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1.  The investigation of life-threatening child abuse and Munchausen syndrome by proxy. 
Journal of Medical Ethics  1995;21(1):9-13.
The use of covert video surveillance in the investigation of suspected life-threatening child abuse and Munchausen syndrome by proxy raises important ethical questions. That the recently reported provision of this facility in North Staffordshire was not presented to a Local Research Ethics Committee (LREC) for approval as a research exercise raises important questions about the ethical review of research and practice. The case made for avoiding such review is first set out and then examined. The three main premisses which form the basis of the view that LREC approval is not required are identified and tested in turn. The conclusion is that there is an undeniable element of research involved in the procedure and that the welfare of all those subjected to the surveillance would be best protected by the submission of the protocol to an independent committee for ethical assessment.
PMCID: PMC1376524  PMID: 7776355
3.  Covert Treatment in Psychiatry: Do No Harm, True, But Also Dare to Care 
Mens Sana Monographs  2008;6(1):81-109.
Covert treatment raises a number of ethical and practical issues in psychiatry. Viewpoints differ from the standpoint of psychiatrists, caregivers, ethicists, lawyers, neighbours, human rights activists and patients. There is little systematic research data on its use but it is quite certain that there is relatively widespread use. The veil of secrecy around the procedure is due to fear of professional censure. Whenever there is a veil of secrecy around anything, which is aided and abetted by vociferous opposition from some sections of society, the result is one of two: 1) either the activity goes underground or 2) it is reluctantly discarded, although most of those who used it earlier knew it was needed. Covert treatment has the dubious distinction of suffering both such secrecy and disapproval.
Covert treatment has a number of advantages and disadvantages in psychotic disorders. The advantages are that it helps solve practical clinical problems; prevents delays in starting treatment, which is associated with clinical risks and substantial costs; prevents risk of self-destructive behaviour and/or physical assault by patient; prevents relapse; and prevents demoralization of staff. The disadvantages are that it maybe used with malafide intent by caregivers with or without the complicity of psychiatrists; it may be used to force conformity in dissenters; and the clinician may land himself in legal tangles even with its legitimate use. In addition, it may prevent insight, encourage denial, promote unhealthy practices in the treating staff and prevent understanding of why noncompliance occurs in the first place.
Some support its use in dementia and learning disorders but oppose it in schizophrenia. The main reason is that uncooperative patients of schizophrenia (and related psychoses) are considered to be those who refuse treatment but retain capacity; while in dementia and severe learning disorder, uncooperative patients are those who lack capacity. This paper disputes this contention by arguing that although uncooperative patients of schizophrenia (and related psychoses) apparently retain capacity, it is limited, in fact distorted, since they lack insight. It presents the concept of insight-unconsciousness in a patient of psychosis. Just as an unconscious patient has to be given covert medical/surgical treatment, similarly an insight-unconscious patient with one of the different psychoses (in the acute phase or otherwise) may also have to be given covert treatment till he regains at least partial insight. It helps control psychotic symptoms and assists the patient in regaining enough insight to realize he needs treatment. Another argument against covert treatment is that people with schizophrenia have the capacity to learn and therefore can learn that they are required to take medications, but if medications are given covertly it may well fuel their paranoia. However, it should be noted that the patient who has lack of insight cannot learn unless he regains that insight, and he may need covert treatment to facilitate this process. Covert treatment can fuel the paranoia, true, but it can also control the psychotic symptoms sufficiently so that regular treatment can be initiated. In a patient who refuses to accept that he is sick and when involuntary commitment is not an option to be considered, covert treatment is the only option, apart from physical restraint. Ultimately, a choice has to be made between a larger beneficence (control of symptoms and start of therapy) and a smaller malevolence (necessary therapy, but without the patient's knowledge and consent).
A number of practical clinical scenarios are outlined wherein the psychiatrist should adopt covert treatment in the best interests of the patient. Ethical issues of autonomy, power, secrecy and malafide intent arise; each of these can be countered only by non-malfeasance (above all, do no harm) under the overarch of beneficence (even above that, dare to care). An advance directive with health care proxy that sanctions covert treatment is presented. Questions raised by the practical clinical scenarios are then answered.
The conclusions are as follows: covert treatment, i.e, temporary treatment without knowledge and consent, is seldom needed or justified. But, where needed, it remains an essential weapon in the psychiatrist's armamentarium: to be used cautiously but without guilt or fear of censure. However, the psychiatrist must use it very judiciously, in the rarest of rare cases, provided: i) he is firmly convinced that it is needed for the welfare of the patient; ii) it is the only option available to tide over a crisis; iii) continuing efforts are made to try and get the patient into regular psychiatric care; iv) the psychiatrist makes it clear that its use is only as a stop-gap; v) he is always alert to the chances of malevolence inherent in such a process and keeps away from conniving or associating with anything even remotely suspicious; and vi) he takes due precautions to ensure that he does not land into legal tangles later.
The need of the hour is to explore in greater detail the need and justification for covert treatment, to lay out clear and firm parameters for its legitimate use, follow it up with standard literature and, finally, to establish clinical practice guidelines by unconflicted authors.
The term “covert treatment” is preferable to “surreptitious prescribing”; they should not be used synonymously, the latter term being reserved for those cases where there is malafide intent.
PMCID: PMC3190565  PMID: 22013352
Covert Treatment; Surreptitious prescribing; Beneficence; Non-malfeasance; Unhealthy staff practices; Autonomy; Secrecy; Malafide intent; Noncompliance; Relapse prevention; Insight-unconscious; Advance directive; Health care proxy; Dare to Care; Do no harm
4.  Ethical use of covert videoing techniques in detecting Munchausen syndrome by proxy. 
BMJ : British Medical Journal  1993;307(6904):611-613.
