Oversight of Dual-Use Research: What Role for Ethics Committees?

The World Health Organization (WHO) Global Guidance Framework for the Responsible Use of the Life Sciences addresses the governance of biorisks, including dual-use research, for countries. It emphasizes engaging multisectoral stakeholders such as governments, scientific bodies, health and research institutes, standard-setting organizations, funding bodies, and others. Ethics constitutes a key component of the framework. Given the high social impact of such research and the importance of trust, risk, and benefit, national ethics committees could make a valuable contribution by providing ethical guidance in the decisionmaking process. The purpose of this study was to examine the role of national ethics committees in the context of governance and oversight of dual-use research at the national level. We conducted a landscape analysis of the activities of ethics committees in dual-use research oversight. We also searched the WHO database on National Ethics Committees for publications related to dual-use research and/or misuse of life sciences research and gathered additional documentation from national ethics committees websites and through author contacts. Results showed that in the context of the wide range of oversight mechanisms for dual-use research in countries, national ethics committees have contributed to guiding policy and assessing dual-use research risks in only a limited number of countries. Recommendations from those countries include establishing a multistakeholder, coordinated oversight mechanism at the country level; strengthening international linkages to guide, harmonize, and reinforce national and international efforts; and involving ethics committees as an expert resource in the governance and oversight process.

[Personalized health†: definition, characters and prospects for the future]. / Santé personnalisée†: définition, caractéristiques et perspectives pour le futur.

Personalization is at the center of medical practice. With the sequencing of the genome, the rise in technologies and big data processing capacities, it was then envisioned in an even more precise way, for more targeted treatments on patients' distinctive features. In the last few years, prospects for this personalization went in the direction of public health. Beyond patients, the aim is thus to pursue the entire population, to identify and adjust action on the social, environmental, and biomedical factors that make individuals vulnerable in a health perspective. This is referred as personalized health. Its objective is to better understand the interactions between these factors for a more efficient approach of healthcare and interventions on the social conditions for maintaining the good health of all.

La personnalisation des soins est au centre de la pratique médicale. Avec le séquençage du génome, l'essor des technologies et du traitement de données massives, elle est maintenant envisagée de manière encore plus précise pour des soins toujours plus ciblés sur les caractéristiques des patients. Depuis quelques années, ces techniques déploient aussi leur potentiel en matière de santé publique. Au-delà des patients, il s'agit ici de viser toute la population, pour identifier et ajuster l'action sur les facteurs sociaux, environnementaux et biomédicaux qui rendent les individus vulnérables du point de vue de la santé. On parle de santé personnalisée. Son objectif est de mieux comprendre les interactions entre ces facteurs pour une approche plus efficace des soins et des interventions sur les conditions sociales du maintien de la bonne santé pour tous.

A Call for the Application of Patient Safety Culture in Medical Humanitarian Action: A Literature Review.

OBJECTIVES: The aims of the study were to assess lessons learned on patient safety in Organization for Economic Cooperation and Development (OECD) countries and to assess whether they are applied or can be applied to the humanitarian medicine. METHODS: This is (a) a 2013-2018 rapid literature review of reviews and systematic reviews articles (PubMed database) on "patient safety" and "medical error" to look for lessons learned regarding patient safety in OECD countries and (b) a rapid literature review (PubMed and Embase databases) on "humanitarian medicine" and "patient safety," from their creation to 2018, to find any articles related to patient safety in humanitarian medicine. In both reviews were excluded articles specifically related to one device, disease, or medical act. These reviews were complemented by a Google search. RESULTS: Of the 245 references retrieved, 104 met the inclusion criteria. Of 308 references, 39 respected the inclusion criteria. In OECD countries, patient safety comprises correlated measures taken at three levels. The micro level focuses on individual staff involved in healthcare provision or management; the meso level focuses on medical institutions; the macro level focuses on national healthcare systems. Only one reference mentioned the implementation of a medical error reporting and analysis system in medical humanitarian organization. CONCLUSIONS: The adoption of strategies and a culture of safety will need to be adapted to address the variety of intervention contexts and to respond first to the fears and expectations of humanitarian staff. Medical humanitarian organizations, in the absence of an overarching authority for the sector, have a major responsibility in the development of a general patient safety policy applicable in all their operations.

Knowledge, attitudes, and Expectations of Medical Staff Toward Medical Error Management Policies in Humanitarian Medicine: A Qualitative Study.

