As the frequency of internet-based research has increased, it is important for researchers to consider how the conditions in which data are collected may influence the risks to participants. In particular, because internet-based data collection often occurs outside a clinical or research setting, there may be unintentional disclosures of a participant’s involvement in a research study of which the researcher is unaware. The current analysis examined the responses of men who have sex with men participating in an internet-based HIV behavioral risk study when queried about the possible disclosure of their participation in the study. Fewer than 2% of participants indicated that their participation in the research study was disclosed, and all but one indicated no negative outcomes associated with the disclosure. As the field of online research continues to expand, it is important to consider risks that are unique to internet-based research, and to monitor these risks to ensure that the confidentiality of research subjects is maintained.
If trials of therapeutic interventions are to serve society’s interests, they must be of high methodological quality and must satisfy moral commitments to human subjects. The authors set out to develop a clinical-trials compendium in which standards for the ethical treatment of human subjects are integrated with standards for research methods.
The authors rank-ordered the world’s nations and chose the 31 with >700 active trials as of 24 July 2008. Governmental and other authoritative entities of the 31 countries were searched, and 1004 English-language documents containing ethical and/or methodological standards for clinical trials were identified. The authors extracted standards from 144 of those: 50 designated as ‘core’, 39 addressing trials of invasive procedures and a 5% sample (N=55) of the remainder. As the integrating framework for the standards we developed a coherent taxonomy encompassing all elements of a trial’s stages.
Review of the 144 documents yielded nearly 15 000 discrete standards. After duplicates were removed, 5903 substantive standards remained, distributed in the taxonomy as follows: initiation, 1401 standards, 8 divisions; design, 1869 standards, 16 divisions; conduct, 1473 standards, 8 divisions; analysing and reporting results, 997 standards, four divisions; and post-trial standards, 168 standards, 5 divisions.
The overwhelming number of source documents and standards uncovered in this study was not anticipated beforehand and confirms the extraordinary complexity of the clinical trials enterprise. This taxonomy of multinational ethical and methodological standards may help trialists and overseers improve the quality of clinical trials, particularly given the globalisation of clinical research.
There are several good reasons for UK Department of Health to recommend appraisal of bevacizumab for treatment of eye conditions by the National Institute for Health and Clinical Excellence. These reasons will extend to other drugs when similar situations arise in future.
Citizens today are increasingly expected to be knowledgeable about and prepared to engage with biomedical knowledge. In this article, I wish to reframe this ‘public understanding of science’ project, and place fresh emphasis on public understandings of research: an engagement with the everyday laboratory practices of biomedicine and its associated ethics, rather than of specific scientific facts. This is not based on an assumption that non-scientists are ‘ignorant’ and are thus unable to ‘appropriately’ use or debate science; rather, it is underpinned by an empirically-grounded observation that some individuals may be unfamiliar with certain specificities of particular modes of research and ethical frameworks, and, as a consequence, have their autonomy compromised when invited to participate in biomedical investigations. Drawing on the perspectives of participants in my own sociological research on the social and ethical dimensions of neuroscience, I argue that public understandings of biomedical research and its ethics should be developed both at the community level and within the research moment itself, in order to enhance autonomy and promote more socially robust science. Public bioethics will have play a key role in such an endeavour, and indeed will contribute in important ways to the opening up of new spaces of symmetrical engagement between bioethicists, scientists, and wider publics – and hence to the democratisation of the bioethical enterprise.
Neuroscience; Public Bioethics; Public Engagement; Public Understanding of Science; Research Ethics
From the perspective of investigators conducting research involving pregnant women and fetuses, a woman's decision about whether to have an abortion can sometimes be relevant to the suitability of the woman and fetus as research subjects. However, prominent ethicists disagree over whether it is permissible for a woman's decision about abortion to be an inclusion or exclusion criterion for participation in research. A widely-held view is that fetuses to be aborted and fetuses to be carried to term should be treated equally as research subjects. Some hold that this principle implies that a woman's decision about whether to have an abortion should not be an inclusion or exclusion criterion. This paper identifies types of research in which investigators might want to have inclusion or exclusion criteria based on decisions about abortion. It examines the arguments for and against having the woman's decision about abortion as such criteria. It is argued that there are types of research in which such criteria are ethically permissible.