Munchausen syndrome by proxy is an especially malignant form of child abuse in which the carer (usually the mother) fabricates or exacerbates illness in the child to obtain medical attention. It can result in serious illness and even death of the child and it is difficult to detect. Some investigators have used video to monitor the carer's interaction with the child without obtaining consent--covert videoing. The technique presents several ethical problems, including exposure of the child to further abuse and a breach of trust between carer, child, and the professionals. Although covert videoing can be justified in restricted circumstances, new abuse procedures under the Children Act now seem to make its use unethical in most cases. Sufficient evidence should mostly be obtained from separation of the child and carer or videoing with consent to enable action to be taken to protect the child under an assessment order. If the new statutory instruments prove ineffective in Munchausen syndrome by proxy covert videoing may need to be re-evaluated.
PMCID: PMC1678946  PMID: 8401021
5.  Ghost Authorship in Industry-Initiated Randomised Trials 
PLoS Medicine  2007;4(1):e19.
Ghost authorship, the failure to name, as an author, an individual who has made substantial contributions to an article, may result in lack of accountability. The prevalence and nature of ghost authorship in industry-initiated randomised trials is not known.
Methods and Findings
We conducted a cohort study comparing protocols and corresponding publications for industry-initiated trials approved by the Scientific-Ethical Committees for Copenhagen and Frederiksberg in 1994–1995. We defined ghost authorship as present if individuals who wrote the trial protocol, performed the statistical analyses, or wrote the manuscript, were not listed as authors of the publication, or as members of a study group or writing committee, or in an acknowledgment. We identified 44 industry-initiated trials. We did not find any trial protocol or publication that stated explicitly that the clinical study report or the manuscript was to be written or was written by the clinical investigators, and none of the protocols stated that clinical investigators were to be involved with data analysis. We found evidence of ghost authorship for 33 trials (75%; 95% confidence interval 60%–87%). The prevalence of ghost authorship was increased to 91% (40 of 44 articles; 95% confidence interval 78%–98%) when we included cases where a person qualifying for authorship was acknowledged rather than appearing as an author. In 31 trials, the ghost authors we identified were statisticians. It is likely that we have overlooked some ghost authors, as we had very limited information to identify the possible omission of other individuals who would have qualified as authors.
Ghost authorship in industry-initiated trials is very common. Its prevalence could be considerably reduced, and transparency improved, if existing guidelines were followed, and if protocols were publicly available.
Of 44 industry-initiated trials, there was evidence of ghost authorship in 33, increasing to 40 when a person qualifying for authorship was acknowledged rather than appearing as an author.
Editors' Summary
Original scientific findings are usually published in the form of a “paper”, whether it is actually distributed on paper, or circulated via the internet, as this one is. Papers are normally prepared by a group of researchers who did the research and are then listed at the top of the article. These authors therefore take responsibility for the integrity of the results and interpretation of them. However, many people are worried that sometimes the author list on the paper does not tell the true story of who was involved. In particular, for clinical research, case histories and previous research has suggested that “ghost authorship” is commonplace. Ghost authors are people who were involved in some way in the research study, or writing the paper, but who have been left off the final author list. This might happen because the study “looks” more credible if the true authors (for example, company employees or freelance medical writers) are not revealed. This practice might hide competing interests that readers should be aware of, and has therefore been condemned by academics, groups of editors, and some pharmaceutical companies.
Why Was This Study Done?
This group of researchers wanted to get an idea of how often ghost authorship happened in medical research done by companies. Previous studies looking into this used surveys, whereby the researchers would write to one author on each of a group of papers to ask whether anyone else had been involved in the work but who was not listed on the paper. These sorts of studies typically underestimate the rate of ghost authorship, because the main author might not want to admit what had been going on. However, the researchers here managed to get access to trial protocols (documents setting out the plans for future research studies), which gave them a way to investigate ghost authorship.
What Did the Researchers Do and Find?
In order to investigate the frequency and type of ghost authorship, these researchers identified every trial which was approved between 1994 and 1995 by the ethics committees of Copenhagen and Frederiksberg in Denmark. Then they winnowed this group down to include only the trials that were sponsored by industry (pharmaceutical companies and others), and only those trials that were finished and published. The protocols for each trial were obtained from the ethics committees and the researchers then matched up each protocol with its corresponding paper. Then, they compared names which appeared in the protocol against names appearing on the eventual paper, either on the author list or acknowledged elsewhere in the paper as being involved. The researchers ended up studying 44 trials. For 31 of these (75% of them) they found some evidence of ghost authorship, in that people were identified as having written the protocol or who had been involved in doing statistical analyses or writing the manuscript, but did not end up listed in the manuscript. If the definition of authorship was made narrower, and “ghost authorship” included people qualifying for authorship who were mentioned in the acknowledgements but not the author list, the researchers' estimate went up to 91%, that is 40 of the 44 trials. For most of the trials with missing authors, the ghost was a statistician (the person who analyzes the trial data).
What Do These Findings Mean?
In this study, the researchers found that ghost authorship was very common in papers published in medical journals (this study covered a broad range of peer-reviewed journals in many medical disciplines). The method used in this paper seems more reliable than using surveys to work out how often ghost authorship happens. The researchers aimed to define authorship using the policies set out by a group called the International Committee of Medical Journal Editors (ICMJE), and the findings here suggest that the ICMJE's standards for authorship are very often ignored. This means that people who read the published paper cannot always accurately judge or trust the information presented within it, and competing interests may be hidden. The researchers here suggest that protocols should be made publicly available so that everyone can see what trials are planned and who is involved in conducting them. The findings also suggest that journals should not only list the authors of each paper but describe what each author has done, so that the published information accurately reflects what has been carried out.
Additional Information.
