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“A Form of Practical Machinery”: The Origins of Research Ethics Committees in the UK, 1967–1972

Published online by Cambridge University Press:  07 December 2011

Adam Hedgecoe
Adam Hedgecoe
Affiliation:
Centre for Economic and Social Aspects of Genomics (Cesagen), 6 Museum Place, Cardiff University, Cardiff CF10 3BG, UK; e-mail: HedgecoeAM@cardiff.ac.uk
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Given the centrality of ethics review by independent committees (called Research Ethics Committees, or RECs, in the UK) to modern biomedical research, and the ubiquity of complaints about such review on the part of researchers, it is curious that little attention has been paid to these organizations by medical historians in contrast to the work done on the role of institutions such as the British Medical Association (BMA) and the General Medical Council (GMC) in the development of medical professional ethics, and the general evolution of medical professionals' ethical values. Thus while some work has explored the origins of modern medical ethics teaching in the UK and the parallel development of academic bioethics, there has been very little consideration of how Research Ethics Committees specifically were set up and evolved in the late 1960s and early 1970s. Although some scholars have discussed the development of the British REC system, this work tends to provide little beyond an outline of major events. These might include a report from the Royal College of Physicians (RCP) in 1967, the Department of Health's ‘Red Book’ of 1991 outlining the responsibilities of Local Research Ethics Committees (LRECs) and, more recently, the introduction of multicentre RECs (MRECs) in 1997.

Type
Articles
Information
Medical History , Volume 53 , Issue 3 , July 2009 , pp. 331 - 350
Copyright
Copyright © The Author(s) 2009. Published by Cambridge University Press

References

1Louise Robinson, Deborah Murdoch-Eaton and Yvonne Carter, ‘NHS research ethics committees’, Br. Med. J., 2007, 335: 6; P Wainwright and J Saunders, ‘What are local issues? The problem of the local review of research’, J. Med. Ethics, 2004, 30 (3): 313–17; Christopher Martyn, ‘The ethical bureaucracy’, Q. J. Med., 2003, 96 (5): 323–4; Iain Chalmers, ‘Lessons for research ethics committees’, Lancet, 2002, 359: 174; N R Dunn, A Arscott and R D Mann, ‘Costs of seeking ethics approval before and after the introduction of multicentre research ethics committees’, J. R. Soc. Med., 2000, 93 (10): 511–12; T E Stacey, ‘Ethical review of research in the NHS: the need for change’, J. R. Coll. Physicians Lond., 1998, 32 (3): 190–2; A E While, ‘Research ethics committees at work’, J. Med. Ethics, 1996, 22 (6): 352–5; Hans-Georg Eichler, ‘Hazards of misguided ethics committees’, Lancet, 1995, 346: 1115–16; U J Harries, P H Fentem, W Tuxworth and G W Hoinville, ‘Local research ethics committees: widely differing responses to a national survey protocol’, J. R. Coll. Phys. Lond., 1994, 28 (2): 150–4; M I Watling and J K Dewhurst, ‘Current experience of central versus local ethics approval in multicentre studies’, J. R. Coll. Phys. Lond., 1993, 27 (4): 399–402; T J Berry, T E Ades and C S Peckham, ‘Too many ethics committees’, Br. Med. J., 1990, 301: 1274; Editorial, ‘Research ethical committees’, Lancet, 7 May 1983, i: 1026; Peter J Lewis, ‘The drawbacks of research ethics committees’, J. Med. Ethics, 1982, 8 (2): 61–4.

2The best work on the context and early stages of REC development is offered by Jenny Hazelgrove, ‘The old faith and the new science: the Nuremberg Code and human experimentation ethics in Britain, 1946–73’, Soc. Hist. Med., 2002, 15 (1): 109–35; idem, ‘British research ethics after the second world war: the controversy at the British Postgraduate Medical School, Hammersmith Hospital’, in Volker Roelcke and Giovanni Maio (eds), Twentieth century ethics of human subjects research, Stuttgart, Franz Steiner, 2004, pp. 181–97.

