I Want You: How to Conduct Ethical and Successul Recruitment at BMC/BUMC

June 2023 Issue

Author(s):

  • Matt Ogrodnik, MS, CIP
    Director, Office of Human Research Affairs
  • Lin Themelis, BA, MA, CIP,
    IRB Administrator
  • Jamie Merrill, MPH, CIP,
    Director, Institutional Review Board

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Introduction

Recruiting enough research participants to fulfill your sample size is important for answering your study question and for ensuring that the risks of the research remain reasonable in relation to the potential benefits, as discussed in the May 2021 Feature Article Fulfilling Your Sample Size: What is Required and Why. Yet, while the Boston Medical Center (BMC) and Boston University Medical Campus (BUMC) Institutional Review Board (IRB) understands the important of successful recruitment, not all potential recruitment methods are appropriate for every study. Recruitment methods are considered fair and appropriate:   if the privacy and confidentiality of potential subjects is protected; the recruitment materials are accurate; any costs of the research are not expected to unfairly exclude potential subjects; any payments constitute a reasonable reimbursement for time and effort and are not so large as to constitute undue influence to participate; and the consent process will convey information needed for potential subjects to consider whether or not to participate.

This month’s Feature Article will discuss the IRB’s considerations and requirements when reviewing recruitment methods (and recruitment materials); describe the types of recruitment methods that are used by researchers at BMC and BUMC; and explain when certain methods may or may not be appropriate depending on the specifics of a research study.

 

IRB Review of Recruitment Methods and Materials

 

As outlined in the HRPP Policies and Procedures, the information provided about recruitment procedures in your electronic INSPIR IRB application must include a detailed description of how the research population will be identified, and explain how potential subjects will be contacted and provided information about the study. If your study has a separate detailed protocol and uses our BMC/BUMC Protocol Template, then you will also be asked to at least broadly describe your recruitment procedures there as well. This is to ensure that you start thinking about how you plan to recruit subjects as early as possible in the design of your study.

The recruitment plan should draw subjects from a population selected to distribute the risks and benefits of the research in an equitable manner. The recruitment procedures must employ adequate confidentiality protections for potentially damaging information.   For example, if potential subjects are being recruited because they have a health condition such as HIV/AIDS or a psychiatric disorder, then the recruitment process should ensure that this will not be revealed to anyone other than the potential subject.

The IRB will evaluate the plans proposed for selecting and recruiting subjects based on the following information from the submission:

  • Recruitment information (Section 7.2.2.6); and
  • Subjects (Section 7.2.2.10); and
  • Costs and Payment (Section 7.2.2.11); and
  • Consent Information (Section 7.2.2.12); and
  • Inclusion and Exclusion Criteria (Section 7.2.2.14.2).

 

Requirements for Recruitment Materials

 

The IRB has specific requirements for recruitment materials which are codified in the HRPP Policies and Procedures. All recruitment materials must be submitted and approved by the IRB prior to use.  This includes any advertising or publicity information including recruitment letters, flyers, posters, public service announcements, newspaper, radio and television advertisements, and Internet content seeking study subjects for research. Please note that if recruitment materials are not ready at the time of initial submission, then they may be submitted subsequent to approval (or exemption) as an amendment. No recruitment materials may be used until IRB approval is obtained. If materials are posted in locations off-campus, then they must comply with the requirements of the institutions where the recruitment materials are distributed or posted.

Recruitment materials should include the following information, as applicable to the type of material:

  • A clear statement that this is research and not treatment; and
  • A statement about the purpose of the research; and
  • The eligibility criteria (summary form); and
  • Time commitments and other commitments for subjects; and
  • The location of the research; and
  • The name and telephone number or email address of a contact person or office; and
  • The institution’s logo (when appropriate); and
  • Any reimbursement or payments provided to subjects, with the following restrictions:
    • The amount may be specified by stating, for example, “up to $xxx”; and
    • The amount may NOT be emphasized by using large, bold, underlined, italicized font or by putting this information first in the ad before the study purpose, procedures, and time commitment.

