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Rapid Responses: Rapid Responses published:
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Is the Silence of “all” National Health Service Authorities on Biophysical Semeiotics ethical?
- Sergio Stagnaro (25 February 2005)
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Ethics Committees for Audits or Audits for Ethics Committees?
- Mayer Brezis, MD MPH, Professor of Medicine (25 February 2005)
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But who decides when review is needed?
- Peter Grifiths (26 February 2005)
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Audit or Research: Ask the committee
- Mark S Schreiner (26 February 2005)
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Audit vs Research - pragmatism vs principle
- Tim Coupe (27 February 2005)
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Case scenarios
- Maneesh Gupta (27 February 2005)
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Resource poor countries need special attention
- Ike Anya (1 March 2005)
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Ethics, audit, and research: all shades of grey
- Terence W. Wiseman (1 March 2005)
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Request for information
- susanne mccabe (1 March 2005)
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Comments on Case Scenarios
- David Carr (8 March 2005)
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Questions about Journal's Ethics Committees
- susanne mccabe (9 March 2005)
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The audit and research fog; navigating the grey areas
- Craig Gannon (15 March 2005)
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Junior Doctors will Peril
- Michael J Reid (28 March 2005)
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Re: Junior Doctors will Peril - (but would they?)
- susanne mccabe soostevens@hotmail.com (29 March 2005)
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Re: Re: Junior Doctors will Peril - (but would they?)
- Michael J Reid (13 May 2005)
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Questions beget questions
- Gordon B Drummond (17 September 2005)
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Sergio Stagnaro, Specialist in Blood. Gastrointestinal, and Metabolic Diseaeses. Researcher in Biophysical Semeiotics Via Erasmo Piaggio 23/8 16037 Riva Trigoso (Genova) Italy
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Sirs, I agree, of course, with the statement that “Ethical considerations should apply to all medical practice, but many people act as if they apply only to research”. However, I cannot define ethical the behaviour of “all” National Health Service Authorities, particularly the italian NHS Authority, ethics committees, journal editors, including BMJ, although it posts kindly my weekly Rapid Responses, a.s.o. (with the only exclusion of “Planning for the EU public Health Portal” all ’URL: http://www.google.it/search?q=cache:U5A- DtWmRDsJ:europa.eu.int/comm/health/ph_information/documents/ ev_20030710_co01_en.pdf+single+patient+based+medicine+and+st agnaro&hl=it&ie=UTF -8 Pg 36) regarding my researches with the aid of Biophysical Semeiotics (See www.semeioticabiofisica.it, and Bibliography). This was initiated 50 years ago as Auscultatory Percussion, and resulted in the discovery of a large number of constitutions--dyslipidaemic, diabetic, hypertensive, arteriosclerotic, glaucomatous, osteoporotic, and particularly Oncological. That is, an Oncological Terrain is conditio sine qua non of malignancy (2-6). All these Biophysical Semeiotics results were met by silence for 50 years! Neither corroboration nor falsification--non-ethical and non-scientific behaviour! 1) Wade D.T.Ethics, audit, and research: all shades of grey. BMJ 2005;330:468-471 (26 February), doi:10.1136/bmj.330.7489.468 2) Stagnaro Sergio, Stagnaro-Neri Marina. Introduzione alla Semeiotica Biofisica. Il Terreno oncologico”. Travel Factory SRL., Roma, 2004. http://www.travelfactory.it/semeiotica_biofisica.htm 3) Stagnaro S., Stagnaro-Neri M., Le Costituzioni Semeiotico- Biofisiche.Strumento clinico fondamentale per la prevenzione primaria e la definizione della Single Patient Based Medicine. Ediz. Travel Factory, Roma, 2004. 4) Stagnaro-Neri M., Stagnaro S., Cancro della mammella: prevenzione primaria e diagnosi precoce con la percussione ascoltata. Gazz. Med. It. – Arch. Sc. Med. 152, 447,1993 5) Stagnaro-Neri M., Stagnaro S., Diagnosi Clinica Precoce dell’Osteoporosi con la Percussione Ascoltata. Clin.Ter. 137, 21-27, 1991 [ MEDLINE] 6) Stagnaro S., Diet and Risk of Type 2 Diabetes. N Engl J Med. 2002 Jan 24;346(4):297-298. letter [MEDLINE]. Competing interests: None declared |
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Mayer Brezis, MD MPH, Professor of Medicine, Director, Center for Quality & Safety Hadassah Hebrew University Hospital
