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Increasing value and reducing waste in biomedical research regulation and management

Summary After identification of an important research question and selection of an appropriate study design, waste can arise from the regulation, governance, and management of biomedical research. Obtaining regulatory and governance approval has become increasingly burdensome and disproportionate to... Full description

Journal Title: The Lancet (British edition) 2014, Vol.383 (9912), p.176-185
Main Author: Salman, Rustam Al-Shahi, Prof
Other Authors: Beller, Elaine, MAppStat , Kagan, Jonathan, PhD , Hemminki, Elina, Prof , Phillips, Robert S, BM BCh , Savulescu, Julian, Prof , Macleod, Malcolm, Prof , Wisely, Janet, PhD , Chalmers, Iain, DSc
Format: Electronic Article Electronic Article
Language: English
Subjects:
Quelle: Alma/SFX Local Collection
Publisher: England: Elsevier Ltd
ID: ISSN: 0140-6736
Link: https://www.ncbi.nlm.nih.gov/pubmed/24411646
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recordid: cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_3952153
title: Increasing value and reducing waste in biomedical research regulation and management
format: Article
creator:
  • Salman, Rustam Al-Shahi, Prof
  • Beller, Elaine, MAppStat
  • Kagan, Jonathan, PhD
  • Hemminki, Elina, Prof
  • Phillips, Robert S, BM BCh
  • Savulescu, Julian, Prof
  • Macleod, Malcolm, Prof
  • Wisely, Janet, PhD
  • Chalmers, Iain, DSc
subjects:
  • Article
  • Bioethics
  • Biomedical Research
  • Biomedical Research - legislation & jurisprudence
  • Biomedical Research - organization & administration
  • Biomedical Research - standards
  • Efficiency
  • Experiments
  • Failure
  • Hypotheses
  • Hypothesis testing
  • Internal Medicine
  • Laws, regulations and rules
  • Management
  • Medical research
  • Medicine, Experimental
  • Regulation
  • Regulatory approval
  • Research Design
  • Research Design - standards
  • Studies
ispartof: The Lancet (British edition), 2014, Vol.383 (9912), p.176-185
description: Summary After identification of an important research question and selection of an appropriate study design, waste can arise from the regulation, governance, and management of biomedical research. Obtaining regulatory and governance approval has become increasingly burdensome and disproportionate to the conceivable risks to research participants. Regulation and governance involve interventions that are assumed to be justified in the interests of patients and the public, but they can actually compromise these interests. Inefficient management of the procedural conduct of research is wasteful, especially if it results in poor recruitment and retention of participants in well designed studies addressing important questions. These sources of waste can be minimised if the following four recommendations are addressed. First, regulators should use their influence to reduce other causes of waste and inefficiency in research. Second, 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. Third, researchers and research managers should increase the efficiency of recruitment, retention, data monitoring, and data sharing in research through use of research designs known to reduce inefficiencies, and further research should be done to learn how efficiency can be increased. Finally, everyone, particularly those responsible for health-care systems, should promote integration of research into everyday clinical practice. Regulators and researchers should monitor adherence to each of these recommendations and publish metrics.
language: eng
source: Alma/SFX Local Collection
identifier: ISSN: 0140-6736
fulltext: fulltext
issn:
  • 0140-6736
  • 1474-547X
url: Link


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descriptionSummary After identification of an important research question and selection of an appropriate study design, waste can arise from the regulation, governance, and management of biomedical research. Obtaining regulatory and governance approval has become increasingly burdensome and disproportionate to the conceivable risks to research participants. Regulation and governance involve interventions that are assumed to be justified in the interests of patients and the public, but they can actually compromise these interests. Inefficient management of the procedural conduct of research is wasteful, especially if it results in poor recruitment and retention of participants in well designed studies addressing important questions. These sources of waste can be minimised if the following four recommendations are addressed. First, regulators should use their influence to reduce other causes of waste and inefficiency in research. Second, 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. Third, researchers and research managers should increase the efficiency of recruitment, retention, data monitoring, and data sharing in research through use of research designs known to reduce inefficiencies, and further research should be done to learn how efficiency can be increased. Finally, everyone, particularly those responsible for health-care systems, should promote integration of research into everyday clinical practice. Regulators and researchers should monitor adherence to each of these recommendations and publish metrics.
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subjectArticle ; Bioethics ; Biomedical Research ; Biomedical Research - legislation & jurisprudence ; Biomedical Research - organization & administration ; Biomedical Research - standards ; Efficiency ; Experiments ; Failure ; Hypotheses ; Hypothesis testing ; Internal Medicine ; Laws, regulations and rules ; Management ; Medical research ; Medicine, Experimental ; Regulation ; Regulatory approval ; Research Design ; Research Design - standards ; Studies
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abstractSummary After identification of an important research question and selection of an appropriate study design, waste can arise from the regulation, governance, and management of biomedical research. Obtaining regulatory and governance approval has become increasingly burdensome and disproportionate to the conceivable risks to research participants. Regulation and governance involve interventions that are assumed to be justified in the interests of patients and the public, but they can actually compromise these interests. Inefficient management of the procedural conduct of research is wasteful, especially if it results in poor recruitment and retention of participants in well designed studies addressing important questions. These sources of waste can be minimised if the following four recommendations are addressed. First, regulators should use their influence to reduce other causes of waste and inefficiency in research. Second, 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. Third, researchers and research managers should increase the efficiency of recruitment, retention, data monitoring, and data sharing in research through use of research designs known to reduce inefficiencies, and further research should be done to learn how efficiency can be increased. Finally, everyone, particularly those responsible for health-care systems, should promote integration of research into everyday clinical practice. Regulators and researchers should monitor adherence to each of these recommendations and publish metrics.
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