Sometime in the past few years, 18 Western Australians received a phone call which must have been both surprising and distressing.
They were told that researchers studying tissue taken from either them or their next of kin suggested that they were at high risk of having a hereditary form of bowel cancer.
This must have come as a dreadful shock to these people because they or their family members had not given consent for their tissue to be used as part of research.
Perth researchers have described how ethics bodies gave them approval to conduct this study without them getting permission from the 1,050 patients whose tissue, removed during treatment for bowel cancer, was examined.
The researchers argued that getting consent from the patients would have been too difficult and time consuming, and stopped the study going ahead. They claim that the benefits of the study — it has subsequently led to a change in policy to recommend screening for this form of cancer in all patients younger than 60 diagnosed with bowel cancer — outweighed the potential negatives of invading people’s privacy.
We were alarmed when we read this report recently in The Medical Journal of Australia, “Waiver of individual consent in research: when do potential benefits to the community outweigh private rights?”
The key concerns arising from this article are two. First clinical researchers with a vested interest in the research in question seemingly feel competent to judge the balance between ‘potential benefits to the community’ and ‘private rights’.
Such a cavalier attitude to judging what is in the public’s interests is unacceptable. The value judgements about this sort of trade off between on the one hand “the risk of harm from invasion of privacy” and on the other “the potential benefits from the study” are or should be based on informed community preferences.
The second concern is that ethics committees do not represent the community. They do usually have some lay representation but as a minority and they are there as individuals, not as representatives of the community. The judgments of “experts” dominate.
What is needed in Australia is a recognition that many issues around informed consent are social ethical matters. As such, the voice of the informed community needs to heard, possibly through some form of deliberative democracy such as citizens’ juries.
Currently, as ethics committees are constituted, that community voice is largely absent, or at best muted. Right now that void is then filled, as in this study, by clinical researchers who have no ethically justifiable basis for making social judgments.
The MJA report raises that old question: do the ends justify the means? Not in this case, we believe. However, it is not our opinion but the community’s that should matter – and they weren’t asked.
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