Literature DB >> 16260798

Research governance: where did it come from, what does it mean?

Sara Shaw1, Petra M Boynton, Trisha Greenhalgh.   

Abstract

For a variety of historical and social reasons, research has become increasingly formalized and regulated. This change has potential benefits (reduction in fraud and misconduct, protection of vulnerable groups, financial probity) but also disadvantages (increased paperwork, time delays, constraints on research freedom). The terms 'research' and 'governance' mean different things in different contexts. Even with explicit guidance, ambiguities must be resolved by human judgement. Variation in the nature and outcome of approval decisions is therefore a fact of life. The type of approval needed for a research study depends on the official remit of the approval body, the question to be addressed; the methods to be used; the context in which the work will take place; the level of analysis and interpretation; and the plans for how the findings will be presented and used.

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Year:  2005        PMID: 16260798      PMCID: PMC1275997          DOI: 10.1177/014107680509801110

Source DB:  PubMed          Journal:  J R Soc Med        ISSN: 0141-0768            Impact factor:   18.000


  19 in total

1.  Clinical trials in developing countries: a review of the moral issues.

Authors:  D P Lackey
Journal:  Mt Sinai J Med       Date:  2001-01

2.  Uses and abuses of Tuskegee.

Authors:  A L Fairchild; R Bayer
Journal:  Science       Date:  1999-05-07       Impact factor: 47.728

3.  Bureaucracy of ethics applications.

Authors:  David S Wald
Journal:  BMJ       Date:  2004-07-31

4.  Academic clinical research in the new regulatory environment.

Authors:  Brian Gennery
Journal:  Clin Med (Lond)       Date:  2005 Jan-Feb       Impact factor: 2.659

5.  Sharing stories: complex intervention for diabetes education in minority ethnic groups who do not speak English.

Authors:  Trisha Greenhalgh; Anna Collard; Noorjahan Begum
Journal:  BMJ       Date:  2005-03-19

6.  Determining when quality improvement initiatives should be considered research: proposed criteria and potential implications.

Authors:  D Casarett; J H Karlawish; J Sugarman
Journal:  JAMA       Date:  2000-05-03       Impact factor: 56.272

7.  Over-regulation of clinical research: a threat to public health.

Authors:  Charles Warlow
Journal:  Clin Med (Lond)       Date:  2005 Jan-Feb       Impact factor: 2.659

8.  Returning to the Alder Hey report and its reporting: addressing confusions and improving inquiries.

Authors:  S Dewar; P Boddington
Journal:  J Med Ethics       Date:  2004-10       Impact factor: 2.903

9.  When does quality improvement count as research? Human subject protection and theories of knowledge.

Authors:  J Lynn
Journal:  Qual Saf Health Care       Date:  2004-02

10.  Oversight of quality improvement: focusing on benefits and risks.

Authors:  Bernard Lo; Michelle Groman
Journal:  Arch Intern Med       Date:  2003-06-23
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  10 in total

1.  The Department of Health's research governance framework remains an impediment to multi-centre studies: findings from a national descriptive study.

Authors:  Tara Kielmann; Alison Tierney; Rosemary Porteous; Guro Huby; Aziz Sheikh; Hilary Pinnock
Journal:  J R Soc Med       Date:  2007-05       Impact factor: 5.344

2.  Changes in the institutional review board submission process for multicenter research over 6 years.

Authors:  Monika Pogorzelska; Patricia W Stone; Elizabeth Gross Cohn; Elaine Larson
Journal:  Nurs Outlook       Date:  2010 Jul-Aug       Impact factor: 3.250

3.  Patient informed governance of distributed research networks: results and discussion from six patient focus groups.

Authors:  Laura A Mamo; Dennis K Browe; Holly C Logan; Katherine K Kim
Journal:  AMIA Annu Symp Proc       Date:  2013-11-16

4.  Research governance impediments to clinical trials: a retrospective survey.

Authors:  Rustam Al-Shahi Salman; Timothy M Brock; Martin S Dennis; Peter A G Sandercock; Philip M White; Charles Warlow
Journal:  J R Soc Med       Date:  2007-02       Impact factor: 5.344

5.  Increasing value and reducing waste in biomedical research regulation and management.

Authors:  Rustam Al-Shahi Salman; Elaine Beller; Jonathan Kagan; Elina Hemminki; Robert S Phillips; Julian Savulescu; Malcolm Macleod; Janet Wisely; Iain Chalmers
Journal:  Lancet       Date:  2014-01-08       Impact factor: 79.321

6.  Bureaucracy stifles medical research in Britain: a tale of three trials.

Authors:  Helen Snooks; Hayley Hutchings; Anne Seagrove; Sarah Stewart-Brown; John Williams; Ian Russell
Journal:  BMC Med Res Methodol       Date:  2012-08-16       Impact factor: 4.615

Review 7.  Research governance: ethical issues.

Authors:  Anne Slowther; Petra Boynton; Sara Shaw
Journal:  J R Soc Med       Date:  2006-02       Impact factor: 18.000

8.  Towards equitable genomics governance in Africa: Guiding principles from theories of global health governance and the African moral theory of Ubuntu.

Authors:  Nchangwi Syntia Munung; Jantina de Vries; Bridget Pratt
Journal:  Bioethics       Date:  2022-01-18       Impact factor: 2.512

9.  Patient Governance in a Patient-Powered Research Network for Adult Rheumatologic Conditions.

Authors:  W Benjamin Nowell; Jeffrey R Curtis; Rachelle Crow-Hercher
Journal:  Med Care       Date:  2018-10       Impact factor: 2.983

10.  Using evidence when planning for trial recruitment: An international perspective from time-poor trialists.

Authors:  Heidi R Gardner; Shaun Treweek; Katie Gillies
Journal:  PLoS One       Date:  2019-12-10       Impact factor: 3.240

  10 in total

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