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An ethical framework for the regulation of biomedical research

Biomedical research is of great social and economic value, but it comes with physical, psychological and other harmful threats or risks. While focused groups are developing risk-adapted approaches to regulating biomedical research, more information and evaluation is needed regarding the ethical ramifications.
An ethical framework for the regulation of biomedical research
Patient organisations, investigators, sponsors, and other stakeholders have increasingly voiced dissatisfaction with the standing regulatory framework. This prompted a shift in attention and support for the idea that risk-adapted regulation systems can promote research within the constraints of adequate subject protection.

The EU-funded project ETHICAL RISK (An ethical framework for the risk-based regulation of biomedical research) explored the opportunities and challenges of risk-adapted approaches to regulating biomedical research.

A first objective was to address ethical questions related to risk-adapted approaches to regulating research. These included justifications for regulating biomedical research as well as for risk-adapted approaches to informed consent and ethical oversight, and how research risks relate to the social value of research. The second objective was to develop an ethical framework for risk-adapted approaches to regulating biomedical research.

Research was conducted in both Europe and the United States. The outcomes focus on the central question of how research should be regulated and also enforced. The findings are not in favour of a strictly risk-adapted framework for the ethical oversight of research as there are considerations other than high or low risk for study subjects.

As such, a defensible regulatory framework for research should, overall, support proportionate regulation. Three steps must be taken in this direction: identify indicators for when research might compromise relevant ethical goals; define different levels of potential ethical compromise with respect to realising these goals; and determine the appropriate level of research regulation and oversight at each level of potential ethical compromise.

Project work resulted in eight research papers published in peer-reviewed journals and one Bioethics journal special issue. ETHICAL RISK delivered a total of 12 talks, including at Stanford University, Oxford University, the World Congress of Bioethics, the European Forum for Good Clinical Practice (EFGCP) and the United Kingdom Health Research Authority. The team organised an international workshop and four plenary sessions at relevant conferences, and took part in four international workshops on research ethics.

ETHICAL RISK has advanced important work on the regulation and oversight of biomedical research, justifying why research should be regulated and the implications for how. The work has implications for policymakers, regulators, researchers, research ethicists and study participants.

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Ethical framework, biomedical research, risk-adapted approaches, ETHICAL RISK, risk-based regulation
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