Recruitment materials must not include:

  • Any exculpatory language (statements waiving or appearing to waive any legal rights or providing a release from liability for negligence); or
  • Any claims, either explicit or implicit, about a drug, biologic agent, or device under investigation that are inconsistent with FDA labeling; or
  • Any terms, such as “new treatment,” “new medication,” or “new drug,” without explaining that a test article is investigational.

Promotional materials must also be approved by Boston University Chobanian & Avedisian School of Medicine Communications, the Goldman School of Dental Medicine Communications Office, Boston University School of Public Health Communications, or the Boston Medical Center Communications and Marketing Department, depending on the Home Institution of the Principal Investigator. The IRB assists in ensuring that this institutional requirement is met by reviewing the certificate of approval received from the relevant office after your materials are reviewed and approved. This certificate needs to be attached to your electronic INSPIR IRB submission when submitting the materials for IRB review. The intake form for submitting your materials for this Communications approval is found here.

These offices can also help with the development of a recruitment plan for your study, as described in the September 2019 Feature Article Recruitment Help. The intake form for submitting your materials for this Communications approval is found here.

 

Types of Recruitment Methods

Opt-In Recruitment:

Opt-in recruitment is when individuals view publicly-available recruitment materials and make the decision to proactively reach out to the study team to learn more about the study. This is considered a form of “passive” recruitment, as potential participants need to contact you.

Promotional Materials:

The most common opt-in methods involve posting or distributing the types of promotional materials described above, such as flyers, brochures/pamphlets, and posters. Opt-in recruitment also includes advertisements broadcasted via social media, websites, television, and radio.

For-Profit Recruitment Companies:

There are also commercial companies that will assist you with study recruitment for a fee. These companies are most often utilized by industry-sponsored multi-center studies, as the sponsor chooses the vendor and covers the costs. However, this is also an option for PI-initiated studies at BMC/BUMC.  These companies, such as BuildClinical or TrialSpark, run advertising campaigns and/or post recruitment materials about the study, and host a platform where interested individuals can provide contact information and/or answer early-stage screening questions. Individuals who are deemed eligible for further contact with the study team are routed to the participating study site that is most appropriate for them (usually the site that is geographically closest); or, in single-site studies, the site connected directly to the study team.

Tabling at Community Events:

Another common form of opt-in recruitment is “tabling” at community events or other locations where eligible subjects may be present. This is when the study team sets up a table or booth to distribute materials and discuss the study with individuals who are interested.

Listservs:

One way to reach a wide range of potential participants is to obtain approval to use an existing Listserv to send out recruitment messages. This type of recruitment is generally opt-in because the message either directly links the individual to the consent language and study (for survey studies), or the message provides the contact information for the research team with instructions to reach out if interested. Please note that you must obtain approval from the stewards of the Listserv prior to utilizing this method, and you should include a statement in your application confirming that this approval will be obtained.

As the decision to contact the study team is completely in the hands of the potential subject when the above opt-in methods are used, these methods are nearly always approvable for any type of research study provided the materials satisfy the criteria outlined in the HRPP policies above.

Opt-Out Recruitment:

Opt-out recruitment involves the study team proactively identifying potentially eligible research subjects, reaching out directly to these individuals to provide information about the study, and giving them the opportunity to either learn more via planned follow-up by the research team, or giving them the option to “opt-out” of further contact about the study.

Obtaining Information on Potentially Eligible Participants:

Medical Record Pre-Screening:

The most common starting point for opt-out recruitment at BMC/BUMC IRB is eligibility pre-screening using BMC medical records. This can involve using the services provided by the Clinical Data Warehouse for Research, querying medical records or existing patient lists, and/or reviewing upcoming clinic schedules. This type of access to protected health information for eligibility pre-screening requires an approved waiver of HIPAA authorization from the IRB, so do not engage in these activities until your study is approved or given an exemption determination. Waivers of HIPAA authorization for eligibility pre-screening are requested by checking “Yes” in the HIPAA Compliance section of the electronic IRB application, and then completing all questions that are generated.

