MAiD as a case study in evidence for policy making: An account of the CCA assessment on medical assistance in dying.

In December 2016, the Council of Canadian Academies (CCA) was asked by the Government of Canada to undertake an assessment on Medical Assistance in Dying (MAiD), following from Parliament's passage of Bill C-14: An Act to amend the Criminal Code and to make related amendments to other Acts. The CCA was asked to undertake an assessment of the state of knowledge on three topics that Parliament excluded from C-14: requests for MAiD by mature minors, advance requests for MAiD, and requests for MAiD where a mental disorder is the sole underlying medical condition. Here, we describe the way that the CCA responded to the request from the Government of Canada using a multidisciplinary expert panel approach, how different forms of evidence were identified and used, the impact of the CCA assessment as part of the broader conversation occurring in Canada, and its implications for health leaders.

Sharing with Strangers: Governance Models for Borderless Genomic Research in a Territorial World.

One of the practices that has defined the ethos of genomic research to date is a commitment to open and rapid sharing of genomic data and resources. As genomic research evolves into an international enterprise, this commitment is being challenged by the need to respect the interests of those it involves and implicates, from individual scientists and subjects to institutions and nations. In this essay, we first describe the types of claims that different stakeholders are making about the disposition of genomic data and samples. Next, we illustrate the complexities of these multiple claims by applying them to the case of one ongoing international genomics initiative, the H3Africa Consortium. Finally, in the light of these complexities, we conclude by comparing and contrasting four governance models for future international data-sharing policy and practices in genomics.

Ethics and Childhood Vaccination Policy in the United States.

Childhood immunization involves a balance between parents' autonomy in deciding whether to immunize their children and the benefits to public health from mandating vaccines. Ethical concerns about pediatric vaccination span several public health domains, including those of policymakers, clinicians, and other professionals. In light of ongoing developments and debates, we discuss several key ethical issues concerning childhood immunization in the United States and describe how they affect policy development and clinical practice. We focus on ethical considerations pertaining to herd immunity as a community good, vaccine communication, dismissal of vaccine-refusing families from practice, and vaccine mandates. Clinicians and policymakers need to consider the nature and timing of vaccine-related discussions and invoke deliberative approaches to policy-making.

Industry Support of Medical Research: Important Opportunity or Treacherous Pitfall?

Pharmaceutical and device manufacturers fund more than half of the medical research in the U.S. Research funding by for-profit companies has increased over the past 20 years, while federal funding has declined. Research funding from for-profit medical companies is seen as tainted by many academicians because of potential biases and prior misbehavior by both investigators and companies. Yet NIH is encouraging partnerships between the public and private sectors to enhance scientific discovery. There are instances, such as methods for improving drug adherence and post-marketing drug surveillance, where the interests of academician researchers and industry could be aligned. We provide examples of ethically performed industry-funded research and a set of principles and benchmarks for ethically credible academic-industry partnerships that could allow academic researchers, for-profit companies, and the public to benefit.

Protecting Ideas: Ethical and Legal Considerations When a Grant's Principal Investigator Changes.

Ethical issues related the responsible conduct of research involve questions concerning the rights and obligations of investigators to propose, design, implement, and publish research. When a principal investigator (PI) transfers institutions during a grant cycle, financial and recognition issues need to be addressed to preserve all parties' obligations and best interests in a mutually beneficial way. Although grants often transfer with the PI, sometimes they do not. Maintaining a grant at an institution after the PI leaves does not negate the grantee institution's obligation to recognize the PI's original ideas, contributions, and potential rights to some forms of expression and compensation. Issues include maintaining a role for the PI in determining how to take credit for, share and publish results that involve his or her original ideas. Ascribing proper credit can become a thorny issue. This paper provides a framework for addressing situations and disagreements that may occur when a new PI continues the work after the original PI transfers. Included are suggestions for proactively developing institutional mechanisms that address such issues. Considerations include how to develop solutions that comply with the responsible conduct of research, equitably resolve claims regarding reporting of results, and avoid the possibility of plagiarism.

Benchmarks for ethically credible partnerships between industry and academic health centers: beyond disclosure of financial conflicts of interest.