Please access these Web sites via the online version of this summary at
Read the Perspective by Liz Wager, which discusses these findings in more depth
The International Committee of Medical Journal Editors (ICMJE) is a group of general medical journal editors who have produced general guidelines for biomedical manuscripts; their definition of authorship is also described
The Committee on Publication Ethics is a forum for editors of peer-reviewed journals to discuss issues related to the integrity of the scientific record; the Web site lists anonymized problems and the committee's advice, not just regarding authorship, but other types of problems as well
Good Publication Practice for Pharmaceutical Companies outlines common standards for publication of industry-sponsored medical research, and some pharmaceutical companies have agreed to these
PMCID: PMC1769411  PMID: 17227134
6.  A reply to Professor Seedhouse. 
Journal of Medical Ethics  1999;25(4):349-350.
This brief reply gives a few references and clarifies some points in order to emphasize that a number of Professor Seedhouse's assertions are debatable and that his criticism of slovenly scholarship and his unbridled ad hominem argumentation are out of place and easily refuted.
PMCID: PMC479247  PMID: 11645178
7.  Microbicide research in developing countries: have we given the ethical concerns due consideration? 
BMC Medical Ethics  2007;8:10.
HIV prevention research has been fraught with ethical concerns since its inception. These concerns were highlighted during HIV vaccine research and have been elaborated in microbicide research. A host of unique ethical concerns pervade the microbicide research process from trial design to post-trial microbicide availability. Given the urgency of research and development in the face of the devastating HIV pandemic, these ethical concerns represent an enormous challenge for investigators, sponsors and Research Ethics Committees (RECs) both locally and internationally.
Ethical concerns relating to safety in microbicide research are a major international concern. However, in the urgency to develop a medically efficacious microbicide, some of these concerns may not have been anticipated. In the risk-benefit assessment of research protocols, both medical and psycho-social risk must be considered. In this paper four main areas that have a potential for medical and/or psycho-social harm are examined. Male partner involvement is controversial in the setting of covert use of microbicides. However, given the long-term exposure of men to experimental products, this may be methodologically, ethically and legally important. Covert use of microbicides may impact negatively on relationship dynamics leading to psychosocial harm to varying extents. The unexpectedly high rates of pregnancy during clinical trials raise important methodological and ethical concerns. Enrollment of adolescents without parental consent generates ethical and legal concerns that must be carefully considered by RECs and trial sites. Finally, paradoxical outcomes in recent trials internationally have advanced the debate on the nature of informed consent and responsibility of researchers to participants who become HIV positive during or after trials.
Phase 3 microbicide trials are an undisputed research and ethical priority in developing countries. However, such trials must be conducted with attention to both methodological and ethical detail. It is imperative that guidelines are formulated to ensure that high ethical standards are maintained despite the scientific urgency of microbicide development. Given the controversy raised by emergent ethical issues during the course of microbicide development, it is important that international consensus is reached amongst the various ethics and regulatory agencies in developing and developed countries alike.
PMCID: PMC2082018  PMID: 17877834
9.  Some ethical issues surrounding covert video surveillance--a response. 
Journal of Medical Ethics  1995;21(2):104-115.
In a recent article in this journal our unit was accused of a number of errors of judgment in applying covert video surveillance (CVS) to infants and children suspected of life-threatening abuse. The article implied, that on moving from the Royal Brompton Hospital in London to North Staffordshire Hospital, we failed to present our work to the Research Ethics Committee (REC). We did send our protocol to the REC though we did not consider that, after a total of 16 patients had been documented as being the subject of life-threatening abuse, this was research. The REC in Staffordshire agreed with us. We were also accused of undertaking work that should be pursued by the Police. We agree with this. However, unlike the Metropolitan Police the Staffordshire Police would not undertake CVS. We fail to agree that 'working together' with parents is necessarily practical or safe when trying to protect children from life-threatening abuse of this kind.
PMCID: PMC1376632  PMID: 7646728
10.  Inclusion of Ethical Issues in Dementia Guidelines: A Thematic Text Analysis 
PLoS Medicine  2013;10(8):e1001498.
Clinical practice guidelines (CPGs) aim to improve professionalism in health care. However, current CPG development manuals fail to address how to include ethical issues in a systematic and transparent manner. The objective of this study was to assess the representation of ethical issues in general CPGs on dementia care.
Methods and Findings
To identify national CPGs on dementia care, five databases of guidelines were searched and national psychiatric associations were contacted in August 2011 and in June 2013. A framework for the assessment of the identified CPGs' ethical content was developed on the basis of a prior systematic review of ethical issues in dementia care. Thematic text analysis and a 4-point rating score were employed to assess how ethical issues were addressed in the identified CPGs. Twelve national CPGs were included. Thirty-one ethical issues in dementia care were identified by the prior systematic review. The proportion of these 31 ethical issues that were explicitly addressed by each CPG ranged from 22% to 77%, with a median of 49.5%. National guidelines differed substantially with respect to (a) which ethical issues were represented, (b) whether ethical recommendations were included, (c) whether justifications or citations were provided to support recommendations, and (d) to what extent the ethical issues were explained.
Ethical issues were inconsistently addressed in national dementia guidelines, with some guidelines including most and some including few ethical issues. Guidelines should address ethical issues and how to deal with them to help the medical profession understand how to approach care of patients with dementia, and for patients, their relatives, and the general public, all of whom might seek information and advice in national guidelines. There is a need for further research to specify how detailed ethical issues and their respective recommendations can and should be addressed in dementia guidelines.
Please see later in the article for the Editors' Summary
Editors’ Summary
In the past, doctors tended to rely on their own experience to choose the best treatment for their patients. Faced with a patient with dementia (a brain disorder that affects short-term memory and the ability tocarry out normal daily activities), for example, a doctor would use his/her own experience to help decide whether the patient should remain at home or would be better cared for in a nursing home. Similarly, the doctor might have to decide whether antipsychotic drugs might be necessary to reduce behavioral or psychological symptoms such as restlessness or shouting. However, over the past two decades, numerous evidence-based clinical practice guidelines (CPGs) have been produced by governmental bodies and medical associations that aim to improve standards of clinical competence and professionalism in health care. During the development of each guideline, experts search the medical literature for the current evidence about the diagnosis and treatment of a disease, evaluate the quality of that evidence, and then make recommendations based on the best evidence available.
