A5088140695- Ethics in Clinical Research
- Biomedical Ethics and Regulation
- Viral Infections and Outbreaks Research
- Vaccine Coverage and Hesitancy
- Ethics in medical practice
- Global Health and Surgery
- Research Data Management Practices
- Health Systems, Economic Evaluations, Quality of Life
- Mental Health and Patient Involvement
- Patient-Provider Communication in Healthcare
- Disaster Response and Management
- Data Analysis and Archiving
- Global Maternal and Child Health
- COVID-19 Digital Contact Tracing
- Ethics and Legal Issues in Pediatric Healthcare
- Palliative Care and End-of-Life Issues
- Patient Dignity and Privacy
- Health Policy Implementation Science
- Mosquito-borne diseases and control
- Genetic Associations and Epidemiology
- Data-Driven Disease Surveillance
- Childhood Cancer Survivors' Quality of Life
- SARS-CoV-2 and COVID-19 Research
- Grief, Bereavement, and Mental Health
- Healthcare cost, quality, practices
University of Auckland
2022-2025
Wellcome Centre for Ethics and Humanities
2014-2024
University of Oxford
2014-2024
St John New Zealand
2022
Double Helix (United States)
2017
Genomics (United Kingdom)
2009
Centre for Human Genetics
2009
Griffith University
2001
Salisbury District Hospital
1992
University of Wales
1992
Genome-wide association studies (GWAS) provide a powerful means of identifying genetic variants that play role in common diseases. Such present important ethical challenges. An increasing number GWAS is taking place lower income countries and there pressing need to identify the particular challenges arising such contexts. In this paper, we draw upon experiences MalariaGEN Consortium specific issues raised by research Africa, Asia Oceania. We explore three key areas: protecting interests...
Consent and community engagement (CE) in health research are two aspects of a single concern—that is carried out respectful manner where social value maximized. There important overlaps interdependencies between consent CE; for example, CE can provide insights into how best to tailor context be an component processes. Engaging communities also have intrinsic instrumental beyond consent; as means showing respect identifying appropriate ways working respectfully. In this paper we critically...
Seeking consent for genetic and genomic research can be challenging, particularly in populations with low literacy levels, emergency situations. All of these factors were relevant to the MalariaGEN study influencing immune responses malaria northern rural Ghana. This sought identify issues arising practice during enrollment paediatric cases severe matched healthy controls into study.The used a rapid assessment incorporating multiple qualitative methods including depth interviews, focus group...
Human genetic factors are important determinants of malaria risk. We investigated associations between multiple candidate polymorphisms-many related to the structure or function red blood cells-and risk for severe Plasmodium falciparum and its specific phenotypes, including cerebral malaria, anaemia, respiratory distress.
This report of the WHO Working Group for Guidance on Human Challenge Studies in COVID-19 outlines ethical standards challenge studies. It includes eight Key Criteria related to scientific justification, risk-benefit assessment, consultation and engagement, co-ordination research, site selection, participant expert review, informed consent. The document aims provide comprehensive guidance scientists, research ethics committees, funders, policymakers, regulators deliberations regarding...
Currently there is increasing recognition of the need for research in developing countries where disease burden high. Understanding role local factors important undertaking ethical countries. We explored relating to information and communication during process informed consent, approach that should be followed gaining consent. The study was conducted prior a family-based genetic among people with podoconiosis (non-filarial elephantiasis) southern Ethiopia.We adapted method rapid assessment...
The consent process for a genetic study is challenging when the research conducted in group stigmatized because of beliefs that disease familial. Podoconiosis, also known as 'mossy foot', an example such disease. It condition resulting swelling lower legs among people exposed to red clay soil. very stigmatizing problem endemic areas Ethiopia widely held opinion runs families and untreatable. aim this was explore impact social stigma on obtaining genetics podoconiosis Southern Ethiopia. We...
There is increasing support for sharing individual-level data generated by medical and public health research. This scoping review of empirical research conceptual literature examined stakeholders’ perspectives ethical best practices in sharing, particularly low- middle-income settings. Sixty-nine articles were reviewed, which, only five studies eight focusing on We conclude that contingent the development implementation international local policies processes to practices. Further needed...
The authors have declared that no competing interests exist. MalariaGEN's primary funding is from the Wellcome Trust (077383/Z/05/Z) and Bill & Melinda Gates Foundation via for US National Institutes of Health (566) as part Grand Challenges in Global initiative. Additional support provided by Sanger Institute core Medical Research Council (G0600230). MP SB receive a Enhancement Award Biomedical Ethics (087285/Z/08/Z). member Case Control Consortium Data-access Committee. funders had...
