contain the disclosure statement included above in the General Requirements for Email Use section of this guidance.
- The consent form must include information on how email will be used in the study and the study team must obtain permission to communicate with the subject by email. Template language for use in the consent form is provided below.
- Subjects cannot be required to provide an email address in order to participate in a research study unless the study cannot be carried out without access to email. Additionally, subjects may request – AT ANY TIME – that email no longer be used to communicate about the study, without any loss or penalty.
- Emails may not convey any information about subject’s health or elicit information about subject’s health unless the subject has first given permission to the use of email for this purpose (see General Requirements for Email Use above for more information on this required permission). Even with subject permission, the email should contain as little health information as is necessary to convey the intended message. There are often better ways to communicate with subjects if health information must be included or elicited as part of the communication. For example, rather than request a health history via email, subjects should be directed to a more secure method of communication, such as a Qualtrics survey.
Please see Informed Consent: Additional Model Language - Emailing to Communicate with Subjects
for template language.
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Subject Line: Participants being sought for a [general area of research] research study
[Insert name of researcher or research group] is looking for participants for a research study. You are receiving this email because you are a [insert description of targeted population, e.g. student, employee, faculty] at UW-Madison. Your email address was obtained from [insert source of email addresses; e.g., the UW-Madison Division of Information Technology (DoIT)]. This study is about [insert description of study]. If you take part in this study, you would [provide brief description of what subjects are required to do, how long they would be in the study, and, if they would receive drugs]. To be able to take part in this study, individuals must be/have [briefly describe primary eligibility criteria].
If you are interested in participating or have any questions about the study, please email [insert name and email address of contact] or call [insert name and telephone number of contact].
Email is generally not a secure way to communicate sensitive or health related information as there are many ways for unauthorized users to access email. You should avoid sending sensitive, detailed personal information by email. Email should also not be used to convey information of an urgent nature. If you need to talk to someone immediately or would prefer not to receive study communication by email, please contact [Name, Title, Phone Number].
If DoIT list was used, add the following in smaller font at the end of the message. Only the sections (Registrar's Office or OHR) that apply should be included, depending on the data requested.
The University of Wisconsin-Madison allows researchers to use email to send its faculty, staff, and student information about research opportunities as part of its research mission. Use of these email addresses has been approved by the campus data custodian [Registrar's Office for students and Office of Human Resources for faculty/staff]. The content of this email message has been approved by a University of Wisconsin-Madison Institutional Review Board (IRB). IRBs are charged with protecting the rights and welfare of people who take part in research studies.
University of Wisconsin-Madison Policy and Procedures: E-Mail Communications Involving Protected Health Information
HIPAA FAQs on use of email for research