Why Was This Study Done?
Currently, CPG development manuals do not address how to include ethical issues in CPGs. A health-care professional is ethical if he/she behaves in accordance with the accepted principles of right and wrong that govern the medical profession. More specifically, medical professionalism is based on a set of binding ethical principles—respect for patient autonomy, beneficence, non-malfeasance (the “do no harm” principle), and justice. In particular, CPG development manuals do not address disease-specific ethical issues (DSEIs), clinical ethical situations that are relevant to the management of a specific disease. So, for example, a DSEI that arises in dementia care is the conflict between the ethical principles of non-malfeasance and patient autonomy (freedom-to-move-at-will). Thus, healthcare professionals may have to decide to physically restrain a patient with dementia to prevent the patient doing harm to him- or herself or to someone else. Given the lack of guidance on how to address ethical issues in CPG development manuals, in this thematic text analysis, the researchers assess the representation of ethical issues in CPGs on general dementia care. Thematic text analysis uses a framework for the assessment of qualitative data (information that is word-based rather than number-based) that involves pinpointing, examining, and recording patterns (themes) among the available data.
What Did the Researchers Do and Find?
The researchers identified 12 national CPGs on dementia care by searching guideline databases and by contacting national psychiatric associations. They developed a framework for the assessment of the ethical content in these CPGs based on a previous systematic review of ethical issues in dementia care. Of the 31 DSEIs included by the researchers in their analysis, the proportion that were explicitly addressed by each CPG ranged from 22% (Switzerland) to 77% (USA); on average the CPGs explicitly addressed half of the DSEIs. Four DSEIs—adequate consideration of advanced directives in decision making, usage of GPS and other monitoring techniques, covert medication, and dealing with suicidal thinking—were not addressed in at least 11 of the CPGs. The inclusion of recommendations on how to deal with DSEIs ranged from 10% of DSEIs covered in the Swiss CPG to 71% covered in the US CPG. Overall, national guidelines differed substantially with respect to which ethical issues were included, whether ethical recommendations were included, whether justifications or citations were provided to support recommendations, and to what extent the ethical issues were clearly explained.
What Do These Findings Mean?
These findings show that national CPGs on dementia care already address clinical ethical issues but that the extent to which the spectrum of DSEIs is considered varies widely within and between CPGs. They also indicate that recommendations on how to deal with DSEIs often lack the evidence that health-care professionals use to justify their clinical decisions. The researchers suggest that this situation can and should be improved, although more research is needed to determine how ethical issues and recommendations should be addressed in dementia guidelines. A more systematic and transparent inclusion of DSEIs in CPGs for dementia (and for other conditions) would further support the concept of medical professionalism as a core element of CPGs, note the researchers, but is also important for patients and their relatives who might turn to national CPGs for information and guidance at a stressful time of life.
Additional Information
Please access these Web sites via the online version of this summary at
Wikipedia contains a page on clinical practice guidelines (note: Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
The US National Guideline Clearinghouse provides information on national guidelines, including CPGs for dementia
The Guidelines International Network promotes the systematic development and application of clinical practice guidelines
The American Medical Association provides information about medical ethics; the British Medical Association provides information on all aspects of ethics and includes an essential tool kit that introduces common ethical problems and practical ways to deal with them
The UK National Health Service Choices website provides information about dementia, including a personal story about dealing with dementia
MedlinePlus provides links to additional resources about dementia and about Alzheimers disease, a specific type of dementia (in English and Spanish)
The UK Nuffield Council on Bioethics provides the report Dementia: ethical issues and additional information on the public consultation on ethical issues in dementia care
PMCID: PMC3742442  PMID: 23966839
11.  “Reader, I Detained Him Under the Mental Health Act”: A Literary Response to Professor Fennell’s Best Interests and Treatment for Mental Disorder 
Health Care Analysis  2008;16(3):268-278.
This is a response to Professor Fennell's paper on the recent influence and impact of the best interests test on the treatment of patients detained under the Mental Health Act 1983 (MHA) for mental disorder. I discuss two points of general ethical significance raised by Professor Fennell. Firstly, I consider his argument on the breadth of the best interests test, incorporating as it does factors considerably wider than those of medical justifications and the risk of harm. Secondly, I discuss his contention that the apparent permeability of the line between the interests of the patient and the interests of society is something to be concerned about in itself. Since the overarching theme of the paper is the proper place of social and cultural values, my reponse considers the implications of Fennell's arguments in the light of Charlotte Brontë's novel ‘Jane Eyre’, which, through the character of Bertha Mason (the infamous ‘mad woman in the attic’) provides a provocative study of the relationship between mental disorder and society.
PMCID: PMC2515572  PMID: 18642086
Mental Health Act; Mental Capacity Act; Mental disorder; Best interests; Consent; Treatment
12.  Munchausen Syndrome Masquerading as Bleeding Disorder in a Group of Pediatric Patients 
This short communication is about Munchausen's syndrome in a group of pediatric patients and co morbid Munchausen's syndrome by proxy. A 7-year-old girl presented with spontaneous bleeding from forehead, eyes and scalp. The girl was investigated thoroughly by pediatricians at a tertiary care hospital in western India for all possible bleeding disorders, but there was no conclusive diagnosis. After two days, cases with similar complaints were reported among children residing in the same locality and with similar socioeconomic background. All of them were investigated in detail for possible causes of bleeding but nothing came out. There was a media reporting of the cases as a mysterious bleeding disorder. At this point of time, an expert opinion from the psychiatrist was demanded. Covert video surveillance and series of interviews revealed Munchausen's syndrome and possible Munchausen's syndrome by proxy. An in-depth literature review with special reference to Munchausen's syndrome was carried out to come to a final conclusive diagnosis.