abortion; research ethics; prenatal research; fetus; in utero gene transfer
We examined all 208 closed cases involving official findings of research misconduct published by the US Office of Research Integrity from 1992 to 2011 to determine how often scientists mention in a retraction or correction notice that there was an ethical problem with an associated article. 75 of these cases cited at least one published article affected by misconduct for a total of 174 articles. For 127 of these 174, we found both the article and a retraction or correction statement. Since eight of the 127 published statements consisted of simply the word ‘retracted,’ our analysis focused on the remaining 119 for which a more detailed retraction or correction was published. Of these 119 statements, only 41.2% mentioned ethics at all (and only 32.8% named a specific ethical problem such as fabrication, falsification or plagiarism), whereas the other 58.8% described the reason for retraction or correction as error, loss of data or replication failure when misconduct was actually at issue. Among the published statements in response to an official finding of misconduct (within the time frame studied), the proportion that mentioned ethics was significantly higher in recent years than in earlier years, as was the proportion that named a specific problem. To promote research integrity, scientific journals should consider adopting policies concerning retractions and corrections similar to the guidelines developed by the Committee on Publication Ethics. Funding agencies and institutions should take steps to ensure that articles affected by misconduct are retracted or corrected.
While quizzing during informed consent for research to ensure understanding has become commonplace, it is unclear whether the quizzing itself is problematic for potential participants. In this study, we address this issue in a multinational HIV prevention research trial enrolling injection drug users in China and Thailand.
Enrollment procedures included an informed consent comprehension quiz. An informed consent survey (ICS) followed.
525 participants completed the ICS (Heng County, China=255, Xinjiang, China=229, Chiang Mai, Thailand=41). Mean age was 33 and mean educational level was 8 yrs. While quizzing was felt to be a good way to determine if a person understands the nature of clinical trial participation (97%) and participants did not generally find the quiz to be problematic, minorities of respondents felt pressured (6%); anxious (5%); bored (5%); minded (5%); and did not find the questions easy (13%). ). In multivariate analysis, lower educational level was associated with not minding the quizzing (6–10 yrs versus 0–5 yrs: OR=0.27, p=0.03; more than 11 yrs versus 0–5 yrs: OR=0.18, p=0.03). There were also site differences (Heng County versus Xinjiang) in feeling anxious (OR=0.07; p=<0.01), not minding (OR=0.26; p=0.03), being bored (OR=0.25; p =0.01), and not finding the questions easy (OR=0.10; p=<0.01).
Quizzing during the informed consent process can be problematic for a minority of participants. These problems may be associated with the setting in which research takes place and educational level. Further research is needed to develop, test and implement alternative methods of ensuring comprehension of informed consent.
clinicaltrials.gov number NCT00270257.
informed consent; research ethics; ethics; attitudes
Ethics; research; developing countries; Thailand; Burma; genetics; genetics research ethics; ethics theory; clinical ethics
So-called ‘anonymous’ tissue samples are widely used in research. Because they lack externally identifying information, they are viewed as useful in reconciling conflicts between the control, privacy and confidentiality interests of those from whom the samples originated and the public (or commercial) interest in carrying out research, as reflected in ‘consent or anonymise’ policies. High level guidance documents suggest that withdrawal of consent and samples and the provision of feedback are impossible in the case of anonymous samples. In view of recent developments in science and consumer-driven genomics the authors argue that such statements are misleading and only muddle complex ethical questions about possible entitlements to control over samples. The authors therefore propose that terms such as ‘anonymised’, ‘anonymous’ or ‘non-identifiable’ be removed entirely from documents describing research samples, especially from those aimed at the public. This is necessary as a matter of conceptual clarity and because failure to do so may jeopardise public trust in the governance of large scale databases. As there is wide variation in the taxonomy for tissue samples and no uniform national or international standards, the authors propose that a numeral-based universal coding system be implemented that focuses on specifying incremental levels of identifiability, rather than use terms that imply that the reidentification of research samples and associated actions are categorically impossible.
Increasingly a focus of research as well as media reports and online forums, the use of placebos in clinical medicine extends beyond sugar pills and saline injections. Physician surveys conducted in various countries invariably report that placebos are routinely used clinically, impure placebos more frequently than the pure ones, and that physicians consider them to be of legitimate therapeutic value. Inconsistent study methodologies and physician conceptualisations of placebos may complicate the interpretation of survey data, but hardly negate the valuable insights these research findings provide. Because impure placebos are often not recognised as such by practitioners, they remain at the fringe of many placebo-related debates, hence quietly absent from discussions concerning policy and regulation. The apparent popularity of impure placebos used in clinical practice thus presents unresolved ethical concerns and should direct future discussion and research.
