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Chapter XIV - Participant Recruitment and Review of Outreach Materials

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Recruitment plans for research projects should be designed to fully encompass racial, ethnic, and gender diversity. Efforts to identify and recruit potential human research participants should be designed to respect personal rights to privacy and confidentiality. Everything possible should be done to avoid coercion of participants in their recruitment for research study participation. Recruitment of vulnerable participants should be done with respect to the regulations at 45 CFR 46, Subparts B, C or D, as appropriate.

The IRB will evaluate the recruitment methods to ensure compliance with federal regulations as well as HIPAA Privacy rules. All print, video, web-based and audio advertisements used to solicit prospective research participants (‘directed advertising’) must be reviewed and approved by the IRB prior to dissemination.

The IRB prohibits cold-calling of potential research participants. "Cold-calling" is the practice of investigators or research staff, unknown to the potential research participant, initiating contact with the potential participant based on their prior knowledge of private informationTo avoid a cold-calling scenario, the research study should be introduced to the potential research participant by an individual who, by virtue of his/her position, would normally have access to the potential participant’s confidential information (e.g., the personal physician of the potential participant or a member of the clinic or practice staff). If the potential research participant indicates an interest in study participation, s/he should be instructed to either (a) contact the investigators directly or (b) permit the individual who initiated this contact to share with the research team the person’s interest in study participation so that the researchers can subsequently contact the potential participant and provide more information about the study.

The individual who initially introduced the study to the potential participantshould document this permission in his/her records. As per the HIPAA privacy regulations, a health care provider may not share individually identifiable health information with research investigators without the written authorization of the patient. Hence, whenever there is the possibility that the potential participant’s health information and identity will be shared with members of the research team, a valid HIPAA authorization may be required from the potential participant.

Examples of acceptable methods of contacting and/or recruiting potential research participants include:

  • Direct discussion of the study during a face-to-face interaction with a potential research participant;
  • Mailings sent to the prospective participant from their provider, clinic, or program representative. Mailings can describe the purpose of the study and request that the participant return a postcard or make a telephone call indicating his/her agreement to participate. A less preferable option is to request the person send back a postcard (or call a designated phone number) only if s/he does not wish to participate. If no response is made within a specified time, the participant may then be contacted by the investigator or a member of the research team. A drawback to this approach is that individuals so contacted may feel harassed by the researchers if, for example, they never receive the letter, can't read the letter, or are confused by the instructions. For studies involving children, the letter introducing the study should be sent to the child’s parents and parental permission obtained prior to enrolling the child in the research study;
  • Random digit dialing and reverse directories. This differs from “cold calling” in that the call is being initiated on publicly available information rather than prior knowledge of private information;
  • Public advertisements or notices posted in public places.

Directed advertising includes, but is not limited to, newspaper, radio, TV, Internet ads, audio/video tapes, bulletin boards, posters, and flyers that are intended for prospective participants.
The following are not considered to be 'direct advertising' and do not require prospective IRB review:

  • Communications intended to be seen or heard by health professions, such as “dear doctor” letters and doctor-to-doctor letters (even when soliciting for study participants);
  • News stories, so long as information is not provided regarding recruitment;
  • Publicity intended for other audiences, such as financial page advertisements directed toward prospective investors;
  • Directories of clinical trials on the internet when the system format limits the information provided to the most basic trial information, such as the title, basic eligibility criteria, and how to contact the study site for additional information.

Examples of clinical trial listing services that do not need IRB review and approval include the National Institutes of Health (NIH) website, the NIH National Cancer Institute’s cancer clinical trials listing (Physician Data Query [PDQ]), FDA Clinical Trials, and the government-sponsored AIDS Clinical Trials Information Service (ACTIS).

When information posted on a clinical trial website goes beyond directory listings, such information is considered part of the recruitment and informed consent process and requires IRB review and approval. Examples of information which would exceed basic listing information include descriptions of clinical trial risks and potential benefits or solicitation of identifiable information (e.g., name and contact information).

Advertisements directed at potential research participants should be reviewed at the time of initial IRB review of the protocol. Advertisements directed at potential research participants not reviewed at the time of initial IRB review must be submitted as a modification or amendment to the GA IRB and reviewed in an expedited manner by the IRB Chair, or his/her designee.

  • The IRB will review a final formatted version of printed advertisements to evaluate the relative size of type used and other visual effects;
  • When advertisements are to be taped for broadcast, the IRB will, at a minimum, review and approve the wording of the advertisement prior to taping, and, if made available review the final audio or videotape.

The following criteria must be met to gain IRB approval:

  • Advertisements must contain the word “Research;”
  • Advertisements cannot state or imply a certainty of favorable outcome or other benefits beyond what is outlined in the protocol and consent document;
  • Advertisements cannot state or imply that the drug, biologic, device or other type of intervention is safe or effective for the purposes under investigation;
  • Advertisements cannot state or imply that the test article or other research intervention is known to be superior or equivalent to any other drug, biologic, device or intervention;
  • Advertisements for recruitment into a research study involving an investigational drug, biologic, or device should not use terms such as "new treatment", "new medication", or "new drug" without explaining that the test article is investigational;
  • Advertisements cannot promise “free medical treatment” when the intent is only to state that participants will not be charged for taking part in the investigation;
  • Advertisements may state that participants will be paid but should not emphasize the payment or the amount to be paid by such means as larger or bold type;
  • Advertisements aimed at recruitment of children cannot contain the dollar amount of the compensation;
  • Advertisements cannot include exculpatory language through which the participant or their legally authorized representative waive legal rights or releases the investigator, the sponsor or institution from liability for negligence;
  • Advertisements cannot include compensation for participation in a trial offered by a Sponsor to include a coupon good for a discount on the purchase price of the product once it has been approved for marketing.

The advertisement should generally be limited to the information that potential participants need to determine their eligibility and interest in the research. When appropriately worded, the following items may be included in advertisements, but are not required:

  • The name and address of the clinical investigator and / or research facility;
  • The condition under study and/or the purpose of the research;
  • In summary form, the criteria that will be used to determine eligibility for study participation;
  • A brief list of participation benefits, if any;
  • The time or other commitment required of the participants;
  • The location of the research and the person or office to contact for further information.

Investigators will be notified in writing of IRB approval of advertisements directed at potential research participants. The written notification of IRB approval of the research will include a statement that the advertisement was approved by the IRB. In addition, the correspondence will specify that any substantive modification of the advertisement requires re-approval by the IRB prior to dissemination.

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