BACKGROUND: Patient safety, a major component of quality of care, is now an attribute of health care systems in developed countries at least. Although there is ever more research on this subject in developed countries, humanitarian medicine, mainly implemented in resource-poor countries, has yet to structure its own set of policies and strategies on patient safety and the management of medical errors. OBJECTIVES: We assessed the knowledge, attitudes, and expectations of medical humanitarian staff regarding the development of policies and strategies related to patient safety and medical error management in medical humanitarian action. METHODS: We conducted 36 semistructured interviews with international medical and paramedical staff active in 6 medical humanitarian organizations after having interviewed the medical directors or the person in charge of quality of care and the legal advisors. Interviews were transcribed verbatim and subjected to a thematic analysis. RESULTS: The interviews confirmed the current absence of clear investments in dealing with safety risks in the selected medical humanitarian organizations. The difficulties experienced by medical staff in reporting medical errors such as blame culture, lack of training, and absence of leadership committed on patient safety are nonspecific. Other arguments are related to the specific conditions of humanitarian settings: coexistence of different medical culture, absence of international or local regulations or external pressures, and great diversity of activities and contexts. CONCLUSIONS: Interviewed staff expressed high expectations of receiving guidance from their organizations and support to adopt clear patient safety and medical error management policies adapted to their complex operational and clinical realities.

Including adolescents of childbearing potential in clinical trials with possible exposure to teratogenic medication: a challenge for paediatricians and researchers.

The issue of contraception and pregnancy tests among minor adolescent women participating in clinical trials, whether healthy or suffering from a disease, represents a challenging issue for paediatricians and researchers, given the potential harmful effect of various therapeutic procedures being tested. First, they need to gauge at what age or developmental stage they need to impose pregnancy tests and contraception. Second, if the adolescent denies any sexual activity, it may be ethically questionable to impose such procedures. Third, these professionals must deal with the issue of confidentiality, taking into account the fact that some adolescents engage in penetrative sexual intercourse without their parents or caregivers knowing. Fourth, in such cases, they must assess the extent to which a minor adolescent can be considered as competent (capable of making autonomous decisions) and deserves privacy and confidentiality. There is indeed a legal obligation for the provider to check that sexual experiences and intercourse take place within a safe relationship. Fifth, if the prescription of contraception is warranted, they have to decide who should assist the adolescent in choosing the method. Finally, with the occurrence of a positive pregnancy test, they may face the rare instance of a competent minor adolescent who refuses to inform her parents. This article has been developed by a group of experts under the auspices of swissethics, the Swiss Association of Research Ethics Committees and SwissPedNet, the umbrella organisation that coordinates the paediatric research in Switzerland. The paper reviews how to address practical and ethical questions regarding minor adolescents of childbearing potential enrolled in a clinical trial that may involve teratogenic medication and offers a series of concrete advice and tools for dealing with problematic situations. Most paediatric protocols stipulate that adolescents included in clinical trials involving potentially teratogenic drugs should undergo pregnancy tests and use contraception. The circumstances in which such requirements are undertaken, however, has not been sufficiently addressed. The recommendations presented in this article will assist researchers in assessing which circumstances apply when considering minor adolescents as individuals with childbearing potentials. It also offers concrete suggestions for tackling such situations.

Integrating public health programs and research after the malaria vaccine implementation program (MVIP): Recommendations for next steps.

BACKGROUND: In February 2020, international controversy arose about the ethical acceptability of the WHO Malaria Vaccine Implementation Program (MVIP). Whereas some have argued that this program must be seen as research that is not in line with international ethical standards, notably regarding informed consent and local ethical review, some WHO representatives consider the MVIP as a public health implementation program that need not adhere to these standards. METHODS: We performed a case analysis in light of the 2016 CIOMS International Ethical Guidelines for Health-related Research involving Humans. FINDINGS: We argue that the MVIP has a substantial research component, and that it is prudent to therefore apply ethical norms for research involving humans, such as the CIOMS guidelines. Accordingly, we agree that the ethical requirements of informed consent and independent ethical review have not been met. In addition, we are concerned that the study might not meet CIOMS's social value requirement. RECOMMENDATIONS: We urge WHO to release more details about the process that led to the MVIP program and make the MVIP protocol publicly available. The full protocol should be assessed by the relevant ethics committees, new and already enrolled parents should be informed about the uncertainties under investigation and given a real opportunity to consent or refuse (continued) participation, communities should be engaged, and aspects of MVIP that require alteration in light of ethical review should be altered, if possible. Furthermore, in order to improve good ethical practices, it is necessary to engage in international debate regarding the integration of research and public health programs. Procedurally, vaccine implementation programs that combine both prevention and research should involve the wider international ethics community and ensure participation of the target populations in setting the proper conditions for launching such programs.