PMCID: PMC3195164  PMID: 22021962
Munchausen's syndrome; Munchausen's syndrome by proxy; spontaneous bleeding disorder
13.  Dispelling a few false-positives: A reply to MacGregor and McNamee on doping 
McGregor and MacNamee recently, in this journal, offered several criticisms of an earlier article in which I attempted to refute a number of arguments for the claim that doping in sports is morally wrong. Their criticisms are numerous, but focus on four domains. First, they sketch a view on which the risk profiles of different sports may make doping permissible in some and impermissible in others. Second, they suggest that my criticisms of safety-based arguments assume that doping opponents are bent on harm elimination, rather than harm management. Finally, they offer two methodological criticisms, the first pertaining to my use of analogical arguments, and the second pertaining to the general difficulties of making revisionist arguments in ethics. I defend my criticisms of safety-based arguments by showing that these do not rest on the assumptions McGregor and MacNamee attribute to me and by noting that their own view about the variable relevance of safety considerations is underdeveloped. As for their methodological arguments, I endeavor to show that these are misplaced, in that they either rest on misinterpretations of my earlier article or on an excessively high standard for ethical argumentation.
PMCID: PMC3090578  PMID: 21298346
Sports ethics; Doping; Moral methodology; Sports; Performance enhancement
14.  Evaluation of clinical trials by Ethics Committees in Germany - Experience of applicants with the review of requests for opinion of the Ethics Committees - results of a survey among members of the German Association of Research-Based Pharmaceutical Companies (VFA) 
The review of requests for a positive opinion of the ethics committees (application procedure) as a requirement to start a clinical trial in Germany has been completely redesigned with the transposition of EU Directive 2001/20/EC in the 12th Amendment of the German Medicines Act in August 2004. The experience of applicants (sponsors, legal representatives of sponsors in the EU and persons or organizations authorized by the sponsors to make the application, respectively) in terms of interactions with the ethics committees in Germany has been positive overall, especially with respect to ethics committee adherence to the statutory timelines applicable for review of requests. However, inconsistencies between ethics committees exist in terms of the form and content of the requirements for application documents and their evaluation.
With the objective of further improving both the quality of applications and the evaluation of those applications by ethics committees, a survey among members of the German Association of Research-Based Pharmaceutical Companies (VFA) was conducted from January to April 2008. Based on reasoned opinions issued by the respective ethics committee in charge of the coordinating principal investigator (coordinating ethics committee), the type and frequency of formal and content-related objections to applications according to § 7 of the German Good Clinical Practice (GCP) Regulation were systematically documented, and qualitative and quantitative analyses performed. 21 out of 44 members of the VFA participated in the survey. 288 applications for Phase I–IV studies submitted between January and December 2007 to 40 ethics committees were evaluated.
This survey shows that about one in six applications is incomplete and has formal and/or content objections, respectively, especially those that pertain to documents demonstrating the qualification of the investigator and/or suitability of the facilities. These objections are attributable to some extent to the differing and/or unclear requirements of the individual ethics committees on the content and comprehension of the submission documents. However, applicants also need to pay more attention to the completeness and validity of the submission documents. The majority of content-related objections apply to the patient information and consent documents and study protocols submitted. Applicants on average acted upon only 3 out of 4 objections, for various reasons: the relevant information was already given in the submitted documents, but had not been taken into consideration by the ethics committees; objections were not applicable; objections lacked a legal basis. In such cases the applicants made reference to the specific information already submitted or gave reasons for not acting on the objection. This course of action was accepted by the ethics committees, with few exceptions. The survey sheds light on the existing inconsistencies in the evaluations of applications by the various ethics committees and suggests ways in which the existing constructive dialogue between applicants and ethics committees may provide a basis to further harmonize both the requirements regarding form and content of application documents, and the criteria for evaluation of applications by ethics committees within the legal framework.
PMCID: PMC2716553  PMID: 19675747
ethics committees; application procedure; formal and content-related objections; clinical trials
15.  Ethics committees and the legality of research 
Journal of medical ethics  2007;33(12):732-736.
One role of research ethics committees (RECs) is to assess the ethics of proposed health research. In some countries, RECs are also instructed to assess its legality. However, in other countries they are explicitly instructed not to do so. In this paper, I defend the claim that public policy should instruct RECs not to assess the legality of proposed research (“the Claim”). I initially defend a presumption in favour of the Claim, citing reasons for making research institutions solely responsible for assessing the legality of their own research. I then consider three arguments against the Claim which may over-ride this presumption–namely, that policy should instruct RECs to assess the legality of research because (1) doing so would minimise the costs of assessing the legality of research, (2) whether research is legal may partly determine whether it is ethical and (3) whether research is legal may constitute evidence for whether it is ethical. I reject the first two arguments and note that whether the third succeeds depends on the answer to a more fundamental question about the appropriate nature of REC ethical deliberation. I end with a brief discussion of this question, tentatively concluding that the third argument also fails.
PMCID: PMC2598209  PMID: 18055906
16.  Ethics committees and the legality of research 
Journal of Medical Ethics  2007;33(12):732-736.
