Non-Invasive Prenatal Testing is a technology which provides information about fetal genetic characteristics very early in pregnancy by examining fetal DNA obtained from a sample of maternal blood. NIPT is a morally complex technology that has advanced quickly to market with a strong push from industry developers, leaving many areas of uncertainty still to be resolved, and creating a strong need for health policy that reflects women’s social and ethical values. We approach the need for ethical policy-making by studying the (...) use of NIPT and emerging policy in the province of Ontario, Canada. Using an adapted version of constructivist grounded theory, we conducted interviews with 38 women who have had personal experiences with NIPT. We used an iterative process of data collection and analysis and a staged coding strategy to conduct a descriptive analysis of ethics issues identified implicitly and explicitly by women who have been affected by this technology. The findings of this paper focus on current ethical issues for women seeking NIPT, including place in the prenatal pathway, health care provider counselling about the test, industry influence on the diffusion of NIPT, consequences of availability of test results. Other issues gain relevance in the context of future policy decisions regarding NIPT, including funding of NIPT and principles that may govern the expansion of the scope of NIPT. These findings are not an exhaustive list of all the potential ethical issues related to NIPT, but rather a representation of the issues which concern women who have personal experience with this test. Women who have had personal experience with NIPT have concerns and priorities which sometimes contrast dramatically with the theoretical ethics literature. These findings suggest the importance of engaging patients in ethical deliberation about morally complex technologies, and point to the need for more deliberative patient engagement work in this area. (shrink)

The Médecins Sans Frontières ethics review board has been solicited in an unprecedented way to provide advice and review research protocols in an ‘emergency’ mode during the recent Ebola epidemic. Twenty-seven Ebola-related study protocols were reviewed between March 2014 and August 2015, ranging from epidemiological research, to behavioural research, infectivity studies and clinical trials with investigational products at early development stages. This article examines the MSF ERB’s experience addressing issues related to both the process of review and substantive ethical issues (...) in this context. These topics include lack of policies regarding blood sample collection and use, and engaging communities regarding their storage and future use; exclusion of pregnant women from clinical and vaccine trials; and the difficulty of implementing timely and high-quality qualitative/anthropological research to consider potential upfront harms. Having noticed different standards across ethics committees, we propose that when multiple ethics reviews of clinical and vaccine trials are carried out during a public health emergency they should be accompanied by transparent communication between the ECs involved. The MSF ERB experience should trigger a broader discussion on the ‘optimal’ ethics review in an emergency outbreak and what enduring structural changes are needed to improve the ethics review process. (shrink)

BackgroundWhile evaluation of ethical aspects in health technology assessment has gained much attention during the past years, the integration of ethics in HTA practice still presents many challenges. In response to the increasing demand for expansion of health technology assessment methodology to include ethical issues more systematically, this article reports on a multi-stage study that aimed at construction of a framework for improving the integration of ethics in HTA.MethodsThe framework was developed through the following phases: 1) a systematic review and (...) content analysis of guidance documents for ethics in HTA; 2) identification of factors influencing the integration of ethical considerations in HTA; 3) preparation of an action-oriented framework based on the key elements of the existing guidance documents and identified barriers to and facilitators of their implementation; and 4) expert consultation and revision of the framework.ResultsThe proposed framework consists of three main components: an algorithmic flowchart, which exhibits the different steps of an ethical inquiry throughout the HTA process, including: defining the objectives and scope of the evaluation, stakeholder analysis, assessing organizational capacity, framing ethical evaluation questions, ethical analysis, deliberation, and knowledge translation; a stepwise guide, which focuses on the task objectives and potential questions that are required to be addressed at each step; and a list of some commonly recommended or used tools to help facilitate the evaluation process.ConclusionsThe proposed framework can be used to support and promote good practice in integration of ethics into HTA. However, further validation of the framework through case studies and expert consultation is required to establish its utility for HTA practice. (shrink)