3Russell G Smith, ‘The development of ethical guidance for medical practitioners by the General Medical Council’, Med. Hist., 1993, 37: 56–67; Andrew A G Morrice, ‘“Honour and interests”: medical ethics and the British Medical Association’, in Andreas-Holger Maehle and Johanna Geyer-Kordesch (eds), Historical and philosophical perspectives on biomedical ethics, Aldershot, Ashgate 2002, pp. 11–33; Ivan Waddington, ‘The development of medical ethics—a sociological analysis’, Med. Hist., 1975, 19: 36–51; Sydney A Halpern, Lesser harms: the morality of risk in medical research, Chicago University Press, 2004.

4M Whong-Barr, ‘Clinical ethics teaching in Britain: a history of the London Medical Group’, New Rev. Bioeth., 2003, 1 (1): 73–84; Roger Cooter, ‘The ethical body’, in Roger Cooter and John Pickstone (eds), Medicine in the twentieth century, Amsterdam, Harwood, 2000, pp. 451–68.

5Claire Foster, The ethics of medical research on humans, Cambridge University Press, 2001, pp.140–6; R E Ashcroft, ‘The ethics and governance of medical research: what does regulation have to do with morality?’ New Rev. Bioeth., 2003, 1 (1): 41–58.

6With regard to the impact on biomedical science, see S W G Derbyshire, ‘The rise of the ethics committee: regulation by another name?’, in James Panton and Oliver M Hartwick (eds), Science vs. superstition: the case for a new scientific enlightenment, London, Policy Exchange and University of Buckingham Press, 2006, pp. 35–50; Charles Warlow, ‘Clinical research is under the cosh again’, Br. Med. J., 2004, 329: 241–2; Konrad Jamrozik, ‘Research ethics paperwork: what is the plot we seem to have lost?’ Br. Med. J., 2004, 329: 286–7. Similar claims have been made about the impact of ethics review on social science: Robert Dingwall, ‘An exercise in fatuity: research governance and the emasculation of HSR’, J. Health Serv. Res. Policy, 2006, 11 (4): 193–4; idem, ‘ “Turn off the oxygen …”: comment on the presidential address’, Law and Soc. Rev., 2007, 41 (4): 787–95.

7W C van den Hoonaard, ‘Is research-ethics review a moral panic?’, Can. Rev. Sociol. Anthropol., 2001, 38 (1): 19–36; see also M H Fitzgerald, ‘Punctuated equilibrium, moral panics and the ethics review process’, J. Acad. Ethics, 2005, 2 (4): 1–24.

8Laura J M Stark, ‘Morality in science: how research is evaluated in the age of human subjects regulation’, PhD thesis, Princeton University, 2006, p. 32.

9Whong-Barr, op. cit., note 4 above; Susan E Lederer, ‘Research without borders: the origins of the Declaration of Helsinki’, in Roelcke and Maio (eds), op. cit., note 2 above, pp. 199–217.

10Albert R Jonsen, The birth of bioethics, New York, Oxford University Press, 1998.

11For example, David J Rothman, Strangers at the bedside: a history of how law and bioethics transformed medical decision making, New York, Basic Books, 1991.

12Roger Cooter, ‘The resistible rise of medical ethics’, Soc. Hist. Med., 1995, 8 (2): 257–70, p. 270.

13Stark, op. cit., note 8 above, p. 48.

14Ibid., p. 56.

15Hazelgrove, ‘The old faith and the new science’, op. cit., note 2 above.

16Medical Research Council, ‘Responsibility in investigations on human subjects’, in Report of the Medical Research Council for the year 1962–1963, London, HMSO, 1964, pp. 21–5. For a detailed exploration of the origins of this report, see Talitha Bolton, ‘Consent and the construction of the volunteer: institutional settings of experimental research on human beings in the cold war’, unpublished PhD thesis, University of Kent, 2008.

17World Medical Association declaration of Helsinki: ethical principles for medical research involving human subjects, Helsinki, World Medical Association, 1964.

18Austin Bradford Hill, ‘Medical ethics and controlled trials’, Br. Med. J., 20 April 1963, i: 1043–49, p. 1046.

19Helen S U Hodgson, ‘Medical ethics and controlled trials’, Br. Med. J., 18 May 1963, i: 1339–40, p. 1339.

