Feature Article

New Options for Subject Recruitment
December 2007 Issue

By Anna W. Martin, MPH, and
Mary A. Banks, RN, BS, BSN

Author has nothing to disclose with regards to commercial support.

Educational Objectives:

At the end of this activity, participants should be able to:

• Identify why recruitment methods are important for the protection of human subjects.
• Identify recruitment methods that are likely to be acceptable to the BUMC IRB and others that will likely be unacceptable to the BUMC IRB.
• Recall the maximum number of times the IRB recommends contacting potential subjects.
• Distinguish between opt-in and opt-out recruitment methods.

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• Introduction
• Why recruitment methods are important
• Recruitment letters (including e-mails)
• Types of in-person recruitment
• Opt-in vs. Opt-out
• Secondary recruitment (Snowballing)
• Frequency of contact
• HIPAA regulations
• Conclusion
• Quiz

Introduction

Many a small thing has been made large by the right kind of advertising. ~Mark Twain, A Connecticut Yankee in King Arthur's Court

Recruitment activities set the tone for research studies. They are the first step in the consent process, and are the investigators’ first opportunity to present potential subjects with information about the study. IRBs review recruitment materials and procedures as part of the IRB approval process. This article will discuss common recruitment techniques, and some changes to the BUMC IRB recruitment policy.

Why recruitment methods are important

The IRB uses the Belmont Principle, “Respect for Persons”, to guide its ethical review of recruitment activities. This principle is applied by ensuring that a person’s decision to participate in research is voluntary. Recruitment methods that are coercive (such as aggressive tactics that make people feel unable or reluctant to refuse, giving subjects misleading information about the level of commitment necessary to participate, offering finders fees for subjects, emphasizing the monetary compensation for participation, or over-promising the benefits of the study) are not allowed.

Even when investigators follow proper procedure, such as using an approved HIPAA Preparatory to Research to obtain information about potential subjects, those who are contacted may be confused or offended if they are approached by researchers unknown to them. This is especially true if they believe that these researchers possess private information about them. For example, anyone who receives a letter from an investigator he/she doesn’t know that says, “I’m a researcher from BMC. I’m doing a study on heart disease and I’m contacting you because I know that you had a heart attack last month”, would be understandably concerned.

An important consideration is whether researchers are “known to” or “unknown to” potential subjects. While there is no standard definition for when researchers are “known to subjects”, for the purposes of this article, a researcher would be “known to” an individual if he /she is someone whom the individual would reasonably expect to have access to his/her clinical information (e.g.,. his primary care physician [PCP], specialist, or a member of the same department or medical group as his PCP or specialist). (Note: this differs from whether investigators have the right to know an individual’s private information, which is discussed below).

Recruitment letters (including e-mails)

Under other circumstances, researchers need to recruit patients with specific diseases or conditions; e.g,. patients who have asthma. In these situations, the IRB must consider two points: (1) does the investigator have a right to access the potential subject’s protected health information, and (2) will the potential subjects be upset or concerned that the researchers making the initial contact have private information about them.

To address concern #1, the IRB must ensure that investigators obtain the necessary HIPAA approval in order to access/use protected health information (PHI) for recruitment activity:

• If ALL investigators on the protocol are part of the covered entity, then a HIPAA Preparatory to Research form must be completed and submitted with the protocol.
• If some or all investigators are NOT part of the covered entity, then a HIPAA Waiver of Authorization must be submitted.

• If the investigator or co-investigators are “known to” the potential subjects, then the investigators may send recruitment letters directly to subjects (once approved by the IRB). The investigators must explain (in Section J2 of INSPIR) how they will minimize the chance of subjects misunderstanding that the research is connected to their clinical care (therapeutic misconception), or feeling compelled to participate because they are being asked by their own physician or caregiver.
• If the investigators are NOT known to the subjects, then the investigators must ask someone “known to them” (e.g. the PCP, specialist) for permission to contact their patients.

• That this is for a research study
• The purpose of the study, and why the potential subject is being contacted (why he/she might be eligible)
• The contact information of the researcher and, if possible, more than one method of contact (e.g., phone, return mail, email).

Types of in-person recruitment

Subject-initiated contact: With this method, the subject contacts the research team after reading a flyer, hearing a radio advertisement, etc. The IRB approves of this method of recruitment because the risk of coercion is minimized. The subject makes an active decision to contact the researchers. This recruitment method is the least likely to offend people because they are not being approached without their permission.

Researcher-initiated contact: With this method, the first direct contact with potential subjects is initiated by the researchers. Historically, the BUMC IRB has not approved researcher-initiated recruitment strategies but, instead, has required that researchers be “introduced” to potential subjects by someone “known to” them (e.g., their physician, clinic nurse). In some cases, people who are approached by researchers find it difficult to say “no,” and may even be offended by being approached.

