Subject Enrollment

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Subject Selection

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.

2018 Common Rule Changes: Screening, Recruiting or Determining Eligibility

The IRB may approve a research proposal in which an investigator will obtain information or biospecimens for the purpose of screening, recruiting, or determining the eligibility of prospective subjects without the informed consent of the prospective subject or the subject's legally authorized representative, if either of the following conditions are met:

(1) The investigator will obtain information through oral or written communication with the prospective subject or legally authorized representative, or
(2) The investigator will obtain identifiable private information or identifiable biospecimens by accessing records or stored identifiable biospecimens.

At UCI, the following recruitment guidelines are required to meet this exception:

i. Privacy: The recruitment script / material must address the case where someone other than the potential subject receives the communication. Researchers should be mindful of privacy considerations (i.e., do not disclose any private information – such as a patient diagnosis). Limit phone contact / messages to no more than 5 attempts.
ii. Expertise: Researchers contacting potential subject must be knowledgeable and able to answer questions related to the screening and the main study.
iii. Specific Information: Researchers must include a description of the information and/or biospecimens that will be obtained for the purpose of screening, recruiting, or determining eligibility and the reasons for performing the screening tests.
iv. Confidentiality: Researchers must include a statement that informs the potential subject that if they are not eligible to participate in the study that the identifiable information and / or biospecimens will not be used for research purposes and will be destroyed at the earliest opportunity consistent with conduct of the research.

Recruitment Methods

The following are examples of common recruitment methods for human research studies. All recruitment methods must be described in the IRB Application 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. Direct recruitment of participants unknown to the researchers. Examples include random digit dialing, approaching people in public settings, snowball sampling, use of social networks.
  1. 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.
  2. 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.
  3. 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.
  4. Request a Waiver of Consent/HIPAA Authorization, if applicable for recruitment purposes. Waivers may be granted under the following circumstances:

    1. 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.
    2. 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.
    3. 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 IRB 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.
    4. 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 IRB 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.

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 advertisement and recruitment materials require IRB review and approval.

Generally, such materials are included with the original IRB 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 Amendment.

Recruitment materials are reviewed by the IRB to ensure that:

  1. They are neither misleading nor coercive to potential subjects.
  2. They do not contain exculpatory language.
  3. 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.
  4. If the study involves an 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.
  5. They do not include claims, either explicitly or implicitly, about the drug, biologic, or device under investigation that are inconsistent with FDA labeling.
  6. 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.
  7. They do not include an emphasis of payment or the amount to be paid, by such means as larger or bold type.
  8. 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.
  9. When research is funded by the Department of Defense and involves U.S. military personnel, policies and procedures include additional protections for military research participants.
  10. Department of Justice Regulations and Guidance has additional requirements for research conducted within the Bureau of Prisons.
  11. When lotteries, raffles, and/or drawings are used to recruit or retain participants, they include:
    1. That research participation is not required to be eligible for the lottery, raffle, and/or drawing;
    2. That winning a prize is not guaranteed; and
    3. The approximate chance of winning (e.g., no less than 1 in 1000).

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:

  1. The name of the institution (University of California Irvine or University of California Irvine Medical Center), the name of the Department or Division;
  2. The name of the Lead Researcher (and faculty sponsor, when applicable), and the name of a contact person with an email address and/or telephone number (including area code) to call for information about the study;
  3. 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.);
  4. A straightforward, truthful description of the benefits, if any; and
  5. 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.)
  6. If monetary compensation is offered, it must not be presented as an inducement to participate.

Submission and Approval

If not included with the original protocol submission, a copy of the advertising or recruitment materials should be included in an Amendment. Various templates are available here: IRB Forms → Recruitment Templates.

When approved, the documents will be stamped as approved and dated (in a manner similar to consent forms) and returned to the investigator.

Recruitment Material Master Template - Exempt/Expedited Research Only

The Recruitment Material Master Template may be used for Exempt & Expedited research not regulated by the FDA. When the template is utilized, researchers provide the IRB with a summary of recruitment methods, key information, scripts, fonts, & media that may be utilized across a range of possible recruitment documents. If approved by the IRB, researchers may then generate as many variations of recruitment materials as needed without further submission to the IRB as long as they are restricted to the contents outlined within the master template & adhere to the requirements of UCI HRP Policy 22.

When approved, the master template will be stamped as approved and dated (in a manner similar to consent forms) and returned to the investigator. The IRB will stamp will not review or stamp any final versions of recruitment materials generated from the approved master template. It is the investigators responsibility to maintain copies of any recruitment material generated from the content of an approved master template.

Changes to Recruitment Materials

For most research, any subsequent changes in the content of an approved advertisement must also be submitted for IRB review and approval prior to use.

Exceptions - the following types of changes do not require submission to the IRB for review & approval:

  • For exempt research only, editorial corrections or adding a new recruitment material. Please see the following Protocol Amendments webpage for more details.
  • For exempt or expedited research utilizing the Recruitment Material Master Template, changes to to the template that do not require changes the approved protocol (i.e., contact information).

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 Application 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.

Completion Bonus

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 an Amendment 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 you, including your name, address, and social security number, will be released to the Accounting Office for the purpose of payment."

Note: Studies that involve payment for time and effort of $600 or more in a year should also include the phrase: "...and for tax reporting to the Internal Revenue Service (IRS)."

Lotteries, Raffles, and Drawings

According to the California Department of Consumer Affairs, “California law prohibits lotteries. A lottery is any scheme for the disposition of property by chance among persons who have paid or promised to pay any value for the chance of obtaining the property, with the understanding that it will be disposed of by chance.” (There are three exemptions to this prohibition including the California State Lottery, bingo for charitable purposes and a raffle conducted by a non-profit, tax-exempt organization for charitable purposes.)

Courts have used certain rules to decide whether a scheme includes consideration because it is not always clear. If a person is eligible to win a prize without purchase, there is no consideration and the contest is legal.  If some people may pay money - for example, an admission charge or buy a product - there is not necessarily consideration if others may enter the contest without such a purchase. If eligibility to win a prize is limited to those who have paid money, however, there is consideration and the contest is not legal.

Consideration in the context of research applies when subject compensation is a lottery or raffle to win a prize (e.g., gift certificate, iPad, etc.).  If eligibility to win a prize is limited to those who participate in the research there is consideration therefore the contest is not legal.

The IRB will determine whether lotteries, raffles, and/or drawings may be used to recruit or retain participants. In order for the IRB to consider approving the use of lotteries, raffles, and/or drawings, the following must be considered:

  1. The study involves minimal risk to participants (Exempt or Expedited).
  2. The prize is less than $600 and will not to unduly influence participation in the research.
  3. The Subject Compensation Section of the Protocol Narrative must include the following:
    1. Procedures to ensure that any individual who is asked to participate in the research study but declines, who consents/assents to enroll in the study, or who fails to complete the study, will be given equal compensation by having an equal chance of winning. In other words, if an individual is eligible to participate in the study, and therefore the lottery, raffle and/or drawing, they are not required to participate in the study to be eligible to participate in the lottery, raffle, and/or drawing;
    2. Procedures for the inclusion of an individual who is not asked to participate in the study but wishes to be included in the lottery, raffle, and/or drawing;
    3. A fair method of choosing the winner and how the winner will be notified; and
    4. Disclosure of the approximate chance of winning (e.g., no less than 1 in 1000) in the consent/assent.

This information, along with specifically informing individuals that they are not guaranteed to win any prize in the drawing and that the only compensation they will receive is the “1 in X” chance of winning, must be provided in the consent/assent as well as to those who wish to participate in the lottery but not the research study.