20Reginald S Murley, ‘Medical ethics and controlled trials’, Br. Med. J., 1 June 1963, i: 1474–75; Peter N Grimshaw, ‘Medical ethics and controlled trials’, Br. Med. J., 29 June 1963, i: 1736.

21Editorial, ‘Ethics of human experimentation’, Br. Med. J., 6 July 1963, ii: 1–2.

22M H Pappworth, ‘Human guinea pigs: a warning’, The Twentieth Century, autumn 1962, pp. 66–75; idem, Human guinea pigs: experimentation on man, Harmondsworth, Penguin, 1969 [1967]; idem, ‘“Human guinea pigs”—a history’, Br. Med. J., 1990, 301: 1456–60; Christopher Booth, ‘Maurice Pappworth, MD, FRCP’, Br. Med. J., 1994, 309: 1577–78; Stephen Lock, ‘Obituary: Dr Maurice Pappworth’, Independent, 12 Nov. 1994, p. 42; Paul J Edelson, ‘Henry K. Beecher and Maurice Pappworth: honor in the development of the ethics of human experimentation’, in Roelcke and Maio (eds), op. cit., note 2 above, pp. 219–33.

23Hazelgrove, ‘British research ethics’, op. cit., note 2 above, p. 191.

24Pappworth, Human guinea pigs, op. cit., note 22 above, p. 252.

25Office of the Surgeon General (1966), ‘Investigations involving human subjects, including clinical research’, Memo to the Heads of Institutions Receiving Public Health Service Grants from the Surgeon General, 1 July 1966. Policy and Procedure Order 129.

26Interview, Desmond Laurence, July 2007.

27Royal College of Physicians Archive (hereafter RCP), letter to Professor Max Rosenheim, President Royal College of Physicians from F Avery Jones, A C Dornhorst and D R Laurence, 5 Sept. 1966.

28RCP, letter from Max Rosenheim to F Avery Jones, A C Dornhorst and D R Laurence, 24 Oct. 1966.

29RCP Archive, letter from Registrar of RCP to F A Jones, 9 Jan. 1967.

30Royal College of Physicians of London, Report of the Committee on the supervision of the ethics of clinical investigations in institutions, London, RCP, 1967, p. 4.

31Years later Desmond Laurence wrote to Pappworth, pointing out that although the RCP report predated Pappworth's recommendations concerning RECs in his book, “I have no doubt your 1962 article prepared people's minds for it, including mine when I drafted the letter signed by Dornhurst and Avery Jones in 1966”: Wellcome Library, Archives and Manuscripts, PP/MHP/C.5, letter from Desmond Laurence to Maurice Pappworth, 10 May 1990. This point was reiterated to me in an interview with Laurence in July 2007.

32National Archives, Kew (hereafter NA), FD 9/869, letter from Harold Himsworth to Max Rosenheim, 22 June 1967.

33Although the MRC debated the issues raised by the report for its practices and policies: NA, FD 9/869, memo to Sir Harold [Himsworth], 20 Oct. 1967.

34NA, FD 9/869, letter from Brandon Lush to Sir Peter Medawar, 9 April 1968. The opportunistic, researcher-led nature of the setting up of this committee is supported by the fact that in the autumn of 1970 the NIMR committee was closed down, partly because it had so little work to do: NA, FD 9/869, memo from Brandon Lush, 30 Sept. 1970.

35NA, FD 9/869, letter from Brandon Lush to J S Weiner, 30 April 1968.

36S Westman-Naeser, ‘Current experiences in the Nordic countries’, in Peter Bennett (ed.), Good clinical practice and ethics in European drug research, Bath University Press, 1994, pp. 27–35.

37M H Pappworth, ‘Experiments on man’ Br. Med. J., 2 Sept. 1967, iii: 616.

38M Rosenheim, ‘Supervision of the ethics of clinical investigations in institutions’, Br. Med. J., 12 Aug. 1967, iii: 429–30.

39Wellcome Library, Archives and Manuscripts, PP/MHP/C.1/6, letter from Helen Hodgson to Maurice Pappworth, c. March 1963.

40NA, MH 160/883, letter from Helen Hodgson to Rt. Hon. Kenneth Robinson, Minister of Health, 18 Aug. 1967.

41MRC, op. cit., note 16 above.