Recently, the BUMC IRB Executive Committee determined that the IRB could approve recruitment plans that call for researcher-initiated contact under certain circumstances. In making its decision, the IRB will consider whether the recruitment method is appropriate for the setting; for example, it might be appropriate for the researcher to approach potential subjects in clinics or waiting rooms, but it would be inappropriate in most instances for them to approach patients in their ICU bed, during labor and delivery, or in the pre-op holding area. The IRB will also consider the sensitivity level of the study itself (e.g., approaching people in a general hospital waiting room to find cocaine users would likely not be allowed).

1. A specific description of the exact setting for ALL recruitment activities, who would do the recruitment, and an explanation as to why researcher-initiated contact is appropriate. (In Section J2 of INSPIR)
2. A formal script that will be used when approaching potential subjects.
3. Written approval from the department chair or appropriate administrator in charge of each recruitment setting, indicating that they approve researcher-initiated recruitment in “their” setting. (This can be a letter or email attached in Section S of INSPIR.)
4. If the researcher is also the potential subject’s clinician, then an explanation for how the risk of therapeutic misconception will be minimized.

Opt-in vs. Opt-out

Opt-in: Researchers using this method contact potential subjects, usually with a recruitment letter, and ask them to get in touch with study staff if they wish to learn more about a research study. The investigators must then wait for subjects to contact them. The Opt-in method is more respectful and presents less risk of annoying potential subjects because they only contact the researchers if they are interested in the study. Opt-in recruitment is less popular with investigators since they must passively wait to be contacted by potential subjects, who might not initiate contact even though they might be interested in participating.

Opt-out: Researchers using this method contact potential subjects with a recruitment letter informing them about the existence of a research study. Individuals are told that they will be contacted by the researchers unless they call or mail back a card indicating that they are not interested (opt-out). Potential subjects are more likely to be offended by this approach since they have less choice in deciding whether or not to learn more about the research because they must make an effort to opt out. At the same time, this method is more feasible for investigators, particularly if subjects are difficult to contact or belong to a group that typically does not actively volunteer for research studies.

• The researchers provide justification in the IRB protocol (Section J2) as to why this strategy is appropriate
• The research does not involve very sensitive information (e.g., questions about illicit drug use, sexually transmitted diseases, alcohol abuse, emotional and/or mental disorders)
• The recruitment letter gives the potential subject clear instructions about how to opt out and offers preferably two ways of opting out (e.g., mail, phone, email)
• When subjects who did not opt out are contacted, they are reminded that they were sent a letter and are told at the start of the call that they can “opt out now”
• The number of times the investigator will attempt to contact subjects who do NOT opt-out is limited (usually to three attempts)

Secondary recruitment (Snowballing)

Secondary recruitment methods are used when investigators wish to recruit specific groups of subjects and there is a better chance to access additional eligible subjects through friends and family of existing subjects. Snowballing is also useful when trying to recruit subjects from a certain ethnic minority group or other special group. To protect the privacy of those being recruited, the IRB only approves certain types of snowballing methods.

Subject-initiated Snowballing is when the researcher asks current subjects to pass along recruitment materials or information to friends and family. The subject initiates the contact with family and friends, and these people must contact the researcher if they wish to learn more about the study. This method is acceptable to the IRB.

Researcher-initiated Snowballing is when the researchers ask current subjects for the names and contact information of family and friends who might meet the eligibility criteria and be interested in the study. The researcher then contacts these people directly for recruitment. The IRB does NOT approve this method of recruitment as it can be perceived as disrespectful of people’s privacy.

Modified Snowballing is when investigators ask subjects if they have family and friends who might be eligible and interested in participating in the research. The investigators only get in touch with these secondary contacts AFTER the subject has confirmed that he/she has obtained permission from the family members/friends to have the researchers contact them. This method is acceptable to the IRB.

Frequency of contact

Investigators must indicate in their recruitment plan (Section J2) the number of attempts that they will make to contact potential subjects. The IRB limits the number of attempts allowed to minimize the risk of annoying potential subjects. Unless otherwise approved by the IRB, no more than five attempts may be made to contact potential subjects who have indicated they would like to learn more about the study (opted-in). No more than three attempts may be made to contact potential subjects who have NOT opted out.

HIPAA regulations

If any investigators (whether part of the covered entity or not) are using protected health information from a covered entity to identify potential research subjects, then the HIPAA rules apply. For more information on HIPAA requirements, please see the October 2006 Feature Article and the HIPAA website.

Conclusion

Recruitment is the beginning of the consent process. The IRB reviews recruitment procedures and materials to ensure that they are not coercive and are respectful of subjects. This article outlines some acceptable and non-acceptable recruitment strategies for BUMC research studies.

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