Reforming research ethics committees
BMJ 2005; 331 doi: https://doi.org/10.1136/bmj.331.7517.587 (Published 15 September 2005) Cite this as: BMJ 2005;331:587
All rapid responses
Rapid responses are electronic comments to the editor. They enable our users to debate issues raised in articles published on bmj.com. A rapid response is first posted online. If you need the URL (web address) of an individual response, simply click on the response headline and copy the URL from the browser window. A proportion of responses will, after editing, be published online and in the print journal as letters, which are indexed in PubMed. Rapid responses are not indexed in PubMed and they are not journal articles. The BMJ reserves the right to remove responses which are being wilfully misrepresented as published articles or when it is brought to our attention that a response spreads misinformation.
From March 2022, the word limit for rapid responses will be 600 words not including references and author details. We will no longer post responses that exceed this limit.
The word limit for letters selected from posted responses remains 300 words.
Royal College of Physicians (RCP) Guidelines advise Research Ethics
Committees (RECs) that ‘a [clinical trial] protocol should not be given
[by RECs] an unfavourable opinion on the grounds of [the protocol’s]
supposed illegality’ [1]. That is momentous legal advice; for without REC
favourable opinion it is illegal for a clinical trial to proceed [2].
The Department of Health (DH) endorsed the RCP’s legal advice, in a
published joint letter to the RECs [3].
But now the DH, through its National Research Ethics Service (NRES),
has issued a new draft of its GAfREC (Governance Arrangements for Research
Ethics Committees) [4]. The new draft accepts, at last, what I have been
pointing out [5]. For DH/NRES now admits: ‘RECs must operate according to
the law’. So RECs cannot, after all, express favourable opinion of
clinical trials they in reality think illegal. For the law requires RECs
to ensure that the ‘rights, safety, and well-being of the trial subjects .
. . prevail over the interests of science and society’ [6].
But curiously, DH/NRES adds that RECs (when deciding whether or not
to assent to research proposals before them) need only apply the criteria
set out in law ‘where required’. So are we to understand that the
Secretary of State is seeking to procure breaches of the law? For REC
members will now ponder whether they have been ‘required’, by the trial
sponsor or somebody, to apply the law’s criteria. Yet the requirement to
obey the law arises only from the law itself.
The Department’s notorious endorsement of the RCP’s indefensible
subversion of the law puts REC members on enquiry. For REC members in
breach of the law have unlimited personal liability to injured subjects.
Legal advice offered to REC members by professional and public bodies
decidedly does not have the force of law. REC members should demand the
origin and provenance of such gratuitous advice.
The RCP has admitted that it issued its advice to RECs (that they
ought to assent to trials protocols they think illegal) without itself
taking ‘formal legal opinion’ [7].
So will the DH now disclose what legal opinion it may have obtained
supporting its own idea that the law need be obeyed sometimes, but
sometimes need not?
And may we know who is expected to profit from the breaches of the
law the Department, and the Royal College, envisage?
References
1. Guidelines on the practice of ethics committees in medical
research with human participants: fourth edition. Royal College of
Physicians, September 2007 (para 4.2)
2. Medicines for Human Use (Clinical Trials) Regulations 2004
(Statutory Instrument 2004, No.1031): Part 3(12): and Schedule 1: Part
2(3)
3. nres.npsa.nhs.uk/joint-letter-from-rcp-dh-and-nres
4. nres.npsa.nhs.uk/. . . /harmonized-gafrec-consultation :[para
3.2.10]
5. Correspondence between Laurence DR; Saunders J; Jackson E; Gilmore
IT, http.bmj.com/cgi/eletters/331/7517 (Rapid Response to Ashcroft et al.
6 November 2007 to 12 February 2009)
6. See Ref 2 above: Schedule 1 : Part 2(3)
7. Personal communication from the President of the RCP, 4 March
2008.
Competing interests:
Professor Emeritus
University of London:
past member RCP Committee for Etical Issues in Medicine
Competing interests: No competing interests
Re: And who shall guide the guides? Illegal clinical trials to get Research Ethics Committee assent.
The Medicines for Human Use (Clinical Trials) Regulations 2004 make
it illegal for anyone to start a clinical trial unless a Research Ethics
Committee (REC) has expressed a ‘favourable opinion’ of the protocol [1].