Clinician Referrals:

The IRB will also permit you to obtain information on potentially eligible patients from clinician referrals. This can involve the clinicians only handing out promotional materials to their patients that contain study details and contact information for the research team (opt-in); or, clinicians obtaining permission from their patients to be contacted by the research team (opt-out). For the latter, an initial opt-out message is generally required, and opt-out messages are discussed later in this article. When clinicians send you information on their patients, this constitutes obtaining protected health information without authorization and, therefore, this requires a waiver of HIPAA authorization, similar to medical record pre-screening.

Research Registries or Consented Re-Contact:

Other common methods for obtaining lists of potentially eligible individuals are utilizing information collected from research registries, or information you have collected from prior studies. Research registries are studies in which the main purpose is to enroll subjects for contact about future studies. These registries do not have their own study question; instead, subjects are asked to agree to hear about future research that pertains to them. Contacting subjects who enrolled in prior studies is a great option if you include Re-Contact information in your consent form. Our non-exempt consent form templates include the following language that you can use to facilitate this type of re-contact:

“Re-Contact

We would like to ask your permission to contact you again in the future. This contact would be after your participation in the study has ended. Please initial your choice below:

____Yes   ____No   You may contact me again to let me know about a different research study”

The IRB encourages you to include this option in your consent form if you plan to conduct research studies on a similar subject population in the future, as re-contacting individuals who have consented to this is always approvable.

Opt-Out Messages:

Once you have a list of potentially eligible participants, the most common (and approvable) type of recruitment material is an opt-out message. Opt-out messages can be sent via mail or MyChart, as these are considered secure options. A standard opt-out message provides information about the study, and lets the recipient know that someone from the study team will follow-up with them with a phone call within a certain time frame (10-14 days is recommended) to discuss the study in greater detail. These messages are considered “opt-out” because they also include instructions for contacting the study team if the recipient does *not* want to be contacted to hear more about the study.

In general, if potential subjects are patients at BMC, the opt-out message should either be signed by someone who has a treatment relationship with the recipient OR include a reference to their treating provider after obtaining permission from their provider to use their name in the message. In certain circumstances, if the eligibility criteria are broad (for example: “Adult patient seen in Adult Primary Care”), then the letter may omit reference to a treating provider; and instead, reference that you obtained permission to contact potential subjects from the Clinic Director, Department Chair, or other relevant individual. Another important point about opt-out messages is that if eligibility in the study is based upon a sensitive diagnosis, then you must modify the description of the study purpose to be non-specific enough to protect the recipient’s privacy. As discussed above, protecting the privacy and confidentiality of individuals is an important part of ensuring that recruitment methods are appropriate.

The IRB does not permit you to send opt-out messages or other recruitment materials to individuals by unsecure email or text message if this is the first time you are contacting them. This is because individuals first need to be made aware of the confidentiality risks of receiving information using unsecure methods, and agree to accept these risks. This is why the IRB recommends using mail or MyChart.

The IRB has recently posted a new Opt-Out Recruitment Template for use by the research community. We encourage you to use this template if you plan to use an opt-out strategy in your study.

Approaching Patients in Clinic or as Inpatients:

 Another common strategy that is often used in conjunction with opt-out messages is using your list of eligible patients and/or your list of upcoming clinic schedules to approach patients in clinic. The optimal strategy for this is the “warm hand-off”. The warm hand-off involves the patient’s clinical provider (whether a physician, nurse, PA, or other individual who is seeing them as part of their appointment) asking the patient whether they would be willing to be approached by the member of a research team to discuss a study. The provider does not need to provided a detailed summary of the study; usually, eliciting the patient’s general approval to meet with the research team is sufficient.

Occasionally, the IRB will approve you to approach potential participants in the waiting room. In these instances, you will need to obtain approval from the clinic director to conduct recruitment in the waiting room, and you will need to have a private room or area available for the detailed discussion.