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Professor Wade raises an important question about ethics and audit (Ethics, audit, and research: all shades of grey. Derick T Wade BMJ 2005;330:468-471). We wish to extend his discussion by asking the reverse question: Don't Ethics Committee need themselves audit? What is the quality of the supervision of research by Ethics Committee? How often is the implementation of the research actually surveyed to verify it is done according to the original approval? A couple of years ago, the CBS "60 minutes" program showed shocking ethical violations in research originally approved by Institutional Review Boards in the US and the lack of substantial surveillance of research after approval: the agencies in charge don't have the resources and sometimes don't even have the legal mandate to perform the most important task of actually looking at what is done to research subjects, who quite often don't understand their most basic rights, even under careful conditions (Yuval R, Halon DA, Flugelman MY, Lewis BS: Perceived Patient Comprehension in Acute and Chronic Cardiovascular Clinical Trials. Cardiology 2003;99:68-71). Quality is aiming at evidence-based, patient-centered and system- minded care in health. None of these dimensions justifies invasive testing. Professor Wade's scenario A is the only one really dealing with audit for quality, which could and should be routinely done by non- invasive data collection for outcomes and processes, complications and mortality rates as well functional & subjective performance status of patients. At our institution, our Ethics Committee is automatically approving these non-invasive activities, on the condition that they are also approved by the Department Head. Audit derives from the Latin auditus, a hearing, hardly meaning blood testing or angiographies. Competing interests: None declared |
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Peter Grifiths, Senior Lecturer King's College London
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Professor Wade sets has outlined a set of principles about the need for ethical scrutiny that read like a breath of fresh air. The move from a rule based sytem (research therefore ethical review) to a principles based one (determining when an action in the health care setting raises ethical implications and reviewing accordingly) is surely necessary. However, a central dilema remains. A series of judgements must be made to determine whether a project of any sort raises ethical concerns. Where decisions are made at the margins it is not unreasonable to consult external authority on the need for further review. A principle investigator might (for example) have a somewhat biased view on the likelihood that their own project will achieve its aims. The world of research is littered with examples where such misjugmements have been made, even after considerable external review. Similalry their understanding of the burden imposed on a patient by a particular questionairre might be simply erroneous. My experience of seeking such opinion - generally in relation to student assignments some of which I personally would not even consider audit - is that this almost inevitably results in a request for a full application for ethical scrutiny. It may be that this is because my judgement is extremely poor. However it seems that many of those working for ethics committees (certainly in the UK) are unable to give guidence on principle and feel that they are required to give full scrutiny to everything. Thus the boundary gradually shifts. I have had experience in recent years of students being required to gain ethical approval in order to undertake supervised clinical assessments in practice as part of a course of study; a student who was told that she must obtain Multi-Centre Research Ethics Committee approval in order to write up a service development she undertook in the course of her employment (not you will note in order to do the development) and another who had to complete a full ethics application in order to complete a paper exploring the role of university lecturers in nursing which required that analyse the contents of publicly available documents and briefly interview a number of her peers about their understanding of these. Perhaps some of these did require full ethical scrutiny and approval. My reading of Professor Wades argument would say that none of them did, or at least not by virtue of the fact that they were being 'written up'. However what they all had in common was that the diligent student sought external advice on whether or not such scrutiny was required and in all cases as a result they were required to complete full applications. Of course professor Wade is right - the distinction between research and audit is arbitrary and the fact that in my opinion none of these would even be classified as audit is moot. However the danger of adopting his approach (and believe me I think we should) without recognising the need for a service which is prepared to advise on principles (and has the guts to do so without requiring applicants to complete a full application) is that the number of fronts upon which the mission creep of ethics comitees can progress is expanded. I look forward unhappily to the day that every thought that I share with a patient or student requires formal approval to ensure that there is no dangerous novelty or deviation from the norm implied in it and every student must be approved before comitting to paper any nidea derived from their experience with patients lest it too deviate from an accepted norm. Competing interests: I educate students and frequently seek to avoid the need for them to fill in hugely burdensome applications to ethics comittees. I am spectacularly unsucessful at this. |
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Mark S Schreiner, Associate Professor of Anesthesia in Pediatrics The Children's Hospital of Philadelphia, Philadelphia, PA, 19104, USA