One role of research ethics committees (RECs) is to assess the ethics of proposed health research. In some countries, RECs are also instructed to assess its legality. However, in other countries they are explicitly instructed not to do so. In this paper, I defend the claim that public policy should instruct RECs not to assess the legality of proposed research (“the Claim”). I initially defend a presumption in favour of the Claim, citing reasons for making research institutions solely responsible for assessing the legality of their own research. I then consider three arguments against the Claim which may over‐ride this presumption—namely, that policy should instruct RECs to assess the legality of research because (1) doing so would minimise the costs of assessing the legality of research, (2) whether research is legal may partly determine whether it is ethical and (3) whether research is legal may constitute evidence for whether it is ethical. I reject the first two arguments and note that whether the third succeeds depends on the answer to a more fundamental question about the appropriate nature of REC ethical deliberation. I end with a brief discussion of this question, tentatively concluding that the third argument also fails.
PMCID: PMC2598209  PMID: 18055906
research ethics committees; ethical review; legislation & jurisprudence
17.  Should We Treat Depression with drugs or psychological interventions? A Reply to Ioannidis 
We reply to the Ioannidis's paper "Effectiveness of antidepressants; an evidence based myth constructed from a thousand controlled trials." We disagree that antidepressants have no greater efficacy than placebo. We present the efficacy from hundreds of trials in terms of the percentage of patients with a substantial clinical response (a 50% improvement or more symptomatic reduction). This meta-analysis finds that 42-70% of depressed patients improve with drug and 21%-39% improve with placebo. The response benefit of antidepressant treatment is 33%-11% greater than placebo. Ioannidis argues that it would be vanishingly smaller because systematic biasing in these clinical trials would reduce the drug-placebo difference to zero. Ioannidis' argument that antidepressants have no benefit is eroded by his failures of logic because he does not present any evidence that there are a large number of studies where placebo is substantially more effective than drug. (To reduce to zero, one would also have to show that some of the unpublished studies find placebo better than drug and have substantial systematic or methodological bias). We also present the empirical evidence showing that these methodological concerns generally have the opposite effect of what Ioannidis argues, supporting our contention that the measured efficacy of antidepressants likely underestimates true efficacy.
Our most important criticism is Ioannidis’ basic underlying argument about antidepressants that if the existing evidence is imperfect and methods can be criticized, then this proves that antidepressant are not efficacious. He presents no credible evidence that antidepressants have zero effect size. Valid arguments can point out difficulties with the data but do not prove that a given drug had no efficacy. Indeed better evidence might prove it was more efficacious that originally found.
We find no empirical or ethical reason why psychiatrists should not try to help depressed patients with drugs and/or with psychotherapeutic/behavioral treatments given evidence of efficacy even though our treatment knowledge has limitations. The immense suffering of patients with major depression leads to ethical, moral, professional and legal obligations to treat patients with the best available tools at our disposal, while diligently and actively monitoring for adverse effects and actively revising treatment components as necessary.
PMCID: PMC3123637  PMID: 21569244
18.  Covert video surveillance--an assessment of the Staffordshire protocol. 
Journal of Medical Ethics  1996;22(1):22-25.
An assessment of a protocol devised to guide practitioners thinking of using covert video surveillance. Such surveillance is particularly used to help identify cases of Munchausen's syndrome by proxy. The protocol in question has been written by staff at the Academic Department of Paediatrics, North Staffordshire Hospital, Stoke-on-Trent in association with their local Area Child Protection Committee and has been commended by the Department of Health to others wishing to implement covert video surveillance.
PMCID: PMC1376853  PMID: 8932721
19.  The views of members of Local Research Ethics Committees, researchers and members of the public towards the roles and functions of LRECs. 
Journal of Medical Ethics  1997;23(3):186-190.
BACKGROUND: It can be argued that the ethical conduct of research involves achieving a balance between the rights and needs of three parties-potential research participants, society, and researchers. Local Research Ethics Committees (LRECs) have a number of roles and functions in the research enterprise, but there have been some indications that LREC members, researchers and the public can have different views about these responsibilities. Any such differences are potential sources of disagreement and misunderstanding. OBJECTIVES: To compare the views of LREC members, researchers and the public towards the roles and functions of LRECs. DESIGN: A questionnaire that contained items concerned with a variety of such roles was distributed to general practice patients (as proxies for potential research participants), researchers and LREC members. FINDINGS: While general practice patients believed that the main function of LRECs is to ensure that research participants come to no harm, LREC members were more concerned with the protection of participants' rights. There was also some disagreement between members and researchers with regard to the consideration of proposals on the grounds of scientific merit. CONCLUSIONS: Local Research Ethics Committee members need to be aware of potential differences in views, that they ought to make their priorities clear, and that membership of LRECs ought to reflect the views of both researchers and potential research participants.
PMCID: PMC1377349  PMID: 9220334
20.  The current state of clinical ethics and healthcare ethics committees in Belgium 
Journal of Medical Ethics  2005;31(6):318-321.
Ethics committees are the most important practical instrument of clinical ethics in Belgium and fulfil three tasks: the ethical review of experimental protocols, advising on the ethical aspects of healthcare practice, and ethics consultation. In this article the authors examine the current situation of ethics committees in Belgium from the perspective of clinical ethics. Firstly, the most important steps which thus far have been taken in Belgium are examined. Secondly, recent opinion by the Belgian Advisory Committee on Bioethics with regard to ethics committees is presented and the activities of Belgian ethics committees are discussed. Finally, the option to bring research ethics and clinical ethics under the roof of just one committee is criticised using a pragmatic and a methodological argument. Concomitantly, the authors build an argument in favour of the further development of ethics consultation.
PMCID: PMC1734169  PMID: 15923477
21.  Proportional ethical review and the identification of ethical issues 
Journal of Medical Ethics  2007;33(4):241-245.
Presently, there is a movement in the UK research governance framework towards what is referred to as proportional ethical review. Proportional ethical review is the notion that the level of ethical review and scrutiny given to a research project ought to reflect the level of ethical risk represented by that project. Relatively innocuous research should receive relatively minimal review and relatively risky research should receive intense scrutiny. Although conceptually attractive, the notion of proportional review depends on the possibility of effectively identifying the risks and ethical issues posed by an application with some process other than a full review by a properly constituted research ethics committee. In this paper, it is argued that this cannot be achieved and that the only appropriate means of identifying risks and ethical issues is consideration by a full committee. This implies that the suggested changes to the National Health Service research ethics system presently being consulted on should be strenuously resisted.
