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Recruitment and selection of participants must be equitable (fair or just) within the confines of the study. Researchers may not exclude participants on the basis of gender, race, national origin, religion, creed, education, or socioeconomic status. The benefits and burdens of research must be fairly distributed. Research sponsors may offer to pay Investigators or study personnel an additional fee to encourage participant recruitment efforts and the timely or accelerated opening of research studies. These payments are strictly prohibited per California Heath and Safety Code Section 445 and UCI IRB policy. It is impermissible to pay or accept “finder’s fees.” It is impermissible to accept bonus payments. UCI employees or students cannot accept personal payments from sponsors or other researchers in exchange for accelerated recruitment or referrals of patients. Cash or cash-equivalent payment to health care providers for referral of subjects or potential subjects is not permitted. Other types of compensation (e.g., books, other non-cash gifts) are also prohibited. Recruitment Methods The following are examples of common recruitment methods for human research studies. All recruitment methods must be described in the narrative of the IRB protocol and recruitment materials reviewed and approved by the IRB. 1. Use of advertisements, notices, and/or media to recruit subjects. Examples include flyers posted in public settings, newspaper ads, radio and television advertisement. All advertisements and recruitment materials (e.g., video, audio, telephone scripts, and Social Science recruitment form) require prior IRB approval. 2. If posting an advertisement in the UCI BRIEF please note the following to minimize the likelihood that the advertisement will be altered upon publishing: Keep the advertisement to 80-90 words. Avoid second-person references (“you,” etc.), informal language (e.g., asking questions in the text – “Do you suffer from migraines?”), and try to streamline the style as much as possible (titles/departments revised, capitalization, number format, etc.). 3. Direct recruitment of participants unknown to the researchers. Examples include random digit dialing, approaching people in public settings, snowball sampling, use of social networks. 4. 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 accord with the signed consent. 5. Utilize the UCIMC Clinical Trials website or a similar website to post research study information. School of Medicine researchers can post their clinical investigations on the UCIMC Clinical Trials website by following these instructions: a) Complete the "Standard UCIMC Research Recruitment Advertisement." b) Submit the form to the IRB for approval either as part of a new protocol application or with an electronic IRB protocol modification request. c) Once approved, fax the stamped, IRB-approved recruitment form to Kim Pine, Public Relations Manager, at fax number 714-456-5505. 6. 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. 7. Send an IRB-approved letter to colleagues asking for referrals of eligible individuals/patients interested in the study. The research team may provide the referring colleague an IRB-approved Information sheet about the study to give to the individuals/patients. If interested, the individual/patient contacts the Lead Researcher, or with documented permission from the patient (e.g., note in medical record indicates primary care provider spoke with patient who agreed to be contacted), the LR may be allowed to contact patients about enrollment. Note: A partial waiver of HIPAA authorization must be requested from the IRB. 8. Approach own patients, students, employees. This method raises ethical concerns because individuals may have difficulty saying no to an authority figure. For additional information see Vulnerable Populations - UCI Students, Employees, or Faculty. Moreover, in the context of medical care and the physician/patient relationship, there is the possibility of therapeutic misconception. Note: A discussion must be provided in the IRB protocol narrative of what precautions will be taken to avoid undue influence during recruitment. 9. Request a Waiver of Consent/HIPAA Authorization, if applicable for recruitment purposes. In all cases the waivers must be justified in IRB application and protocol narrative. Waivers may be granted under the following circumstances: Examples: a. Minimal risk studies (i.e., Expedited level of review) in which subjects will be not be contacted (e.g., many chart review studies) researchers request a complete waiver of consent/HIPAA authorization, if applicable. Justification for the waiver must be included in the IRB Application. b. Chart review to identify prospective subjects who will then be contacted and asked to participate in the study. Justification for the waiver to review charts must explain why the study cannot be done without the waiver. A partial waiver may be granted to allow collection of only the minimum amount of information needed to make contact; informed consent is obtained before additional information is gathered. c. It is recommended that patients identified through chart review be approached by someone already involved in their care (e.g., treating physician, administrative and research staff working with the physician). d. In some circumstances it may be necessary for members of the research team who are not involved in the patient's care to make the approach, either in person or by phone or letter. The application should explain why the study cannot be done unless the researchers approach subjects directly. Direct approach by someone not involved in the patient's care is unusual but may be approved only under exceptional circumstances (e.g., emergency care research). e. Large-scale epidemiological studies and other population-based studies may need to identify subjects through registries, medical records in multiple institutions, or other sources. The researchers may need to contact prospective subjects directly rather than through professionals involved in the prospective subjects' health care. This approach involves a greater invasion of privacy than other methods, because researchers without approval from patients gather significant personal health information about the patients, and then contact the patients directly. Justification in the application must explain in detail why it is impossible to do the study unless the IRB grants (1) a partial waiver of informed consent/ HIPAA authorization to obtain subjects' identities and (2) allows researchers to contact subjects directly. Written informed consent and HIPAA authorization is required before additional information is gathered and/or research procedures are initiated. Important Note: If a prospective subject refuses to participate, no identifiable information may be kept about the individual unless s/he consents to allow retention of this information. The protocol narrative should include a description of this consent process. With IRB approval, non-identifying information about those who refuse to participate may be retained/collected; otherwise all information obtained from charts, records, registries must be destroyed.

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