Good collaborative practice: reforming capacity building governance of international health research partnerships.

In line with the policy objectives of the United Nations Sustainable Development Goals, this commentary seeks to examine the extent to which provisions of international health research guidance promote capacity building and equitable partnerships in global health research. Our evaluation finds that governance of collaborative research partnerships, and in particular capacity building, in resource-constrained settings is limited but has improved with the implementation guidance of the International Ethical Guidelines for Health-related Research Involving Humans by The Council for International Organizations of Medical Sciences (CIOMS) (2016). However, more clarity is needed in national legislation, industry and ethics guidelines, and regulatory provisions to address the structural inequities and power imbalances inherent in international health research partnerships. Most notably, ethical partnership governance is not supported by the principal industry ethics guidelines - the International Conference on Harmonization Technical Requirements for Registration of Pharmaceutical for Human Use (ICH) Good Clinical Practice (ICH-GCP). Given the strategic value of ICH-GCP guidelines in defining the role and responsibility of global health research partners, we conclude that such governance should stipulate the minimal requirements for creating an equitable environment of inclusion, mutual learning, transparency and accountability. Procedurally, this can be supported by i) shared research agenda setting with local leadership, ii) capacity assessments, and iii) construction of a memorandum of understanding (MoU). Moreover, the requirement of capacity building needs to be coordinated amongst partners to support good collaborative practice and deliver on the public health goals of the research enterprise; improving local conditions of health and reducing global health inequality. In this respect, and in order to develop consistency between sources of research governance, ICH-GCP should reference CIOMS ethical guidelines as the established standard for collaborative partnership. Moreover, greater commitment and support should be given to co-ordinate, strengthen and enforce local laws requiring equitable research partnerships and health system strengthening.

Informed consent: Do not be afraid.

Informed consent is the cornerstone of the doctor-patient relationship. At least this is how it is presented in theory. In practice, doctors struggle with their obligation to inform their patient before obtaining their approval prior to a medical intervention. In Taiwan, the culture is often mentioned to justify the doctor's reluctance to speak openly with their patient. Invoking the importance of the family in the society, doctors tend to rely less on their patients and more on their relatives to make important decisions. Yet, the cultural argument for not seeking the patients' informed consent sounds more like a mere excuse than the real cause of the difficulties doctors face today in obtaining their patients' consent. This paper argues that today the doctors in Taiwan are mostly governed by the same fear that was the rule in the USA and Europe until the 1980s. It may be time for changing the paradigm, admitting that patients are able to handle even the most dramatic diagnosis. It seems also important to get away from the sterile opposition of doctor's paternalism versus patient's autonomy and to introduce a true partnership between doctors and patients.

National public health law: a role for WHO in capacity-building and promoting transparency.

A robust health infrastructure in every country is the most effective long-term preparedness strategy for global health emergencies. This includes not only health systems and their human resources, but also countries' legal infrastructure for health: the laws and policies that empower, obligate and sometimes limit government and private action. The law is also an important tool in health promotion and protection. Public health professionals play important roles in health law - from the development of policies, through their enforcement, to the scientific evaluation of the health impact of laws. Member States are already mandated to communicate their national health laws and regulations to the World Health Organization (WHO). In this paper we propose that WHO has the authority and credibility to support capacity-building in the area of health law within Member States, and to make national laws easier to access, understand, monitor and evaluate. We believe a strong case can be made to donors for the funding of a public health law centre or unit, that has adequate staffing, is robustly networked with its regional counterparts and is integrated into the main work of WHO. The mission of the unit or centre would be to define and integrate scientific and legal expertise in public health law, both technical and programmatic, across the work of WHO, and to conduct and facilitate global health policy surveillance.