The same law also sets out the basis upon which REC members shall
arrive at their opinion, by imposing conditions and principles that apply
to all clinical trials, including: “The rights, safety, and well-being of
the trial subjects are the most important considerations and shall prevail
over the interests of science and society” [Sch.1 Pt2(3)].
But in a move calculated to subvert the 2004 law, the Royal College
of Physicians (RCP) has advised REC members that: “A protocol [of a
proposed clinical trial] should not be given [by a REC] an unfavourable
opinion on the grounds of [the protocol’s] supposed illegality” [2].
In a recent paper, the barrister Christopher Roy-Toole has shown that
the RCP’s advice is ‘wrong in law’ [3].
The Department of Health and the RCP are now sending to all RECs a
joint letter to ‘reassure’ the RECs that Roy-Toole is ‘erroneous’ [4]. But
the DH/RCP derive their view from their own startling misrepresentation of
Pt.2, S.7(3) of the 2004 law. For the passage they cite does not contain a
statutory definition of the role of a recognised REC (as DH/RCP claim
it does), nor does the passage absolve RECs from their duty under the law
to provide reliable public assurance of patient protection.
Happily, and as Roy-Toole has pointed out, RECs need only obey the
law and should not act on mistaken views offered by official or
professional bodies baffled by competing interests.
As I have said elsewhere, if it were right that a REC could lawfully
express a favourable opinion upon the protocol of what it believed to be
an illegal clinical trial, then that fact would, as a matter of law, have
to be declared to prospective patient or other volunteers [5].
The President of the RCP has declined to cite any legal authority
supporting its bizarre legal advice to RECs. But a distinguished
barrister, Sally Smith QC, sits on the RCP’s Committee for Ethical Issues
in Medicine. In private correspondence with me Sally Smith has refused say
whether or not she believes her committee’s advice (in para 4.2 of the RCP
Guidelines) to be correct law.
I now call upon Sally Smith QC publicly to answer that simple point,
and publicly to cite legal authority for her answer.
References:
1 Medicines for Human Use (Clinical Trials) Regulations 2004.
No.1031. Parts 2,3, Schedule 1.
www.opsi.gov.uk/si/si2004.20041031.html#sch1 (accessed August 2006) (minor
revisions 2006)
2 Guidelines on the practice of ethics committees in medical research with
human participants, Royal College of Physicians, Fourth Edition, September
2007, para 4.2
3 Roy-Toole, C., Illegality in the research protocol: duty of research
ethics committees under the 2001 Clinical Trials Directive. Res Ethics Rev
2008; 4(3): 111-116
4 Taylor, C. Marc; Saunders, J.; & Davies, H., Letter: Research Ethics
Committees and legal opinion (shortened version). Res Ethics Rev 2008;
4(4): 165-166
5 Laurence, D. R., Guide, Guide Thyself: Law & Order in Clinical
Research. Res Ethics Rev 2008; 4(2): 69-72
Competing interests:
Previously member of the Royal College of Physicians Committee for Ethical Issues in Medicine
Competing interests: No competing interests
No person may legally start a clinical trial unless a Research Ethics
Committee (REC) has expressed a favourable opinion upon its protocol [1].
The Royal College of Physicians (RCP), in its new Guidelines on the
Practice of Ethics Committees in Medical Research with Human Participants,
advises REC members that they legally have, and should exercise, a power
to express a favourable opinion of a clinical trial protocol when in truth
they believe the protocol to be illegal [2]. I have argued that this (and
other advice in the Guidelines) is incorrect legal advice which, if
followed, would deprive ‘human participants’ of the protection the law
prescribes [3].
In a published letter of 13th December 2007 the President of the RCP
countered that my ‘assertions about the law are not accepted by legal
opinion available [to the RCP] both before and after publication [of the
Guidelines]’ [3].
Now a college of medical doctors is no natural repository of legal
expertise. So when it is issuing legal advice for others to rely upon,
‘legal opinion available to us’ can only mean counsel’s opinion (from an
eminent and independent QC).
I subsequently pressed for the publication of the opinion [3]. On 4th
March 2008 the President wrote to me refusing to publish it and refusing
to name its source. It had ‘not been sought in the context of a formal
legal opinion’.
I am grateful to the President for his admission. But members of
Research Ethics Committees have only a limited appointing-authority
indemnity [4, 5]. So it will not do for the Royal College of Physicians to
fob them off with views obtained informally from people whose
qualifications, affiliations, conflicting interests and identities are all
to be kept secret.
