Charting Regulatory Stewardship in Health Research: Making the Invisible Visible

This section focuses on the ethical, legal, social, and policy questions arising from research involving human and animal subjects. This article analyses a hitherto largely obscured feature of regulatory environments in health research; namely, the role of regulatory stewardship. Through examples dr...

Ausführliche Beschreibung

Gespeichert in:
Bibliographische Detailangaben
Veröffentlicht in:Cambridge quarterly of healthcare ethics 2018-04, Vol.27 (2), p.333-347
Hauptverfasser: LAURIE, GRAEME T., DOVE, EDWARD S., GANGULI-MITRA, AGOMONI, FLETCHER, ISABEL, MCMILLAN, CATRIONA, SETHI, NAYHA, SORBIE, ANNIE
Format: Artikel
Sprache:eng
Schlagworte:
Online-Zugang:Volltext
Tags: Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
container_end_page 347
container_issue 2
container_start_page 333
container_title Cambridge quarterly of healthcare ethics
container_volume 27
creator LAURIE, GRAEME T.
DOVE, EDWARD S.
GANGULI-MITRA, AGOMONI
FLETCHER, ISABEL
MCMILLAN, CATRIONA
SETHI, NAYHA
SORBIE, ANNIE
description This section focuses on the ethical, legal, social, and policy questions arising from research involving human and animal subjects. This article analyses a hitherto largely obscured feature of regulatory environments in health research; namely, the role of regulatory stewardship. Through examples drawn from research ethics committees, emerging technologies, and governance of research resources, it outlines the essential features of regulatory stewardship, and argues that this concept can demonstrate considerable added value for all parties in delivering and benefiting from efficient and effective navigation of regulatory landscapes. It offers an exposition of the normative principles and associated responsibilities of the concept. The extant invisibility of regulatory stewardship requires fuller recognition and better integration of the approach into the effective functioning of law and regulation in the health research context.
doi_str_mv 10.1017/S0963180117000664
format Article
fullrecord <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_5848747</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><cupid>10_1017_S0963180117000664</cupid><sourcerecordid>2011277465</sourcerecordid><originalsourceid>FETCH-LOGICAL-c519t-84b20ef61508194f9d8d90f652ea21e4bfb425558d9fe99ae2a0798e839a183f3</originalsourceid><addsrcrecordid>eNp1kUtv1DAUha0K1E4LP4ANisSmmxRfx08WSNWIPqQiEAW2lpPcTFwyydROivrv62im5SVWV_L5zrGvDyGvgJ4ABfX2mhpZgKYAilIqJd8jC-DS5Ay4ekYWs5zP-gE5jPEmMYxR2CcHzAhqgLEF-bxsXRh9v8q-4Grq3DiE--x6xJ8u1LH1m8z32QW6bmwTENGFqn2XfXQ_ZsfYYnbZ3_noyw6z79v5gjxvXBfx5W4ekW9nH74uL_KrT-eXy9OrvBJgxlzzklFsJAiqwfDG1Lo2tJGCoWOAvGxKzoQQ6bRBYxwyR5XRqAvjQBdNcUTeb3M3U7nGusJ-DK6zm-DXLtzbwXn7p9L71q6GOys014qrFHC8CwjD7YRxtGsfK-w61-MwRZt-CphSXIqEvvkLvRmm0Kf1ZopqBZLKRMGWqsIQY8Dm6TFA7dyX_aev5Hn9-xZPjseCElDsQt26DL5e4a-7_x_7APV4nxw</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2010871606</pqid></control><display><type>article</type><title>Charting Regulatory Stewardship in Health Research: Making the Invisible Visible</title><source>PAIS Index</source><source>HeinOnline Law Journal Library</source><source>Applied Social Sciences Index &amp; Abstracts (ASSIA)</source><source>Cambridge University Press Journals Complete</source><creator>LAURIE, GRAEME T. ; DOVE, EDWARD S. ; GANGULI-MITRA, AGOMONI ; FLETCHER, ISABEL ; MCMILLAN, CATRIONA ; SETHI, NAYHA ; SORBIE, ANNIE</creator><creatorcontrib>LAURIE, GRAEME T. ; DOVE, EDWARD S. ; GANGULI-MITRA, AGOMONI ; FLETCHER, ISABEL ; MCMILLAN, CATRIONA ; SETHI, NAYHA ; SORBIE, ANNIE</creatorcontrib><description>This section focuses on the ethical, legal, social, and policy questions arising from research involving human and animal subjects. This article analyses a hitherto largely obscured feature of regulatory environments in health research; namely, the role of regulatory stewardship. Through examples drawn from research ethics committees, emerging technologies, and governance of research resources, it outlines the essential features of regulatory stewardship, and argues that this concept can demonstrate considerable added value for all parties in delivering and benefiting from efficient and effective navigation of regulatory landscapes. It offers an exposition of the normative principles and associated responsibilities of the concept. The extant invisibility of regulatory stewardship requires fuller recognition and better integration of the approach into the effective functioning of law and regulation in the health research context.