All advertising material must be reviewed and approved by the Research Ethics Board (REB) prior to implementation. Advertisements may be reviewed through delegated review procedures. The REB will review the information contained in the advertisement and the mode of its communication ((e.g. posters, TV or radio, internet, social media, etc.) to ensure that the procedure for recruiting participants is not coercive and does not state or imply a certainty of favourable outcome or other benefits beyond what is outlined in the consent document and the protocol.
When advertisements are to be taped for broadcast, the REB may either review the final audio/video tape or alternatively, the REB may review the wording of the advertisement prior to taping to preclude re-taping because of inappropriate content.Content of the Advertisements
No claims should be made, either explicitly or implicitly, that a drug, biologic 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 drug, biologic or device. Such representation would be misleading to subjects and would involve promotion of investigational drugs and/or investigational devices.
Advertising for recruitment into investigational drug, biologic or device studies 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 study subjects 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.
The payment should accrue as the study progresses and should not be contingent upon the participants completing the entire study. Payment of a small proportion as an incentive for completion of the study is acceptable, providing that such an incentive is not coercive. The REB will ensure that the amount paid is reasonable and not so large as to unduly coerce participants to stay in the study when they would otherwise have withdrawn.
The amount and schedule of all payments should be presented to the Research Ethics Board (REB) with the initial submission. The REB will review both the amount of payment and the proposed method and timing of disbursement to ensure that neither is coercive or presents undue influence.
All information concerning payment, including the amount and schedule of payment should be clearly explained in the in the REB Submission Form and informed consent form.
In controlled studies, payment to participants should be equal, irrespective of the treatment arm and irrespective of whether they are patients or "normal" (healthy) control 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 (for instance 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 studies; however, compensation can improve participation rates.
TCPS2 reminds us “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 to the Research Ethics Board in the initial application or any amendments 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 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 trial 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 study. 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 legal issues pertaining to lotteries which 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 given when recruiting participants 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, the University of Manitoba 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 REB submission form. The informed consent/consent disclosure, when applicable, as outlined above, must also indicate to participants that a skill testing questions is required when the value of the prize is $50 or greater.
Example of skill testing text problem:
“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, then please answer the following question. (Write your answer in the blank space provided.) Sample mathematical problem- create your own: (13 + 17) divide 10 = ____. “
The REB collects and reviews all study budgets to ensure that funds are allocated in an ethical manner. Payment to researchers, for research that is sponsored by the private sector, should not be so high as to seem coercive. For research funded by the private sector, granting agencies or other organizations the consent form should contain the following (or similar) disclosure to the research participants: The study doctor (and or/ institution) is (are) receiving professional fees and financial support from (name of sponsor/funder) to conduct this study”.
Detailed, itemized financial disclosure in the consent form is not necessary, unless the participant requests it.
Recruitment Bonuses paid to investigators
Awarding or accepting 'Recruitment Bonuses' for the recruitment of a certain number of participants or for the recruitment of participants within a certain period of time is unethical.Offer and Acceptance of Finders' Fees for the Recruitment of Research Subjects
The offer or acceptance of a finder's fee is prohibited (where finders' fees are defined as money or other personal rewards provided to faculty members, trainees or any other individuals simply to identify potential participants for a study).
Compensation to the referring professional may be acceptable when additional duties such as reviewing the clinical protocol and conducting a general eligibility screening are required. The recruit must have provided informed consent for the general eligibility screening to proceed. Compensation to the referee must be disclosed in the informed consent form. Compensation must not be contingent upon the participants acceptance into the protocol, agreement to participate, or completion of the protocol. The REB will consider as nominal compensation that is felt to be reasonable for the time and effort expended by the referring professional.
Researchers affiliated with both the NRC and the University of Manitoba need to submit their research proposals to and receive approval from the Research Ethics Board (REB) of the NRC and a REB of the University of Manitoba prior to initiating the research. The REBs at both institutions operate in compliance with the Tri-Council Policy Statement of Canada (August 1998), the Personal Health Information Act of Manitoba and other applicable national and international regulatory guidelines. This policy has been developed by the NRC REB and the two REBs at the Bannatyne Campus, University of Manitoba in an effort to streamline the ethics review process. (The REB's at the Bannatyne Campus are the Health REB and the Biomedical REB). This policy will be effective starting July 2000.
The Research Ethics Boards at the Bannatyne Campus will conduct an "delegated review" of new research proposals (or amendments to approved proposals) that have been approved by the NRC REB where the following circumstances apply:
The submission for "expedited review" to the University REB must include single copies of the following documents:
The REB at the Bannatyne Campus will maintain a file on each study. If there are concerns about the research proposal or subsequent amendments to it, the Chair of the University REB has the authority to request full board review. The University REB should be updated on all amendments to study procedures or documents, including approval from the NRC REB for such amendments. Both REBs need to be notified of any Serious Adverse Events. The researchers must submit annual study status reports to both REBs for annual renewal of approval. For both REBs, this can be done using the NRC's Annual Study Status Report format.
Where the research involves greater than minimal risk to research participants (e.g. administration of drugs, invasive procedures, or based on the opinion of the REB Chair) the investigator must submit to both the NRC REB and University of Manitoba REB for full board review.
Minutes will be recorded at each REB meeting and the minutes will be approved (or revised as required) at the subsequent meeting. When individuals or organizations request to review the minutes, they will be given access to the sections that pertain to their protocol(s) only, in order to maintain confidentiality. The minutes will include the following information:General information: