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Programme >
Ethics Symposium
Ethical Dilemmas in Clinical Research - Problems and Solutions
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Track type:
Symposium
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Duration:
90 minutes
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Location:
Academia, Level 1, L1-S1
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Topic 1:
Professional and Ethical Risks in Clinical Trials
 Speaker: Dr Ming-Keng Teoh
Professional issues and ethical dilemmas are challenges often faced by doctors in clinical trials. Providing advice and assisting doctors with difficulties arising from their involvement in clinical research is part of the broad range of professional support MPS provides members.
While grant-awarding bodies focus on the merits of the proposal with relevant and robust aims and methodology, local research ethics committees or review boards review and approve research conducted within their jurisdiction. These committees have direct responsibilities to research subjects. Ultimately, it is the researchers who have to manage the diverse pressures from timelines, the need to recruit adequate numbers, fair patient selection, patients opting out and obtaining valid informed consent.
High profile news reports of stem cell research fraud and the TGN1412 clinical trial tragedy are reminders that effective regulatory safeguards and vigilance are needed. Dr Teoh MK will use cases from the MPS case files to highlight the common professional and ethical issues in clinical research.
Topic 2:
Protection for Patientsls Clinical Research Over Regulated?
Speaker: Dr Harpreet Sarna
The Helsinki Declaration in 1964 and primary legislation, such as the European Union Directive 2001/20/EC were introduced to harmonise and encourage good clinical practice in the conduct of clinical trials. Local research ethics committees that review and approve clinical research conducted locally have direct responsibilities to protect research patients. Safeguards must be in place to protect patients who volunteer for clinical research or trials.
Dr Sarna will focus on the specific areas of protection for patients in clinical research specifically, on the young and vulnerable patients; what happens when things go wrong and arranging adequate indemnity to protect research patients and doctors.
Topic 3:
Clinical Research comprises both observational and interventional studies and provides the scientific basis of best practice in clinical medicine. Specifically, the randomised controlled trial remains the most robust and important scientific tool available to determine efficacy and safety of diagnostic and treatment modalities across the entire spectrum of healthcare.
While individual patients may potentially benefit from participation in such studies, the main aim of clinical studies are however to benefit future patients. The ethics of clinical trials pivots around positions of equipoise such that participation in such studies should not disadvantage the patient.
Regulations exist to protect the patient participating in clinical studies from being disadvantaged. Dr Pierce Chow will share a clinician’s perspective about how effectively current regulations balance this against stifling important research that benefits future patients.
Topic 4:
*Information is correct at time of update
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