</description><identifier>ISSN: 0963-1801</identifier><identifier>EISSN: 1469-2147</identifier><identifier>DOI: 10.1017/S0963180117000664</identifier><identifier>PMID: 29509122</identifier><language>eng</language><publisher>New York, USA: Cambridge University Press</publisher><subject>Bioethics ; Committees ; Councils ; Data integrity ; Departments and Columns ; Ethics ; Ethics committees ; Governance ; Health care policy ; Health research ; Landscape ; Law ; Management ; Medical research ; Navigation ; Open access ; Regulation ; Research Ethics</subject><ispartof>Cambridge quarterly of healthcare ethics, 2018-04, Vol.27 (2), p.333-347</ispartof><rights>Copyright © Cambridge University Press 2018</rights><rights>Copyright © Cambridge University Press 2018 This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted re-use, distribution, and reproduction in any medium, provided the original work is properly cited.</rights><rights>Cambridge University Press 2018 2018 Cambridge University Press</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c519t-84b20ef61508194f9d8d90f652ea21e4bfb425558d9fe99ae2a0798e839a183f3</citedby><cites>FETCH-LOGICAL-c519t-84b20ef61508194f9d8d90f652ea21e4bfb425558d9fe99ae2a0798e839a183f3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.cambridge.org/core/product/identifier/S0963180117000664/type/journal_article$$EHTML$$P50$$Gcambridge$$Hfree_for_read</linktohtml><link.rule.ids>164,230,314,780,784,885,12845,27865,27923,27924,30998,55627</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/29509122$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>LAURIE, GRAEME T.</creatorcontrib><creatorcontrib>DOVE, EDWARD S.</creatorcontrib><creatorcontrib>GANGULI-MITRA, AGOMONI</creatorcontrib><creatorcontrib>FLETCHER, ISABEL</creatorcontrib><creatorcontrib>MCMILLAN, CATRIONA</creatorcontrib><creatorcontrib>SETHI, NAYHA</creatorcontrib><creatorcontrib>SORBIE, ANNIE</creatorcontrib><title>Charting Regulatory Stewardship in Health Research: Making the Invisible Visible</title><title>Cambridge quarterly of healthcare ethics</title><addtitle>Camb Q Healthc Ethics</addtitle><description>This section focuses on the ethical, legal, social, and policy questions arising from research involving human and animal subjects. This article analyses a hitherto largely obscured feature of regulatory environments in health research; namely, the role of regulatory stewardship. Through examples drawn from research ethics committees, emerging technologies, and governance of research resources, it outlines the essential features of regulatory stewardship, and argues that this concept can demonstrate considerable added value for all parties in delivering and benefiting from efficient and effective navigation of regulatory landscapes. It offers an exposition of the normative principles and associated responsibilities of the concept. The extant invisibility of regulatory stewardship requires fuller recognition and better integration of the approach into the effective functioning of law and regulation in the health research context.</description><subject>Bioethics</subject><subject>Committees</subject><subject>Councils</subject><subject>Data integrity</subject><subject>Departments and Columns</subject><subject>Ethics</subject><subject>Ethics committees</subject><subject>Governance</subject><subject>Health care policy</subject><subject>Health research</subject><subject>Landscape</subject><subject>Law</subject><subject>Management</subject><subject>Medical research</subject><subject>Navigation</subject><subject>Open access</subject><subject>Regulation</subject><subject>Research