If the College insists that the legal advice it presumes to issue is
correct, let it now obtain and publish the ‘formal legal opinion’ of a QC
who concurs.
Email: d.laurence@virgin.net
References:
1. Medicines for Human Use (Clinical Trials) Regulations 2004.
No.1031. Part 3, 12.
2. Guidelines on the Practice of Ethics Committees in Medical
Research with Human Participants, Fourth edition, Royal College of
Physicians, September 2007, p.27 para 4.2.
3. Correspondence between Laurence D R; Saunders J; Gilmore I T,
http://www.bmj.com/cgi/eletters/331/7517/587 (Rapid Responses to Ashcroft
et al.), (2007-2008).
4. Department of Health: Governance Arrangements for NHS Research
Ethics Committees (GAfREC) (Section A 4.14) www.dh.gov.uk publications
GAfREC
5. Steiner T J. Indemnity for REC members. Research Ethics Review
2006; 2: 39.
Competing interests:
Previously member of Royal College of Physicians Committee for Ethical Issues in Medicine, and Chair of a Research Ethics Committee
Competing interests: No competing interests
Hugh Davies (BMJ Rapid Responses 3 March 2008) says that a Research
Ethics Committee (REC) ought not to give legal advice to others. I had, of
course, agreed with that myself, in the letter to which Hugh Davies
responds: for a REC would be foolish to presume to dispense legal advice.
The Royal College of Physicians (RCP) in its Guidelines for RECs
(para 4.2) also agrees, but goes on to add something quite different, and
quite extraordinary: ‘. . . and a protocol [of a proposed clinical trial]
should not be given [by a REC] an unfavourable opinion on the grounds of
[the protocol’s] supposed illegality’. [1]
The Medicines for Human Use (Clinical Trials) Regulations 2004 is not
an official’s opinion: it is the law. REC members are bound to obey it.
And it provides that no-one may legally start a clinical trial unless a
REC has expressed a favourable opinion upon its protocol.
Hugh Davies is suggesting that REC members need not trouble to
consider, in each clinical trial application before them, whether or not
it is legal for them to express a favourable opinion of its protocol. Yet
it is manifestly illegal for REC members to express a favourable opinion
of a protocol which they believe to be illegal: because they have at that
time no favourable opinion to express. There is nothing in what John
Saunders has said (BMJ Rapid Responses 5 March 2008) which even attempts
to counter this crucial point. For a REC may not abdicate to the sponsor
its own legal responsibilities: the sponsor must persuade the REC that the
protocol is legally compliant; or the sponsor must change the protocol so
that it becomes compliant.
Both John Saunders and Hugh Davies cite, as though they were law,
guidelines issued by their respective organisations. But they are not law,
they are opinion and advice. The decision-making of RECs is now governed
by law. When official, professional, or any other guidelines are
calculated to procure breaches of the law, those guidelines must, as a
matter of law, be disregarded by RECs.
Hugh Davies is a research ethics advisor, and he is the spokesman of
the Department of Health’s National Research Ethics Service. If the
Department wants to tell us that the RCP’s advice in its para 4.2 is
legally correct, then it ought to detail a lawyer, and not just a composer
of guidelines, to tell us exactly how, in law, that can be.
And the RCP itself should now publish in full the legal opinion upon
which it has said it relies [2], and it should identify the source of that
opinion. For the RCP’s para 4.2 is not legally correct. It is a danger to
the rights, safety, and well-being of volunteer clinical trials subjects
when it leads them to participate in illegal trials. And it is a danger to
the personal wealth of volunteer REC members when they unsuccessfully
defend negligence claims.
The consent given by trials subjects will not be legally valid unless
they are told in advance that the REC has assented to the protocol
irrespective of whether it believes the trial to be illegal; and that the
REC may believe the protocol to be in breach of a law specifically
intended to protect trials subjects. And it is the legal duty of the REC
to see to it that prospective trials subjects will indeed be told of that
situation.
Even when endorsed, as we now see, by the Department of Health, the
RCP’s para 4.2 is folly. The RCP must retract it.
References
1 Guidelines on the practice of ethics committees in medical research
with human participants, Fourth edition, Royal College of Physicians,
September 2007, p.27, para 4.2
2 Correspondence between Laurence D R; Saunders J; Gilmore I T,
http://www.bmj.com/cgi/eletters/331/7517 (Rapid Responses to Ashcroft et
al.), (13 December 2007).
