Chapter 42

Participant Recruitment Materials and Practices

Participant Recruitment Practices

Recruitment plans sometimes include the use of Referral Fees or Finder’s Fees. These are payments to someone who is not a member of the study team (for example, a physician with a practice near the study site) paid in return for assistance in finding potential study participants.

In general, fees that are based on actual referrals  that is, paying $X per referred patient – are not considered to be appropriate, because this payment structure creates a financial incentive for referring someone to a study and perhaps encouraging them to be in a study, when the study may not be in their best interests. While this potential conflict of interest applies to all health care providers, the American Medical Association Code of Ethics specifically prohibits the payment of “finder’s fees” for either specialist care referrals or clinical trial referrals and considers this a form of fee-splitting (AMA Code of Medical Ethics Opinion 11.3.4). 

It is possible to compensate referral sources if that compensation is based on the time and effort put into identifying or contacting potential study participants. Compensation for time and effort should be clearly based on that factor- that is, structured as $X/ hour of time spent, or $X for X number of medical records reviewed, regardless of whether that time results in actual referrals. In particular, payment should not be contingent on whether a referred potential participant is eligible for the study (vs. a “screen failure”) or whether they agree to participate in the study. A referral source cannot control whether a potential participant is medically eligible for study participation or whether they decide to participate, and both eligibility assessment and participation decisions of potential study participants should be private.

Referral programs in which fees or other incentives are paid to either current study participants or to other persons who are not health care providers for referring potential participants to a study must also be reviewed by the IRB. The conflict of interest for referral fees is not the same here, since the referring parties are not health care providers, and “per referral” payments are possible in this setting.  Again, payment should not be contingent either on whether a referred potential participant is eligible for the study (vs. a “screen failure”) or whether they agree to participate in the study. A referral source cannot control whether a potential participant is medically eligible for study participation or whether they decide to participate, and payment based on eligibility or consent may encourage the referring party to pressure the referred person to give inaccurate information or to agree to participate when they would prefer not to. Both eligibility assessment (which may reveal personal medical history) and participation decisions of potential study participants should be private.

Participant Recruitment Materials (including advertisements)

Request for review of new or revised participant materials or advertisements can be made through ClinSphere® eReview Manager or IRBNet. Print ads should be submitted as closely as possible to how they will appear in print, so that the Board can assess the impact of design details, such as photographs, other images, font sizes, and styles.

Most changes to approved advertisements must be reviewed by WCG IRB prior to their use, particularly anything that could alter the impact of an advertisement previously reviewed by the Board. Changes to approved advertisements that do not need to be submitted for review include updates to phone numbers or contact names referenced in an advertisement and corrections to spelling.

Please ensure that each of the following materials are submitted as separate, stand-alone documents for individual review (do not combine multiple materials into a single file/document):

  • Scripts/Storyboards (TV, Radio, Screening)
  • Print ads
  • Brochures
  • Flyers
  • Dr. to Dr. Letters/Press Releases

The following items are recommended to be submitted as a single review item (a single document for each):

  • Website (must be submitted together as screenshots of each web page)
  • Text messages (unless you want each message reviewed separately)
  • Email blasts (will be grouped and reviewed by type, such as reminder emails vs. new emails)
  • FAQs (unless you want each reviewed separately)
  • Social media
  • Ad-words Search (unless you want each reviewed separately)
  • Pictures (Images)
  • Banner ads (unless submitted separately)
  • Retention items (unless you want each reviewed separately)
  • Screenshots of applications (unless you want each reviewed separately)

For best results, when submitting participant recruitment materials or other participant materials (diaries, questionnaires, etc.) that have been previously reviewed by WCG IRB, state in the cover letter that the items have been previously reviewed. Our support staff will provide the Board with information about the previous Board review, so that the previous decision of the Board will be taken into account when the materials are reviewed.

When submitting revisions to previously IRB-approved materials, you may submit a redlined (tracked changes) version of the previously approved material or a clean version incorporating the requested changes for review. If you submit a redlined version, the Board will review the material and may approve as submitted or require additional modifications. The IRB-approved material showing the submitted redlined changes and any additional changes required by the Board will be included in the review outcome documentation. Beyond accepting the tracked changes, do not make any additional modifications (including font size and visual effects) to the approved materials.

Information packets, patient brochures, sponsor brochures, and informational videos are all considered recruitment materials if they are intended to be seen by a potential participant.

Documents for Select Sites: WCG automatically approves all study-level documents for new sites during initial review. If any documents are not intended for all sites, provide a list specifying which sites they apply to, in advance. This process applies to, for example, documents specific to particular arms of the research, cohorts, sub-studies, or payment vendors. Supplying this information upfront helps us ensure accurate approval for all submitting sites and can prevent unnecessary holds or delays in the review process. Documents limited to select sites will be labeled “SELECT SITES” at the start of their titles.

Audio and Video Recruitment Materials: All audio and video materials should be accompanied by the script for that material.  

To avoid unnecessary additional production costs due to re-work, it is strongly recommended that WCG IRB approval of scripts for planned audio or visual recruitment materials be obtained before producing the spots. Any Board-required modifications to the material must be reflected in the final version of the recording.  

When audio or video scripts are sent to us for review, we pre-review the script and, if acceptable, approve it with modifications or as submitted. The submitter receives a copy of the script displaying the Board’s required modifications, if any. The final recording must be submitted for final approval before use with participants and MUST match the approved script. Submit a copy of the corresponding script when you send the recording to us for review.

