By Nerilee Hing, Helen Breen, Ashley Gordon
Objective: This paper details how we, as ‘cultural outsiders’, conducted a large gambling survey in an Indigenous Australian community that adhered to Indigenous ethical protocols and values while differing from some standard survey practices. Approach: The paper summarises the ethical guidelines for onducting Indigenous public health research. It describes research processes used in the study in eight generic steps identified in Keeping Research on Track: A Guide for Aboriginal and Torres Strait Islander Peoples About Health Research Ethics.1. It explains how adherence to these guidelines contributed to successful project completion.
Conclusion: The research processes used to conduct this project gave explicit recognition and commitment to respecting Indigenous cultural values and principles. It engaged the Indigenous community in ways that promoted its ownership of the research issue, ensured the validity and reliability of the research data and unearthed potential solutions to problems identified.
Implications: By sharing our experiences in attempting to conduct research that respected these values and principles, we have contributed to culturally appropriate and ethical research with participating Indigenous peoples and communities.
Key words: gambling, Indigenous, ethics, methods.
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By Marcia Angell, M.D.
An essential ethical condition for a randomized clinical trial comparing two treatments for a disease is that there be no good reason for thinking one is better than the other.1,2 Usually, investigators hope and even expect that the new treatment will be better, but there should not be solid evidence one way or the other. If there is, not only would the trial be scientifically redundant, but the investigators would be guilty of knowingly giving inferior treatment to some participants in the trial. The necessity for investigators to be in this state of equipoise2 applies to placebo-controlled trials, as well. Only when there is no known effective treatment is it ethical to compare a potential new treatment with a placebo. When effective treatment exists, a placebo may not be used. Instead, subjects in the control group of the study must receive the best known treatment. Investigators are responsible for all subjects enrolled in a trial, not just some of them, and the goals of the research are always secondary to the well-being of the participants. Those requirements are made clear in the Declaration of Helsinki of the World Health Organization (WHO), which is widely regarded as providing the fundamental guiding principles of research involving human subjects.3 It states, “In research on man [sic], the interest of science and society should never take precedence over considerations related to the wellbeing of the subject,” and “In any medical study, every patient — including those of a control group, if any — should be assured of the best proven diagnostic and therapeutic method.”
Read more: NEJM
By Benjamin Freedman, Ph.D.
The ethics of clinical research requires equipoise — a state of genuine uncertainty on the part of the clinical investigator regarding the comparative therapeutic merits of each arm in a trial. Should the investigator discover that one treatment is of superior therapeutic merit, he or she is ethically obliged to offer that treatment. The current understanding of this requirement, which entails that the investigator have no "treatment preference" throughout the course of the trial, presents nearly insuperable obstacles to the ethical commencement or completion of a controlled trial and may also contribute to the termination of trials because of the failure to enroll enough patients.
I suggest an alternative concept of equipoise, which would be based on present or imminent controversy in the clinical community over the preferred treatment. According to this concept of "clinical equipoise," the requirement is satisfied if there is genuine uncertainty within the expert medical community — not necessarily on the part of the individual investigator — about the preferred treatment. (N Engl J Med 1987; 317: 141–5.)