Guidance

The IRB reviews the process of screening, recruiting, and determining eligibility. The IRB reviews proposed recruitment procedures and advertisements to ensure that they do not violate the regulatory requirements of consent.

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 may be sent to potential participants. A Recruitment Letter Template is available below. If an investigator plans to send a recruitment letter, consider the following issues 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, then you should mention this plan in your initial letter or email so recipients are not surprised or upset by receiving multiple mailings.
• Including a return postcard in the initial mailing, where potential participants can indicate their interest may help avoid sending multiple mailings and let the investigator to know who wishes to participate and who should not be contacted again.
• If your research involves a sensitive topic(e.g., sexually transmitted infections), then you must take extra steps to protect the contact’s privacy and confidentiality. Because you can’t guarantee that the intended person will open the mail, avoid using language or details that could embarrass the recipient. Think carefully about how your materials might affect participants and take precautions to prevent any real or perceived breach of privacy.
• If you plan to follow up by phone, then you should explain this in your initial letter or email so recipients aren’t surprised or upset by an unexpected call. You should also prepare a plan for research staff, including whether it’s appropriate to leave a message (while protecting privacy and confidentiality) and a script outlining what information to share with the participant.

Phone Calls

Generally, the University of Utah IRB does not allow “cold calling” to recruit participants. Cold calling is contacting prospective participants for biomedical research, by phone, who were not expecting such an interaction. If a researcher wishes to contact potential participants by phone, a recruitment letter should be sent prior to the phone call. The IRB strongly recommends that this letter include contact information for the recipient to call if they chose to “opt out” of forthcoming phone contact. This policy helps protect the privacy of potential participants and avoids confusion – such as assuming a call from a medical provider is about medical care rather than research.

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

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 Simple Referral Template below.

HIPAA-Compliant Contact for Research Recruitment

For studies subject to HIPAA, messages sent through email must be encrypted. Text messages and voicemails must not include PHI. General language, such as “a research opportunity” should be used. Careful consideration should be given to avoid sharing any information that could identify the participant or disclose sensitive health details.

For recruiting via Epic MyChart, researchers must submit a service request with Clinical Research Support Office (CRSO), describe the process in the IRB application including CRSO approval. 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.

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.

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 must be approved by the IRB for each individual study. Informed consent procedures must also 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. Also, if medical records are screened as a part of the recruitment process, a Request for a Waiver of Authorization should be submitted (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 Simple Referral Template (available on the IRB website under Forms) 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 (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 go live.

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

FDA Information Sheet: Recruiting Study Subject

Recruitment Letter Template

Simple Referral 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. Is 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. Is 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. Is 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. 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 is addressed in the IRB-approved letter. If potential participants do not respond to the letter within the specified timeframe, the researcher or someone from the research team may call them.
4. 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 participants via physical address, or another e-mail address prior to initiating a follow-up phone call.
5. 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 mailing out a letter?
   No. “Cold calls” outside of contacts in a clinic setting (e.g. waiting room) are not acceptable.
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, as long as this procedure and a HIPAA waiver of authorization was approved by the IRB. The researcher may record the minimal information needed in order to contact eligible participants.
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.