This article explores the accounts of Canadian-trained health professionals working in humanitarian and development organizations who considered not treating a patient or group of patients because of resource limitations. In the narratives, not treating the patient(s) was sometimes understood as the right thing to do, and sometimes as wrong. In analyzing participants’ narratives we draw attention to how medications and equipment are represented. In one type of narrative, medications and equipment are represented primarily as scarce resources; in another, they are (...) represented as patient care. In the contexts respondents were working, medications and equipment were often both patient care interventions and scarce resources. The analytic point is that health professionals tend to emphasize one conceptualization over the other in coming to assert that not treating is right, or wrong. Rendering tacit ethical frameworks more explicit makes them available for reflection and debate. (shrink)

Humanitarian health care practitioners working outside familiar settings, and without familiar supports, encounter ethical challenges both familiar and distinct. The ethical guidance they rely upon ought to reflect this. Using data from empirical studies, we explore the strengths and weaknesses of two ethical models that could serve as resources for understanding ethical challenges in humanitarian health care: clinical ethics and public health ethics. The qualitative interviews demonstrate the degree to which traditional teaching and values of clinical health ethics seem insufficient (...) for addressing all the realities of health care practice during humanitarian missions. They equally suggest that greater good orientations of public health ethics can thwart the best intentions of health care professionals wanting to attend to the interests of individual patients. Even though neither is complete on its own for helping guide health professionals on field missions, taken together these models have much to offer. At the same time, the narratives of the humanitarian health care workers illustrate how some of the crucial differences between public health ethics and clinical ethics generate tensions in humanitarian health practice. We offer an analysis of some of the complexities this creates for humanitarian health care ethics, and consider ways of adjudicating between the two models. (shrink)

BackgroundStigma refers to a distinguishing personal trait that is perceived as or actually is physically, socially, or psychologically disadvantageous. Little is known about the opinion of those who have more or less stigmatizing health conditions regarding the need for consent for use of their personal information for health research.MethodsWe surveyed the opinions of people 18 years and older with seven health conditions. Participants were drawn from: physicians' offices and clinics in southern Ontario; and from a cross-Canada marketing panel of individuals (...) with the target health conditions. For each of five research scenarios presented, respondents chose one of five consent choices: (1) no need for me to know; (2) notice with opt-out; (3) broad opt-in; (4) project-specific permission; and (5) this information should not be used. Consent choices were regressed onto: demographics; health condition; and attitude measures of privacy, disclosure concern, and the benefits of health research. We conducted focus groups to discuss possible reasons for observed consent choices.ResultsWe observed substantial variation in the control that people wish to have over use of their personal information for research. However, consent choice profiles were similar across health conditions, possibly due to sampling bias. Research involving profit or requiring linkage of health information with income, education, or occupation were associated with more restrictive consent choices. People were more willing to link their health information with biological samples than with information about their income, occupation, or education.ConclusionsThe heterogeneity in consent choices suggests individuals should be offered some choice in use of their information for different types of health research, even if limited to selectively opting-out. Some of the implementation challenges could be designed into the interoperable electronic health record. However, many questions remain, including how best to capture the opinions of those who are more privacy sensitive. (shrink)

Health care professionals who travel from their home countries to participate in humanitarian assistance or development work experience distinctive ethical challenges in providing care and services to populations affected by war, disaster or deprivation. Limited information is available about organizational practices related to preparation and support for health professionals working with non-governmental organizations. In this article, we present one component of the results of a qualitative study conducted with 20 Canadian health care professionals who participated in international aid work. The (...) findings reported here relate to expatriate clinicians’ experiences and perceptions of ethics preparation, training and support. The strategies examined include pre-departure training and preparation, in-field supports and retrospective debriefing of ethical issues. Participants experienced a range of training and supports as beneficial for addressing ethical challenges in humanitarian assistance and development work. Participants also expressed ambivalence or scepticism about the benefits offered by specific modalities. This analysis can contribute to informing discussions of how organizations and individual practitioners can best develop, implement and utilize ethics training and support for international aid work. (shrink)