42NA, MH 160/883, letter from G E Godber to all consultants in the Hospital Service ref: H/R125/22, 17 July 1967.

43NA, MH 160/883, memo from M R Edwards to Mr Morris, ref: H.S.1A A517, 25 Aug. 1967.

44Rudolph Klein, The new politics of the NHS, 4th ed., Harlow, Prentice Hall, 2001, p. 64.

45NA, MH 160/883, memo from D J Morris to Mr Hales, 31 Aug. 1967.

46NA, MH 160/883, memo from J C Hales to Mr Morris, 7 Sept. 1967.

47NA, MH 160/883, letter from G E Godber to Sir Thomas Holmes Sellers, 8 June 1967.

48NA, MH 160/883, memo from J C Hales to Mr Morris, ref: P.S.O./823/20, 7 Sept. 1967.

49NA, MH 160/883, memo from D J Morris to Mr Hales, 8 Sept. 1967.

50NA, MH 160/883, memo from D J Morris to Mr Salter and Dr Cohen, 6 Oct. 1967.

51NA, MH 160/883, memo from H C Salter to Dr Cohen, 1 Nov. 1967.

52NA, MH 160/883, memo from R H L Cohen to Mr Salter and CMO, 14 Nov. 1967.

53NA, MH 160/883, memo from H C Salter to CMO, 17 Nov. 1967.

54NA, MH 160/883, memo from G E Godber to Dr Cohen, 27 Nov. 1967.

55NA, MH 160/883, meeting with Secretaries of Board of Governors of Provincial teaching hospitals, Supplement to brief, ref: SEC. B.G.4/68, 1 May 1968.

56The origin of the decision to circulate the RCP report itself (rather than a summary, for example) is unclear. Writing two years later, one official suggested that the idea “seems to have come from us [i.e. the Ministry], nudged by the Patients Assn”: NA, MH 160/884, memo 41, from Chambers to Mr Taggart, 3 Dec. 1969.

57NA, MH 160/883, memo from D J Morris to Dr McGregor and Dr Evans, 8 March 1968.

58NA, MH 160/883, memo from Kenneth Robinson, 21 March 1968. This is an interpretation of the memos (which refer to additions to the “penultimate paragraph” or “paragraph three” of the circular) without actual sight of the draft circular itself, which is not included in the records.

59NA, MH 160/883, memo from H C Salter to Mrs Hauff, 15 March 1968.

60NA, MH 160/883, memo from N J Evans to Mr Morris, 12 March 1968.

61Ministry of Health, Supervision of the ethics of clinical investigations, 1968, HM68(33).

62NA, MH 160/883, letter from G E Godber, CMO to SAMOs, 3 May 1968.

63The printing orders suggest that 11,500 copies of the circular, 11,200 copies of the CMO's letter to consultants and 25,000 copies of the RCP report were printed off. Distribution lists suggest that copies of the CMO's letter and the RCP report were actually sent to 8094 consultants via SAMOs and 2867 consultants at teaching hospitals in the first instance.

64NA, MH 160/884, memo from D J Morris to Mr Hales and Dr Gregor, 29 May 1968.

65NA, MH 160/884, letter from U Miller (Hon. Secretary PA) to R S Mathews, 16 May 1968.

66NA, MH 160/884, letter from M I Brabant to U Miller, 3 June 1968.

67NA, MH 160/884, letter from Elizabeth Brooks to Mr Peel, 16 May 1968. This letter was forwarded to the Ministry by John Peel, the author's MP.

68NA, MH 160/884, letter from Julian Snow to John Peel, MP, ref: A2788/18, July 1968.

69NA, MH 160/884, memo 12 from D J Morris to CMO, 13 Aug. 1968.

70NA, MH 160/884, letter from W J Tarlton to DHSS, 19 Nov. 1968.

71NA, MH 160/884, letter from D J Morris to W J Tarlton, 13 Dec. 1968.

72NA, MH 160/884, letter from Max Rosenheim to G E Godber, 24 Oct. 1969.

73NA, MH 160/884, letter from G E Godber to Max Rosenheim, 31 Oct. 1969. Godber clearly thought that the RCP would “get better co-operation from doctors themselves than the Department would”: NA, MH 160/884, memo from G E Godber to Dr Yellowlees and Dr Cohen, 31 Oct. 1969.