PMCID: PMC2652784  PMID: 17400625
22.  Why Do Women Not Use Antenatal Services in Low- and Middle-Income Countries? A Meta-Synthesis of Qualitative Studies 
PLoS Medicine  2013;10(1):e1001373.
In a synthesis of 21 qualitative studies representing the views of more than 1,230 women from 15 countries, Kenneth Finlayson and Soo Downe examine the reasons why many women in low- and middle-income countries do not receive adequate antenatal care.
Almost 50% of women in low- and middle-income countries (LMICs) don't receive adequate antenatal care. Women's views can offer important insights into this problem. Qualitative studies exploring inadequate use of antenatal services have been undertaken in a range of countries, but the findings are not easily transferable. We aimed to inform the development of future antenatal care programmes through a synthesis of findings in all relevant qualitative studies.
Methods and Findings
Using a predetermined search strategy, we identified robust qualitative studies reporting on the views and experiences of women in LMICs who received inadequate antenatal care. We used meta-ethnographic techniques to generate themes and a line-of-argument synthesis. We derived policy-relevant hypotheses from the findings. We included 21 papers representing the views of more than 1,230 women from 15 countries. Three key themes were identified: “pregnancy as socially risky and physiologically healthy”, “resource use and survival in conditions of extreme poverty”, and “not getting it right the first time”. The line-of-argument synthesis describes a dissonance between programme design and cultural contexts that may restrict access and discourage return visits. We hypothesize that centralised, risk-focused antenatal care programmes may be at odds with the resources, beliefs, and experiences of pregnant women who underuse antenatal services.
Our findings suggest that there may be a misalignment between current antenatal care provision and the social and cultural context of some women in LMICs. Antenatal care provision that is theoretically and contextually at odds with local contextual beliefs and experiences is likely to be underused, especially when attendance generates increased personal risks of lost family resources or physical danger during travel, when the promised care is not delivered because of resource constraints, and when women experience covert or overt abuse in care settings.
Please see later in the article for the Editors' Summary
Editors' Summary
Although maternal deaths worldwide have almost halved since 1990, according to the latest figures, every day roughly 800 women and adolescent girls still die from the complications of pregnancy or childbirth: in 2010, 287,000 women died during or following pregnancy and childbirth, with almost all of these deaths (99%) occurring in low-resource settings. Most maternal deaths are avoidable, as the interventions to prevent or manage the most common complications (severe bleeding, infections, high blood pressure during pregnancy, and unsafe abortion) are well known. Furthermore, many of these complications can be prevented, detected, or treated during antenatal care visits with trained health workers.
Why Was This Study Done?
The World Health Organization (WHO) recommends a minimum of four antenatal visits per pregnancy, but according to WHO figures, between 2005 and 2010 only 53% of pregnant women worldwide attended the recommended four antenatal visits; in low-income countries, this figure was a disappointing 36%. Unfortunately, despite huge international efforts to promote and provide antenatal care, there has been little improvement in these statistics over the past decade. It is therefore important to investigate the reasons for poor antenatal attendance and to seek the views of users of antenatal care. In this study, the researchers combined studies from low- and middle-income countries (LMICs) that included women's views on antenatal care in a meta-synthesis of qualitative studies (qualitative research uses techniques, such as structured interviews, to gather an in-depth understanding of human behaviour, and a meta-synthesis combines and interprets information across studies, contexts, and populations).
What Did the Researchers Do and Find?
The researchers searched several medical, sociological, and psychological databases to find appropriate qualitative studies published between January 1980 and February 2012 that explored the antenatal care experiences, attitudes, and beliefs of women from LMICs who had chosen to access antenatal care late (after 12 weeks' gestation), infrequently (less than four times), or not at all. The researchers included 21 studies (out of the 2,997 initially identified) in their synthesis, representing the views of 1,239 women from 15 countries (Bangladesh, Benin, Cambodia, Gambia, India, Indonesia, Kenya, Lebanon, Mexico, Mozambique, Nepal, Pakistan, South Africa, Tanzania, and Uganda) who were either interviewed directly or gave their opinion as part of a focus group.
The researchers identified three main themes. The first theme reflects women's views that pregnancy is a healthy state and so saw little reason to visit health professionals when they perceived no risk to their well-being—the researchers called this theme, “pregnancy as socially contingent and physiologically healthy.” The second theme relates to women's limited financial resources, so that even when antenatal care was offered free of charge, the cost of transport to get there, the loss of earnings associated with the visit, and the possibility of having to pay for medicines meant that women were unable to attend—the researchers called this theme “resource use and survival in conditions of extreme poverty.” The third theme the researchers identified related to women's views that the antenatal services were inadequate and that the benefits of attending did not outweigh any potential harms. For example, pregnant women who initially recognized the benefits of antenatal care were often disappointed by the lack of resources they found when they got there and, consequently, decided not to return. The researchers called this theme “not getting it right the first time.”
What Do These Findings Mean?
These findings suggest that there may be a misalignment between the principles that underpin the provision of antenatal care and the beliefs and socio-economic contexts of pregnant women in LMICs, meaning that even high-quality antenatal care may not be used by some pregnant women unless their views and concerns are addressed. The themes identified in this meta-synthesis could provide the basis for a new approach to the design and delivery of antenatal care that takes local beliefs and values and resource availability into account. Such programs might help ensure that antenatal care meets pregnant women's expectations and treats them appropriately so that they want to regularly attend antenatal care.
