Conflicts of interest in clinical guidelines, advisory committee reports, opinion pieces, and narrative reviews: associations with recommendations.

BACKGROUND: Treatment and diagnostic recommendations are often made in clinical guidelines, reports from advisory committee meetings, opinion pieces such as editorials, and narrative reviews. Quite often, the authors or members of advisory committees have industry ties or particular specialty interests which may impact on which interventions are recommended. Similarly, clinical guidelines and narrative reviews may be funded by industry sources resulting in conflicts of interest. OBJECTIVES: To investigate to what degree financial and non-financial conflicts of interest are associated with favourable recommendations in clinical guidelines, advisory committee reports, opinion pieces, and narrative reviews. SEARCH METHODS: We searched PubMed, Embase, and the Cochrane Methodology Register for studies published up to February 2020. We also searched reference lists of included studies, Web of Science for studies citing the included studies, and grey literature sources. SELECTION CRITERIA: We included studies comparing the association between conflicts of interest and favourable recommendations of drugs or devices (e.g. recommending a particular drug) in clinical guidelines, advisory committee reports, opinion pieces, or narrative reviews. DATA COLLECTION AND ANALYSIS: Two review authors independently included studies, extracted data, and assessed risk of bias. When a meta-analysis was considered meaningful to synthesise our findings, we used random-effects models to estimate risk ratios (RRs) with 95% confidence intervals (CIs), with RR > 1 indicating that documents (e.g. clinical guidelines) with conflicts of interest more often had favourable recommendations. We analysed associations for financial and non-financial conflicts of interest separately, and analysed the four types of documents both separately (pre-planned analyses) and combined (post hoc analysis). MAIN RESULTS: We included 21 studies analysing 106 clinical guidelines, 1809 advisory committee reports, 340 opinion pieces, and 497 narrative reviews. We received unpublished data from 11 studies; eight full data sets and three summary data sets. Fifteen studies had a risk of confounding, as they compared documents that may differ in other aspects than conflicts of interest (e.g. documents on different drugs used for different populations). The associations between financial conflicts of interest and favourable recommendations were: clinical guidelines, RR: 1.26, 95% CI: 0.93 to 1.69 (four studies of 86 clinical guidelines); advisory committee reports, RR: 1.20, 95% CI: 0.99 to 1.45 (four studies of 629 advisory committee reports); opinion pieces, RR: 2.62, 95% CI: 0.91 to 7.55 (four studies of 284 opinion pieces); and narrative reviews, RR: 1.20, 95% CI: 0.97 to 1.49 (four studies of 457 narrative reviews). An analysis combining all four document types supported these findings (RR: 1.26, 95% CI: 1.09 to 1.44). One study investigating specialty interests found that the association between including radiologist guideline authors and recommending routine breast cancer screening was RR: 2.10, 95% CI: 0.92 to 4.77 (12 clinical guidelines). AUTHORS' CONCLUSIONS: We interpret our findings to indicate that financial conflicts of interest are associated with favourable recommendations of drugs and devices in clinical guidelines, advisory committee reports, opinion pieces, and narrative reviews. However, we also stress risk of confounding in the included studies and the statistical imprecision of individual analyses of each document type. It is not certain whether non-financial conflicts of interest impact on recommendations.

Constructing 'exceptionality': a neglected aspect of NHS rationing.

In the British NHS the principle of exceptionality involves assessing whether a patient is sufficiently different from the generality of patients to justify providing a treatment, such as an expensive cancer drug, not approved for routine funding. In England, individual requests for certain high-cost treatments are considered by local panels that examine exceptionality alongside treatment efficacy and cost as the main criteria for funding. This was also the case in Wales until September 2017. Our paper draws on audio recordings of panel meetings and interviews in a Welsh Health Board to investigate how exceptionality was constructed in discussions. It focuses on the problematic combination of different decision criteria in meeting talk, particularly regarding the discourses associated with efficacy and exceptionality. Exceptionality is a fluid category that raised questions about the evidence-based nature of panel decision making. In particular, the paper discusses the use of subgroup data from RCTs and the difficulty of deciding how small a subgroup of patients should be before it is deemed exceptional. Determining exceptionality has been an important mechanism for deciding that a minority of NHS patients can still receive high-cost treatments not routinely provided for all. As a neglected rationing mechanism it warrants sociological examination.

Bioethics and multiculturalism: nuancing the discussion.

