Subject Selection, Recruitment and Compensation
- Subject Selection
- Recruitment Methods
- Advertisements/Recruitment Materials Requirements
- Payments to Participants
Recruitment and selection of participants must be equitable 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.
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.
Equitable - fair or just; used in the context of selection of participants to indicate that the benefits and burdens of research are fairly distributed.
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.
- 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.
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.).
- Direct recruitment of participants unknown to the researchers. Examples include random digit dialing, approaching people in public settings, snowball sampling, use of social networks.
- 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.
- 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:
- Complete the "Standard UCIMC Research Recruitment Advertisement."
- Submit the form to the IRB for approval either as part of a new protocol application or with an electronic IRB protocol modification request.
- Once approved, fax the stamped, IRB-approved recruitment form to Kim Pine, Public Relations Manager, at fax number 714-456-5505.
- 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 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.
Approach own patients, students, employees. This method raises ethical concerns because individuals may have difficulty saying no to an authority figure. To protect against even the appearance of undue influence or coercion, UCI researchers may not actively recruit participants from within their own department or classroom. See for additional under 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.
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:
- 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.
- 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.
- 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).
- 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).
- 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.
Advertisements and Recruitment Materials Requirements
Advertisements and recruitment materials for human research subjects (posters, flyers, newspaper/magazine ads, scripts for radio/TV, electronic mail, or solicitations from outside sources) are considered an extension of the informed consent and subject selection processes. Accordingly, final versions of all advertisment and recruitment materials require IRB review and approval.
Generally, such materials are included with the original application as part of the overall recruitment plan. Advertisements may also be submitted for approval at any time following approval of the human research study by submitting an electronic Modification request (e-MOD).
Recruitment materials are reviewed by the IRB to ensure that:
- They are neither misleading nor coercive to potential subjects.
- They do not contain exculpatory language.
- They make no claims either explicitly or implicitly that might lead a subject to believe that an investigational/experimental treatment is proven safe and effective and/or equivalent or superior to other treatments.
- If the study involves investigational drug, biologic or device, the advertisement does not use terms such as "new treatment," "new medication" or "new drug" without explaining that the test article is investigational. Phrases such as "receive new treatments" or "receive new therapy" mislead study subjects to believe they will be receiving newly improved products of proven benefit.
- They do not include claims, either explicitly or implicitly, about the drug, biologic, or device under investigation that are inconsistent with FDA labelling.
- They do not allow compensation for participation in a trial offered by a Sponsor to include a coupon good for a discount on the purchase price of the product once it has been approved for marketing.
- They do not include an emphasis of payment or the amount to be paid, by such means as larger or bold type.
- They do not promise "free medical treatment," when the intent is only to state that subjects will not be charged for taking part in the study.
- When research is funded by the Department of Defence and involves U.S. military personnel, policies and procedures include additional protections for military research participants.
- Department of Justice Regulations and Guidance has additional requirements for research conducted within the Bureau of Prisons.
Refer to the Human Research Protections Standard Operating Policies and Procedures for specific guidance regarding the above, including additional requirements or contact Human Research Protections Staff for more information regarding advertisement, recruitment and compensation.
All Recruitment Materials Should Contain, at Least, the Following Information:
- The name of the institution (University of California Irvine or University of California Irvine Medical Center), the name of the Department or Division, the name of the Lead Researcher (and faculty sponsor, when applicable), and the name of a contact person with a telephone number (including area code) to call for information about the study;
- The purpose of the research and, in summary form, the eligibility criteria that will be used to admit subjects into the study (e.g., adults on medication for high blood pressure, diabetic patients on insulin; normal, healthy adults; etc.);
- A straightforward, truthful description of the benefits, if any; and
- The location of the research and time commitment, if appropriate (e.g., subjects will have to come to the UCI campus on 4 separate occasions; the research will take 2 hours on one day, etc.)
If monetary compensation is offered, it must not be presented as an inducement to participate. For example:
Acceptable: Subjects will be financially compensated for their participation; subjects will receive $5.00 for each blood sample; subjects will receive a free physical examination and blood tests.
Unacceptable: EARN $500! Get FREE medical care!
Submission and Approval
If not included with the original protocol submission, a copy of the advertising or recruitment materials should be uploaded to an e-MOD request. When approved, the documents will be stamped as approved and dated (in a manner similar to consent forms) and returned to the investigator. One copy will be placed in the IRB protocol file.
Changes to Recruitment Materials
Any subsequent changes in the content of an approved advertisement must also be submitted for IRB review and approval prior to use.
Occasionally, newspapers or magazines may alter copy to fit available space. Therefore, when submitting an advertisement to a newspaper or magazine, a cover letter should be included stating that the text has institutional approval and cannot be altered.
Payments to Participants
Payment to research participants for participation in studies is not considered a benefit. Rather, it should be considered compensation for time and inconvenience or a recruitment incentive. The amount and schedule of all payments should be described in the IRB protocol at the time of initial review, including a summary of both the amount of payment and the proposed method and timing of disbursement to assure that neither are coercive or present undue influence. Procedures for prorating payment should the participant withdraw should be included in the IRB application and informed consent document(s).
Timing of Payments
Credit for payment should accrue as the study progresses and not be contingent upon the participant completing the entire study. Unless it creates undue inconvenience or a coercive practice, payment to participants who withdraw from the study may be paid at the time the study would have been completed had they not withdrawn. For example, in a study lasting only a few days, it would be permissible to allow a single payment date at the end of the study, even to participants who withdraw before completion. However, for a study lasting several months, it would not be permissible to allow a single payment date. Participants who withdraw before completion of the study should receive accrued compensation in a timely manner.
While the entire payment should not be contingent upon completion of the entire study, payment of a small proportion as an incentive for completion is acceptable, providing that such incentive is not coercive. The IRB will determine whether the amount paid as a bonus for completion is reasonable and not so large as to unduly induce participants to stay in the study when they would otherwise have withdrawn.
Disclosure of Payments
All information concerning payment, including the amount and schedule of payment(s), should be described in the informed consent document.
Alterations in Payments
Any changes in participant compensation or flexibility of the payment schedule must be reported to the IRB as a modification prior to implementation.
Payment Methods and Fund Management
Payments to research participants must be in accordance with the UCI Accounting policy and procedures for payments to research subjects. The policy includes various methods of payment, options for fund management and other requirements for compensation and reimbursement of research participants.
Reporting Payments to the IRS
The Internal Revenue Service (IRS) requires that UCI (or whomever is paying the participants for their participation) report payments in excess of $600 per calendar year on Form 1099-Misc. The filing of these forms necessitate that the name and social security number of the participant be collected and released to the Office of Accounting to process the Form 1099-Misc. The collection and release of this information must be addressed thoroughly in the informed consent document so that it is clear to the participant that his or her identity will be released for the purpose of payment and reporting.
When the identity of the subject will be released to the Accounting Office for payment, the following information should be included in the informed consent:
"Personal information about me, including my name, address, and social security number, will be released to the Accounting Office for the purpose of payment."
Note: studies that involve a reimbursement of $600 or more in a year should also include:
"...and for tax reporting to the Internal Revenue Service (IRS)."