Guidance

The IRB reviews the process of screening, recruiting, and determining eligibility for research. The IRB reviews proposed recruitment procedures and advertisements to ensure that they do not violate the regulatory requirements of consent. All recruitment methods should include protections for potential participant privacy and confidentiality and should consider the specific circumstances of the individuals being recruited.

Advertising

Advertising is a common method used by researchers to recruit potential participants. For more information on advertisements (including advertising guidelines, internet advertising, etc.) please see the University of Utah IRB Guidance, Advertisements.

In-Person Recruitment

A researcher may have direct contact with potential participants. For example, a professor is conducting a psychology study and may have students who would be interested in participating in a study. The professor would like to invite his students to participate in his research study. Or a treating physician is conducting a study on diabetes and may have patients who would be interested in participating in the study. The treating physician would like to invite some of her patients to participate in the research study. In both examples, the researcher has direct contact with potential participants and plans to introduce the study directly. The researcher must present a plan to the IRB describing how contact is made with potential participants and how coercion is eliminated or reduced.

Recruitment Letters

Recruitment letters, including emails, may be sent to potential participants. A Recruitment Letter Template is available below. The IRB application should describe the timing, method, and frequency of recruitment communication including any planned follow-up. If an investigator plans to send a recruitment letter or email, consider the following when formulating a recruitment plan:

• If you plan to send a follow-up recruitment letter or email (and questionnaire or survey, as applicable) to individuals who do not respond to the initial letter or email, describe this plan in your message to potential participants.
• A reasonable follow-up plan may include one reminder communication. A follow-up email may be appropriate approximately 7 days after the initial email.
• A follow-up recruitment letter sent by postal mail may be appropriate approximately 14 days after the initial mailing to allow sufficient time for delivery and consideration before sending a reminder.
• If you plan to follow-up by phone if individuals do not respond to your initial letter or email, explain this plan in the initial recruitment letter or email so recipients know to expect a follow-up call. See the Phone Calls section below for additional guidance.
• Providing a mechanism for potential participants to express interest or decline further contact (e.g., a return postcard, reply email, secure electronic form, or other response mechanism) may help minimize unnecessary follow-up communications and respect participant preferences.
• If the research involves a sensitive topic (e.g., sexually transmitted infections), take additional steps to protect potential participants privacy and confidentiality. Avoid using language or details that could disclose sensitive information or cause embarrassment. Consider how recruitment materials may affect participants and take precautions to prevent any real or perceived breach of privacy.

Phone Calls

Generally, the University of Utah IRB does not allow “cold calling” to recruit research participants. Cold calling is contacting prospective participants by telephone when they were not expecting to be contacted about a research study.

If investigators plan to contact potential participants by phone, they should first send a recruitment letter or email describing the study and informing recipients that a follow-up call may occur. The initial recruitment communication should include contact information that recipients may use to decline future recruitment communications and the expected timeline for a follow-up phone call. Providing recipients with advance notice and an opportunity to opt out helps protect participant privacy, respects participant autonomy, and reduces confusion between research communications and clinical care.

An appropriate follow-up plan may include a phone call no sooner than 7 days after an initial recruitment email, or no sooner than 14 days after an initial recruitment letter, provided the initial email or letter explains that a follow-up call will occur.

Investigators should describe the phone call recruitment process in the IRB application, including whether voicemail messages may be left and methods for protecting participant privacy and confidentiality. If applicable, the study’s recruitment call script should be attached to the study application.

The IRB generally does not consider a recruitment call for a study related to someone’s job or career to be cold calling. Contacting individuals at their workplace may be acceptable if this is described in the application and approved by the IRB.

Researchers may want to contact individuals using a random sampling method. A random sampling method means the investigator doesn’t have any information about a person other than their contact information or the investigator is simply calling randomized phone numbers. The IRB will approve this recruitment strategy on a case-by-case basis. There should be sufficient safeguards to protect privacy, and the study would likely need to be minimal risk.

If individuals have given prior written permission to be contacted by researchers, the IRB will allow the researcher to contact those individuals by telephone without sending a recruitment letter or email before the call. Please see the Recruitment Letter Template.

