Final Report Summary - ETHICAL RISK (An ethical framework for the risk-based regulation of biomedical research)
Background
Biomedical research has important social and economic value. It helps to promote individual and population health, boosts competitiveness and innovative capacity, and thereby contributes to economic growth. Yet, biomedical research exposes study participants to risks of physical, psychological and other harm. Research also poses risks to public health when the science is poor. The ethical acceptability of biomedical research therefore critically depends on protecting participants’ rights and interests, while promoting the scientific and social value of the research. Research regulations are designed to ensure that these requirements are met.
Patient organizations, investigators, sponsors, and others are increasingly dissatisfied with the existing regulatory framework. Many stakeholders criticize this framework for adopting a “one-size-fits-all” approach. They contend that existing regulations formulate the same regulatory requirements for research involving very different levels of risk, and thereby unnecessarily delay or stifle medical progress.
To address this criticism, regulators in the U.K. U.S. Switzerland and other countries are currently developing more “risk-based” or risk-adapted approaches to regulating biomedical research. A key feature of these approaches is that they aim to calibrate subject protections (e.g. ethical review, informed consent) to the risks that studies pose to participants. The underlying idea is that risk-adapted systems of regulation and oversight can promote research within the constraints of adequate subject protection. However, the ethical ramifications of this idea have not been evaluated in sufficient depth.
Project objectives
This project aimed to explore the opportunities and challenges of risk-adapted approaches to regulating biomedical research. Using an interdisciplinary approach that combines conceptual, normative and policy analysis, and expert consultation, the project pursued two overarching goals:
1) To address the ethical questions raised by risk-adapted approaches to regulating research, including what justifies regulating biomedical research, how to conceptualize research risks, whether and when risk-adapted approaches to informed consent and ethical oversight are justified, and how research risks relate to the social value of research.
2) To develop an ethical framework for risk-adapted approaches to regulating biomedical research.
Work performed
The project comprised the following activities:
1) Substantive work on 8 research papers, published in peer-reviewed bioethics and health policy journals (7 papers) and books (1 paper), as well as 1 special issue of the journal Bioethics
2) Delivery of a total of 12 talks, among others at Stanford University, Oxford University, the World Congress of Bioethics, the European Forum for Good Clinical Practice (EFGCP) and the U.K. Health Research Authority
3) Organization of 1 international workshop and 4 plenary sessions at academic and professional conferences on topics related to risk-adapted approaches to regulating biomedical research
4) Research stay at the ETHOX Centre, University of Oxford, and research visits in Stanford and McGill
5) Active participation in 4 international workshops on research ethics and the UCL/KCL Research Group on Social Values and Health Priority-Setting
6) Commentary on topical events in research ethics, notably the trials of experimental Ebola interventions, in academic publications and newspaper/TV interviews (e.g. Science Magazine, BBC)
Main results
The project’s overarching results can be summarized as follows:
1) The regulation of biomedical research is grounded in the societal interest in research and the rights and welfare of research participants. The central question therefore is not whether research should be regulated, but how it should be regulated, and how regulation should be enforced.
2) A strictly risk-adapted framework for the ethical oversight of research is not tenable. Such a framework would design ethical oversight solely on the basis of whether the research poses high or low risks to participants. However, while risks to participants are always ethically salient, other considerations are equally important, from an ethical as well as a regulatory perspective. For example, a study without informed consent may be ethically unproblematic when it is low-risk, or a low-risk study may be ethically problematic even when informed consent is obtained. Accordingly, research regulation and oversight should be proportionate to the ethical concerns (risk-related and non-risk related) raised by the given research. In other words, risk-adapted regulation and oversight are only one aspect of a defensible regulatory framework for research. The overall of such a framework should be proportionate regulation.
3) Developing a framework for proportionate research regulation and oversight requires taking three steps. The first step is to identify indicators for when research studies might compromise relevant ethical goals for research, such as the goals of protecting participants’ rights and interests, ensuring the scientific and social value of research, promoting justice, and promoting public trust in research. The second step is to define different levels of potential ethical compromise with respect to realizing these goals, based on relevant indicators. The third step is to determine the appropriate level of research regulation and oversight (if any) at each level of potential ethical compromise. Risk-adapted approaches to informed consent in research are on example for which the project has specified these steps in detail.
Expected final results and their potential impact and use
The project as a whole has resulted in a body of normative work on the regulation and oversight of biomedical research. It justifies why research should be regulated, what this means for how it should be regulated, and which concrete steps policymakers and regulators need to take in order to improve the regulation of biomedical research. This work is of interest not only to policymakers and research regulators, but also to research participants, researchers and research ethicists. The project’s main ideas have been (and will continue to be) disseminated to these stakeholders.