Clinical ethics; education for healthcare professionals; healthcare for specific diseases/groups
Informed consent is perhaps more relevant to surgical specialties than to other clinical disciplines. Fundamental to this concept is the provision of relevant information for the patient to make an informed choice about a surgical intervention. The opinions of surgeons in Nigeria about informed consent in their practice were surveyed.
A cross-sectional survey of surgeons in Nigeria was undertaken in 2004/5 using self-administered semistructured questionnaires.
There were 102 respondents, 85.3% of whom were men and 58.8% were aged 31–40 years. 43.1% were consultants and 54.0% were surgical trainees. 27.4% were in surgical subspecialties, 26.5% in general surgery and 21.6% were obstetricians and gynaecologists. 54.9% agreed that sufficient information is not provided to patients while obtaining their consent for surgical procedures. They listed medicolegal reasons (70.6%), informing patients about benefits, risks and alternatives (64.7%) and hospital policy (50.0%) as some reasons for obtaining consent for surgical procedures. When patients decline to give consent for surgery, 84.3% of them thought that poor communication between surgeons and patients may be contributory. They identified taking a course in bioethics during surgical training and compulsory communication skills course as some ways to improve communication between surgeons and patients.
Most Nigerian surgeons seemed to have a good knowledge of the informed consent requirements and process but fall short in practice. There is a need to improve the surgeon–patient relationship in line with modern exigencies to provide interactive environments for fruitful patient communication and involvement.
Medical Ethics has many unsung heros and heroines. Here we celebrate one of these and on telling part of her story hope to place modern medical ethics and bioethics in the UK more centrally within its historical and human contex.
Medical ethics; suicide/assisted suicide; rights; right to refuse treatment; resource allocation; bioethics
Adult; Aged; Attitude of Health Personnel; Decision Making; ethics; Euthanasia; ethics; legislation & jurisprudence; psychology; Female; France; Humans; Infant, Newborn; Intensive Care Units, Neonatal; ethics; legislation & jurisprudence; Male; Medical Staff, Hospital; psychology; Middle Aged; Nursing Staff, Hospital; psychology; Parents; psychology; Young Adult; neonatal intensive care; ethical dilemmas; legislation; professionals; EURONIC; qualitative research
The ability to sequence individual genomes is leading to the identification of an increasing number of genetic risk factors for serious diseases. Knowledge of these risk factors can often provide significant medical and psychological benefit, but also raises complex ethical and social issues. This paper focuses on one area of rapid progress: the identification of mutations causing long QT syndrome and other cardiac channel disorders, which can explain some previously unexplained deaths in infants (SIDS) and children and adults (SUDS) and prevent others from occurring. This genetic knowledge, discovered posthumously in many cases, has implications for clinical care for surviving family members who might carry the same mutations. The information obtained from genetic testing, in the context of personal and family history, can guide individually tailored interventions that reduce risk and save lives. At the same time, obtaining and disclosing genetic information raises difficult issues about confidentiality and decision making within families. We draw on the experience of the Montefiore-Einstein Center for Cardiogenetics, which has played a leading role in the genetic diagnosis and clinical management of cardiac channel diseases, to explore some of the challenging ethical questions arising in affected families with adolescent children. We focus on the related issues of (1) family confidentiality, privacy and disclosure and (2) adolescent decision making about genetic risk, and argue for the value of interdisciplinary dialogue with affected families in resolving these issues.
The search for cause of death is important to improve knowledge and provide answers for the deceased’s relatives. Medical autopsy following unexplained death in hospital is one way to identify cause of death, but difficult to carry out routinely. Post mortem sampling (PMS) of tissues via thin biopsy needle or “mini incisions” in the skin may be a useful alternative. We aimed to assess how this approach is perceived by intensive care doctors, and secondarily, to evaluate how this practice is considered in ethical terms in France.
Study of PMS practices immediately after death in 10 intensive care departments. The medical director of each centre was interviewed by phone and asked to describe practices in their unit and identify questions raised concerning this practice.
PMS is routinely performed in 70% of units, without obtaining formal consent and without precise rules for communicating results. Approaches to PMS differed between centres, but all physicians felt that PMS is useful, firstly for the scientific information provided, but also for the information it provides for relatives. All physicians regret the lack of standards to structure PMS practices.
Information from post-mortem examination is important for society, to inform about causes of death; for doctors, to improve practices; and for decision-makers responsible for organising care. Debate persists regarding the balance between individual rights and community interests. We purport that an approach for identifying cause of death could easily be integrated into the relationship between carers and relatives, provided full transparency is maintained.