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As Wade (1) makes clear, the distinction between whether an activity is research or an audit is often grey. Allowing the investigator/auditor to make the determination whenever things aren't black or white risks the possibility that some research will not receive appropriate review. The Office of Human Research Protections has created a series of flowcharts to help investigators and Ethics Committees in the United States determine whether or not an activity constitutes research.(2) Investitigators are not allowed to make the determination by themselves. At our institution, we require a brief one or two page submission to our Ethics Committee that describes the proposed activity. If the committee makes the determination that the activity is research, then the investigator must make a complete submission, if a determination is made that the activity is exempt, then the audit can commence without further oversight. Apparently, when it comes to defining deceased patients as human subjects, there is a difference between Europe and the United States. Wade states that using post-mortem material always requires ethics review.(1) In the United States, only living subjects are considered "human subjects".(3) (1) Wade DT. Ethics, audit, and research: all shades of grey. BMJ 2005;330:468-71. (2) Human Subject Regulations Decision Charts http://www.hhs.gov/ohrp/humansubjects/guidance/decisioncharts.htm accessed February 25, 2005. (3) Code of Federal Regulations, Title 45 Part 46 Protection of Human Subjects. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. Accessed February 25, 2005 Competing interests: None declared |
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Tim Coupe, Clinical Audit Officer Coventry PCT
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Prof Wade makes a welcome contribution to the long running debate about the ethics of audit and research. My experience has been that clinical audit staff and clinicians doing audit do consider these issues. Many NHS Trusts also have arangements for some form of local review for ethically problemmatic audit projects (a simple letter to the chair of the local ethics commitee for instance)which work very well. The potential problem with clinical audit is that anybody can do it, with or without their employers support or knowledge, which is why Wade is quite right to place responsibility squarely with the investigator in any project. My personal view is that in the UK the ethical principles underpining research governance should be clearly and explicitly extended to clinical audit. I do think it's interesting that all four of Wade's scenario's contain no mention of informed consent from any participant, which makes them all unethical in my book. My experience also supports Abbasi's view that journals can exert considerable influence on investigators actions by not publishing papers. This does act as a powerful, though not perfect, disincentive to investigators wanting to re-brand research as audit. I await further developments from the DOH on this issue with interest. Competing interests: The author is a clinical audit officer. |
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Maneesh Gupta, Consultant Psychiatrist Merseycare NHS Trust, L9 7AL
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Ethical dilemmas are difficult to take a stand on. I realised this as I tried to formulate my response to the four cases described in this article. I haven't answered all the questions. A. Conducting the audit without patient consent is one way in which NHS is bypassing the ethical review process. By "asking" patients to return for angiography and exercise testing, consent is being assumed for the audit/study. B. Yes, an external review should have been sought. The study involves human tissue, and needs to go through an ethical approval process. The lack of consent of patients means it is not ethical and should not be published as research. C. The registrar should have sought an external ethical review. The "research" involves real patients. Their behavior in case of fire alarm, as an outcome of the study, has to be vetted by an external reviewer/committee. How do we know that the only researcher was focussing more on his study outcomes than in helping his patients to move to a safe place. D. It is ethical if patients have given informed consent to the study. Competing interests: None declared |
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Ike Anya, Specialist Registrar in Public Health Bristol North PCT, Bristol BS2 8EE
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In the context of the current debate on ethics committees and their review of research, it is important to consider the situation in resource poor countries. Increasingly, Western researchers and institutions are carrying out research in resource poor settings, often in collaboration with local researchers and institutions. Often research from these collaborations are published with the tag- line " Ethics approval was obtained from the ethics committees in both institutions". Yet this seemingly innocuous sentence often does not tell the whole story. In many resource poor settings, ethics committees do not exist or are in a formative stage. Sometimes, the collaborators from the West have to instigate the setting up of a research ethics committee, in some cases, also arranging funding for training the members. This can potentially compromise the effectiveness of the committee. Even where ethics committees exist, the asymmetry of power between relatively privileged, well funded researchers from the West and the less fortunate local researchers may pose serious obstacles to effective ethical review of research proposals. Even in the West, it is unclear how well ethics committees can monitor research that they have approved to ensure that the execution remains within the defined boundaries. In such circumstances, independent review,at the time of publication such as that described by Abbasi and Heath may be useful. While conscious of the need to avoid additional unnecessary layers of bureaucracy which may stifle research, it is important that the ethics review process remains fit for purpose and is not reduced to a tick-box exercise. Competing interests: None declared |