Text Messages

The University of Utah IRB generally does not allow “cold text messaging” to recruit prospective participants. If investigators plan to use text messaging for recruitment, they should describe the process in the IRB application, including the timing, frequency, content of recruitment messages, and any planned reminder messages. The application should also describe how prospective participants may opt out of future text message communications.

Recruitment text messages must be sent using an institutionally approved messaging platform and must not include Protected Health Information (PHI) or other sensitive information.

HIPAA-Compliant Contact for Research Recruitment

For studies subject to HIPAA Privacy Rule, recruitment communications containing PHI must be sent using institutionally approved secure or encrypted methods, as applicable.

Emails containing PHI must be sent using institutionally approved secure or encrypted methods. Text messages and voicemail messages must not include PHI. General language, such as “a research opportunity,” should be used to avoid disclosing sensitive health information or an individual’s potential eligibility for a study.

For recruiting via Epic MyChart, researchers must submit a service request with Clinical Research Support Office (CRSO) and describe the process in the IRB application, including a statement CRSO approval will be sought prior to initiating recruitment via MyChart. Recruitment letter templates for MyChart are provided by CRSO.

VA Research

VA researchers must make initial contact with a prospective participant in person or by letter prior to initiating any phone contact, unless there is written documentation that the participant is willing to be contacted by telephone or email about the study in question or a specific type of research (e.g., can contact for any cardiovascular studies, etc.). Initial contact by letter or phone must include the provision of a phone number or other contact information that the prospective participant can use to verify that the study is VA research. This does not apply if a veteran calls in response to a posted advertisement. Requesting social security numbers by telephone is prohibited. Any subsequent telephone contact must be limited to the scope of the IRB-approved protocol.

Recruitment and Enrollment of U.S. Military Personnel

For research subject to Department of Defense regulations, additional protections for military research participants are required as follows:

• Officers are not permitted to influence the decision of their subordinates
• Officers and senior non-commissioned officers may not be present at the time of recruitment.
• Officers and senior non-commissioned officers must have a separate opportunity to participate.
• When recruitment involves a percentage of a unit, an independent ombudsman must be present.

Collection and Maintenance of Information for the Purposes of Recruitment

If a database or registry is created with the intent of using information to recruit participants for research purposes and has information in it that WILL NOT be analyzed for research purposes, IRB approval is not required. University of Utah departments may create and maintain a research recruitment database or registry of individuals who have given permission to be called in the future for research opportunities. The information in the database must not contain information that will be analyzed for research. If the only purpose of the database is to contact individuals in the future to tell them about research opportunities, IRB approval is not required since information in the database will not be analyzed for research purposes.

A data manager should ensure the proper confidential storage of the information. When contact information is to be shared with multiple investigators, the data manager must verify IRB approval (including specific approval of the recruitment method) prior to releasing contact information to the interested investigator. Initial contact procedures and informed consent procedures must be approved by the IRB for each individual study.

If a database or registry collects information for recruitment but also collects additional information that will be analyzed for research purposes, IRB approval is required for that project.

1. Collection of Health Information
   If information obtained from a medical record is included in a recruitment database, IRB approval and informed consent/authorization is required for creation of the database to satisfy HIPAA. If medical records are screened as a part of the recruitment process, a Request for a Waiver of Authorization should be included, with appropriate justification (see “Use of Medical Records for Recruitment” below or refer to Appendix A of this document). The investigator should describe the screening process in the research proposal.
2. Participant Pools
   Some University of Utah departments create participant pools that collect contact information for recruitment in research studies. These participant pools typically collect additional information for research purposes. Since the participant pool is not only a recruitment resource but also collects and stores additional data about students that can be analyzed in the research, IRB approval is required.

Recruitment through an Established Database Containing Health Information

Potential participants that are identified via query of the University of Utah Health Sciences Center’s Enterprise Data Warehouse (EDW), the Utah Population Data Base (UPDB), or other established database(s) must be referred to the study team by a treating physician, or as appropriate, the database manager. In this model, the treating physician or database manager contacts the participant and asks whether he/she will allow the research team to make contact regarding the study. The treating physician or database manager makes a note indicating whether the potential participant agrees to be contacted and will keep this on file. The treating physician or database manager may use the Recruitment Letter Template to collect the potential participant’s contact information and written permission to be contacted.

