General Recruitment Practices and Advertisements
General Recruitment
Recruitment of participants into a study may not begin prior to final 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 continuation. The content of recruitment materials and the method for communicating it cannot contain misleading or exculpatory language or tactics that create undue influence.
Examples of acceptable methods of recruitment include general advertisements in print, radio or televised format, mailings using purchased lists available to the public, class announcements, e-mail listserve, or participation in health fairs. Investigators may re-contact participants from a previous study if the request for permission to re-contact for future studies was part of the consent process in the original study.
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 to individuals not employed by them.
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
Advertisements should contain limited 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 while the rest of the ad is in lower case 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)".
Advertisements cannot incorporate elements that:
- state or imply a certainty of favorable outcome or other benefit beyond what is in the informed consent form;
- For studies on nutritional supplements:
- make claims that the supplement is safe or effective for the purpose under investigation or that it is known to be equivalent or superior to any other supplement;
- use terms such as new treatment or new supplement without identifying it as investigational.
- For FDA-regulated research studies:
- make claims that the drug, device or biologic is safe or effective for the purpose under investigation or that the drug, device or biologic is known to be equivalent or superior to any other drug, device or biologic;
- use terms such as new treatment, new medication or new drug without identifying it as investigational.
If the study involves the use of FDA regulated products (drugs or devices) no claims should be made, either explicitly or implicitly, that the drug or device is safe or effective for the purposes under investigation, or that the drug or device is in any way equivalent or superior to any other drug or device. Such representation would not only be misleading to participants but would also be a violation of the FDA's regulations concerning the promotion of investigational drugs (21 CFR 312.7(a)) and of investigational devices (21 CFR 812(7)).
Advertisements may be reviewed through the expedited review process. The IRB reserves the right to require full board review of any recruitment material.
The IRB must review and approve the final taped version of any radio or TV advertisement. The ad may be granted approval pending amendments based on the script, but the final product must be submitted for additional review and approval to ensure consistency with the language / tone presented in the script. The final approval of taped ads may be granted through the expedited review process by the Chair, Vice Chair or designated experienced IRB member.