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Ethical Requirements & Development of Guidelines for Pediatric Trials in Developing Countries

4903
Duration : 60 Minutes

Dr. Nagina Parmar,

Dr. Nagina Parmar has 15 years of clinical research experience as a certified clinicalresearch professional in academia and hospital. Her expertise as clinical research professional lies incoordinating various Phase I, II and III national and international clinical trials and investigator initiate Read more


This 1-hr virtual seminar will help you understand the key ethical issues and challenges associated with pediatric studies in developing countries. These issues become more prominent in pandemic situations like COVID-19. Pediatric populations in developing countries are extremely vulnerable participants in clinical research. I will discuss some of the key ethical issues and challenges associated with pediatric studies in developing countries during COVID-19 and suggest how these can be addressed.

Course Objectives:

This webinar will provide in-depth understanding of the main ethical considerations when conducting research in developing countries.

Upon completion of this webinar, attendees should be able to:

• identify the key ethical issues such as consent process, role of ethics committee, fair selection and social norms that are often observed in pediatric studies
• Identify the regulations that govern human subjects in developing countries during COVID-19
• Identify the guidelines that govern human subjects in developing countries
• Recognise the key challenges associated with pediatric studies in developing countries during COVID-19
• identify the means how these challenges can be addressed
• identify the options or strategies to move forward during the pandemic e.g. COVID-19

Why Should You Attend:

Conducting research in pediatric populations has been the focus of much debate over the years. Pediatric research – whether in infants, children, or adolescents – is ethically more challenging than research in adults. Children can easily be coerced and exploited, so they must rely on their parents or guardians to make the best decisions on their behalf, including whether to participate in a clinical trial or not. Trial participation is even more sensitive in developing countries where the socioeconomic status of participants is often low and access to healthcare is restricted. Parental decisions on clinical trial participation are likely to be influenced by the promise of economic benefits and better healthcare for their child. Therefore, in order to understand the research in pediatric populations and especially in developing countries, the insight to in depth knowledge of both domestic states regulations and guidelines is particularly important. The most important consensus should be that children must be protected from unnecessary risks because of their vulnerability, lack of autonomy and limited ability to understand and evaluate research.

Course Outline:

• What are the main ethical considerations?
• How about Guidelines? Can guidelines assist in mitigating the risk associated with participation in the clinical trials?
• Examples of guidelines in developing countries.
• What are the changes in the guidelines provided by Office of Health and Research protections during COVID-19?
• The way forward? Especially in the situations like in pandemic situations e.g. COVID-19.

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

This topic applies to personnel / companies doing research or involved in the clinical trials. The following will benefit most include:

• Principle Investigators
• Senior Clinical Research Associates(CRAs)
• Clinical Research Project Manager
• Research Assistants
• Clinical Research Coordinator (SC)
• Contract Research Organizations (CROs)
• Institutional Review Boards (IRBs)
• Site Management Organizations (SMOs)

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

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Subject : Ethical Requirements & Development of Guidelines for Pediatric Trials in Developing Countries


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