Recruitment of Subjects

Last Revised: 10.2015

Prior Version: 7.2007

Recruitment of Subjects

Introduction

Recruitment of participants is one of the most challenging aspects of research involving human subjects. It is an essential part of the research protocol and must be presented in sufficient detail to allow the IRB to fully assess the investigator’s plan. Recruitment of participants must be equitable and include racial, ethnic, educational, socioeconomic, and gender diversity appropriate to the research study. Exclusion of any specific group (e.g., women of child-bearing potential) must be justified in the protocol. Both the benefits and risks of research participation must be equitably distributed. All recruitment efforts must respect personal rights to privacy and confidentiality and be compliant with HIPAA regulations, when applicable.

Definitions

Finders’ Fees are money paid for recruiting/referring participants on a per-participant basis.

Bonus Payments are payments to investigators, research staff or the institution as an incentive to accelerate the enrollment of participants.

Cold Calling is when a researcher initiates contact with an unknown potential research participant.

Advertisement is any form of communication aimed directly to potential research participants to promote and announce an investigator’s study and request for participants.

Secondary Recruitment refers to asking a study participant for identifying information about friends, family members or others with the intent to contact that secondary person as potential research participants.

Policy

Recruitment procedures must be designed so that informed consent, parent/guardian permission, and assent are given freely, and there is no coercion or undue influence. In order to evaluate this, the IRB must know who the study participants will be, what incentive(s) is being offered, and the conditions under which a payment is issued. Financial payment, academic credit, gifts, gift cards, or raffles should be reasonable for the time, expenses, discomfort, or inconvenience of participating. The IRB must review all of the research documents and activities that bear directly on the rights and welfare of the participants of proposed research, including the methods and material that investigators propose to use to recruit study participants. Potential participants may not be contacted for a different research study unless documented permission was granted in a previous IRB-approved study.

Contacting Potential Participants by Phone

Prospective participants may have their first contact over the phone with a member of the research staff or third-party person who follows a script to discuss the study and to determine basic eligibility for the specific study. Scripts read by the researcher or other individuals assisting in the recruitment of participants must be submitted to the IRB for review and approval. The IRB must review these procedures and documents to assure that they adequately protect the rights and welfare of prospective participants. Examples of when scripts are needed include phone screeners who will be interacting with potential subjects; any phone conversation that communicates standard research study information.

The IRB must have assurance that any information collected about prospective participants will be appropriately handled including the destruction of identifying information if the potential participant is not interested or eligible for participation. A recruitment/cover letter giving brief information about the study and informing the potential participant that he or she will be receiving a call from the study staff is recommended.

Contacting Potential Participants in Person

A researcher or his or her staff may approach prospective study participants about participation in any IRB-approved protocol. The researcher may approach the potential participant about participation in his or her own protocol or on behalf of another investigator.

Engaging prospective study participants is usually allowed but the method of obtaining names and contact information, who will contact the potential participants, how permission will be obtained from the treating physician, and how data confidentiality will be protected, must be presented in detail in the protocol. Investigators must obtain permission from a study site (e.g., school, factory or business) before approaching prospective study participants. The IRB will want copies of letters of cooperation or IRB approvals from each study site prior to approval.

Advertisements

Advertising materials are part of the recruitment process and should be submitted as part of the initial IRB electronic application. Investigators must obtain IRB approval for all television, radio, videotape or print advertisements, posters, flyers, handouts, e-mail solicitations, websites, and other recruitment methods and materials intended for the recruitment of prospective participants to a research protocol.

Advertisements are directly related to the informed consent process and must be consistent and guard against coercion and undue influence. The IRB must ensure that appropriate safeguards exist to protect the rights and welfare of research participants. Advertising or soliciting for study participants is the start of the informed consent and participant selection processes. In order to evaluate advertisements, the protocol must state who the participants will be and what compensation, if any, is being offered; and describe how the material will be used, distributed, and/or posted. This is especially critical when a study may involve participants from a vulnerable population (i.e., university students, children, cognitively impaired).

The IRB pays particular attention to risk and potential benefit information to ensure it is presented in a balanced and fair manner. The information presented should not mislead, for example, by promising benefits or implying a benefit beyond that potentially provided by the research. If advertising materials become available after initial approval or have been modified, the materials in questions must be submitted to the IRB via an Amendment Form. The materials may not be used until the IRB approves them.