Adult; Autopsy; ethics; psychology; statistics & numerical data; Cause of Death; Family; psychology; France; Hospital Mortality; Humans; Informed Consent; ethics; psychology; Intensive Care; Middle Aged; Tissue and Organ Harvesting; ethics; Post mortem sampling; autopsy; intensive care; ethics
Decisions on limiting life-sustaining treatment for patients in the vegetative state (VS) are emotionally and morally challenging. In Germany, doctors have to discuss, together with the legal surrogate (often a family member), whether the proposed treatment is in accordance with the patient's will. However, it is unknown whether family members of the patient in the VS actually base their decisions on the patient's wishes.
To examine the role of advance directives, orally expressed wishes, or the presumed will of patients in a VS for family caregivers' decisions on life-sustaining treatment.
Methods and sample
A qualitative interview study with 14 next of kin of patients in a VS in a long-term care setting was conducted; 13 participants were the patient's legal surrogates. Interviews were analysed according to qualitative content analysis.
The majority of family caregivers said that they were aware of aforementioned wishes of the patient that could be applied to the VS condition, but did not base their decisions primarily on these wishes. They gave three reasons for this: (a) the expectation of clinical improvement, (b) the caregivers' definition of life-sustaining treatments and (c) the moral obligation not to harm the patient. If the patient's wishes were not known or not revealed, the caregivers interpreted a will to live into the patient's survival and non-verbal behaviour.
Whether or not prior treatment wishes of patients in a VS are respected depends on their applicability, and also on the medical assumptions and moral attitudes of the surrogates. We recommend repeated communication, support for the caregivers and advance care planning.
Neuroethics; psychology; clinical ethics; care of the dying patient; definition/determination of death
Population-based research is enhanced by biological measures, but biological sampling raises complex ethical issues. The third British National Survey of Sexual Attitudes and Lifestyles (Natsal-3) will estimate the population prevalence of five sexually transmitted infections (STIs) (Chlamydia trachomatis, Neisseria gonorrhoeae, human papillomavirus (HPV), HIV and Mycoplasma genitalium) in a probability sample aged 16–44 years. The present work describes the development of an ethical approach to urine testing for STIs, including the process of reaching consensus on whether to return results. The following issues were considered: (1) testing for some STIs that are treatable and for which appropriate settings to obtain free testing and advice are widely available (Natsal-3 provides all respondents with STI and healthcare access information), (2) limits on test accuracy and timeliness imposed by survey conditions and sample type, (3) testing for some STIs with unknown clinical and public health implications, (4) how a uniform approach is easier to explain and understand, (5) practical difficulties in returning results and cost efficiency, such as enabling wider STI testing by not returning results. The agreed approach, to perform voluntary anonymous testing with specific consent for five STIs without returning results, was approved by stakeholders and a research ethics committee. Overall, this was acceptable to respondents in developmental piloting; 61% (68 of 111) of respondents agreed to provide a sample. The experiences reported here may inform the ethical decision making of researchers, research ethics committees and funders considering population-based biological sampling.
Sexually transmitted disease; anonymous testing; cross sectional survey; ethics; healthcare for specific diseases/groups; HIV infection and aids; scientific research; epidemiology
Elizabeth Fenton has criticized an earlier article of ours in which we claim that, by providing humankind with means of causing its destruction, the advance of science and technology has put it in a perilous condition which it might take the development of genetic or biomedical techniques of moral enhancement to get out of. The development of these techniques would however require further scientific advances, thus forcing humanity deeper into the danger zone created by modern science. Fenton argues that we undervalue the benefits of scientific advances. We believe that our argument rather relies upon attaching a special weight to even very slight risks of major catastrophes, and attempt to vindicate this weighting.
Researchers and ethicists have long been concerned about the expectations for direct medical benefit expressed by participants in early phase clinical trials. Early work on the issue considered the possibility that participants misunderstand the purpose of clinical research or that they are misinformed about the prospects for medical benefit from these trials. Recently, however, attention has turned to the possibility that research participants are simply expressing optimism or hope about their participation in these trials. The ethical significance of this therapeutic optimism remains unclear. This paper argues that there are two distinct phenomena that can be associated with the term ‘therapeutic optimism’—one is ethically benign and the other is potentially worrisome. Distinguishing these two phenomena is crucial for understanding the nature and ethical significance of therapeutic optimism. The failure to draw a distinction between these phenomena also helps to explain why different writers on the topic often speak past one another.