Biomedical research has important social and economic value. It helps to promote individual and population health, boosts competitiveness and innovative capacity, and thereby contributes to economic growth. Yet, biomedical research exposes study participants to risks of physical, psychological and other harm. Research also poses risks to public health when the science is poor. The ethical acceptability of biomedical research therefore critically depends on protecting participants’ rights and interests, while promoting the scientific and social value of the research. Research regulations are designed to ensure that these requirements are met.
Patient organizations, investigators, sponsors, and others are increasingly dissatisfied with the existing regulatory framework. Many stakeholders criticize this framework for adopting a “one-size-fits-all” approach. They contend that existing regulations formulate the same regulatory requirements for research involving very different levels of risk, and thereby unnecessarily delay or stifle medical progress.
To address this criticism, regulators in the U.K. U.S. Switzerland and other countries are currently developing more “risk-based” or risk-adapted approaches to regulating biomedical research. A key feature of these approaches is that they aim to calibrate subject protections (e.g. ethical review, informed consent) to the risks that studies pose to participants. The underlying idea is that risk-adapted systems of regulation and oversight can promote research within the constraints of adequate subject protection. However, the ethical ramifications of this idea have not been evaluated in sufficient depth.
Project objectives
This project aimed to explore the opportunities and challenges of risk-adapted approaches to regulating biomedical research. Using an interdisciplinary approach that combines conceptual, normative and policy analysis, and expert consultation, the project pursued two overarching goals:
1) To address the ethical questions raised by risk-adapted approaches to regulating research, including what justifies regulating biomedical research, how to conceptualize research risks, whether and when risk-adapted approaches to informed consent and ethical oversight are justified, and how research risks relate to the social value of research.
2) To develop an ethical framework for risk-adapted approaches to regulating biomedical research.
Work performed
The project comprised the following activities:
1) Substantive work on 8 research papers, published in peer-reviewed bioethics and health policy journals (7 papers) and books (1 paper), as well as 1 special issue of the journal Bioethics
2) Delivery of a total of 12 talks, among others at Stanford University, Oxford University, the World Congress of Bioethics, the European Forum for Good Clinical Practice (EFGCP) and the U.K. Health Research Authority
3) Organization of 1 international workshop and 4 plenary sessions at academic and professional conferences on topics related to risk-adapted approaches to regulating biomedical research
4) Research stay at the ETHOX Centre, University of Oxford, and research visits in Stanford and McGill
5) Active participation in 4 international workshops on research ethics and the UCL/KCL Research Group on Social Values and Health Priority-Setting
6) Commentary on topical events in research ethics, notably the trials of experimental Ebola interventions, in academic publications and newspaper/TV interviews (e.g. Science Magazine, BBC)
Main results
The project’s overarching results can be summarized as follows:
1) The regulation of biomedical research is grounded in the societal interest in research and the rights and welfare of research participants. The central question therefore is not whether research should be regulated, but how it should be regulated, and how regulation should be enforced.
2) A strictly risk-adapted framework for the ethical oversight of research is not tenable. Such a framework would design ethical oversight solely on the basis of whether the research poses high or low risks to participants. However, while risks to participants are always ethically salient, other considerations are equally important, from an ethical as well as a regulatory perspective. For example, a study without informed consent may be ethically unproblematic when it is low-risk, or a low-risk study may be ethically problematic even when informed consent is obtained. Accordingly, research regulation and oversight should be proportionate to the ethical concerns (risk-related and non-risk related) raised by the given research. In other words, risk-adapted regulation and oversight are only one aspect of a defensible regulatory framework for research. The overall of such a framework should be proportionate regulation.
3) Developing a framework for proportionate research regulation and oversight requires taking three steps. The first step is to identify indicators for when research studies might compromise relevant ethical goals for research, such as the goals of protecting participants’ rights and interests, ensuring the scientific and social value of research, promoting justice, and promoting public trust in research. The second step is to define different levels of potential ethical compromise with respect to realizing these goals, based on relevant indicators. The third step is to determine the appropriate level of research regulation and oversight (if any) at each level of potential ethical compromise. Risk-adapted approaches to informed consent in research are on example for which the project has specified these steps in detail.
Expected final results and their potential impact and use
The project as a whole has resulted in a body of normative work on the regulation and oversight of biomedical research. It justifies why research should be regulated, what this means for how it should be regulated, and which concrete steps policymakers and regulators need to take in order to improve the regulation of biomedical research. This work is of interest not only to policymakers and research regulators, but also to research participants, researchers and research ethicists. The project’s main ideas have been (and will continue to be) disseminated to these stakeholders.