Basics of IRB Approved Advertisements and Subject Recruitment Training for Investigators and Research Personnel

What is Subject Recruitment? “the action of finding new people to join an organization or support a cause” Google “to persuade (someone) to join you in some activity or to help you” Merriam-Webster “to increase enrollment into clinical trials” Wikipedia

According to our HRPP Manual “Investigators are required to provide a detailed description of subject identification and recruitment methods as part of the IRB application. If the investigator/study personnel have no direct patient care relationship with a potential research subject they should include a clearly written description of how subjects will be identified and/or approached in a manner that protects their privacy and confidentiality.” http://elpaso.ttuhsc.edu/research/committees/irb/resources/_documents/HRPP%20Manual%20El%20Paso%20October%2024%202016.pdf

What are Some Acceptable Forms of Recruitment? advertisements notices and/or media announcements a letter describing the project with research personnel contact information provided to colleagues for general distribution to their patient population so that interested persons may then self-refer study personnel may recruit from within their own patient population by describing the project and reviewing the informed consent document with potentially eligible subjects. http://elpaso.ttuhsc.edu/research/committees/irb/resources/_documents/HRPP%20Manual%20El%20Paso%20October%2024%202016.pdf

What are Some Unacceptable Forms of Recruitment? Study personnel with no professional relationship with the potential research subject searching through medical records or existing databases (e.g. registries) for qualified subjects and subsequently contacting those patients directly Presenting the research immediately prior to sensitive or invasive procedures (e.g. cardiac surgery) when the person is potentially distracted/nervous, medicated and/or temporarily decisionally impaired retaining sensitive information obtained at screening - without the consent of those who either failed to qualify or refused to participate - for possible future study participation http://elpaso.ttuhsc.edu/research/committees/irb/resources/_documents/HRPP%20Manual%20El%20Paso%20October%2024%202016.pdf

What is an Advertisement? “a notice or announcement in a public medium promoting a product, service, or event or publicizing a job vacancy” Google “something (such as a short film or a written notice) that is shown or presented to the public to help sell a product or to make an announcement” Merriam-Webster “A notice, such as a poster or a paid announcement in the print, broadcast, or electronic media, designed to attract public attention or patronage” The Free Dictionary

What are Some Forms of Advertisements that You’ve Seen Used for Subject Recruitment?

How is Advertisement Defined in our HRPP Manual? “The IRB defines advertisement/recruitment materials as any research-related information that will be seen or heard by a potential subject before he or she has signed a consent form for the study. This means recruitment materials may include: printed items in newspapers, magazines, flyers, posters, and so forth; radio, TV, video scripts and recordings; internet postings; web pages; informational brochures; letters to potential subjects; imprinted items (notebooks, bags, and so forth).” http://elpaso.ttuhsc.edu/research/committees/irb/resources/_documents/HRPP%20Manual%20El%20Paso%20October%2024%202016.pdf

Keep in Mind… According to our manual “Advertising for recruitment is considered to be the beginning of the informed consent process, therefore all recruiting and advertising materials must be approved by the IRB prior to use. An expedited review may be used for approval, but advertising may also be referred for full board review at the reviewer’s discretion.” http://elpaso.ttuhsc.edu/research/committees/irb/resources/_documents/HRPP%20Manual%20El%20Paso%20October%2024%202016.pdf

What Information Can be on the Advertisement According to our Manual? name, address of investigator and research facility; condition under study and or purpose of the research; summary of inclusion / exclusion criteria; brief list of procedures involved; time commitment required; compensation/reimbursement; location of research and contact person for further information. http://elpaso.ttuhsc.edu/research/committees/irb/resources/_documents/HRPP%20Manual%20El%20Paso%20October%2024%202016.pdf

What Information Cannot be on the Advertisement According to our Manual? claims, either explicit or implicit, that the drug, biologic, device or other type of intervention is safe or effective for the purposes under investigation; catchy words like “free” or “exciting”; claims, either explicit or implicit, that the test article is known to be equivalent or superior to any other drug, biologic, device or intervention; terms such as "new treatment," "new medication" or "new drug" without explaining that the test article is investigational, meaning non-FDA-approved; promise of "free medical treatment," when the intent is only to say that participants will not be charged for taking part in the investigation; an emphasis on the payment or the amount to be paid, by such means as larger or bold type. The IRB has the authority to approve whether compensation information shall be included in the advertisement. http://elpaso.ttuhsc.edu/research/committees/irb/resources/_documents/HRPP%20Manual%20El%20Paso%20October%2024%202016.pdf

Do I Need Any Other Approvals? “Formal approval at the facility where any advertisement is to be posted may be required. For example advertisements posted at TTUHSC El Paso must comply with TTUHSC OP 61.03 Posting of Notices on TTUHSC Property. Non-TTUHSC El Paso facilities may have their own specific requirements.” YES! http://elpaso.ttuhsc.edu/research/committees/irb/resources/_documents/HRPP%20Manual%20El%20Paso%20October%2024%202016.pdf

So What do Approved Advertisements Look Like? GOOD QUESTION!!

Summary Subject recruitment is the action of increasing enrollment onto clinical trials There are acceptable and unacceptable recruitment methods Advertisements are a part of subject recruitment Advertisements are announcements designed to attract public attention There are acceptable and unacceptable forms of information that can be on an advertisement According to our policy, you may need approvals outside of the IRB to post advertisements

Resources TTUHSC El Paso HRPP Manual: http://elpaso.ttuhsc.edu/research/committees/irb/resources/_documents/HRPP%20Manual%20El%20Paso%20October%2024%202016.pdf

Questions?

Scenario An investigator is approved to conduct a study about the effectiveness of a natural product curcumin. The product is an anti-inflammatory particle found in the turmeric root, which is a relative of ginger. Subjects need to be diagnosed with early stage alzheimer’s disease, be between the ages of 55-85 and not be currently on any treatment for the condition. Subjects will have physical exams, diagnostic tests, lab tests, memory tests and need to complete a diary. All research related procedures and the product are covered/provided by the study. The study includes 10 visits during a 2 year period.

What Information Can be on the Advertisement According to our Manual? name, address of investigator and research facility; condition under study and or purpose of the research; summary of inclusion / exclusion criteria; brief list of procedures involved; time commitment required; compensation/reimbursement; location of research and contact person for further information. http://elpaso.ttuhsc.edu/research/committees/irb/resources/_documents/HRPP%20Manual%20El%20Paso%20October%2024%202016.pdf