Recruitment and advertising
Recruitment of study subjects
Recruitment is considered the start of the informed consent process. Direct advertising for research subjects, such as advertising intended to be seen or heard by prospective subjects to solicit their participation in the study, must be reviewed and approved by the IRB.
Materials should reflect that the project is research and explain the purpose, procedures, and time commitment. Materials must be clear, concise, and in language that does not influence a subject’s participation.
NOTE: FDA guidance states that the following are not included as the direct recruitment of study subjects:
- Communications intended to be seen or heard by health professionals, such as doctor- to-doctor letters.
- News stories not intended to target recruitment of study subjects
- Publicity intended for other audiences, such as financial page advertisements director toward prospective investors
Requirements
- All recruitment materials and the mode of communication in their final form that directly target subjects must be approved by the IRB before implementation (e.g. oral scripts, newspaper, radio, TV, bulletin boards, posters, and flyers)
- The amount of compensation may be listed in recruitment materials so long as the amount is not overly emphasized
- Northern Arizona University prohibits “finder’s fees” (payments to professionals in exchange for referrals of potential subjects) and “bonus payments” (payments designed to accelerate recruitment that were tied to the rate or timing of enrollment)
- The IRB generally prohibits ‘cold-calling’ of research subjects for participation in studies. Examples of acceptable contact include:
- Subjects can directly contact a researcher from contact information displayed on an advertisement
- Subjects can be contacted via snowball method of recruitment. In this scenario, subjects agree to have their name forwarded to a researcher by someone they know (e.g. treating physician or friend forwards subject name Recruitment and Advertising HRPP Office Use Only PI Eligibility v2019-8 Page 2 of 3 to researcher after a subject has said it was OK)
- Direct targeted recruitment of subjects can occur when the method and form are IRB approved (e.g. recruitment of students in a classroom)
Advertising for clinical trials over the internet
Approval of clinical trials on the internet is NOT required in certain instances when the system format limits the information provided to basic trial information. Examples of such sites include: ClinicalTrials.gov, National Cancer Institute clinical trial listing, University of Arizona clinical trial listing, and government-sponsored AIDS clinical trials information services. The information posted must be limited to:
- Title
- Purpose of the study
- Protocol summary
- Basic eligibility criteria
- Study site location(s)
- How to contact the site for further information
Although approval of the language provided in the listing service may not be required, as with all recruitment methods, if the listing is intended for recruitment purposes, the use should be identified in the protocol/application as such.
When the opportunity to add additional descriptive information is not precluded by the database system, HRSP review and approval is required to assure that any additional information does not promise or imply a certainty of cure or other benefit beyond what is contained in the protocol and the consent document. Similarly, any other type of recruiting completed via websites, web postings or the use of social media must be submitted for HRSP review and approval.
Advertisements
Advertisements used to recruit study subjects should state only the information needed for prospective participants to determine their interest and eligibility. The following items may be included in the advertisements
- The name and address of the investigator and/or research facility
- The condition under study and/or the purpose of the research
- A summary of the criteria that will be used to determine eligibility for the study
- A brief list of participation benefits, if any (e.g., a no-cost health examination)
- The time or other commitment required of the subjects 6. The location of the research and the person or office to contact for further information
Do
- Use the term ‘research’ or a synonym when describing the study
- Use the term ‘investigational’ or a synonym when describing the study
- Submit final scripts or recordings for IRB review and approval prior to use or broadcast
Do Not
- Use language or graphics that can be coercive or misleading
- State or imply a guarantee of benefits, cures, or favorable outcomes
- Use terms such as ‘new treatment,’ ‘new medication,’ or ‘new drug’ without explaining the test article is investigational
- Emphasize ‘free’ treatment or study products
- Claim the study product or procedure is safe, effective, equivalent, or superior to other options
- Place emphasis on payment
- Advertise or place materials in a ‘job section’ of Craigslist or other similar website
Recruitment and future contact databases
Frequently researchers want to keep a list of contact information on potential subjects to contact about future research projects. These databases do NOT require IRB review if:
- The potential subject has freely given their contact information to you for purposes of being put into a contact database about future research opportunities,
- The database will be used only for contacting subjects, and
- No additional information will be obtained from the medical record of the potential subject to include in the database.
Databases that are considered repositories or will be analyzed for research purposes require IRB approval.
NOTE: If the database access PHI from a medical record, the signed Authorization of the subject is required before the information may be put into the database. Additional paperwork is required. Please contact HRSP or the HIPAA Privacy Program.
Version 2019-8