Seminar 1 – Ethics of data sharing in health research
2 November 2020
Data sharing has the potential to increase scientific efficiency by maximising the availability and utility of data, and can be critical to generating knowledge during a public health emergency. Research funders and journals are increasingly promoting open sharing to improve the transparency and utility of research, with the ultimate aim of improving health. However, the research community are also concerned about the harms of data sharing, such as the potential to exacerbate existing inequalities, particularly if data sharing benefits only researchers from well-resourced institutions, leaving researchers in low-resourced settings worse off.
Panel: Phaik Yeong Cheah, University of Oxford, Thailand
Gloria Mason, National Research Ethics Board, Liberia
Oommen John, The George Institute for Global Health, India
The following questions were discussed at GFBR 2018 and formed the basis of the seminar’s panel discussion. The full GFBR meeting report is available at this link.
What are the possible benefits and harms associated with data sharing?
What do we need to do to ensure that data sharing policies and processes are respectful of participants and communities and what are the limits and tensions?
What are the key features of a governance framework for sharing patient data for health research? Are some features distinct for research during public health emergencies?
What policy changes are needed to underpin a governance framework that enables responsible sharing of health data?
Seminar 2 – Ethics of adaptive trial designs
16 November 2020
The urgency of the COVID-19 pandemic has necessitated the investigation of multiple potential therapies in a timely way. In this context, adaptive trials are taking place to investigate multiple treatments and that are intended to continue beyond the evaluation of any one treatment. These complex trials have the potential to answer more questions efficiently and improve care for research participants by dropping therapies that are shown to be ineffective, but they present challenges. How should the risks and benefits be communicated to participants, understanding that the benefit:harm ratio may change over the course of the study? What consent model is appropriate for such dynamic trials? And how can regulators and research ethics committeesbe supported to understand and evaluate these statistically and logistically complex trials?
Panel:Srinivas Murthy, BC Children’s Hospital Research Unit, Canada
Fyezah Jehan, Aga Khan University, Pakistan
Jerome Singh, University of KwaZulu-Natal, Durban, South Africa; and Dalla Lana School of Public Health, University of Toronto, Toronto, Canada
GFBR 2017 focused on a range of novel trials designs, including adaptive trials. See the meeting pageand the report for fulldetails of the meeting and its conclusions. Building on that discussion in the context of COVID-19, the following questions were discussed during the 2020 seminar:
How have adaptive platform trials been employed in the COVID-19 research response, and why (e.g. RECOVERY, Solidarity, REMAP-CAP)?
What unique ethical issues have these adaptive platform trials for COVID-19 treatments faced in an LMIC setting? Have these factors constrained the use of the design?
How have the benefits and risks of study participation been conceptualized in these COVID-19 studies
What consent models are being used in adaptive trials for COVID-19 therapies?
Reflecting on the experience of using adaptive trials for COVID-19, what policy and/or governance mechanisms are required to support the use of these designs in future?
Seminar 3: Ethics of research in pregnancy
30 November 2020
Recent evidence suggests that pregnant women are at a higher risk of morbidity and mortality from COVID-19, compared with age-matched women who are not pregnant. Yet the historical and systematic exclusion of pregnant women from research continues in the context of the COVID-19 pandemic, resulting in a lack of evidence for this population. How can pregnant women be ethically and safely included in research and what part should researchers play in this? What role is there for community engagement to reconcile cultural norms and beliefs with the ethical and clinical rationale for research during pregnancy? And how do current governance mechanisms and regulation help or hinder the inclusion of pregnant women in research?
Panel: Marian Knight, Nuffield Department of Population Health, University of Oxford, UK
Loulou Kobeissi, Scientist, Universal Health Coverage – Life Course Division (UHC/LC)/ SRH Integration in Health Systems (SHS); Department of Sexual and Reproductive Health and Research (SRH), World Health Organization (WHO)
Sonali Kochhar, Global Healthcare Consulting, India; Department of Global Health, University of Washington, Seattle, USA
GFBR 2016 focused on the ethics of research in pregnancy. See the meeting page and report for full details of the meeting and its conclusions. The proceedings and case studies are also available in Reproductive Health. This seminar reflected on the GFBR 2016 findings in the context of COVID-19 and addressed the following questions:
To what extent are pregnant women being included in current COVID-19 research? What are the ethical arguments for inclusion and what are the barriers?
How can researchers balance the need to investigate interventions for pregnant women’s health in preventing and treating COVID-19 and avoiding risk to them and their foetus?
How can research be facilitated in a context in which there are many socio-cultural norms about pregnancy that may impact on research efforts (e.g. where a partner or other family member may have socially assumed rights with regard to a pregnant woman’s decision-making, or where there are cultural views on pregnant women giving blood or receiving an intervention)?
What is the role of engagement to explain the ethical and clinical rationale for inclusion, and who should be engaged?
How do current governance mechanisms and regulation help or hinder research during pregnancy and how should regulatory authorities prepare for the inclusion of pregnant women in trials in advance of public health emergencies?