Literature DB >> 16388050

Research governance: regulating risk and reducing harm?

Sara Shaw1, Geraldine Barrett.   

Abstract

Risk assessment can be thought of as the lens through which we anticipate the consequences of research and the impact of the actions of researchers. The way in which risk of harm is managed in research is strongly influenced by the surrounding social and political environment, leading to differences in national and local styles of regulation and review. Different research studies carry different risks, so systems for review and approval must adapt to the question being asked and the nature of the study. Researchers can never wholly guarantee safety in any research but participants and researchers must be offered reasonable protection within any study, with appropriate arrangements in place should something go wrong.

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Year:  2006        PMID: 16388050      PMCID: PMC1325075          DOI: 10.1177/014107680609900109

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


  19 in total

1.  A sociological account of the growth of principlism.

Authors:  J H Evans
Journal:  Hastings Cent Rep       Date:  2000 Sep-Oct       Impact factor: 2.683

2.  The case for a new system for oversight of research on human subjects.

Authors:  K Jamrozik
Journal:  J Med Ethics       Date:  2000-10       Impact factor: 2.903

3.  The organ retention furore: the need for consent.

Authors:  J R Bennett
Journal:  Clin Med (Lond)       Date:  2001 May-Jun       Impact factor: 2.659

4.  The concept of risk in biomedical research involving human subjects.

Authors:  P H Van Ness
Journal:  Bioethics       Date:  2001-08       Impact factor: 1.898

Review 5.  Risk, Helsinki 2000 and the use of placebo in medical research.

Authors:  John Saunders; Paul Wainwright
Journal:  Clin Med (Lond)       Date:  2003 Sep-Oct       Impact factor: 2.659

Review 6.  Why we should not seek individual informed consent for participation in health services research.

Authors:  J Cassell; A Young
Journal:  J Med Ethics       Date:  2002-10       Impact factor: 2.903

7.  DECLARATION OF HELSINKI. RECOMMENDATIONS GUIDINGS DOCTORS IN CLINICAL RESEARCH.

Authors:  I A RITS
Journal:  World Med J       Date:  1964-09

8.  Collective danger and individual risk: cultural perspectives on the hazards of medical research.

Authors:  D B Parker; R J Barrett
Journal:  Intern Med J       Date:  2003 Sep-Oct       Impact factor: 2.048

9.  Bereaved parents' experience of research participation.

Authors:  Kari Dyregrov
Journal:  Soc Sci Med       Date:  2004-01       Impact factor: 4.634

Review 10.  Confidentiality and the public interest in medical research--will we ever get it right?

Authors:  Michel P Coleman; Barry G Evans; Geraldine Barrett
Journal:  Clin Med (Lond)       Date:  2003 May-Jun       Impact factor: 2.659

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  5 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.  Regulation and the social licence for medical research.

Authors:  Mary Dixon-Woods; Richard E Ashcroft
Journal:  Med Health Care Philos       Date:  2008-07-17

3.  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

4.  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

5.  Conducting a prospective evaluation of the development of a complex psycho-oncological care programme (isPO) in Germany.

Authors:  Sandra Salm; Natalia Cecon; Imke Jenniches; Holger Pfaff; Nadine Scholten; Antje Dresen; Theresia Krieger
Journal:  BMC Health Serv Res       Date:  2022-04-22       Impact factor: 2.908

  5 in total

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