What information and the extent of information research participants need in informed consent forms: a multi-country survey

Background: The use of lengthy, detailed, and complex informed consent forms (ICFs) is of paramount concern in biomedical research as it may not truly promote the rights and interests of research participants. The extent of information in ICFs has been the subject of debates for decades; however, no clear guidance is given. Thus, the objective of this study was to determine the perspectives of research participants about the type and extent of information they need when they are invited to participate in biomedical research. Methods: This multi-center, cross-sectional, descriptive survey was conducted at 54 study sites in seven Asia-Pacific countries. A modified Likert-scale questionnaire was used to determine the importance of each element in the ICF among research participants of a biomedical study, with an anchored rating scale from 1 (not important) to 5 (very important). Results: Of the 2484 questionnaires distributed, 2113 (85.1%) were returned. The majority of respondents considered most elements required in the ICF to be \u27moderately important\u27 to \u27very important\u27 for their decision making (mean score, ranging from 3.58 to 4.47). Major foreseeable risk, direct benefit, and common adverse effects of the intervention were considered to be of most concerned elements in the ICF (mean score = 4.47, 4.47, and 4.45, respectively). Conclusions: Research participants would like to be informed of the ICF elements required by ethical guidelines and regulations; however, the importance of each element varied, e.g., risk and benefit associated with research participants were considered to be more important than the general nature or technical details of research. Using a participant-oriented approach by providing more details of the participant-interested elements while avoiding unnecessarily lengthy details of other less important elements would enhance the quality of the ICF

Ethics preparedness for infectious disease outbreaks research in India: A case for novel coronavirus disease 2019

In the past decade, India has witnessed several outbreaks/epidemics (such as H1N1, H5N1, avian influenza, Ebola, SARS, Zika and Nipah) which were successfully tackled with appropriate research[1]. India with its 1.3 billion population residing in densely populated areas in resource-constrained environments is at constant risk for any emerging outbreaks that can cause rapid spread of infection. There have been considerable investments in preparedness for rapid responses and to create a conducive environment to undertake therapeutic or disease prevention research. Research is needed when the outbreak is ongoing or after it has subsided

Allocating Scarce Unproven Interventions during Public Health Emergencies: Insights from the WHO MEURI Framework

10.1080/15265161.2020.1795539The American Journal of Bioethics200941-4

Top five ethical lessons of COVID-19 that the world must learn

As the world reflects upon one year since the first cases of coronavirus disease 2019 (COVID-19) and prepare for and experience surges in cases, it is important to identify the most crucial ethical issues that might lie ahead so that countries are able to plan accordingly. Some ethical issues are rather obvious to predict, such as the ethical issues surrounding the use of immunity certificates, contact tracing, and the fair allocation of vaccines globally. Yet, the most significant ethical challenge that the world must address in the next year and beyond is to ensure that we learn the ethical lessons of the first year of this pandemic. Learning from our collective experiences thus far constitutes our greatest moral obligation. Appreciating that decision-making in the context of a pandemic is constrained by unprecedented complexity and uncertainty, beginning in June 2020, an international group of 17 experts in bioethics spanning 15 countries (including low-, middle-, and high-income countries) met virtually to identify what we considered to be the most significant ethical challenges and accompanying lessons faced thus far in the COVID-19 pandemic. Once collected, the group met over the course of several virtual meetings to identify challenges and lessons that are analytically distinct in order to identify common ethical themes under which different challenges and lessons could be grouped. The result, described in this paper, is what this expert group consider to be the top five ethical lessons from the initial experience with COVID-19 that must be learned

ETHICS AND GOVERNANCE OF ARTIFICIAL INTELLIGENCE FOR HEALTH:WHO GUIDANCE

See: https://www.who.int/publications/i/item/9789240029200: The WHO guidance on Ethics & Governance of Artificial Intelligence for Health is the product of eighteen months of deliberation amongst leading experts in ethics, digital technology, law, human rights, as well as experts from Ministries of Health. While new technologies that use artificial intelligence hold great promise to improve diagnosis, treatment, health research and drug development and to support governments carrying out public health functions, including surveillance and outbreak response, such technologies, according to the report, must put ethics and human rights at the heart of its design, deployment, and use.The report identifies the ethical challenges and risks with the use of artificial intelligence of health, six consensus principles to ensure AI works to the public benefit of all countries. It also contains a set of recommendations that can ensure the governance of artificial intelligence for health maximizes the promise of the technology and holds all stakeholders – in the public and private sector – accountable and responsive to the healthcare workers who will rely on these technologies and the communities and individuals whose health will be affected by its use