Ethics</subject><issn>0963-1801</issn><issn>1469-2147</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><sourceid>IKXGN</sourceid><sourceid>7QJ</sourceid><sourceid>7TQ</sourceid><sourceid>8G5</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AVQMV</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>K50</sourceid><sourceid>M1D</sourceid><sourceid>M2O</sourceid><recordid>eNp1kUtv1DAUha0K1E4LP4ANisSmmxRfx08WSNWIPqQiEAW2lpPcTFwyydROivrv62im5SVWV_L5zrGvDyGvgJ4ABfX2mhpZgKYAilIqJd8jC-DS5Ay4ekYWs5zP-gE5jPEmMYxR2CcHzAhqgLEF-bxsXRh9v8q-4Grq3DiE--x6xJ8u1LH1m8z32QW6bmwTENGFqn2XfXQ_ZsfYYnbZ3_noyw6z79v5gjxvXBfx5W4ekW9nH74uL_KrT-eXy9OrvBJgxlzzklFsJAiqwfDG1Lo2tJGCoWOAvGxKzoQQ6bRBYxwyR5XRqAvjQBdNcUTeb3M3U7nGusJ-DK6zm-DXLtzbwXn7p9L71q6GOys014qrFHC8CwjD7YRxtGsfK-w61-MwRZt-CphSXIqEvvkLvRmm0Kf1ZopqBZLKRMGWqsIQY8Dm6TFA7dyX_aev5Hn9-xZPjseCElDsQt26DL5e4a-7_x_7APV4nxw</recordid><startdate>201804</startdate><enddate>201804</enddate><creator>LAURIE, GRAEME T.</creator><creator>DOVE, EDWARD S.</creator><creator>GANGULI-MITRA, AGOMONI</creator><creator>FLETCHER, ISABEL</creator><creator>MCMILLAN, CATRIONA</creator><creator>SETHI, NAYHA</creator><creator>SORBIE, ANNIE</creator><general>Cambridge University Press</general><scope>IKXGN</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>0-V</scope><scope>3V.</scope><scope>7QJ</scope><scope>7RV</scope><scope>7TQ</scope><scope>7X7</scope><scope>7XB</scope><scope>88C</scope><scope>88E</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>AABKS</scope><scope>ABSDQ</scope><scope>ABUWG</scope><scope>AEUYN</scope><scope>AFKRA</scope><scope>ALSLI</scope><scope>AVQMV</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DHY</scope><scope>DON</scope><scope>DPSOV</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>HEHIP</scope><scope>K50</scope><scope>K9.</scope><scope>KB0</scope><scope>KC-</scope><scope>M0S</scope><scope>M0T</scope><scope>M1D</scope><scope>M1P</scope><scope>M2L</scope><scope>M2O</scope><scope>M2S</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>Q9U</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>201804</creationdate><title>Charting Regulatory Stewardship in Health Research: Making the Invisible Visible</title><author>LAURIE, GRAEME T. ; DOVE, EDWARD S. ; GANGULI-MITRA, AGOMONI ; FLETCHER, ISABEL ; MCMILLAN, CATRIONA ; SETHI, NAYHA ; SORBIE, ANNIE</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c519t-84b20ef61508194f9d8d90f652ea21e4bfb425558d9fe99ae2a0798e839a183f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>Bioethics</topic><topic>Committees</topic><topic>Councils</topic><topic>Data integrity</topic><topic>Departments and Columns</topic><topic>Ethics</topic><topic>Ethics committees</topic><topic>Governance</topic><topic>Health care policy</topic><topic>Health research</topic><topic>Landscape</topic><topic>Law</topic><topic>Management</topic><topic>Medical research</topic><topic>Navigation</topic><topic>Open access</topic><topic>Regulation</topic><topic>Research Ethics</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>LAURIE, GRAEME T.</creatorcontrib><creatorcontrib>DOVE, EDWARD S.</creatorcontrib><creatorcontrib>GANGULI-MITRA, AGOMONI</creatorcontrib><creatorcontrib>FLETCHER, ISABEL</creatorcontrib><creatorcontrib>MCMILLAN, CATRIONA</creatorcontrib><creatorcontrib>SETHI, NAYHA</creatorcontrib><creatorcontrib>SORBIE, ANNIE</creatorcontrib><collection>Cambridge Journals Open Access</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Social Sciences Premium Collection</collection><collection>ProQuest Central (Corporate)</collection><collection>Applied Social Sciences Index &amp; Abstracts (ASSIA)</collection><collection>Nursing &amp; Allied Health Database</collection><collection>PAIS Index</collection><collection>Health &amp; Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Healthcare Administration Database (Alumni)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>Philosophy Collection</collection><collection>Philosophy Database</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest One Sustainability</collection><collection>ProQuest Central UK/Ireland</collection><collection>Social Science Premium Collection</collection><collection>Arts Premium Collection</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>PAIS