Competing interests:
Previously member of the Royal college of Physicians Committee for Ethical Issues in Medicine:Chairman of a Research Ethics Committee.
Competing interests: No competing interests
Desmond Laurence’s latest assertions are fantasy. RECs do not
“procure” the commencement of a trial by giving a favourable opinion of it
if they have any concerns about its lawfulness. They are expected to
advise the investigator to seek legal advice. This opinion is copied to
those involved in Research Governance under the Standard Operating
Procedures. Compliance with the law is the responsibility of the
investigator. It is impossible to commence a trial that might be illegal
without deliberately flouting the REC’s advice.
Apart from that impossibility, a volunteer could not be told that a
clinical trial included the REC’s opinion that a trial is illegal because
the REC does not express a legal opinion (as Laurence incorrectly
asserts).
The restriction of the REC to expressing ethical opinion only is, of
course, laid down by the Research Governance Framework, with which he
appears unfamiliar.
The logic of expressing an ethical opinion despite possible reservations
about the law is no more unlawful than expressing a scientific or economic
or literary or anything else opinion, despite reservations about the law.
Ethics and law are not the same thing. It’s actually as simple as that.
Competing interests:
as previously declared
Competing interests: No competing interests
Research Ethics committees and the law.
In response to Professor Laurence (BMJ Letters Feb 19, 2008), it is
clear RECs can not deliver a legal opinion and there are good reasons for
this.
Guidance is unambiguous. It is not part of their review and they are
not accountable for a legal decision.
The Research Governance for Health and Social Care (2nd edition,
2005) states in Section 3.12.7:
"It is not the responsibility of research ethics committees described
above to give legal advice"
The Governance Arrangements for NHS Research Ethics Committees
(GAfREC) (Section 9.11, July 2001) reiterates this advice:
"It is not the role of the REC to offer legal opinion, but it may
advise the applicant and the host NHS body whenever it is of the opinion
that further expert legal advice might be helpful to them."
This advice is, of course, almost identical to that expressed by the
Royal College of Physicians in its Guidelines (section 4.2):
"RECs should avoid expressing a legal opinion and a protocol should
not be given an unfavourable opinion on the grounds of its supposed
illegality. Should a committee believe that a proposal contravenes the
law, it should ask the principal investigator to seek further independent
legal advice."
It is not necessary for the REC to review that advice as the REC's
only function is to offer an ethical opinion and not a legal one. The
responsibility for ensuring compliance with the law rests with the
investigator, under the aegis of the research governance structures.
Competing interests:
I work as the Research Ethics Advisor at the National Research Ethics Service and have been involved in implementing guidance for RECs
Competing interests: No competing interests
The Royal College of Physicians (RCP) is now advising Research Ethics
Committee (REC) members that:
a protocol [of a proposed clinical trial] should not be given [by a REC]
an unfavourable opinion on the grounds of [the protocol’s] supposed
illegality [1].
An illegal protocol will typically be one which denies to research
subjects the protection prescribed by the Medicines for Human Use
(Clinical Trials) Regulations 2004.
Undoubtedly, a REC cannot give legal advice to trials sponsors. But
as must we all, a REC must determine for itself that each of its own
proposed actions is legal. And it is certainly not legal for a REC to
procure the commencement of a clinical trial by expressing a favourable
opinion of it, when it actually believes the trial to be illegal, and so
has at that time no favourable opinion to give.
The RCP’s advice is a serious error. But John Saunders, Chairman of
the RCP’s Committee for Ethical Issues in Medicine, and an honorary
professor in connection with Law in Healthcare, has recently said that ‘It
is recognised that RECs cannnot reject a [proposed] protocol on legal
grounds . . .’ [2]. Who recognises this, he does not say.
Prospective trials subjects must, by law, be given every known fact
that bears materially upon the decision to volunteer [3]. So if a REC were
to follow the RCP’s advice, then prospective volunteers would have to be
told that the REC’s ‘favourable opinion’ included an opinion that the
trial was illegal, and that (for example) it appeared to deny to patient
volunteers the protection the 2004 law demands for them.
