In 2009, Chalmers and Glasziou1 identified many avoidable sources of waste and inefficiency in biomedical research, which are elaborated upon in this Series. After identification of an important research question and selection of an appropriate study design, waste can be noticeable and quantifiable from the way in which research is regulated and managed.2 Furthermore, foreknowledge of regulatory and management requirements can affect researchers' choice of research question and study design, resulting in unnoticed and unquantifiable waste, such that important research is identified but never addressed. Ultimately, waste arises from questions being overlooked or unnecessarily addressed, research being underpowered or done too slowly, and research being too costly.
A consensus on the need to regulate biomedical research arose from Nazi research atrocities3 and abuses of people in mainly non-therapeutic research,4, 5 such that by the 1980s, the need for ethics review and prelicensing regulation of biomedical research involving human beings was not controversial. Similarly, published revelations of maltreatment of experimental animals in preclinical research led to it becoming more regulated.6 Nowadays, permission to do biomedical research (regulatory approval) is needed in accordance with requirements of national or regional laws or professional authorities. Research ethics committees are independent regulators of most types of biomedical clinical research, whereas additional specific regulators oversee research involving data, devices, drugs, embryos, radiation, and tissue, among others. Regulatory functions are also undertaken by institutional bodies concerned with biomedical research governance, which is “…the system of administration and supervision through which research is managed, participants and staff are protected, and accountability is assured”.7 The procedural conduct (management) of biomedical research that has regulatory approval indicates not only the customs and habits of researchers, but also the regulatory requirements.
Recommendations
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People regulating research should use their influence to reduce other causes of waste and inefficiency in research
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Monitoring—people regulating, governing, and managing research should measure the extent to which the research they approve and manage complies with the other recommendations in this Series
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Regulators and policy makers should work with researchers, patients, and health professionals to streamline and harmonise the laws, regulations, guidelines, and processes that govern whether and how research can be done, and ensure that they are proportionate to the plausible risks associated with the research
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Monitoring—regulators, individuals who govern and manage research, and researchers should measure and report delays and inconsistencies that result from failures to streamline and harmonise regulations
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Researchers and research managers should increase the efficiency of recruitment, retention, data monitoring, and data sharing in research through the use of research designs known to reduce inefficiencies, and do additional research to learn how efficiency can be increased
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Monitoring—researchers and methodologists should do research to identify ways to improve the efficiency of biomedical research
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Everyone, particularly individuals responsible for health-care systems, can help to improve the efficiency of clinical research by promoting integration of research in everyday clinical practice
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Monitoring—people responsible for management of health-care systems or research should measure the proportions of patients who are enrolled in research
However, the increasing burden, inconsistency, and complexity of regulation in the past two decades, sometimes out of proportion to the risk of the research,2 has attracted increasing criticism in many countries, including the UK, Canada, and the USA. Research ethics committees were the earliest regulators, and so account for most evaluations, but an increasing number of additional regulatory steps have also caused problems.7, 8
In this report, we consider how both regulation (including governance) and management affect the wastefulness and value of biomedical research. First, we describe how regulation can contribute to the fundamental sources of waste and inefficiency in biomedical research, and cite one example from preclinical research. Second, we describe evidence for waste and inefficiency in clinical research arising from the burden and inconsistency of regulation (including governance), and how these permissions are often disproportionate to the conceivable risks of the research. Third, we describe sources of waste and inefficiency in the management of clinical research. Fourth, we make recommendations for increasing value and reducing waste, and list measures to monitor how successful these recommendations have been. Further reading for each section is provided in the appendix.