Relationships between industry and university-based researchers have been commonplace for decades and have received notable attention concerning the conflicts of interest these relationships may harbor. While new efforts are being made to update conflict of interest policies and make industry relationships with academia more transparent, the development of broader institutional partnerships between industry and academic health centers challenges the efficacy of current policy to effectively manage these innovative partnerships. In this paper, we argue that existing strategies to reduce conflicts of interest are not sufficient to address the emerging models of industry-academic partnerships because they focus too narrowly on financial matters and are not comprehensive enough to mitigate all ethical risk. Moreover, conflict-of-interest strategies are not designed to promote best practices nor the scientific and social benefits of academic-industry collaboration. We propose a framework of principles and benchmarks for "ethically credible partnerships" between industry and academic health centers and describe how this framework may provide a practical and comprehensive approach for designing and evaluating such partnerships.

Attitudes about the use of newborn dried blood spots for research: a survey of underrepresented parents.

OBJECTIVE: To identify the relative importance of factors that impact parents' attitudes toward use of their child's dried newborn blood spots for research purposes. METHODS: Respondents were parents aged 18 and older with at least one child aged 17 or younger born in Indiana visiting an urban pediatrics clinic. They were asked to rate the acceptability of hypothetical scenarios involving the research use of blood spots. Three pieces of information varied between the scenarios: 1) who would be conducting the research; 2) whether the child's identity would be linked to the spots; and 3) whether and how often the parents' consent would be sought before the research began. RESULTS: A total of 506 predominantly black and low-income parents completed the survey. The conjoint analysis model showed good fit (Pearson's R = 0.998, P < .001). The rank order of factors affecting parents' attitudes was: 1) consent (importance score = 64.9), 2) whether the child's identity was linked to the spot (importance score = 19.4), and 3) affiliation of the researcher using the spots (importance score = 14.6). Respondents preferred being asked for their consent each time their children's spots would be used. They preferred that the children's identity not be linked to the spots and that the research be conducted by university researchers, though these issues had less impact on attitudes than consent. CONCLUSIONS: Parents strongly prefer that consent be sought for each use of their children's blood spots. These findings have implications for future research and policy-making decisions.

Patient understanding of benefits, risks, and alternatives to screening colonoscopy.

BACKGROUND: While several tests and strategies are recommended for colorectal cancer (CRC) screening, studies suggest that primary care providers often recommend colonoscopy without providing information about its risks or alternatives. These observations raise concerns about the quality of informed consent for screening colonoscopy. METHODS: We conducted a telephone survey (August 2008 to September 2009) of a convenience sample of 98 patients scheduled for a screening colonoscopy to assess their understanding of the procedure's benefits, risks, and alternatives and their sources of information. RESULTS: Fully 90.8% of subjects described the purpose of screening colonoscopy in at least general terms. Just 48.0% described at least one risk of the procedure. Only 24.5% named at least one approved alternative test. Just 3.1% described the minimal required elements for informed consent: the benefit of colonoscopy, both of the major risks, and at least one approved alternative test. Compared to subjects with higher levels of education or income, fewer subjects with lower levels of education or income could name at least one risk of colonoscopy or one approved alternative test to colonoscopy. For benefits, risks, and alternatives, a smaller percentage of subjects responding reported obtaining information from their doctors than from other sources. CONCLUSIONS: Patients scheduled for screening colonoscopy have limited knowledge of its risks and alternatives; subjects with lower education levels and lower income have even less understanding. For patients who do not receive additional information until they have begun the preparation for the test, the quality of informed consent may be low.

Privacy protectionism and health information: is there any redress for harms to health?

Health information collected by governments can be a valuable resource for researchers seeking to improve diagnostics, treatments and public health outcomes. Responsible use requires close attention to privacy concerns and to the ethical acceptability of using personal health information without explicit consent. Less well appreciated are the legal and ethical issues that are implicated when privacy protection is extended to the point where the potential benefits to the public from research are lost. Balancing these issues is a delicate matter for data custodians. This article examines the legal, ethical and structural context in which data custodians make decisions about the release of data for research. It considers the impact of those decisions on individuals. While there is strong protection against risks to privacy and multiple avenues of redress, there is no redress where harms result from a failure to release data for research.

The vulnerabilities of orphaned children participating in research: a critical review and factors for consideration for participation in biomedical and behavioral research.