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Terence W. Wiseman, Member, Trent MREC. Formerly Chairman, Lincolnshire LREC. Trent Region
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I have often been asked to define the differences in Audit and Research and my rule of thumb has been: "Audit is the process of verifying that PREVIOUSLY LAID DOWN PROCEDURES have been carried out according to the protocol or rules. Anything else is probably research." This rule of thumb has served many researchers and auditors well. Competing interests: None declared |
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susanne mccabe, retired cf24 3pf
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At the end of your article thanks are given to 'Liz Wager' and 'Peter Halligan' for 'advising and stimulating some changes'. With apologies to both but could you say who they are please? Competing interests: long standding interest in ethical issues |
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David Carr, Consultant Physician University Hospital of North Tees, Stockton on Tees, TS19 8PE
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I venture some comments on the scenarios described in this article, chiefly because the responses on bmj.com so far are mostly not about the scenarios themselves. It is difficult to formulate all-encompassing principles here, but in general I would prefer that formal ethics committee approval should be needed only for projects that actively involve patients (and/or volunteers) in something beyond normal clinical management. Research, broadly, should define best clinical practice, while audit should test whether best practice is routinely being carried out correctly; but I agree that there are “grey” cases. Scenario A 1) Should the study have taken place? 2) Should an ethical review have taken place before starting? We are not told whether there is already published research comparing the two surgical techniques. If such research had not already been done, with results certain enough to guide policy, some project might be justifiable. This would clearly be “research” rather than “audit”, and would require ethical consideration, especially as the project involved performing an invasive procedure. Lack of randomisation and risk-adjustment are such serious weaknesses that the project as described was unethical. If previous research had already identified best policy with sufficient certainty, then the project was unnecessary. If previous research had shown that the two techniques were similar in outcome, then “audit” would presumably seek only to check the surgeons’ results - better done by comparing their results with other institutions using the same technique. However, I feel that a potentially risky, extra invasive test should not be used for that purpose. 3) Publish? As either audit or research the item has serious weaknesses and probably doesn’t deserve publication. (However, should journals routinely publish a list of work submitted to them as research or audit, but rejected for publication on ethical grounds, with a brief statement of why?) Scenario B 1) Should the authors have sought external ethical review? 2) Publish? Here the researchers are making what appears to be good use of “historic” material, by applying a new technique that will have no effect on the patients from whom the material was originally obtained. My view is that ethical approval is not necessary. If the journal agrees that ethical permission is unnecessary then the journal should publish the work. If the journal considers that ethical approval should have been obtained, and could be obtained retrospectively, then the journal could still publish the work. The scenario raises a general issue of how “historic” material should be handled. Should there be a “time limit”? For example, would ethical permission be needed if a new technique were applied to an Egyptian mummy, a pathology museum specimen from the 19th century, or biopsy material from a patient who died 25 years ago? Scenario C 1) Should the registrar have sought external ethical review? 