Avoir une infrastructure sanitaire solide dans chaque pays est la meilleure stratégie à long terme de préparation aux urgences sanitaires mondiales. Il s'agit non seulement des systèmes de santé et de leurs ressources humaines, mais aussi de l'infrastructure juridique des pays en matière de santé: les lois et les politiques qui permettent, obligent et parfois limitent l'action du gouvernement et du secteur privé. La législation est également un outil important pour la promotion et la protection de la santé. Les professionnels de la santé publique jouent un rôle important vis-à-vis de la législation sanitaire - de l'élaboration des politiques à leur application, en passant par l'évaluation scientifique de l'impact des lois sur la santé. Les États membres sont déjà chargés de faire part de leurs lois et règlements nationaux en matière de santé à l'Organisation mondiale de la Santé (OMS). Le présent article suggère que l'OMS, qui dispose de l'autorité et de la crédibilité pour le faire, participe au renforcement des capacités dans le domaine de la législation sanitaire des États membres et facilite l'accès, la compréhension, le contrôle et l'évaluation des lois nationales. Des arguments convaincants peuvent être présentés aux bailleurs de fonds pour le financement d'un centre ou d'une unité de législation de la santé publique qui disposerait du personnel nécessaire, entretiendrait de solides relations avec ses homologues régionaux et serait intégré aux principaux travaux de l'OMS. La mission de cette unité ou de ce centre consisterait à définir et intégrer l'expertise scientifique et juridique dans la législation de la santé publique, sur le plan technique et programmatique, dans le cadre des travaux de l'OMS, et à réaliser et faciliter la surveillance des politiques sanitaires mondiales.

Una infraestructura sanitaria firme en todos los países es la estrategia de preparación más eficaz a largo plazo para tratar las emergencias sanitarias en todo el mundo. Esto no solo incluye los sistemas sanitarios y sus recursos humanos, sino también la infraestructura legal para la salud de cada país: las leyes y políticas que facultan, obligan y, en ocasiones, limitan la acción privada y del gobierno. La legislación también es una herramienta importante para el fomento y la protección de la salud. Los profesionales de la salud pública tienen funciones fundamentales en la legislación sanitaria: desde el desarrollo de políticas a través de su puesta en vigor, hasta la evaluación científica del impacto sanitario de las leyes. Ya se ha encomendado a los Estados Miembros que comuniquen sus leyes y normativas de salud nacionales a la Organización Mundial de la Salud (OMS). Este artículo propone que la OMS tenga la autoridad y credibilidad para dar apoyo a la creación de capacidad de las leyes sanitarias de los Estados Miembros, y para facilitar el acceso, la comprensión, la supervisión y la evaluación de las leyes nacionales. Creemos que hay argumentos firmes a favor de las contribuciones para la financiación de un centro o unidad de derecho de salud pública que cuente con el personal adecuado, tenga un sistema de redes sólido con sus contrapartes regionales y esté integrado con el trabajo principal de la OMS. La misión de la unidad o centro sería definir e integrar la experiencia científica y legal en la ley de salud pública, tanto en el aspecto técnico como programático, a través del trabajo de la OMS, así como dirigir y facilitar el control de las políticas sanitarias globales.

The legal and ethical aspects of the right to health of migrants in Switzerland.

The right to health of migrant populations, whether they are foreign nationals, foreign workers, tourists, asylum seekers or refugees, is enshrined in international human rights treaties. The effectiveness of the implementation of this fundamental right thus lies in national legal frameworks. In spite of its long humanitarian tradition, Switzerland has a strict migration policy, and while it has established a non-discriminatory legal framework for the protection and promotion of the right to health, its laws and regulations sometimes codify differences in treatment between foreign nationals and Swiss residents based on distinct situations. On the basis of shared responsibilities between the Federal State and the 26 cantons, this article describes the Swiss legal and regulatory approach to the right to health, the ways it is currently implemented and the possible vectors for an improved integration of migrants into the health system.

Consensus standards for introductory e-learning courses in human participants research ethics.

This paper reports the results of a workshop held in January 2013 to begin the process of establishing standards for e-learning programmes in the ethics of research involving human participants that could serve as the basis of their evaluation by individuals and groups who want to use, recommend or accredit such programmes. The standards that were drafted at the workshop cover the following topics: designer/provider qualifications, learning goals, learning objectives, content, methods, assessment of participants and assessment of the course. The authors invite comments on the draft standards and eventual endorsement of a final version by all stakeholders.