Ads for All Sites: Advertisements which will be used by some or all participating investigators should be identified as such in the cover letter or submission form. Identifying shared advertisements as such will help ensure consistent review of materials for all participating sites.

Logos: If the Board considers elements of a logo in an advertisement to be unduly influential, incorrect, or out of compliance, they will direct that the logo be removed from the ad or be modified to eliminate the objectionable element(s).

Public Service Announcements and Phone System “on hold” Messages: Public service announcements and audio scripts of messages that will be broadcast to callers who have been placed on hold are considered recruitment materials, will be reviewed by the Board and, if acceptable, approved either “as submitted” or “as modified.”

Website Content: WCG IRB review requirements for web content are dependent on the type of content in question.

ClinicalTrials.gov and similar sites which provide a limited set of pre-formatted fields for inclusion of recruitment content do not need to be submitted for IRB review. If requested, WCG IRB will review submissions of such content. FDA Guidance regarding use of media advertising to recruit participants can be found at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recruiting-study-subjects.

Website content can be reviewed either in relation to a specific protocol or as generic recruitment material. (See Generics.) If the material is reviewed and approved as a “generic,” an expiration date is assigned (usually a year from the approval), and the Board conducts re-review of the content when the expiration date approaches unless WCG IRB receives a request to close the file.

Content on websites and changes made to approved website content should be submitted for Board review before they are posted to the web. The website owner is responsible for receiving approval before using that content for recruitment. Websites should be submitted as screenshots of individual web pages combined into one PDF of the whole website (only pages relevant to the research must be submitted).

Participant recruitment content on sponsor, investigator, or Site Management Organization websites requires IRB review. Only the content relevant to research should be submitted for review. Submit to us only website content which provides information to potential participants about research participation, as well as information about specific studies that WCG IRB oversees. General website information that does not relate to research participation, such as disease information or driving directions to the research office, does not require review.

It may be appropriate to request WCG IRB review of these materials as “generic” recruitment materials (See section below titled Review of “Generic” Materials). The content should not be posted until WCG IRB has approved it. 

WCG IRB does not review the content of the links to other websites that are present on submitted websites. The website owner should ensure the links are appropriate.

Doctor to Doctor Materials, Press Releases: The FDA Information Sheets state:

Direct advertising includes, but is not necessarily limited to: newspaper, radio, TV, bulletin boards, posters, and flyers that are intended for prospective subjects. Not included are: (1) communications intended to be seen or heard by health professionals, such as “dear doctor” letters and doctor-to-doctor letters (even when soliciting for study subjects), (2) news stories and (3) publicity intended for other audiences, such as financial page advertisements directed toward prospective investors.

Based on this guidance, WCG IRB does not require prior IRB review of doctor-to-doctor letters, press releases, or interviews with the media, and there is no need to provide WCG IRB with copies of these materials. However, if you would like to have IRB review for such materials, we will provide a review upon submission. Please note WCG IRB Policy on submitted press releases: WCG IRB reviews submitted press releases as advertising.

When multiple advertisements or participant materials are submitted as one document, WCG IRB staff separate the file into individual documents for review. Each document is considered a unique material due to differences in text/content and communication method (video, social media, etc.). As even minor changes in text can alter the meaning or impact for participants, any differences in the documents would require a separate review and are listed individually on the IRB Certificate of Action. Your invoice will reflect this.

When separating multiple items into individual documents for review, staff try to keep similar materials together for cost savings and efficiency in the review. For example, “social media” ads are routinely processed as one document, as opposed to being reviewed individually into separate Facebook, Instagram ads, etc.

Recruitment Material: Criteria for Approval of Advertising

  • No statement or implication of a certainty of favorable outcome or other benefits beyond what is in the consent document and protocol.
  • No exculpatory language.
  • No emphasis on payment or the amount to be paid, by such means as larger or bold type.
  • No promise of “free treatment” when the intent is only to say participants will not be charged for taking part in the research.
  • Limit the information to what the prospective participants need to determine their eligibility and interest.

Additional criteria for clinical trials:

  • No claims, either explicitly or implicitly, about the drug, biologic, or device under investigation that are inconsistent with FDA labeling.
  • No use of terms, such as “new treatment,” “new medication,” or “new drug,” without explaining that the test article is investigational.
  • No inclusion of compensation for participation to include a coupon good for a discount on the purchase price of the product once it has been approved for marketing.

Recruitment of Participants From International Locations

WCG does not restrict research sites in the U.S. from enrolling eligible participants in clinical research studies that require them to cross the international border by land or by air.

Special Considerations for Use of Artificial Intelligence (AI) Tools in The Recruitment Process in Research Studies

WCG will review the Investigator or site’s use of third-party AI tools as part of their recruitment plan. WCG recommends the investigators use only validated AI tools and perform test runs on their datasets to ensure it meets their expectations. The recruitment plan should include a description of the third-party AI tool, source of data interrogated, and privacy and confidentiality measures implemented to protect the participants.

WCG envisions several scenarios where third-party AI tools can be utilized in a recruitment plan.

  1. An AI tool with chatbot functionality that analyzes user generated interrogated EMR datasets to confirm eligibility criteria and contacts the eligible participants via SMS text messages or e-mail to gauge their interest in the proposed study before directing them to research staff at the site.
  2. An AI chatbot that engages with potential participants who respond to WCG approved advertisements posted on social media platforms. The AI tool may perform initial screening before directing them to research staff at the site.
  3. An AI tool to facilitate searching for eligible participants in accessible, publicly available datasets, and patient registries with permission to build a cohort for further screening.