Introduction: Variation across research ethics boards in conditions placed on access to medical records for research purposes raises concerns around negative impacts on research quality and on human subject protection, including privacy.Aim: To study variation in REB consent requirements for retrospective chart review and who may have access to the medical record for data abstraction.Methods: Thirty 90-min face-to-face interviews were conducted with REB chairs and administrators affiliated with faculties of medicine in Canadian universities, using structured questions around a case study (...) with open-ended responses. Interviews were recorded, transcribed and coded manually.Results: Fourteen sites required individual patient consent for the study to proceed as proposed. Three indicated that their response would depend on how potentially identifying variables would be managed. Eleven sites did not require consent. Two suggested a notification and opt-out process. Most stated that consent would be required if identifiable information was being abstracted from the record. Among those not requiring consent, there was substantial variation in recognising that the abstracted information could potentially indirectly re-identify individuals. Concern over access to medical records by an outside individual was also associated with requirement for consent. Eighteen sites required full committee review. Sixteen allowed an external research assistant to abstract information from the health record.Conclusions: Large variation was found across sites in the requirement for consent for research involving access to medical records. REBs need training in best practices for protecting privacy and confidentiality in health research. A forum for REB chairs to confidentially share concerns and decisions about specific studies could also reduce variation in decisions. (shrink)

The conduct of research in settings affected by disasters such as hurricanes, floods and earthquakes is challenging, particularly when infrastructures and resources were already limited pre-disaster. However, since post-disaster research is essential to the improvement of the humanitarian response, it is important that adequate research ethics oversight be available. We aim to answer the following questions: 1) what do research ethics committee members who have reviewed research protocols to be conducted following disasters in low- and middle-income countries perceive as the (...) key ethical concerns associated with disaster research?, and 2) in what ways do REC members understand these concerns to be distinct from those arising in research conducted in non-crisis situations? This qualitative study was developed using interpretative description methodology; 15 interviews were conducted with REC members. Four key ethical issues were identified as presenting distinctive considerations for disaster research to be implemented in LMICs, and were described by participants as familiar research ethics issues that were amplified in these contexts. First, REC members viewed disaster research as having strong social value due to its potential for improving disaster response, but also as requiring a higher level of justification compared to other research settings. Second, they identified vulnerability as an overarching concern for disaster research ethics, and a feature that required careful and critical appraisal when assessing protocols. They noted that research participants’ vulnerabilities frequently change in the aftermath of a disaster and often in unpredictable ways. Third, they identified concerns related to promoting and maintaining safety, confidentiality and data security in insecure or austere environments. Lastly, though REC members endorsed the need and usefulness of community engagement, they noted that there are significant challenges in a disaster setting over and above those typically encountered in global health research to achieve meaningful community engagement. Disaster research presents distinctive ethical considerations that require attention to ensure that participants are protected. As RECs review disaster research protocols, they should address these concerns and consider how justification, vulnerability, security and confidentially, and community engagement are shaped by the realities of conducting research in a disaster. (shrink)

It remains unclear what patient advocacy actually entails and what values it ought to embody. It will be useful to ascertain whether advocacy means supporting any decision the patient makes, or if the advocate can claim to represent the patient by asserting well-intentioned paternalistic claims on the patient's behalf. This is especially significant because the position of advocate brings with it certain privileges on the basis of of presumed insight into patient-perceived interests, namely, entitlement to take part in clinical decision (...) making and increased professional standing. Three issues related to patient advocacy will be explored: are patient advocates necessary; what does advocacy entail, and who ought to represent patients in this way—arguments for and against prospective candidates will also be covered. The paper considers whether advocates are necessary since not only can they be dangerously paternalistic, but the salutary values advocacy embodies are already part of good professional health care. (shrink)