What May be Included in Advertisements

Any advertisement to recruit participants should be limited to the information the prospective participant needs to determine eligibility and interest. When appropriately worded, the following items may be included in advertisements:

· The condition and/or the purpose of the research in summary form.

· Statement that the study is research.

· The criteria that will be used to determine eligibility for the study in summary form.

· A brief list of participation benefits, if any (e.g., a no-cost health examination).

· The time or other commitment required of participants.

· The location of the research and the person or office to contact for further information.

· Compensation may be mentioned, but not as a specified amount or as a benefit.

What Not to Include in Advertisements

· A statement or implication of certainty of a favorable outcome or other benefits beyond what is outlined in the consent document and the protocol.

· Claims, either explicitly or implicitly, that the research procedures are safe or effective, or that the research procedures are known to be equivalent or superior to any other procedure, method, technique, etc.

· Promise of a free service or item when the intent is only to say participants will not be charged for taking part in the research and/or when investigator cannot provide or arrange a free service or item.

· Emphasize the compensation, by such means as larger or bold type.

· The specified amount to be paid.

· Include any exculpatory language.

IRB Approval Stamp on Advertisements

The IRB stamps all advisements indicating their approval and date approved via iRIS. There may be instances where these approval stamps automatically inserted through iRIS are placed in inappropriate locations on the advertisement. In these cases, investigators can use a clean unstamped copy of your advertisement as long as it represents the IRB-stamped document and contains the IRB approval date.

Contacting Potential Participants Using Electronic Media (including email)

All Internet recruitment materials directed at potential participants are considered advertisements and the same rules apply. This includes information posted on social media websites (e.g., Twitter, Facebook, YouTube, etc.), community boards, recruitment registries, (e.g., ResearchMatch), chat rooms, or other websites. Investigators are required to provide the IRB copies of letters or emails of cooperation for electronic study sites. In the event that the site is open to the public, including researchers, investigators must provide verification that the site is public.

Web forms may ask visitors to answer questions regarding eligibility for a specific study. If identifiable private information is collected via the website, the IRB will review plans for protecting the confidentiality of that information and ensure that the website clearly explains how identifiable private information might be used. The IRB must have written assurance that any information collected about prospective participants will be appropriately handled.

Secondary Recruitment

Secondary recruitment refers to asking a study participant for identifying information about friends, family members or others with the intent to contact them as potential research participants. While there are important research reasons that secondary recruitment is needed, it must be approached in a manner that respects the privacy of the potential participants. Failure to hear from primary or secondary participants cannot imply consent to further contact.

Exception to the Standard Method for Contact

The IRB allows investigators to obtain information about potential participants from enrolled study participants if ALL the following criteria are met:

· The person is not called without sending an IRB-approved letter in advance.

· The rationale for this approach, including how the contact information will be kept confidential, is justified in the protocol.

It is the IRB policy that investigators may ask enrolled participants in an approved IRB study for the names, addresses, and/or e-mail of relatives or other persons who may be contacted by the investigator to participate in the study or an aspect of the study (e.g., genetic screening). Telephone numbers and other health related information maybe NOT be solicited by the investigator or provided by the study participant to the investigator. Health information is excluded by implication (e.g., requesting identifying information to contact the subject’s relatives who have diabetes). The enrolled participant should be asked to inform the person that their name, address, and/or e-mail have been provided to an investigator.

Payment for Recruitment

Payments to investigators, research staff and the institution as an incentive to accelerate the enrollment of participants (i.e., bonus payments) are prohibited. The IRB requires full disclosure of any financial arrangements that may encourage investigator to recruit participants for research participation that may not be in the subject’s best interests. In some special circumstances, individuals who are not formally listed on the protocol may be performing specific research-related activities (such as a receptionist participating in the recruitment process), but solely in the role of service provider.

The IRB prohibits the use of finders’ fees for recruitment or identification of potential study participants. If payments for recruitment are proposed, they must be justified in detail in the protocol including defining the work that is done by the recruiters. The protocol must also explain what measures are taken to ensure that payments will not lead to undue influence or coercion of study participants.

References or Regulatory Citations

45 CFR 46.111(a)(3)

45 CFR 46.116

OHRP Guidance on Written IRB Procedures, July 1, 2011

OHRP Guidance on Clinical Trial Websites

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