Refer to the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans for a complete discussion
Ethical research has at its core a relationship of trust that must exist between the investigator and the research participant. This relationship is put at risk by conflicts of interest (COI) on the part of the investigator. These conflicts have always existed, but the potential for these have increased with the pressures to commercialize research. Some of these areas will be reviewed below, but by necessity will be incomplete. The investigator must disclose all and any real, potential and perceived COI to the REC when a protocol is submitted for review by the committee. Often, an investigator has a COI and is unaware of it, a discussion with the chairman or members of the committee may be of value to the investigator when he or she is unclear about a given situation.
A crude measure of whether or not a COI exists is as follows:
Would the researcher feel comfortable if the information was published on the front page of a major newspaper in Montreal?
The following should be considered:
There are various levels of conflict of interest from the obvious to the not so obvious:
- At one end consider the situation where the investigator is being paid personally and privately for participants enrolled in the study, and where the funds are not handled through a hospital research account, (a theoretical situation that is not permitted by the guidelines). This will of course cloud the judgment of the investigator, and a coercive element would almost naturally enter in the enrollment process. In this situation the COI is so pervasive that even simple disclosure is not acceptable. The researcher will have to abandon the practice in order to conduct the research. The personal gain here is obvious.
- At the other end a financial interest in the sponsoring company may also result in a COI, if this is not fully disclosed to the committee and to the participant. This information must be disclosed to the participant in the Consent Form. If there is disclosure, the COI may be resolved.
The budget for a study must be submitted (in a detailed manner) with the protocol before a project will receive final approval from the committee.
This is in compliance with the Tri- Council guidelines Article 11.11 as noted below:
REBs shall ensure that clinical trial budgets are reviewed to ensure that conflicts of interest are identified and minimized, or otherwise managed.REBs may delegate the review of clinical trial budgets to an appropriate institutional body. The body should ensure financial conflicts of interest are reported to the REB. When no such institutional body exists, the REBs shall review clinical trial budgets for financial conflicts of interest. As a general guide, payments for clinical trial procedures should be no greater than the usual amounts charged by health care providers for the provision of comparable services. Researchers should disclose all kinds and amounts of payment to the REB (see Article 7.4). A particular concern in the context of clinical trials is the use of inappropriate incentives by the sponsor to encourage researchers to recruit participants quickly and without regard to their suitability for the trial. Differential incentives paid for different levels of recruitment, such as higher per-participant payments for those recruited above a set target, may also encourage inappropriate recruitment practices and should be prohibited. The REB can assist the researcher in identifying these and other types of financial conflicts and managing them appropriately (see Article 7.4).
Publication Rights and COI Investigators entering an agreement with a sponsoring drug company MUST have the right of publication. No contracts are allowed that limit these rights. The company may have a manuscript for prior review for a limited period of time for a rebuttal, but not have any veto power over publication
Patients and COI
An investigator enrolling his own patients in a project may be conceived as a potential COI because an element of coercion may be involved. The patient may feel "obliged" to enroll in order to "please" his doctor. Thus, steps must be taken to avoid this situation by having another person discuss enrollment with the patient.
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