Prospective volunteers would then surely flee. So the RCP’s legal
advice is hardly helpful to the Department of Health-sponsored UK Clinical
Research Collaboration, which is calling for ‘large numbers of [new
patient volunteers]’ for the purpose of ‘improving national health and
increasing national wealth’.
References:
1 Guidelines on the practice of ethics committees in medical
research with human participants, 4th edition, Royal College of
Physicians, September 2007, p.27, para 4.2.
2 Saunders J. Meeting the needs of the investigator and the REC member.
Res Ethics Rev (2007) Vol 3, No.4, pp.111-112.
3 Medicines for Human Use (Clinical Trials) Regulations 2004, Sch.1, Pt. 2
(9).
Competing interests:
Previously member of the Royal College of Physicians Committee for Ethical Issues in Medicine: Contributor to previous editions of RCP Guidelines for Research Ethics Committees.
Competing interests: No competing interests
The President of the Royal College of Physicians, and the Chair of
its Committee for Ethical Issues in Medicine, assert that a Research
Ethics Committee (REC) must determine whether, in a proposed trial,
‘clinical equipoise’ exists, and if it does not, whether there will be
‘minimal risk’. The President, and the committee Chair argue that, if the
REC is able to determine that either of these obtains, then patient
volunteers in the trial would be in no worse a position than are ordinary
clinical practice patients. So there could be compliance with the
Medicines for Human Use (Clinical Trials) Regulations 2004, even if the
trial sponsor does not provide for patient volunteers the enforceable
right of compensation for non-negligent injury.
The Medicines for Human Use (Clinical Trials) Regulations 2004 state
that ‘The rights, safety, and well-being of the trial subjects are the
most important considerations and shall prevail over the interests of
science and society’. That is the law.
In relying on a supposed loophole of ‘clinical equipoise’, the Royal
College has descended into intellectual muddle. Clinical trials are
typically statistical studies. And statistical studies are only needed
when the beneficial and adverse consequences of the clinical use of, for
example, a particular new molecular entity cannot be adequately predicted.
So valid calculations of ‘equipoise’, and ‘minimal’ risk, cannot in
general be made.
In research ‘clinical equipoise’, and ‘minimal risk’, are
particularly elusive circumstances, usually identifiable only with
hindsight. In general RECs will be unable reliably to ascertain that
either of them has been certainly identified by the sponsor.
The President, and the committee Chair, go on to say that the
enforceable right of compensation for subjects who suffer non-negligent
injury is ‘not available in . . . research in the NHS’. But that only
shows that RECs are failing to require the NHS to observe the 2004 law.
As members of RECs will know, advice and opinion from the Royal
College, or from the Department of Health, do not have the force of law.
REC members are liable personally if they are negligent, and they have
only a limited appointing-authority indemnity. So they must be ready to
justify themselves in court if they decide to dispense with the
enforceable right of compensation for research subjects who suffer non-
negligent injury. As do we all in daily life, REC members need always to
make prior legal judgements about their own proposed actions.
So it is clearly necessary that the Royal College now publish, in
full, the ‘legal opinion [it obtained] both before and after publication
[of its new Guidelines for RECs]’. Publication will enable REC members to
judge for themselves of the scope and applicability of that hidden advice,
and to evaluate it for themselves using their own common judgement and
experience.
Competing interests:
Previously member of Royal College of Physicians Committee for Ethical Issues in Medicine.
Competing interests: No competing interests
The Royal College of Physicians wishes to respond to Desmond
Laurence’s letter of 25th November in order to refute its allegations.
The intention in research is new knowledge but the moral case for
special indemnity is based upon risk, not intent. Provided genuine
uncertainty/equipoise exists, there is no additional risk to patients and
hence no requirement for arrangements for indemnity for non-negligent
injury. Patients do not take a risk on behalf of society in ethical
therapeutic trials. They take the same risks as anyone else.
As stated in the latest edition of the Royal College of Physicians
(RCP) ‘Guidelines on the practice of ethics committees’ (5.10), equipoise
cannot exist in patho-physiological studies of the effects of disease (-
which may involve, for example, taking blood samples or administering
isotopes-) or in much observational research. Ethical justification rests
upon considerations of minimal risk, as defined in the Guidelines (5.13).