International</collection><collection>PAIS International (Ovid)</collection><collection>Politics Collection</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>Sociology Collection</collection><collection>Art, Design &amp; Architecture Collection</collection><collection>ProQuest Health &amp; Medical Complete (Alumni)</collection><collection>Nursing &amp; Allied Health Database (Alumni Edition)</collection><collection>ProQuest Politics Collection</collection><collection>Health &amp; Medical Collection (Alumni Edition)</collection><collection>Healthcare Administration Database</collection><collection>Arts &amp; Humanities Database</collection><collection>Medical Database</collection><collection>Political Science Database</collection><collection>Research Library</collection><collection>Sociology Database</collection><collection>Research Library (Corporate)</collection><collection>Nursing &amp; Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Cambridge quarterly of healthcare ethics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>LAURIE, GRAEME T.</au><au>DOVE, EDWARD S.</au><au>GANGULI-MITRA, AGOMONI</au><au>FLETCHER, ISABEL</au><au>MCMILLAN, CATRIONA</au><au>SETHI, NAYHA</au><au>SORBIE, ANNIE</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Charting Regulatory Stewardship in Health Research: Making the Invisible Visible</atitle><jtitle>Cambridge quarterly of healthcare ethics</jtitle><addtitle>Camb Q Healthc Ethics</addtitle><date>2018-04</date><risdate>2018</risdate><volume>27</volume><issue>2</issue><spage>333</spage><epage>347</epage><pages>333-347</pages><issn>0963-1801</issn><eissn>1469-2147</eissn><abstract>This section focuses on the ethical, legal, social, and policy questions arising from research involving human and animal subjects. This article analyses a hitherto largely obscured feature of regulatory environments in health research; namely, the role of regulatory stewardship. Through examples drawn from research ethics committees, emerging technologies, and governance of research resources, it outlines the essential features of regulatory stewardship, and argues that this concept can demonstrate considerable added value for all parties in delivering and benefiting from efficient and effective navigation of regulatory landscapes. It offers an exposition of the normative principles and associated responsibilities of the concept. The extant invisibility of regulatory stewardship requires fuller recognition and better integration of the approach into the effective functioning of law and regulation in the health research context.</abstract><cop>New York, USA</cop><pub>Cambridge University Press</pub><pmid>29509122</pmid><doi>10.1017/S0963180117000664</doi><tpages>15</tpages><oa>free_for_read</oa></addata></record>
fulltext fulltext
identifier ISSN: 0963-1801
ispartof Cambridge quarterly of healthcare ethics, 2018-04, Vol.27 (2), p.333-347
issn 0963-1801
1469-2147
language eng
recordid cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_5848747
source PAIS Index; HeinOnline Law Journal Library; Applied Social Sciences Index & Abstracts (ASSIA); Cambridge University Press Journals Complete
subjects Bioethics
Committees
Councils
Data integrity
Departments and Columns
Ethics
Ethics committees
Governance
Health care policy
Health research
Landscape
Law
Management
Medical research
Navigation
Open access
Regulation
Research Ethics
title Charting Regulatory Stewardship in Health Research: Making the Invisible Visible
url https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-11T16%3A03%3A50IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Charting%20Regulatory%20Stewardship%20in%20Health%20Research:%20Making%20the%20Invisible%20Visible&rft.jtitle=Cambridge%20quarterly%20of%20healthcare%20ethics&rft.au=LAURIE,%20GRAEME%20T.&rft.date=2018-04&rft.volume=27&rft.issue=2&rft.spage=333&rft.epage=347&rft.pages=333-347&rft.issn=0963-1801&rft.eissn=1469-2147&rft_id=info:doi/10.1017/S0963180117000664&rft_dat=%3Cproquest_pubme%3E2011277465%3C/proquest_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2010871606&rft_id=info:pmid/29509122&rft_cupid=10_1017_S0963180117000664&rfr_iscdi=true