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Human Rights and the Failure of Research Governance
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Children have been exposed to unjustifiable risks that in some cases amount to research abuse. Powerful, financially interconnected stakeholders control all facets of research, including the approval process. Physician investigators, their academic institutions, and institutional review boards (IRBs) all come under the influence of funding sponsors, whose interests conflict with the best interest of children. Children cannot rely on IRBs or on any of the existing research oversight agencies to protect them, for research too often takes inordinate risks in the name of the greater good.
This was part of a point-counterpoint with Princeton's Peter Singer for the Journal of Disability Policy Studies. I argued for Singer's participation on the grounds many in the disability community disliked him by reputation but had not heard or read his arguments. In this exchange I argued, and he protested, what I described as an ideology of normalcy pervading bioethics and an emphasis on normalcy rather than human diversity. Singer criticized my interpretation of his work and my description of bioethics as an ideology. This was the first of three articles and a commentary added to the exchange.
In February, the online magazine Slate published an article with the title, "Go Away, Ethics Police; Leave the NIH Alone." The author of the piece was Richard Epstein, a law professor at the University of Chicago and a senior fellow at the Maclean Center for Clinical Medical Ethics. The "ethics police" to whom Epstein objected were the critics who had pushed the National Institutes of Health (NIH) into adopting a strict new set of conflict-of-interest regulations. Last year, a muckraking series of reports in the Los Angeles Times revealed that some NIH scientists had parlayed their elite scientific positions into lucrative consulting contracts with the pharmaceutical industry. Several NIH scientists had received more than 600,000 from Schering AG and other companies at the same time that his institute conducted studies for Schering and pledged it 114,000 from the makers of cholesterol-lowering drugs.
This book describes the history of experimentation on human beings, traces the development of committee review of research on human beings, and reports on the committee review internationally. It includes a critique of the philosophy and politics of the review process.
This paper offers a critical appraisal of the regulatory approach towards risk assessments of new biomedical technologies, with a particular emphasis on gene transfer and stem cell research. While the therapeutic and commercial potential of this research is well publicized, the normative and methodological problems pertaining to the assessment of its potential risks to research participants have received less attention. We build on previous analyses of risk assessment as a value-laden, political exercise in regulatory science. Parties to a risk debate can bring different value-frameworks to the process of biomedical research review. We see the potential for a conflict of interest if risk assessments are formulated exclusively by the parties who propose the research, which is currently often the case. They might be more prone to taking risks for the sake of possible benefits and much less risk cautious than the research participants who assume the risks. We argue for a review process which aims to balance the interests of those proposing risk by providing a mandate for the critical interests of those who might assume it. In the paper, we classify two general types of risk that have been highlighted by gene transfer and stem cell research: risks to persons and risks to social values. We then consider three risks which we believe the law should address. These are risks of physical or psychological harm to participants, risks to the objectivity and scientific integrity of research that are posed by conflicts of interest; and briefly, risks to other social values, e.g., public trust in the ethical conduct of research. These are very different areas of risk, but we argue that there is merit in addressing them jointly. In areas where there are problems with the understanding and transmission of risk information to subjects, there is greater concern about impact of conflicts of interest and more reason to develop a fully independent review of risks. We sketch some principles and guidelines for institutional reforms that could inspire the further development of a regulatory or legislative model for the oversight of research with human participants.
Research review boards, established to protect the rights and welfare of human research subjects, have to ensure that conflicts of interest do not interfere with the ethical conduct of medical research. Private, commercial review boards, which increasingly review research protocols, are themselves affected by a structural conflict of interest. Within the regulatory setting, procedural conflict-of-interest rules are essential because of the absence of clear substantive rules in research review and the reliance on the fairness and good judgment of institutional review board members. Current guidelines and regulations lack adequate conflict-of-interest rules and provide insufficient details on the substantive rules. Because commercial review boards are similar to administrative courts and tribunals, rules of administrative law on bias are applied to determine when a conflict of interest jeopardizes the purposes of research review; administrative law has always judged financial conflicts of interest severely. The structure of private review tends to breach a core principle of administrative law and procedural justice. Reform of the research review system will reinforce public trust in the process.