Orphans are a subpopulation with a unique set of additional vulnerabilities. Increasing focus on children's rights, pediatric global health, and pediatric research makes it imperative to recognize and address unique vulnerabilities of orphaned children. This paper describes the unique vulnerabilities of the orphaned pediatric population and offers a structured set of factors that require consideration when including orphans in biomedical research. Pediatric orphans are particularly vulnerable due to decreased economic resources, psychosocial instability, increased risk of abuse, and delayed/decreased access to healthcare. These vulnerabilities are significant. By carefully considering each issue in a population in a culturally specific and study-specific manner, researchers can make valuable contributions to the overall health and well-being of this uniquely vulnerable population.

Ethics of implementing Electronic Health Records in developing countries: points to consider.

Electronic Health Record systems (EHRs) are increasingly being used in many developing countries, several of which have moved beyond isolated pilot projects to active large-scale implementation as part of their national health strategies. Despite growing enthusiasm for adopting EHRs in resource poor settings, almost no attention has been paid to the ethical issues that might arise. In this article we argue that these ethical issues should be addressed now if EHRs are to be appropriately implemented in these settings. We take a systematic approach guided by a widely accepted ethical framework currently in use for developing countries to first describe the ethical issues, and then propose a set of 'Points to Consider' to guide further thinking and decision-making.

Biobanking and public health: is a human rights approach the tie that binds?

Ethical principles guiding public health and genomic medicine are often at odds: whereas public health practice adopts collectivist principles that emphasize population-based benefits, recent advances in genomic and personalized medicine are grounded in an individualist ethic that privileges informed consent, and the balancing of individual risk and benefit. Indeed, the attraction of personalized medicine is the promise it holds out to help individuals get the "right medicine for the right problem at the right time." Research biobanks are an effective tool in the genomic medicine toolbox. Biobanking in public health presents a unique case study to unpack some of these issues in more detail. For example, there is a long history of using banked tissue obtained under clinical diagnostic conditions for later public health uses. But despite the collectivist approach of public health, the principles applied to the ethical challenges of biobanking (e.g. informed consent, autonomy, privacy) remain individualist. We demonstrate the value of using human rights as a public health ethics framework to address this tension in biobanking by applying it to two illustrative cases.

Extending the reach of public health genomics: what should be the agenda for public health in an era of genome-based and "personalized" medicine?

The decade following the completion of the Human Genome Project has been marked by divergent claims about the utility of genomics for improving population health. On the one hand, genomics is viewed as the harbinger of a brave new world in which novel treatments rectify known causes of disease. On the other hand, genomics may have little practical relevance to the principal causes or remedies of diseases which are predominantly social or environmental in origin, particularly in low- and middle-income countries. Those supportive of a role for public health genomics argue that increasing knowledge of genomics and molecular pathology could unlock effective diagnostic techniques and treatments, and better target public health interventions. To resolve some of these tensions, an international multidisciplinary meeting was held in May 2010 in Ickworth, United Kingdom, with the aim of setting an agenda for the development of public health in an era of genome-based and "personalized" medicine. A number of key themes emerged, suggesting a need to reconfigure both the focus for existing genomic research and the stage at which funding is targeted, so that priority is given to areas of greatest potential health impact and that translation from basic science to implementation is given greater emphasis. To support these developments, there should be an immediate, sustained and systematic effort to provide an evidence base. These deliberations formed the basis for six key recommendations, which could guide the practice of public health in an era of genomics and personalized medicine.

The value of using top-down and bottom-up approaches for building trust and transparency in biobanking.

With the domestic and international proliferation of biobanks and their associated connections to health information databases, scholarly attention has been turning from the ethical issues arising from the construction of biobanks to the ethical issues that emerge in their operation and management. Calls for greater transparency in governance structures, coupled with stern reminders of the value of maintaining public trust, are seen as critical components in the success of these resources. Two different approaches have been adopted for addressing these types of ethical issues: the first is a 'top-down' approach which focuses on developing policy, procedures, regulations and guidelines to aid decision-makers. The second is a 'bottom-up' approach, which begins with those who are most affected by the issues and attempts to inductively develop consensus recommendations and policy. While both approaches have merit, I argue that more work needs to be done on 'bottom-up' strategies if trust and transparency are to be more than mere slogans. Using 2 case examples from Indiana, the paper summarizes data from a set of surveys we recently conducted that address issues arising from biobanks that provide some insight into issues associated with trust and transparency.