Advertisements and recruitment material are considered an extension of the informed consent and participant selection process. As such, recruitment of participants into a study may not begin prior to IRB approval. The IRB must approve all recruitment methods and material (flyers, letters, brochures, e-mail advertisements, radio announcements, etc.) prior to use. Materials must also be submitted for review and re-approval at the time of continuing review. The content of recruitment materials and the method for communicating it cannot create undue influence or contain misleading or exculpatory language.
The following are examples of common recruitment methods for human research studies. All recruitment methods must be described in the protocol application.
- Use advertisements, notices, and/or media to recruit subjects. Examples include flyers posted in public settings, newspaper ads, and radio and television advertisements.
- Direct recruitment of participants unknown to the researchers. Examples include random digit dialing, approaching people in public settings, snowball sampling, use of social networks, and Craigslist.
- Maintain a separate IRB-approved recruitment protocol to develop a database of potential participants (preparatory to research). The participants/patients provide consent ahead of time to be contacted for future research studies. Researchers contact patients about participation in IRB-approved studies in accordance with the signed consent.
- Provide colleagues with an IRB-approved Introduction letter describing the study. This letter would explain the purpose and procedures of the study and inform individuals how to contact the research team. Researchers are prohibited from having access to participant/patient names, addresses, or phone numbers; interested individuals must initiate contact.
- Send an IRB-approved letter to certain individuals asking for referrals of eligible participants interested in the study. The researchers may provide the referring individual with IRB-approved recruitment material for the study to give to potential participants. If interested, the participant contacts the researchers for additional information.
- Approach your own students or employees. This method raises ethical concerns because individuals may have difficulty saying no to an authority figure. For strategies to minimize undue influence, refer to the IRB policies and procedures regarding Review of Studies Involving Vulnerable Populations.
For studies that involve recruitment of patients from a medical practice or other treatment facility, it is not acceptable for investigators not affiliated with that practice or facility to directly recruit patients. The initial contact must be initiated by the physician or an employee of the practice or facility. Recruitment can take the form of a flyer posted in the waiting area or handed to potential participants by a physician or employee of the practice or facility. Due to HIPAA regulations, medical practices or treatment facilities may not give out telephone numbers or addresses of their patients.
If applicable to the study design, or required by a funding agency, the PI is responsible for tracking the ethnicity or race of participants who are recruited into studies. In such cases, investigators should ask participants to self-identify at the time of consent.
Advertisements should contain information that provides enough detail to allow the prospective participant to determine his/her eligibility and interest. Visual effects that may create undue influence cannot be used, for example, placing the phrase “GET PAID $100!!!” in all capital letters or an extra large font while the rest of the ad is in lower case or a smaller font is not acceptable.
Generally, the elements of any advertisement to recruit participants should be limited to the following:
- the name of the PI and UConn Storrs department affiliation;
- an accurate description of the condition under study and/or the research purpose, e.g., “low fat vs. low carb diets for weight loss,” or “acculturation of Cuban immigrants;”
- in summary form, the key eligibility criteria that will be used to admit (or exclude) participants into the study, e.g., acceptable age range or unacceptable physical limitations;
- a straightforward and truthful description of the benefits, if any, to the participant from participating in the study, e.g., “free health screening;”
- if applicable, a statement that compensation is available or a statement of how much compensation is available, e.g., “Participants may receive up to $100;”
- the amount / length of time or other commitment required of the participants;
- the location of the research and contact information for obtaining additional information.
Advertisements must display the IRB validation stamp, unless an exception has been granted by the IRB. If it is not feasible to make copies of the validated version, it is acceptable to use the exact wording of the validation stamp: “UConn IRB, Approval On (date), Approved until (date), Approved by (initials).”
Recruitment information sent by email to listservs, Craigslist, etc. must include the following statement, “This research study was approved by the UConn IRB, Protocol # __________.”
Advertisements cannot incorporate elements that:
- state or imply a certainty of favorable outcome or other benefit beyond what is in the informed consent form;
- Use catchy words like “free” or “exciting.”
- For FDA regulated research studies (new drugs/devices) or studies on nutritional supplements:
- make claims that the supplement, drug, device or biologic is safe or effective for the purpose under investigation or that the supplement, drug, device or biologic is known to be equivalent or superior to any other supplement drug, device or biologic;
- use terms such as “new treatment,” “new supplement” or “new medication” without identifying it as investigational.
Refer to the FDA’s regulations concerning the promotion of investigational drugs (21 CFR 312.7(a)) and of investigational devices (21 CFR 812(7)) for additional information.
Recruitment/Advertising Tips and Suggestions
- Understand the target population. What media does the population read or view? Where do they go for information?
- Make concerted efforts to recruit participants from minority and under-represented groups. Describe those efforts in the protocol application.
- Spend the time to make the recruitment flyers easy to read and understand. Advertisements must be written using lay language, at an 8th grade reading level (similar to the level used popular magazines and newspapers) that is appropriate for the participant population. You should select a font style and size that is easy to read such as Times Roman , Arial, or Garamond.
A sample, recruitment flyer template is available for your reference.
Source material for this policy guidance was provided by the University of California – Irvine IRB. The UConn IRB gratefully acknowledges this support.