In his recent analysis of multiculturalism, Tom Beauchamp has argued that those who implement multicultural reasoning in their arguments against common morality theories, such as his own, have failed to understand that multiculturalism is neither a form of moral pluralism nor ethical relativism but is rather a universalistic moral theory in its own right. Beauchamp's position is indeed on the right track in that multiculturalists do not consider themselves ethical relativists. Yet, Beauchamp tends to miss the mark when he argues that multiculturalism is in effect a school of thought that endorses a form of moral universalism that is akin to his own vision of a common morality. As a supporter of multiculturalism, I would like to discuss some aspects of Beauchamp's comments on multiculturalism and clarify what a multicultural account of public bioethics might look like. Ultimately, multiculturalism is purported as a means of managing diversity in the public arena and should not be thought of as endorsing either a version of moral relativism or a universal morality. By simultaneously refraining from the promotion of a comprehensive common moral system while it attempts to avoid a collapse into relativism, multiculturalism can serve as the ethico-political framework in which diverse moralities can be managed and in which opportunities for ethical dialogue, debate and deliberation on the prospects of common bioethical norms are made possible.

Assessment of orientation practices for ethics consultation at Harvard Medical School-affiliated hospitals.

BACKGROUND: Few studies have been conducted to assess the quality of orientation practices for ethics advisory committees that conduct ethics consultation. This survey study focused on several Harvard teaching hospitals, exploring orientation quality and committee members' self-evaluation in the American Society of Bioethics and Humanities (ASBH) ethics consultation competencies. METHODS: We conducted a survey study that involved 116 members and 16 chairs of ethics advisory committees, respectively (52% and 62.5% response rates). Predictor variables included professional demographics, duration on committees and level of training. Outcome variables included familiarity with and preparedness in the ASBH competencies and satisfaction with orientations. We hypothesised that responses would be associated with both the aforementioned predictors and whether or not participants had encountered the ASBH competencies in training. RESULTS: A majority of respondents found their orientation curricula to be helpful (62%), although a significant portion of respondents did not receive any orientation (24%) or were unsatisfied with their orientation (14%). Familiarity with ASBH competencies was a statistically significant predictor of respondents' self-evaluation in particular categories (54% had heard of the competencies). Standard educational materials were reported as offered during orientation, such as readings (50%) and case studies (41%); different medium resources were less evidenced such as videos on ethics consultation (19%). CONCLUSIONS: Institutions should re-evaluate orientation practices for ethics committee members that perform ethics consultation. Integrating ASBH competencies and useful methods into a resourceful pedagogy will help improve both member satisfaction with orientation and preparation in consultation.

Clinic, courtroom or (specialist) committee: in the best interests of the critically Ill child?

Law's processes are likely always to be needed when particularly intractable conflicts arise in relation to the care of a critically ill child like Charlie Gard. Recourse to law has its merits, but it also imposes costs, and the courts' decisions about the best interests of such children appear to suffer from uncertainty, unpredictability and insufficiency. The insufficiency arises from the courts' apparent reluctance to enter into the ethical dimensions of such cases. Presuming that such reflection is warranted, this article explores alternatives to the courts, and in particular the merits of specialist ethics support services, which appear to be on the rise in the UK. Such specialist services show promise, as they are less formal and adversarial than the courts and they appear capable of offering expert ethical advice. However, further research is needed into such services - and into generalist ethics support services - in order to gauge whether this is indeed a promising development.

The Design of the Internet's Architecture by the Internet Engineering Task Force (IETF) and Human Rights.

The debate on whether and how the Internet can protect and foster human rights has become a defining issue of our time. This debate often focuses on Internet governance from a regulatory perspective, underestimating the influence and power of the governance of the Internet's architecture. The technical decisions made by Internet Standard Developing Organisations (SDOs) that build and maintain the technical infrastructure of the Internet influences how information flows. They rearrange the shape of the technically mediated public sphere, including which rights it protects and which practices it enables. In this article, we contribute to the debate on SDOs' ethical responsibility to bring their work in line with human rights. We defend three theses. First, SDOs' work is inherently political. Second, the Internet Engineering Task Force (IETF), one of the most influential SDOs, has a moral obligation to ensure its work is coherent with, and fosters, human rights. Third, the IETF should enable the actualisation of human rights through the protocols and standards it designs by implementing a responsibility-by-design approach to engineering. We conclude by presenting some initial recommendations on how to ensure that work carried out by the IETF may enable human rights.

Canada on course to introduce permissive assisted dying regime.

Canada's Supreme Court decided in February 2015 that the criminalisation of assisted dying in the country violates the country's citizens and residents constitutional rights. This paper reviews policy recommendations produced by a special expert advisory panel appointed by Canada's provinces and territories, where the responsibility for the provision of health care lies. It also reviews a similar document produced by a special federal parliamentary committee. Based on the review of these two milestone documents it is argued that a Canadian consensus seems to emerge that foreshadows a permissive regulatory regime in that country.