2) Publish? I agree that there was no experimentation, and provided that the registrar was using only information about patients in his own care, then no external ethical review seems necessary. The registrar should have discussed this with his consultant(s), not just the senior nurse of the ward! If the journal agrees that ethical permission is unnecessary then the journal could publish the work. If the journal considers that ethical approval should have been obtained, and could be obtained retrospectively, then the journal could still publish the work. Scenario D 1) Was it ethical? It is unethical to randomise patients to an inferior treatment if the superior treatment is available and accessible at the time. In this scenario however other considerations may apply, e.g.: a) Could the stroke unit accommodate all cases of stroke or would some have gone inevitably to general wards? If the latter, then some method of allocating the cases was presumably in operation (first-come-first served, age, clinical judgement, consultant etc.), and it may have been ethical to use randomisation as an alternative. b) Was the question being addressed in this project in some way subtly different from the previously published work showing superiority of stroke units over general wards? (Perhaps “stroke-unit-care” would be for a shorter duration than in the previous publications. Perhaps here a physician or multidisciplinary team specialising in stroke, purporting to offer optimal stroke care outside the stroke unit, visited the general wards. Perhaps the general wards were working to an agreed protocol of stroke care matching that in the stroke unit itself.) These points would need to be made clear, but might well justify the project as research. 2) Publish? If the journal is satisfied that the work is justified by considerations such as those above then it should allow publication, preferably also ensuring that the published article contains the necessary background information to justify the project. The journal should have the right to over-rule the ethics committee that has approved the project if the journal feels that the project is unethical. Competing interests: None declared |
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susanne mccabe, retired cf24 3pf
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Does an Ethics Committee of a Journal have the authority to overide the decisions of formally appointed NHS Ethics Committees regulated by governments? In which case could any group of people descibe themselves as an Ethics Committee? If Journal Ethics Committees are self regulated bodies - which if any public organisation are they accountable to? If a member of an Ethics Committee submts an individual rather than joint article, should this be declared as a Personal Opinion? Should only a few members of an Ethics Committee be asked to contribute their opinion or the whole committee if an article is written by a contributor who identifies him/herself as a member of the Ethics Committee? If other members , whose assistnce has not been requested,of an identified committee , would like to contribute an opinion, should they be asked before publication? The authority and obligations of Committees and of members of Journal Ethics Committee both as individuals and as members of the collective committee can seem blurred in these respects. Competing interests: previous work involved reorganisation of some ethics cttees |
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Craig Gannon, Consultant in Palliative Medicine The Princess Alice Hospice, West End Lane, Esher, Surrey, KT10 8NA, United Kingdom
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Dear Editor, Wade’s informative review highlighted the under-appreciated point that clinical audit requires the same rigor as research (1). The paper usefully focused on overlapping ethical considerations, in particular that attempting to distinguish audit from research when considering the need to seek ethical approval was only an academic exercise. While numerous overlaps between research and audit were described, the opportunity to clarify their differences was not maximised. Admittedly an inability to differentiate research from audit owes as much to wisdom as any lack of understanding. Uncertainty is compounded by the inconsistent use of both of the labels “research” and “audit” (whether accidental or not). To further the confusion, audit and research often co-exist within a single project. Audit itself doesn’t ever answer “why” best practice isn’t being followed (though it may precipitate hypotheses). Instead, simultaneous (or subsequent) research will examine the “why” (testing hypotheses) and it is this research component that requires the addition data collection, not audit, which shouldn’t impact on normal clinical practice (if the data is useful, always collect it, if the data is not that useful, it’s not worth auditing). However, and no matter how tempting, the limitations of and difficulties posed by trying to separate research from audit should not be used as excuse to lose the division altogether. A pivotal distinction remains: research looks for new knowledge to advance best practice, while audit checks delivered care for variance from best practice (2). In achieving different goals, both approaches are required for quality of care to improve. Harm may follow mislabelling or blurring of the definitions of audit and research: • Only one of the disciplines flourishes (either practice or theory improves but not both) • Sub-optimal methodology is chosen, that generates questionable results (opportunity missed and resources wasted if nothing else) • Inappropriate dissemination of results (missing the true target audience; in-house for audit or external for research) Following discussion within a multi-centre regional audit group, a simple tool was proposed to distinguish audit from research when considering observational studies, the area of most confusion (2). 1. Wade DT, “Ethics, audit, and research: all shades of grey” BMJ 2005; 330: 468-471 2. Gannon C, “Reflections on Clinical Audit in Palliative Care following an Attempt to Audit Urinary Catheterization” International Journal of Palliative Nursing 2004; 10 (11): 524-532 Competing interests: None declared |