74NA, MH 160/884, letter from Helen Hodgson to P R Molineux, 11 March 1970.

75NA, MH 160/884, memo 47 from D J Clark to Mr Molineux, 21 April 1970.

76NA, MH 160/884, letter from P R Molineux to H Hodgson, 23 April 1970.

77NA, MH 160/884, letter from C Cox to P R Molineux, 25 June 1970; NA, MH 160/884, letter from General Secretary to P R Molineux, 21 Oct. 1970.

78NA, MH 160/884, letter from P R Molineux to C Cox, 3 July 1970.

79NA, MH 160/884, letter from H Hodgson to P R Molineux, 16 Nov. 1970.

80NA, MH 160/884, letter from C M Hallett to Secretary, RCP, 16 Nov. 1970.

81NA, MH 160/884, letter from G M G Tibbs to C M Hallett, 26 Nov. 1970.

82NA, MH 160/884, letter from G D Forwell to D J Morris, 3 Feb. 1971.

83NA, MH 160/884, memo 67 from V Poole to Dr J Wilson, 20 April 1971.

84Royal College of Physicians of London, Committee on the Supervision of the ethics of Clinical Investigations in institutions, A follow up enquiry for the College, April 1971.

85NA, MH 160/884, letter from G M G Tibbs to C M Hallett, 20 May 1971.

86RCP, op. cit., note 84 above, p. 2.

87Ibid., p. 5.

88NA, MH 160/884, letter from U Miller, no addressee, 24 May 1971.

89NA, MH 160/884, memo 1 from G R A Gill to Mr Smith, 11 June 1971.

90NA, MH 160/884, memo 2 from Mr Smith to Dr Archibald, 30 June 1971.

91NA, MH 160/884, memo 6 from Dr McGregor to Dr Archibald, 20 July 1971.

92NA, MH 160/884, memo 9 from Mr Yates to Miss Wavish, 13 Aug. 1971.

93NA, MH 160/884, letter from G E Godber to Max Rosenheim, 1 June 1971.

94NA, MH 160/884, letter from G M C Tibbs to H S U Hodgson, 14 July 1971.

95Parliamentary Question from Joyce Butler, Hansard, HC (series 5), vol. 822, col. 59 (27 July 1971).

96NA, MH 160/884, letter from Helen Hodgson to Sir Keith Joseph, 16 Aug. 1971.

97NA, MH 160/884, memo from Smith to Brandis, 13 Sept. 1971.

98NA, MH 160/884, letter from Michael Allison to Joyce Butler MP, 30 Sept. 1971.

99NA, MH 160/884, memo from L H Brandis to Mr Qades, 15 Sept. 1971.

100NA, MH 160/884, letter from H Hodgson to Sir Keith Joseph, 14 Oct. 1971.

101‘London hospitals reject new allegations of unjustified experiments on patients’, The Times, Wed. 13 Oct. 1971, issue 58297, page 2.

102NA, MH 160/884, meeting of Secretaries of London Boards of Governors on 21 October 1971, Brief for Chairman (Mr J S Orme).

103NA, MH 160/884, memo 2 from Smith to Miss Wavish and Mr Brandis, 22 Oct. 1971.

104NA, MH 160/884, memo 3 from unknown to Dr Cohen, n.d (23 or 24 Oct. 1971).

105NA, MH 160/884, memo 5 from unclear to Mr Brandis, 26 Oct. 1971.

106William Molloy, Adjournment debate, Hansard, HC (series 5) vol. 825, cols. 320–323 (3 Nov. 1971).

107Michael Alison, Adjournment debate, Hansard, HC (series 5), vol. 825, cols. 324–328 (3 Nov. 1971).

108NA, MH 160/185, memo 3 from W E Wavish to Mr Smith, 21 Dec. 1971.

109Ibid.

110Ibid.

111RCP, op. cit., note 84 above, p. 1.

112NA, MH 160/185, memo 14 from E R Hammer to Mr Gidden, 3 March 1972.

113Michael Alison, written answer, Hansard, HC (series 5), vol. 829, col. 550 (28 Jan. 1972).

114Hazelgrove, both references cited in note 2 above.