Advertising and Payments for Project Participants
Advertising for Project Participants
All advertising material must be reviewed and approved by CHIPER prior to implementation.
CHIPER will review the information contained in the advertisement and the mode of its communication, such as posters, TV or radio ads, social media posts, to ensure that the procedure for recruiting participants is not coercive and does not state or imply a certainty of a favorable outcome or other benefits beyond what is outlined in the consent document and the protocol, if applicable.
When advertisements are to be taped for broadcast, CHIPER may either review the final audio or video tape or alternatively, CHIPER may review the wording of the advertisement prior to taping to preclude re-taping because of inappropriate content.
Content of Advertisements
No claims should be made, either explicitly or implicitly, that any investigational product or device is safe or effective for the purposes under investigation, or that the test article is known to be equivalent or superior to any other product or device. Such representation would be misleading to participants and would involve promotion of investigational products or devices.
Advertising for recruitment into investigational product or device projects should not use terms such as “new treatment,” “new medication” or “new drug” without explaining that the test article is investigational. A phrase such as “receive new treatments” implies that all project participants will be receiving newly marketed products of proven worth.
Advertisements should not promise “free medical treatment” or “free medication” when the intent is only to say participants will not be charged for taking part in the investigation.
Advertisements may state that the participants will be paid but should not emphasize the payment or the amount to be paid.
Payment to Project Participants
Payment to participants for participation in research projects should not be considered a benefit. It is a method for compensating research participants for out-of-pocket expenses, such as parking or meals, and/or lost wages as a result of time spent on the project. Payment to participants should not constitute “undue inducement” by leading to an increase in voluntariness or a decrease in the understanding with which participants agree to participate.
The payment should accrue as the project progresses and should not be contingent upon the participants completing the entire project. Payment of a small proportion as an incentive for completion of the project is acceptable, providing that such an incentive is not coercive. CHIPER will ensure that the amount paid is reasonable and not so large as to unduly coerce participants to stay in the project when they would otherwise have withdrawn.
The amount and schedule of all payments should be detailed in the Harmony Health Research Application, and this should match with the information in the informed consent form, if applicable. CHIPER will review both the amount of payment and the proposed method and timing of disbursement to ensure that neither is coercive nor presents undue influence.
In projects with controlled groups, payment to participants should be equal, irrespective of whether they are interventional or control group participants.
Gifts and Incentives
“Incentives” or “compensation,” include anything offered to participants, monetary or otherwise, to encourage participation in research. This is distinct from reimbursing participants for minor incidental expenses they incur by participating in the research, such as transportation costs or parking, which is not problematic from an ethics perspective. It should not be assumed that people must be compensated in order to participate in research projects; however, compensation can improve participation rates.
TCPS 2 Article 3.1 reminds us that “because incentives are used to encourage participation in a research project, they are an important consideration in assessing voluntariness. Where incentives are offered to participants, they should not be so large or attractive as to encourage reckless disregard of risks. “
To ensure voluntariness of consent is not compromised, the researcher must justify in their Harmony application the particular mode and level of incentive.
The researcher should consider applicable issues such as economic circumstances of those in the pool of prospective participants, the age and decision-making capacity of participants, the customs and practices of the community, and the magnitude and probability of harms that may affect the voluntariness of consent in their project.
TCPS 2 Article 3.1 also states “Guardians and authorized third parties should not receive incentives for arranging the involvement in research of the individual they represent. However, they may accept reasonable incentives or compensation on behalf of that individual, as long as these are suitable to the circumstances.”
Items that are directly related to the procedures in the project may be given to the participants. For example, pens may be given where participants are required to complete diary cards, and medical aids, such as breast self-exam cards, may be given if relevant to the project. Only items that cannot be perceived as being “unduly coercive” may be given to participants.
Use of Lotteries as an Incentive
Some researchers may wish to compensate participants using a draw or lottery—defined as a chance to win a substantial prize—instead of or in addition to giving every participant a smaller prize.
There are federal regulations pertaining to lotteries that must be taken into account if this method is used. For example, a lottery must not require participants to pay money or other valuable consideration in order to participate. The probability of winning the prize should be described as part of informed consent. In addition, winning the lottery must be based on skill as well as chance. Thus, many lotteries require the participants to answer a skill-testing question in order to qualify for a chance to win the prize.
As a guide for researchers who choose to use this method, CHIPER will require that prizes with a value of $50 or greater have the participant answer a skill-testing question to qualify to win the prize.
Researchers must outline the odds of winning in both the informed consent form/consent disclosure and the Harmony application. The informed consent/consent disclosure, when applicable, as outlined above, must also indicate to participants that a skill testing question is required when the value of the prize is $50 or greater.
Example of skill testing problem text:
“By participating, you are eligible to win a (insert prize). Under federal law, it is necessary that you answer a skill-testing question correctly in order to qualify for a chance to win the prize. If you wish to be considered for this prize, please answer the following question. (Write your answer in the blank space provided.) Sample mathematical problem (create your own): (13 + 17) divided by 10 = ____. “