e-MOPs

Ethics & Engagement across the Wellcome Trust Major Overseas Programmes

Featured Project: Consent and assent in paediatric research - recommendations for low-income settings

Dr Phaik Yeong Cheah is a 2013 Global Health Bioethics Network Fellow

Biosketch:

Dr. Phaik Yeong Cheah is the head of the Clinical Trials Support Group (CTSG) in Oxford University’s and the Wellcome Trust’s Thailand Major Overseas Programme (MOP) in Thailand. She leads a team of twenty members who support researchers throughout the MOP network, irrespective of geography or discipline, in all aspects of clinical research. Core functions of the group involve oversight of all research involving human subjects, clinical trial development, protocol writing, ethical committee applications, statistical advice, data management, trial coordination and project management, providing Good Clinical Practice (GCP) training, trial monitoring and ethics support. As part of the MOP’s community engagement strategy, she helps manage the Tak Province Community Ethics Advisory Board (T-CAB) on the Thai-Burmese Border, provide their research agenda, and create a monitoring and evaluation scheme.

Phaik Yeong’s research interests include developing ethical and pragmatic cost-efficient approaches to managing and conducting high quality clinical trials in resource-limited settings whilst ensuring compliance to local and international requirements. She is particularly interested in ethical issues in community engagement, data sharing, consent and assent in paediatric research.

Before working in Thailand, Phaik Yeong was a member of the Clinical Trials and Research Governance team at Oxford, where her responsibilities included advising, reviewing and approving research protocols, providing research ethics and Good Clinical Practice training for researchers, and monitoring and auditing clinical trials on behalf of the University. Phaik Yeong graduated in Pharmacy and has a Ph.D. in Pharmacy.

Project Title: Consent and assent in paediatric research - recommendations for low-income settings

This project asks the question: What are the special considerations of consent and assent in paediatric research in low-income settings?

Although there has been much discussion in the literature about consent and assent in paediatric research, little has been written about the unique challenges in low-income settings. There are additional considerations in these difficult and complex environments where research is most needed and the disease burden is high. International guidelines suggest that children provide assent for medical research in addition to their parent’s consent. However, the concept of assent lacks clarity and the current guidelines are confusing. 

The project will consist of a week-long bioethics course, a detailed literature review on consent and assent in paediatric research, a month-long apprenticeship at the Ethox Centre in Oxford to carry out the research and write the manuscript (with a view to publication in an international peer-reviewed journal), as well as international dissemination of project findings through presentations at conferences around the world.

Comment by Michael Parker on May 9, 2013 at 21:34

This sounds like a great project. It would be really interesting to hear from others across the MOPs about whether you face particular ethical challenges in recruiting children to research and when and how issues related to assent arise.

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