Ethical issues in genomic research on the African continent: experiences and challenges to ethics review committees.

This is a report on a workshop titled 'Ethics for genomic research across five African countries: Guidelines, experiences and challenges', University of the Witwatersrand, Johannesburg, South Africa, 10 and 11 December 2012. The workshop was hosted by the Wits-INDEPTH partnership, AWI-Gen, as part of the H3Africa Consortium.

The Assisted Dying Bill and the role of the physician.

This article explores the role of the physician in the Assisted Dying Bill, which is currently progressing through the House of Lords. The Supreme Court decision in Nicklinson and Others has alerted Parliament to the possibility that the current prohibition against assisted suicide may breach Article 8 of the European Convention in relation to the right to choose how to end one's life. In this article, the role of healthcare professionals in the proposed legalisation of physician-assisted suicide is examined, together with consideration of key ethical concerns over who might be permitted to access assisted dying. Whether the proposed law presents an ethically sound alternative to the current prohibition against assisting in suicide is not clear, but Parliament must now respond in order to address human rights issues and the call to legalise medically assisted suicide.

Historical development and current status of organ procurement from death-row prisoners in China.

BACKGROUND: In December 2014, China announced that only voluntarily donated organs from citizens would be used for transplantation after January 1, 2015. Many medical professionals worldwide believe that China has stopped using organs from death-row prisoners. DISCUSSION: In the present article, we briefly review the historical development of organ procurement from death-row prisoners in China and comprehensively analyze the social-political background and the legal basis of the announcement. The announcement was not accompanied by any change in organ sourcing legislations or regulations. As a fact, the use of prisoner organs remains legal in China. Even after January 2015, key Chinese transplant officials have repeatedly stated that death-row prisoners have the same right as regular citizens to "voluntarily donate" organs. This perpetuates an unethical organ procurement system in ongoing violation of international standards. CONCLUSIONS: Organ sourcing from death-row prisoners has not stopped in China. The 2014 announcement refers to the intention to stop the use of organs illegally harvested without the consent of the prisoners. Prisoner organs procured with "consent" are now simply labelled as "voluntarily donations from citizens". The semantic switch may whitewash sourcing from both death-row prisoners and prisoners of conscience. China can gain credibility only by enacting new legislation prohibiting use of prisoner organs and by making its organ sourcing system open to international inspections. Until international ethical standards are transparently met, sanctions should remain.

Epistocracy for online deliberative bioethics.

The suggestion that deliberative democratic approaches would suit the management of bioethical policymaking in democratic pluralistic societies has triggered what has been called the "deliberative turn" in health policy and bioethics. Most of the empirical work in this area has focused on the allocation of healthcare resources and priority setting at the local or national level. The variety of the more or less articulated theoretical efforts behind such initiatives is remarkable and has been accompanied, to date, by an overall lack of method specificity. We propose a set of methodological requirements for online deliberative procedures for bioethics. We provide a theoretical motivation for these requirements. In particular, we discuss and adapt an "epistocratic" proposal and argue that, regardless of its merits as a general political theory, a more refined version of its normative claims can generate a useful framework for the design of bioethical forums that combine maximal inclusiveness with informed and reasonable deliberation.

Motivations and perceptions of community advisory boards in the ethics of medical research: the case of the Thai-Myanmar border.

BACKGROUND: Community engagement is increasingly promoted as a marker of good, ethical practice in the context of international collaborative research in low-income countries. There is, however, no widely agreed definition of community engagement or of approaches adopted. Justifications given for its use also vary. Community engagement is, for example, variously seen to be of value in: the development of more effective and appropriate consent processes; improved understanding of the aims and forms of research; higher recruitment rates; the identification of important ethical issues; the building of better relationships between the community and researchers; the obtaining of community permission to approach potential research participants; and, the provision of better health care. Despite these diverse and potentially competing claims made for the importance of community engagement, there is very little published evidence on effective models of engagement or their evaluation. METHODS: In this paper, drawing upon interviews with the members of a Community Advisory Board on the Thai-Myanmar border, we describe and critically reflect upon an approach to community engagement which was developed in the context of international collaborative research in the border region. RESULTS AND CONCLUSIONS: Drawing on our analysis, we identify a number of considerations relevant to the development of an approach to evaluating community engagement in this complex research setting. The paper also identifies a range of important ways in which the Community Advisory Board is in practice understood by its members (and perhaps by community members beyond this) to have morally significant roles and responsibilities beyond those usually associated with the successful and appropriate conduct of research.