In these situations, it is the responsibility of the research ethics
committee (REC) to satisfy itself that risk is indeed minimal where there
is no possibility of benefit. The situation regarding compensation for non
-negligent harm should be detailed in participant information materials
(4.28). Such compensation arrangements are not available in such research
in the NHS without proof of negligence. The rights, safety and well being
of the individual do prevail over those of science and society, provided
risk is minimal.
To express this differently, the voluntary acceptance of a minimal
risk in the interests of a third party does not create a moral obligation
to be provided with a contract of indemnity without proof of negligence.
Laurence’s assertions about the law are not accepted by legal opinion
available to us both before and after publication, nor indeed by others.
The RCP does not lead RECs to disregard the law as alleged.
All working groups at the RCP are established by its Council, after
application and review. In common with other reports, these Guidelines
were reviewed, debated and amended by Council on completion. As previously
stated, the College's Ethical Issues Committee (CEIM) provided overall
supervision of the project only, and declarations of conflicting interest
are not therefore required in this particular context. However, Desmond
Laurence will be informed personally by letter of the declarations of
conflicting interest by committee members and these will be published on
the College’s website to ensure access for all.
Professor Ian Gilmore MD FRCP
President
Royal College of Physicians
Professor John Saunders MD FRCP
Chair
RCP Ethical Issues in Medicine Committee
(Interests as declared previously)
Competing interests:
(Ian Gilmore) President of the Royal College of Physicians, and Chairman of its Board of Trustees.
Competing interests: No competing interests
Regulation Roll-back?
In recent days it has been admitted(1) that between 1946 and 1948
American medical researchers intentionally infected unsuspecting
Guatemalan prisoners with syphilis. It is ironic that, during the same
period, American judges at Nuremberg(2) were hanging doctors for '. . .
atrocities [against prisoners] committed in the name of medical science'.
The despicable crimes of medical researchers, in Guatemala and in
Europe, show what researchers are capable of permitting themselves to do
when allowed to be their own judges in ethical questions.
I have pointed out elsewhere(3) that the Royal College of Physicians
(RCP), in its published research Guidelines(4), urges Research Ethics
Committee (REC) members to express a 'favourable opinion' of proposed
clinical trials which they believe to be illegal. Prospective volunteer
subjects are reassuringly told that, as the law(5) requires, the clinical
trial has passed the 'REC favourable opinion' test; but they are not told
that it may be a favourable opinion of illegal medical experimentation
upon human subjects.
It is fortuitous that the crimes committed by medical researchers in
Guatemala have come to light now when the Academy of Medical Sciences is
conducting an 'independent' government-sponsored review of medical
research regulation. For the Academy, before it had even commenced its
review, had already published6 its conclusion: 'Healthcare in the UK is
being jeopardised by a stifling regulatory and governance framework for
medical research'.
Medical researchers in Guatemala and in Nazi Europe evidently were
not encumbered by the regulatory burdens of which the Academy complains.
And United Kingdom researchers are not so burdened now, if the Royal
College's advice (that illegality should be ignored) is followed.
What serious claim to be 'independent'(6) can an academy of medical
scientists have when it sets out to review public regulation of medical
scientists' own research on human subjects?
And why did the Royal College, as it has admitted(7), seek no formal
legal opinion before issuing its bizarre advice that RECs should ignore
illegality in clinical trials?
References:
1 U.S. apologies for syphilis test in Guatemala.
nytimes.com/2010/10/02/health/research/02infect . . . .
2 United States Holocaust Memorial Museum. The Doctors Trial.
ushmm.org/research/doctors/
3 Laurence DR. And who shall guide the guides? Favouring the illegal.
(7 March 2008) bmj.com/content/331/7517/587/reply ; Laurence DR. Guide,
guide thyself: law and order in clinical research. Research Ethics Review
(2008) Vol 4, No.2, 69-72
4 Royal College of Physicians. Guidelines on the practice of ethics
committees in medical research with human participants, Fourth edition.
2007. ch 4. p.27. RECs and legal opinion. Section 4.2.
5 Medicines for Human Use (Clinical Trials) Regulations 2004.
legislation.gov.uk/uksi/2004/1031 (Part 3, para 12)
6 Academy of Medical Sciences: Media Statement: (26 March 2010):
acmedsci.ac.uk
7 Laurence DR. And who shall guide the guides? Obeying the law,
sometimes. (28 July 2009) bmj.com/content/331/7517/reply
Competing interests: Previously member of Royal College of Physicians Committee on Ethical Issues in Medicine