Research governance: Panacea or problem?

Clinical Medicine, Journal of the Royal College of Physicians of London

Volumn 5, Issue 3, 2005, Pages 235-239

  Samanta, Ash ^a,c   Samanta, Jo ^b  

^a UNIVERSITY HOSPITALS OF LEICESTER NHS TRUST   (United Kingdom)

^b DE MONTFORT UNIVERSITY   (United Kingdom)

^c LEICESTER ROYAL INFIRMARY   (United Kingdom)

Author keywords

Central Office for Research Ethics Committees (COREC); European Union Clinical Trials Directive; Implications for NHS research; Medical research; NHS research; Research; Research governance

Indexed keywords

CLINICAL RESEARCH; CLINICAL TRIAL; ETHICS; HEALTH CARE DELIVERY; HEALTH CARE QUALITY; LAW; LEGAL ASPECT; MEDICAL STAFF; MONITOR; ORGANIZATION; RESPONSIBILITY; REVIEW;

EID: 21744461319     PISSN: 14702118     EISSN: None     Source Type: Journal    
DOI: 10.7861/clinmedicine.5-3-235     Document Type: Review

References (39)

1. www.dh.gov.uk/PolicyAndGuidance/ResearchAndDevelopment/
2. Halligan A, Donaldson L. Implementing clinical governance: turning vision into reality. BMJ 2001;322:1413-17.
3. Wingfield K, Ormond-Walshe S, Ray S. Risks in the advancement of medicine. New Law J 2002;152:325-6.
4. NHS Executive West Midlands Regional Office. Report of a review of the research framework in North Staffordshire Hospitals NHS Trust (Griffiths Report). Leeds: NHS Executive, 2000. www.doh.gov.uk/wmro/northstaffs.htm
5. Hey E, Chalmers I, Griffiths R, Stacey T, Struthers J. Investigating allegations of research misconduct: the vital need for due process. BMJ 2000;321:752.
6. Smith R. Babies and consent: yet another NHS scandal [editorial]. BMJ 2000;320:1285-6.
7. Ferriman A. Consultant suspended for research fraud. BMJ 2000; 321:1429.
8. Dyer C. Consultant struck off over research fraud. BMJ 1997;315: 205-10.
9. Lock S, Wells F. Fraud and misconduct in medical research. London: BMJ Publishing, 1996.
10. Wells FO. Ethical issues in the pharmaceutical industry. Br J Urology 1995;76(Suppl 2):41-7.
11. Woods K. Implementing the European Clinical Trials Directive. BMJ 2004;328:240-41.
12. Mayor S. Squeezing academic research into a commercial straitjacket. BMJ 2004;328:1036.
13. Moulton B. Save European Research Campaign. BMJ 2004;328:286.
14. AG's Reference Case No 6 of 1980 [1981] 2 All ER 1057, R v Brown [1994] 2 All ER 75.
15. Royal College of Physicians. Research involving patients. Report of a Working Party. London: RCP, 1990.
16. Samanta A, Samanta J. Legal standard of care: a shift from the traditional Bolam test. Clin Med 2003;3:443-6.
17. Samanta J, Dunford R, Samanta A. Chester v Afshar: implications for clinical negligence. Health Care Risk Report 2005;11:22-3.
18. Peto J. Data protection, informed consent, and research. BMJ 2004; 328:1029-30.
19. Wanless D. Securing good health for the whole population. Final report, 25 February 2004. www.hm-treasury.gov.uk/consultations_and_ legislation/wanless
20. Samanta A, Samanta J, Price D. Who owns my body - thee or me? The human tissue story continues. Clin Med 2004;4:327-31.
21. Stauch M, Wheat K, Tingle J. Sourcebook on medical law, 2nd edn. London: Cavendish, 2002.
22. General Medical Council. Research: the role and responsibilities of doctors. February 2002. www.gmc-uk.org/standards/research.htm. Accessed 27/01/2005
23. Mason JK, McCall Smith RA, Laurie GT. Law and medical ethics, 6th edn. London: Butterworths, 2002.
24. Saunders J. Developing clinical ethics committees. Clin Med 2004; 4:232-4.
25. Warlow C. Clinical research under the cosh again. BMJ 2004;329:241-2.
26. Ward HJT, Cousens SN, Smith-Bathgate B, Leitch M et al. Obstacles to conducting epidemiological research in the UK general population. BMJ 2004;329:277-9.
27. Central Office for Research Ethics Committees. The ethical governance and regulation of student projects: a proposal. London: COREC: January 2004. Accessed at www.corec.org.uk/applicants/index 16 December 2004.
28. Wald DS. Bureaucracy of ethics applications. BMJ 2004;329:282-4.
29. Jamrozick K. Research ethics paperwork: what is the plot we seem to have lost? BMJ 2004;329:286-7.
30. Jones A M, Bamford B. The other face of research governance. BMJ 2004;329:280-1.
31. Parker M, Ashcroft B, Wilkie AOM, Kent A. Ethical review of research into rare genetic disorders. BMJ 2004;329:288-9.
32. Glasziou P, Chalmers I. Ethics review roulette: what can we learn? BMJ 2004;328:121-2.
33. Pattison J, Stacey T. Seeking a balance: response from the Department of Health and COREC. BMJ 2004;329:622.
34. Wainwright P, Saunders J. What are local issues? The problem of the local review of research. J Med Ethics 2004;30:313-17.
35. Research Governance Framework for Health and Social Care, www.dh.gov.uk - Second draft published April 2003.
36. Ferguson PR. Legal and ethical aspects of clinical trials: the views of researchers. Med Law Rev 2003;11:48-66.
37. Meredith S. Commentary: better support for investigators is essential. BMJ 2004;329:285.
38. Soteriou P, Hek G. Research governance and students: what are NHS Trusts looking for? Nurse Researcher 2004;11:22-31.
39. Samanta A, Samanta J. Regulation of the medical profession: fantasy, reality and legality. JRSM 2004;97:211-18.