To the Editor:
We read with interest the article coauthored by Ms. Tracey Tremayne-Lloyd and Dr. Gary Srebrolow, Research ethics approval for human and animal experimentation: Consequences of failing to obtain approval – including legal and professional liability 2007; 51(1):56–60.
The article contained many valid points, and highlighted the importance of practitioners obtaining free and informed consent in health research.
We wish to draw attention to several points made in the article.
The authors state “REB reviews are generally only conducted where the test will be funded by an organization that requires ethics review.” They then suggest that “If an investigator is able to fund research by alternative means, it is possible to avoid a REB review altogether.”
The first statement is misleading. While ethics review may be required by some funding agencies and not others, such reviews are a mandatory component of the research process at most public institutions (e.g., universities, medical institutions) where the research will be carried out. It is the nature of the research, and not the source of funding, that mandates ethics review. Indeed, research not requiring funding may still need to undergo ethics review. Consistent with the Tri-Council Policy Statement, such institutions require that all research protocols involving humans undergo review and approval by an REB before they are initiated. Furthermore, privacy legislation in many provinces requires that researchers who want to use clinical information for research purposes obtain the consent of their patients or request a waiver of consent from an appropriately constituted REB.
The second statement in this paragraph suggesting that researchers can take steps to avoid REB review altogether is very worrisome. REBs exist to ensure scientific research is held to a high ethical standard and respect for human dignity is maintained. Peer review of the ethical integrity of research protocols is a safeguard that serves to protect dignity and rights of research subjects and should not be viewed as a burden or impediment to the conduct of research. Chiropractic researchers have a fiduciary relationship to their clients as research subjects and, as members of the scholarly community, have a responsibility to foster integrity in research. These obligations demand a commitment to ethical research practice that should encourage REB review.
REBs operate to protect the interests of institutions that support the research, in addition to protecting the interests of human research subjects. Although, as described by the authors, the disciplinary power of REBs is typically limited to financial recourse, allegations of ethical misconduct, or failure to obtain ethics approval, may be referred for management under an institution’s provisions for academic or professional misconduct. Individuals may face direct sanctions ranging from reprimand through to termination of employment.
Finally, the authors outline numerous avenues that researchers may face liability. Submission of research protocols to an REB for review provides a means of catching potential ethical transgressions before they become a liability.
Respectfully submitted,