The Thailand Major Overseas Programme coordinates large multi-center studies in tropical medicine and generates vast amounts of data. As the data sharing movement gains momentum, we wanted to understand attitudes experiences relevant stakeholders about what constitutes good practice. We conducted 15 interviews three focus groups discussions involving 25 participants found that they generally saw as something positive. Data was viewed a means contribute scientific progress lead better quality...
There is increasing recognition of the importance sharing research data within international scientific community, but also ethical and social challenges this presents, particularly in context structural inequities varied capacity research. Public involvement essential to building locally responsive policies, including on sharing, little has involved stakeholders from low-to-middle income countries.Between January June 2014, a qualitative study was conducted Kenya involving sixty with...
Increased global sharing of public health research data has potential to advance scientific progress but may present challenges the interests stakeholders, particularly in low-to-middle income countries. Policies for should be responsive views, there is little evidence systematic study these from low-income This qualitative explored views on fair data-sharing processes among 60 stakeholders Kenya with varying experience, using a deliberative approach. Stakeholders’ attitudes were informed by...
The abundance of South African clinical and public health research data has the potential to unlock important valuable future advances in biomedical science. Amid increasing calls for more effective sharing individual-level data, commitment promote access is evident within Africa’s sector, but national guidance regulation are absent. This qualitative study examined perceptions, experiences concerns 32 stakeholders about data-sharing practices. There was consensus utility publicly funded...
For many decades, access to human biological samples, such as cells, tissues, organs, blood, and sub-cellular materials DNA, for use in biomedical research, has been central understanding the nature transmission of diseases across globe. However, limitations current ethical regulatory frameworks sub-Saharan Africa govern collection, export, storage reuse these samples have resulted inconsistencies practice a number concerns sample donors, researchers research ethics committees. This paper...
Abstract In recent years, there has been an increase in the establishment of biobanks for genetic and genomic studies around globe. One example this is Human Heredity Health Africa Initiative (H3Africa), which established sub‐region to facilitate future indigenous studies. The concept ‘broad consent’ proposed as a mechanism enable potential research participants give permission their samples be used However, questions remain about acceptability model consent. Drawing on findings from...
Guidance requires that consent processes for research be appropriately tailored to their cultural context. This paper discusses the use of rapid assessments identify and ethical issues arising when explaining in studies The Gambia Ethiopia. provided insights into appropriate ways providing information minimize risk stigmatizing vulnerable populations; participants' views about most important provide understandings research; perceived constraints upon reaching voluntary decisions...
Efforts to internalize data sharing in research practice have been driven largely by developing international norms that not incorporated opinions from researchers low- and middle-income countries. We sought identify the issues around ethical context of involving women children urban India. interviewed researchers, managers, participants associated with a Mumbai non-governmental organization, as well other organizations members ethics committees. conducted 22 individual semi-structured...
Antimicrobial resistance (AMR) poses an increasing threat to patient care and population health there is a growing need for novel therapies tackle AMR. Bacteriophage (phage) therapy re-emerging antimicrobial strategy with the potential transform how bacterial infections are treated in patients populations. Currently, UK, phages can be used as unlicensed medicinal products on 'named-patient' basis. We make ethical case why it crucially important UK invest Good Manufacturing Practice (GMP)...
It is increasingly recognized that effective and appropriate data sharing requires the development of models good data-sharing practice capable taking seriously both potential benefits to be gained importance ensuring rights interests participants are respected risk harms minimized. Calls for greater individual-level from biomedical public health research receiving support among researchers funders. Despite its importance, presents important ethical, social, institutional challenges in...
International science funders and publishers are driving a growing trend in data sharing. There is mounting pressure on researchers low- middle-income settings to conform new sharing policies, despite minimal empirically grounded accounts of the ethical challenges implementing policies these settings. This study used in-depth interviews focus group discussions with 48 stakeholders Vietnam explore experiences, attitudes, expectations that inform effective approaches clinical research data....
Research funders, regulatory agencies, and journals are increasingly expecting that individual-level data from health research will be shared. Broad consent to such sharing is considered appropriate, feasible acceptable in low- middle-income settings, but date limited empirical has been conducted inform the design of processes. We examined stakeholder perspectives about how best seek broad Mahidol Oxford Tropical Medicine Unit, which implemented a policy January 2016. Between February August...