Patients participating in the shared benefits of publicly funded health care enjoy the benefits of treatments tested on previous patients. Future patients similarly depend on treatments tested on present patients. Since properly designed research assumes that the treatments being studied are-so far as is known at the outset-equivalent in therapeutic value, no one is clinically disadvantaged merely by taking part in research, provided the research involves administering active treatments to all participants. This paper argues that, because no other practical or moral considerations count decisively against so doing, we could and should oblige patients to agree to receive indicated treatment within the terms of any concurrent research protocols. This ensures their treatment will benefit not only themselves but also future patients through contributing to new knowledge. By analogy with the paying of income tax, patients should not be allowed to "veto" their social responsibility to take part in clinical research.
Over the past two decades, institutional review boards (IRBs) have transformed the conduct of clinical research, in the process protecting human subjects and setting an admirable standard for monitoring the ethics of science. Nevertheless, the very proliferation of these committees, in addition to changing the character and sponsorship of new research, suggests that a ¿one size fits all¿ approach to the governance of human experimentation may have outlived its usefulness. It may be time to remove the ¿I¿ from the IRB and create a system with greater national oversight. Whether such a change can be accomplished within the current political climate is debatable. But the need for such a shift is becoming increasingly apparent.
A dilemma confronts physician-investigators in the conduct of research with patient-subjects. As physicians they are dedicated to caring for their patients, healing their pain, reducing their suffering. As investigators they are dedicated to caring for their research, advancing knowledge for the benefit of science and future patients. These two commitments conflict whenever an individual physician-investigator comes face to face with an individual patient-subject. Indeed, in this encounter between two persons, four personae confront one another: the physician, the investigator, the patient in need of immediate help, and the subject who may himself be helped or who may help future patients.
This paper examines the culture, the dynamics and the financial underpinnings that determine how medical research is being conducted on children in the United States. Children have increasingly become the subject of experiments that offer them no potential direct benefit but expose them to risks of harm and pain. A wide range of such experiments will be examined, including a lethal heartburn drug test, the experimental insertion of a pacemaker, an invasive insulin infusion experiment, and a fenfluramine "violence prediction" experiment. Emphasis, however, is given to psychoactive drug tests because of the inherent ethical and diagnostic problems involved in the absence of any objective, verifiable diagnostic tool. Effort is made to provide readers comprehensive reference sources to evidence-based reports about the serious risks these drugs pose for adults and children so that the reader may judge whether the benefits (if any) outweigh the risks for children.
Offers to health-care professionals of finder's fees ranging between 5,000 per subject referred to clinical trials are now common in the United States and Canada. Finder's fees have to be situated in the larger context of the commercialization of medical research and the growing demand for research subjects. This article first discusses the context in which these financial recruitment incentives are used and the potential impact on research subjects and on the integrity of the research process itself. The authors then argue that it is inappropriate to rely on IRBs to curb the negative consequences of this practice, because of the conflicts of interest embedded in the current IRB system and the vagueness of the guidelines they are asked to apply. The authors highlight how more stringent legal means can be used to control this practice, including statutes governing the professions, tort law, law of fiduciary duty, and criminal law. They emphasize that stricter oversight of conflicts of interest by institutional and regulatory authorities and better enforcement of existing regulatory and legal remedies are needed to safeguard the rights and well-being of research subjects and to preserve the integrity of the research process.
Leopards break into the temple and drink to the dregs what is in the sacrificial pitchers; this is repeated over and over again; finally it can be calculated in advance, and it becomes part of the ceremony.
–Franz Kafla
For more than two decades, significant controversies have been brewing over the efficacy and safety of Selective Serotonin Reuptake Inhibitors (or SSRIs) and other treatments for depression, and also over the expansion of their use for the treatment of a variety of other conditions. These controversies culminated, in June 2004, with alawsuit intended by Eliot Spitzer, Attorney General of the State of New York. The lawsuit accused pharmaceutical giant GlaxoSmith-Kline of “repeated and persistent fraud by misrepresentation, concealing and otherwise failing to disclose to physicians information in its control concerning the safety and effectiveness of its antidepressant medication paroxetine” (better known as “Paxil”) in treating children and adolescents suffering from depression.
When a patient could be offered one of multiple established treatments, doctors should be able to offer treatment only if the patient agrees to participate in research aimed at determining which of the treatments is most effective. Making treatment conditional on research participation will help researchers complete badly needed studies.
AHRP Comments Re: EPA proposed rule for human pesticide research
- Alliance For Health Research Protection
Big Pharma's shameful secret
- D Evans
- M Smith
- L Willen
American bio-ethics: Crossing human rights and health law boundaries
- G Annas
Ethics for sale. Slate
- C Elliott
- T Lemmens
Integrating values in risk analysis of biomedical research: The case for regulatory and law reform
- D R Waring
- T Lemmens