Biomedical Ethics, Clinical Research Ethics and Patients' Rights

Ignorance is not a privilege. It is your misfortune. What you do not know can hurt you or your business or work. Clinical research covers research projects (e.g. human stem cell research) involving healthy volunteers and patients. Certain aspects of clinical trials and research remain controversial as public opinion of what is ethically acceptable varies across cultures and over time. Ethical parameters remain undefined and it is difficult to make any comprehensive law fulfilling the public consensus.

With the rapid developments in medical technology, life sciences and human genome project, there is a range of ethical issues to be considered. The doctrine of informed consent and patient medical confidentiality raise important questions to be addressed in this one-day seminar.

What makes Clinical Research Ethical?

• International Guidelines of World Medical Association
• The Nuremburg Code of Ethics in Medical Research (1949) – The Basic Principles
• The Declaration of Helsinki (1964) – 12 Fundamental Principles
• The Belmont Report (1979)
• Council of International Organizations of Medical Sciences (CIOMS)
• Compensation for Research Injuries – case studies, human experiments, ex gratia payments
• Dangerous Liaisons – unrecognized hazards, deceit is current failings, etc
• Fundamental Principles of Biomedical Ethics
• Human Medical Research
• Informed Consent to Clinical Trials
• Ethics Goes Beyond Law
• Professional Standards of Doctors and Investigators – Hippocratic Oath, Declaration of Geneva
• Is it Ethical to use a Placebo Arm?
• Clinical Research Combined with Professional Care
• Non-Therapeutic Clinical Research
• BioEthics Advisory Committee – recommendations, human stem cell research and therapeutic cloning
• Legal Obligation in Clinical Research – sponsor/manufacturer obligations for negligence, etc

Course material will be given and should serve as an invaluable reference. Participants will benefit from the lively interactive session with the lecturer and her guest speakers too.