Additional Information
Please access these websites via the online version of this summary at
Wikipedia describes antenatal care (note that Wikipedia is a free online encyclopedia that anyone can edit)
The World Health Organization has a wealth of information relating to pregnancy, including antenatal care
The UK National Institute for Health and Clinical Excellence has evidence-based guidelines on antenatal care
The White Ribbon Alliance for Safe Motherhood has a series of web pages and links relating to respectful maternity care in LMICs
International Federation of Gynecology and Obstetrics is an international organization with connections to various maternity initiatives in LMICs
International Confederation of Midwives has details of the Millennium Development Goals relating to maternity care
PMCID: PMC3551970  PMID: 23349622
23.  International variation in ethics committee requirements: comparisons across five Westernised nations 
BMC Medical Ethics  2002;3:2.
Ethics committees typically apply the common principles of autonomy, nonmaleficence, beneficence and justice to research proposals but with variable weighting and interpretation. This paper reports a comparison of ethical requirements in an international cross-cultural study and discusses their implications.
The study was run concurrently in New Zealand, UK, Israel, Canada and USA and involved testing hypotheses about believability of testimonies regarding alleged child sexual abuse. Ethics committee requirements to conduct this study ranged from nil in Israel to considerable amendments designed to minimise participant harm in New Zealand. Assessment of minimal risk is a complex and unreliable estimation further compounded by insufficient information on probabilities of particular individuals suffering harm. Estimating potential benefits/ risks ratio and protecting participants' autonomy similarly are not straightforward exercises.
Safeguarding moral/humane principles should be balanced with promotion of ethical research which does not impede research posing minimal risk to participants. In ensuring that ethical standards are met and research has scientific merit, ethics committees have obligations to participants (to meet their rights and protect them from harm); to society (to ensure good quality research is conducted); and to researchers (to treat their proposals with just consideration and respect). To facilitate meeting all these obligations, the preferable focus should be promotion of ethical research, rather than the prevention of unethical research, which inevitably results in the impediment of researchers from doing their work. How the ethical principles should be applied and balanced requires further consideration.
PMCID: PMC111059  PMID: 11964190
24.  Consent and assent in paediatric research in low-income settings 
BMC Medical Ethics  2014;15:22.
In order to involve children in the decision-making process about participation in medical research it is widely recommended that the child’s assent be sought in addition to parental consent. However, the concept of assent is fraught with difficulties, resulting in confusion among researchers and ethics committees alike.
In this paper, we outline the current international debate surrounding pediatric consent and assent, and its unique challenges arising in low-income settings. We go on to propose some key requirements for a fit-for-purpose assent model in these difficult settings. The paper recommends that children who are competent, that is, children who are judged to be able to understand and retain relevant information, weigh this information in making a mature judgment, come to a decision and communicate the decision, should be able to consent for themselves. Our proposal is that where the decision about whether to participate in a study is of comparable complexity to the decisions the child is used to making in other aspects of his or her life, it should be made by the child him or herself. The relevant level of complexity should be judged by local standards rather than standards of the developed world. In the paper we explore some of the practical challenges and counter arguments of implementing this proposal. As in high-income settings, we argue that in the case of children who are judged to lack this level of competence both parental consent and assent from the child should be sought and go on to define assent as involving the child to the extent compatible to his or her maturity and with cultural norms and not as obtaining the child’s permission to proceed.
The concept of assent in the current guidelines is confusing. There is an urgent need for clearer guidelines that can be adapted for all types of paediatric research wherever it is to be carried out and an evidence-base concerning good assent/consent practice. This paper argues that a context specific approach should be adopted when assessing whether consent or assent should be sought from children in low-income settings.
PMCID: PMC3973992  PMID: 24597948
Consent; Assent; Paediatric research; Low-income setting; Children
25.  Left-Ventricular Structure in the Southall And Brent REvisited (SABRE) Study 
Hypertension  2013;61(5):1014-1020.
Cardiometabolic risk is elevated in South Asians and African Caribbeans compared with Europeans, yet whether this is associated with ethnic differences in left-ventricular structure is unclear. Conventional M-mode or 2-dimensional echocardiography may be misleading, because they calculate left-ventricular mass and remodeling using geometric assumptions. Left-ventricular structure was compared in a triethnic population-based cohort using conventional and 3-dimensional echocardiography on 895 individuals (aged 55–85 years; 427 European, 325 South Asian, 143 African Caribbean). Left-ventricular mass was indexed, and left-ventricle remodeling index and relative wall thickness were calculated. Anthropometry, blood pressure, and fasting bloods were measured. Three-dimensional left-ventricular mass index did not differ between Europeans (mean±SE, 29.8±0.3 g/m2.7) and African Caribbeans (29.9±0.5 g/m2.7; P=0.9), but it was significantly lower in South Asians (28.1±0.4 g/m2.7; P<0.0001) compared with Europeans. These findings persisted on multivariate adjustment. In contrast, conventional left-ventricle mass index was significantly higher in African Caribbeans (46.4±0.9 g/m2.7) than in Europeans (41.9±0.5 g/m2.7; P<0.0001). Left-ventricle remodeling index was the highest in African Caribbeans and the lowest in South Asians. Relative wall thickness was also higher in African Caribbeans, but no different in South Asians, compared with Europeans. Differences in left-ventricle remodeling index were attenuated by adjustment for cardiometabolic factors between African Caribbeans and Europeans only. In conclusion, left-ventricular mass is lower in South Asians and equivalent in African Caribbeans compared with Europeans, even when cardiometabolic risk factors are accounted for. Left-ventricular remodeling rather than hypertrophy may explain the increased risk of heart failure in people of African Caribbean origin.
PMCID: PMC4083483  PMID: 23478098
cardiometabolic disease; conventional echocardiography; ethnicity; left-ventricular mass; left-ventricular remodeling; three-dimensional echocardiography

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