BackgroundThe role of consent for research use of health information is contentious. Most discussion has focused on when project-specific consent may be waived but, recently, a broader range of consent options has been entertained, including broad opt-in for multiple studies with restrictions and notification with opt-out. We sought to elicit public values in this matter and to work toward an agreement about a common approach to consent for use of personal information for health research through deliberative public dialogues.MethodsWe conducted seven (...) day-long public dialogues, involving 98 participants across Canada. Immediately before and after each dialogue, participants completed a fixed-response questionnaire rating individuals' support for 3 approaches to consent in the abstract and their consent choices for 5 health research scenarios using personal information. They also rated how confident different safeguards made them feel that their information was being used responsibly.ResultsBroad opt-in consent for use of personal information garnered the greatest support in the abstract. When presented with specific research scenarios, no one approach to consent predominated. When profit was introduced into the scenarios, consent choices shifted toward greater control over use. Despite lively and constructive dialogues, and considerable shifting in opinion at the individual level, at the end of the day, there was no substantive aggregate movement in opinion. Personal controls were among the most commonly cited approaches to improving people's confidence in the responsible use of their information for research.ConclusionBecause no one approach to consent satisfied even a simple majority of dialogue participants and the importance placed on personal controls, a mechanism should be developed for documenting consent choice for different types of research, including ways for individuals to check who has accessed their medical record for purposes other than clinical care. This could be done, for example, through a web-based patient portal to their electronic health record. Researchers and policy makers should continue to engage the public to promote greater public understanding of the research process and to look for feasible alternatives to existing approaches to project-specific consent for observational research. (shrink)

Humanitarian healthcare work presents a range of ethical challenges for expatriate healthcare professionals, including tragic choices requiring the selection of a least-worst option. In this paper we examine a particular set of tragic choices related to the prioritization of care and allocation of scarce resources between individuals in situations of widespread and urgent health needs. Drawing on qualitative interviews with clinicians, we examine the nature of these choices. We offer recommendations to clinical teams and aid organizations for preparing and supporting (...) frontline clinicians in their efforts to determine the least-worst option, and in their responsibility for making such choices. (shrink)

BackgroundThe amount of research utilizing health information has increased dramatically over the last ten years. Many institutions have extensive biobank holdings collected over a number of years for clinical and teaching purposes, but are uncertain as to the proper circumstances in which to permit research uses of these samples. Research Ethics Boards (REBs) in Canada and elsewhere in the world are grappling with these issues, but lack clear guidance regarding their role in the creation of and access to registries and (...) biobanks.MethodsChairs of 34 REBS and/or REB Administrators affiliated with Faculties of Medicine in Canadian universities were interviewed. Interviews consisted of structured questions dealing with diabetes-related scenarios, with open-ended responses and probing for rationales. The two scenarios involved the development of a diabetes registry using clinical encounter data across several physicians' practices, and the addition of biological samples to the registry to create a biobank.ResultsThere was a wide range of responses given for the questions raised in the scenarios, indicating a lack of clarity about the role of REBs in registries and biobanks. With respect to the creation of a registry, a minority of sites felt that consent was not required for the information to be entered into the registry. Whether patient consent was required for information to be entered into the registry and the duration for which the consent would be operative differed across sites. With respect to the creation of a biobank linked to the registry, a majority of sites viewed biobank information as qualitatively different from other types of personal health information. All respondents agreed that patient consent was needed for blood samples to be placed in the biobank but the duration of consent again varied.ConclusionParticipants were more attuned to issues surrounding biobanks as compared to registries and demonstrated a higher level of concern regarding biobanks. As registries and biobanks expand, there is a need for critical analysis of suitable roles for REBs and subsequent guidance on these topics. The authors conclude by recommending REB participation in the creation of registries and biobanks and the eventual drafting of comprehensive legislation. (shrink)

In this article, we present an ethics framework for health practice in humanitarian and development work: the ethics of engaged presence. The ethics of engaged presence framework aims to articulate in a systematic fashion approaches and orientations that support the engagement of expatriate health care professionals in ways that align with diverse obligations and responsibilities, and promote respectful and effective action and relationships. Drawn from a range of sources, the framework provides a vocabulary and narrative structure for examining the moral (...) dimensions of providing development or humanitarian health assistance to individuals and communities, and working with and alongside local and international actors. The elements also help minimize or avoid certain miscalculations and harms. Emphasis is placed on the shared humanity of those who provide and those who receive assistance, acknowledgement of limits and risks related to the contributions of expatriate health care professionals, and the importance of providing skillful and relevant assistance. These elements articulate a moral posture for expatriate health care professionals that contributes to orienting the practice of clinicians in ways that reflect respect, humility, and solidarity. Health care professionals whose understanding and actions are consistent with the ethics of engaged presence will be oriented toward introspection and reflective practice and toward developing, sustaining and promoting collaborative partnerships. (shrink)