Alternatively, the researcher may create a recruitment letter to be approved and sent from the treating physician or the database manager; the cost of sending the letter is the responsibility of the researcher. The letter must state that the patient is being contacted on behalf of the researcher. The purpose of this letter is to inform participants about a study and ask them to contact the researcher.

Studies for You

Studies For You is a recruitment tool to share research opportunities with the public at the University of Utah. By completing the “Studies For You” section in the ERICA application, the study will be listed on the University’s research website. To use this feature, see the Points to Consider section below or the Studies For You Investigator FAQs. The IRB will review this recruitment method as part of its standard process. Once the study is approved in ERICA, the listing will be published on the Studies For You website.

Use of Medical Records for Recruitment

The University of Utah IRB requires investigators to request a waiver of authorization if using medical records for screening or recruitment. Please refer to Appendix A of this document for FAQs regarding recruitment of participants for research by University of Utah researchers and research staff acting on behalf of clinicians.

Documents and References

CRSO MyChart Recruitment

CTSI Research SMS Text Message Services

FDA Information Sheet: Recruiting Study Subjects

Recruitment Letter Template

Studies For You

Studies For You Researcher FAQs

University of Utah IRB Guidance: Advertisements

Points to Consider

Appendices

Appendix A: Frequently asked questions (FAQs) regarding recruitment of participants for research by University of Utah researchers and research staff acting on behalf of clinicians

1. Are research staff allowed to access their Principal Investigators’ clinic schedules and look for potential research participants? Yes, as long as this procedure was approved by the IRB. Research staff, listed as authorized personnel on the IRB submission, may review the list directly at the clinic site and identify potential participants.
   1. Are research staff allowed to access these patients’ medical records while looking for potential research participants?
      Yes, as long as this procedure and a HIPAA waiver of authorization for recruitment was approved by the IRB. The research staff, listed as authorized personnel on the IRB submission, may access the patients’ medical records and record pertinent information such as contact information and medical information to assess the pre-eligibility of the potential subject.
2. Are research staff allowed to approach a potential participant while in the clinic?
   Yes, as long as this procedure was approved by the IRB and only after the physician has informed his patient that someone from the research team will come and talk to him/her and the patient has indicated his/her willingness to talk to the research team.
3. After a researcher obtains information from a treating physician or from medical records, can someone from his/her research team call the participant directly, without previously sending an email or letter?
   No. “Cold calls” outside of contacts in a clinic setting (e.g. clinic room) are not acceptable.
4. If potential participants do not respond to an initial IRB-approved letter, is it appropriate to follow-up with a phone call?
   Yes, if the plan for follow-up, including the timeframe for a follow-up call, is addressed in the IRB-approved letter. Follow-up phone calls should only occur a sufficient amount of time after the initial communication is sent to allow participants to consider potential participation and opt-out of contact. Generally, this time frame should be approximately 7–14 days after the initial recruitment letter depending on the method of contact (e.g. email versus physical letter). Additional contacts should be limited and justified to avoid undue influence or participant burden.
5. If e-mails are sent to potential participants and are returned as undeliverable, is it appropriate to call them while knowing initial contact has not been made via e-mail?
   No. If an e-mail is returned as undeliverable, an attempt should be made to reach the participant(s) via physical address, or another e-mail address prior to initiating a follow-up phone call.
6. Can a researcher record available medical information from the chart to assess eligibility and suitability of the potential participant prior to that individual giving informed consent and authorization?
   Yes, if this procedure and a HIPAA waiver of authorization for recruitment purposes were approved by the IRB. The researcher may record the minimum protected health information (PHI) needed to contact eligible participants. After this has been completed, the PHI must be removed from the research record or destroyed, unless participants have given authorization for continued use of the PHI.
7. Which screening activities can be performed by researchers within a covered entity prior to obtaining the participants consent and authorization?
   Researchers within a covered entity can pre-screen potential participants by accessing the available information required from the patient’s medical records if a HIPAA waiver of authorization was approved by the IRB. However, researchers may only record and remove the minimal information required to contact eligible participants to describe the study to them and seek their authorization for participation. Any additional screening tests required to determine the eligibility of the participants should be performed only after the consent and authorization have been obtained from the participant.