Systematic reviews, which were developed to improve policy-making and clinical decision-making, answer an empirical question based on a minimally biased appraisal of all the relevant empirical studies. A model is presented here for writing systematic reviews of argument-based literature: literature that uses arguments to address conceptual questions, such as whether abortion is morally permissible or whether research participants should be legally entitled to compensation for sustaining research-related injury. Such reviews aim to improve ethically relevant decisions in healthcare, research or policy. They are better tools than informal reviews or samples of literature with respect to the identification of the reasons relevant to a conceptual question, and they enable the setting of agendas for conceptual and empirical research necessary for sound policy-making. This model comprises prescriptions for writing the systematic review's review question and eligibility criteria, the identification of the relevant literature, the type of data to extract on reasons and publications, and the derivation and presentation of results. This paper explains how to adapt the model to the review question, literature reviewed and intended readers, who may be decision-makers or academics. Obstacles to the model's application are described and addressed, and limitations of the model are identified.
Bioethics; decision making; ethics and evidence-based medicine (EBM); guideline development; health policy; information ethics; methods in empirical bioethics; review literature as topic; systematic review; technology/risk assessment
Research ethics review is an important process, designed to protect participants in medical research. However, it is increasingly criticised for failing to meet its aims. Here, two researchers reflect on their experiences of applying for ethical approval of observational research in clinical settings. They highlight some problems faced by reviewers and researchers and propose a two-stage ethical review process that would alert researchers to the committee's concerns and allow them to give a more considered response.
This paper will consider the right not to know in the context of psychiatric disorders. It will outline the arguments for and against acquiring knowledge about the results of genetic testing for conditions such as breast cancer and Huntington’s disease, and examine whether similar considerations apply to disclosing to clients the results of genetic testing for psychiatric disorders such as depression and Alzheimer’s disease. The right not to know will also be examined in the context of the diagnosis of psychiatric disorders that are associated with stigma or for which there is no effective treatment.
Disclosures of funding sources and conflicts of interests (COI) in published peer-reviewed journal articles have recently begun to receive some attention, but many critical questions remain, for example, how often such reporting occurs concerning research conducted in the developing world and what factors may be involved.
Of all articles indexed in Medline reporting on human subject HIV research in 2007 conducted in four countries (India, Thailand, Nigeria and Uganda), this study explored how many disclosed a funding source and COI, and what factors are involved.
Of 221 articles that met the criteria, 67.9% (150) disclosed the presence or absence of a funding source, but only 20% (44) disclosed COI. Studies from Uganda were more likely, and those from Nigeria were less likely to mention a funding source (p<0.001). Of articles in journals that had adopted International Committee of Medical Journal Editors (ICMJE) guidelines, 56% did not disclose COI. Disclosure of funding was more likely when: ≥50% of the authors and the corresponding author were from the sponsoring country, the sponsor country was the USA, and the articles were published in journals in which more of the editors were from the sponsoring countries.
Of the published studies examined, over a third did not disclose funding source (ie, whether or not there was a funding source) and 80% did not disclose whether COI existed. Most articles in ICMJE-affiliated journals did not disclose COI. These data suggest the need to consider alteration of policies to require that published articles include funding and COI information, to allow readers to assess articles as fully as possible.
In an online study conducted separately in the UK and the US, participants rated the acceptability and fairness of four interventions: two types of financial incentives (rewards and penalties) and two types of medical interventions (pills and injections). These were stated to be equally effective in improving outcomes in five contexts: (a) weight loss and (b) smoking cessation programmes, and adherence in treatment programmes for (c) drug addiction, (d) serious mental illness and (e) physiotherapy after surgery. Financial incentives (weekly rewards and penalties) were judged less acceptable and to be less fair than medical interventions (weekly pill or injection) across all five contexts. Context moderated the relative preference between rewards and penalties: participants from both countries favoured rewards over penalties in weight loss and treatment for serious mental illness. Only among US participants was this relative preference moderated by perceived responsibility of the target group. Overall, participants supported funding more strongly for interventions when they judged members of the target group to be less responsible for their condition, and vice versa. These results reveal a striking similarity in negative attitudes towards the use of financial incentives, rewards as well as penalties, in improving outcomes across a range of contexts, in the UK and the USA. The basis for such negative attitudes awaits further study.
Allocation of health care resources; population policy; behaviour modification