As rationing decisions become more of an immediate reality for healthcare practitioners it is important to design mechanisms that facilitate carefully deliberated outcomes. No individual can be expected to be able to cover wide debate on their own, so an exercise has been designed that helps generate consensus decisions from diverse opinions. The exercise was piloted with two groups, an undergraduate medical class and the members of a general practice. Though the aims were different for each group, the tool was (...) useful to both for producing the desired outcomes. Expert and non-expert knowledge were drawn upon and rationing prioritisation lists regarding funding of infertility treatment were generated. A description of the exercise and the results produced by the two groups are provided, as well as the theoretical placement for the significance of forming consensus from diversity. (shrink)

This text includes practical coverage of all the issues likely to be of concern to students during their medical careers.

D. N. Rodowick _Gilles Deleuze's Time Machine_ Durham and London: Duke University Press, 1997 ISBN: 0822319705 280 pp.

While evaluation of ethical aspects in health technology assessment has gained much attention during the past years, the integration of ethics in HTA practice still presents many challenges. In response...

The most common solutions to the problem of high pharmaceutical prices have taken the form of regulations, price negotiations, or changes in drug coverage by insurers. These measures for the most part transfer the burden of drug expenditures between pharmaceutical companies and payers or between payers. The aim of this study is to propose an alternative model for the relationship between the main stakeholders involved in the price setting and purchasing of pharmaceuticals, one that encourages a more cooperative approach. We (...) draw from principles of ethics and health economics and apply them to the context of the pharmaceutical industry. The model prioritises two objectives, to make drugs financially accessible to the patients who need them, and to keep pharmaceutical companies viable and profitable. It is centered around the sharing of financial risk between the main stakeholders, which we describe as ‘enlightened risk sharing’. After establishing the foundations of this model, we expand on the type of policies that can follow these principles with current day examples. (shrink)

The application of evidence-based medicine helps clinicians avoid unnecessary procedures and decreases unnecessary harm for future patients while sparing economic burdens. Randomised controlled trials most accurately produce best research evidence. In arthroscopic surgery, however, many procedures have been extensively used without supportive evidence verified with RCTs. In this paper, we introduce two procedures, where over 30 years of procedure usage has continued prior to garnering evidence for the inefficacy of the procedures. The situations are attributed to the fact that clinical (...) trials in arthroscopic surgeries are challenging given the use of placebo controls. A placebo-control RCT can accurately answer research questions about efficacy and safety of surgical procedures; however, the majority of arthroscopic surgeries in practice have not been rigorously tested against placebo surgeries. This is because preparing surgical placebo controls, known as sham surgeries, are ethically controversial. Also considering that high-quality study results often do not change clinical practice due to insufficient knowledge translation, the benefits of such trials may be uncertain to society at large. Additionally, there are a lack of clear guidelines for conducting arthroscopic placebo surgeries in RCTs. We hope that this article helps drive discussion about appropriate use of placebo surgeries in RCTs to produce the best quality evidence in arthroscopic surgery. (shrink)

Trends in ethical research involving humans emphasise the importance of collaboration, of involving research subjects, alongside the researchers in the construction and implementation of research. This paper will explore parallels derived from another tradition of investigation of the human: art and art theory. An artist’s inquiry into the problems of human research will be described, followed by the application of arguments from art theory to research practice. Recently artist Christine Borland has provided examples in which the lack of collaboration in (...) research has caused injustice. Borland’s work reflects these ethical dilemmas and questions the procedures and assumptions involved. In most cases the value of subject anonymity is called into question because it reduces the subjects’ control over themselves. The application of art theory, which has already considered these problems, helps question and explore the ways in which the subject turned object of artistic or scientific interpretation can maintain some control and dignity. (shrink)

In the search for the roots of computer art, the notes of Leonardo provide guiding principles which continue to surface in much of 20th century art. The essay is written in Leonardo's voice to combine excerpts from his early writings with the author's extrapolations from his teachings. This text purports that the heritage of computer art is linked to Renaissance precepts, and descended from the Mechanical age, Visual arts, and Animation. This exploration positions a new movement, herein called ?Pixellence,?? in (...) an historical framework with respect to past art genres. (shrink)