LEADER 03528nam 2200529 450 001 9910404149203321 005 20200218143543.0 010 $a1-78897-535-9 035 $a(CKB)4100000010350946 035 $a(UtOrBLW)eep9781788975353 035 $a(MiAaPQ)EBC6124241 035 $a(oapen)https://directory.doabooks.org/handle/20.500.12854/58050 035 $a(EXLCZ)994100000010350946 100 $a20200418d2020 uy 0 101 0 $aeng 135 $aurun||||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 10$aRegulatory stewardship of health research $enavigating participant protection and research promotion /$fEdward S. Dove 210 1$aNorthampton :$cEdward Elgar Publishing,$d2020. 215 $a1 online resource (232 pages) 225 1 $aElgar studies in law and regulation 300 $aIncludes index. 311 $a1-78897-534-0 320 $aIncludes bibliographical references. 327 $aContents: 1. Introduction -- 2. Conceptual framework - setting the scene for 'protection' and 'promotion' -- 3. The making of recs as health research regulators -- 4. Anthropology of regulation -- 5. Operationalising 'next-generation' health research regulation - what is happening in practice? -- 6. Charting a framework for regulatory stewardship -- 7. Conclusion -- Index. 330 $a"This timely book examines the interaction of health research and regulation with law through empirical analysis and the application of key anthropological concepts to reveal the inner workings of human health research. Through ground-breaking empirical inquiry, Regulatory Stewardship of Health Research explores how research ethics committees (RECs) work in practice to both protect research participants and promote ethical research. This thought-provoking book provides new perspectives on the regulation of health research by demonstrating how RECs and other regulatory actors seek to fulfil these two functions by performing a role of 'regulatory stewardship'. This involves guiding researchers through stages of research approval, as well as seeking to maximise benefits for participants and society while minimising risks. Arguing that participant protection and research promotion should rightly be treated as twin objectives for health research regulators, this book asserts that there is a need for more overt recognition of the importance and function of the deliberative space in which RECs can negotiate the risks relevant to a research application. This book is a key resource for academics and students interested in health research and regulation, and the dynamic interaction of ethics and the law. Regulators and policy-makers will also find it to be an insightful and illuminating text for the practical insights that it reveals about research governance in action"--$cProvided by publisher. 410 0$aElgar studies in law and regulation. 606 $aHealth$xResearch 610 $aHealth Research Regulation 610 $aResearch Ethics 610 $aHealth Law 610 $aResearch Governance 610 $aAnthropology 610 $aResearch Ethics Committees 615 0$aHealth$xResearch. 676 $a613 700 $aDove$b E. S$g(Edward S.),$0978148 712 02$aEdward Elgar Publishing, 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910404149203321 996 $aRegulatory stewardship of health research$92228558 997 $aUNINA