The IRB will also consider approving the recruitment of inpatients. Again, the optimal strategy is to have a clinical provider solicit permission from the patient to be approached in their room. This will likely be required by the IRB for patients who are inpatients due to the severity of their illness. 

Principal Investigators/Co-Investigators Introducing the Study to their Own Patients:

For certain studies, clinicians who are also members of the study team are able to identify potentially eligible participants during the course of routine care. In these instances, the eligibility criteria are generally based upon a health condition that the study clinicians treat clinically. This method of recruitment is almost always approvable by the IRB. However, this introduces therapeutic misconception. Therapeutic misconception exists when the potential participant cannot differentiate between their clinical care, and their participation in a study. This adversely affects their ability to make an autonomous decision about voluntary research participation, and to understand the differences between the purpose of clinical care (to improve their health as an individual patient) and the purpose of research (to collect information to answer the scientific questions asked in the research study in order to help future patients). Research teams should think about ways to mitigate therapeutic misconception; for example, by ensuring that the consent process is conducted by a member(s) of the study team who does not have a clinical relationship with the patient, or by encouraging the patient to seek a second opinion about study participation from someone who is not involved in the research.

Because opt-out recruitment strategies involve active recruitment and do not afford potential participants with the agency to make the first contact with the study team, they are not always approvable for every study. However, if you design your opt-out strategies in a way that minimizes risk to individuals’ privacy and confidentiality, and provide them with the option to opt-out of further study discussion as early as possible, then the IRB will generally be able to work with you on designing these methods in an approvable manner.

Inappropriate Recruitment Methods

There are two types of recruitment methods that are generally never approved by the BMC/BUMC IRB.

Cold-Calling:

If the study eligibility criteria are based on patient health information (such as a particular medical diagnosis), you should not propose to “cold-call” potential participants as one of your recruitment methods. “Cold-calling” in this situation means directly phoning individuals who do not have any prior clinical treatment relationship with the study team (when this phone call is the first point of contact about the study). Instead, you should first send an opt-out message, which, as discussed above, provides some brief summary information about the study and gives the recipient the opportunity to opt-out of speaking further with the study team.

There is a possible exception to this prohibition on cold-calling: The IRB may allow you to call potential participants (without first sending an opt-out message) if the Principal Investigator or co-investigator(s) do have a direct existing clinical relationship with the potential participant(s). In these instances, your recruitment script should clearly indicate that you will reference the individual’s clinical provider and their involvement in the study early in the discussion, so that the potential participant understands why you are aware of their health status and/or possible eligibility for the study.

Snowball Sampling:

The second recruitment method that is almost never approved is “snowball sampling.” “Snowball sampling” in this scenario means asking existing participants (or individuals with whom you have initiated a recruitment discussion) to provide you with the names and direct contact information for other individuals who they think might be interested in hearing about the study. Instead, you can ask the existing/potential participants to provide their acquaintances with information about the study (such as a flyer) so that the recipients can “opt-in” by contacting the study team directly. In this way, the privacy of the acquaintances is protected, and they are afforded the opportunity to decide whether they are comfortable sharing private information with the research team and would like to hear more about the study. Occasionally, if the study eligibility criteria are non-sensitive and/or contact information for eligible subjects might also be publicly-available (interviews with surgical attendings, for example), then it might be appropriate to use a form of snowball sampling. Please first initiate a discussion with the IRB if you would like to use this type of method.

 

Conclusion

Recruiting individuals into your research study is a crucial component of the research enterprise.  It is vital for answering your research question(s); and for helping to ensure that subjects’ time, effort, and potential risks are reasonable in relation to the benefits to science. The IRB understands that recruitment can be difficult, and endeavors to work with you to facilitate study recruitment that is both fruitful and ethically appropriate. By following IRB requirements for recruitment methods and materials, and utilizing the strategies described above, you will be able to work with the IRB on designing methods that are successful for your study.