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Michael J Reid, Research Fellow Blond McIndoe Centre, East Grinstead RH19 3DZ
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As a research fellow I have spent the best part of 6 months filling in forms, attending meetings and making amendments to achieve ethics approval for a relatively simple clinical trial which will form part of my M.D. Thesis. This drawn out process is indeed necessary if we wish to implement change into clinical practice as no one would suggest that as doctors we deserve a carte blanche to experiment with treatments that we think may benefit our patients without appropriate evidence. Audit is however the monitoring of already established practice and as it is not instituting a direct change in practice it should not require ethical approval. If this were to become the case then much audit, mainly the remit of the junior in the team, would not be undertaken due to the time constraints of obtaining ethics approval and conducting the audit within a six month post. This would be to the detriment of patient care (as we would not be monitoring our effectiveness as doctors) but also to the detriment of junior staff as audit is their introduction into the application of clinical effectiveness and research. In an era of publish or peril, where the junior staff have to differentiate themselves from the crowd, eliminating this important process will lessen the separation of the masses. This in combination with the Modernisation of Medical Careers restructuring of training may see an end to many being involved in any sort of evaluation of medical practice or research throughout their training and many who do not progress as a result. Medicine and better clinical practice may miss out. Competing interests: None declared |
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susanne mccabe soostevens@hotmail.com, retired cf24 3pf
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Michael Most people would have no objection to students handling their information as part of their training....it is not difficult to devise a system where consent/refusal of consent is registered on file though. But I wonder if you could clarify one of the points you make please? ie ....'this important process will lessen the separation of the masses'. thank you Competing interests: None declared |
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Michael J Reid, Research Fellow Blond McIndoe Centre, East Grinstead RH193DZ
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The separation of the masses is in reference to those junior medical staff attempting to get onto SHO rotations and SPR rotations. Currently there may be as many as 50-100 applicants per position for popular rotations such as Orthopaedic and Plastic Surgery. The current policy is to separate those candidates on the basis of research and audit undertaken then presented and published. With the introduction of Foundation years and the anticipated rapid progression to higher training ther will be very little time to differentiate oneself from the crowd in order to obtain the elusive number. By introducing the further stumbling block of ethics committee approval for audit, the chances of anyone differentiating themselves in such a short period is unlikely. Hence many candidates who might have distinguished themselves previously and excelled in the hospital environment may struggle to progress which would be a loss to themselves and potentially medicine as a whole. Competing interests: None declared |
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Gordon B Drummond, senior lecturer Edinburgh Royal Infirmary EH16 4HA
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I am amazed at the capacity for ethicists to ask but not answer questions. I almost feel stimulated to fire off a few rhetorical queries in response but will try to keep to statements which will perforce be idiosyncratic. Research and audit are not CV improving activities. If a person has done these, to the bitter end, then it's very good evidence that they have persistence, and may deserve a job.. but it will take a lot longer than an SHO (sorry foundation year or MMClone) will be in one place. So forget the complete audirt cycle, think of something else! Audit is quality control: it should be supported and funded by the NHS. The NHS should be prepared to undertake this without ethics since it's the owner of the data that should be collected whatever. If not - oops I nearly asked a question- it should be doing so, anyway. Research ethics- everyone is perfectly entitled to their opinion. That includes journals. If the journal thinks a work is unethical it can do two things: suppress the data: easy enough if the data is uninteresting. They do that all the time and have the choice, because they only publish what they think is interesting and important. In that case, if it's also unethical, tough. The author will send it to the next journal in the line anyway. Perhaps there should be a way of listing "bad apples" oh dear that was very nearly a question. If the work is interesting or important but unethical: then it's not ethical to conceal the information. Publish, and say that the work is unethical (in the journal's opinion). Scenarios: Competing interests: I am an ethics editor for a basic science journal |
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