ABSTRACT
As more research work is done on eye disorders, more safety rules and regulations are required to ensure the safety of trial subjects. This is the main function of Research Ethics Committees [also known as Institutional Review Boards (IRBs) and Domain Specific Review Boards (DSRBs)]. Tragedies in research in other fields are wake-up calls, such as the death of a healthy young volunteer subject in New York, the termination of a large study sparked by breach of medical confidentiality in Singapore and the South Korean debacle of its pioneering work in cloning. Many issues are still being debated, such as what statutory changes are required to control trials; whether all trials should be reviewed by IRB; if phase IV trials should be exempted; if compensation should be paid for all trial-related injuries; and whether investigators and IRB members be allowed to hold certain amount of shares in drug or device firms. Recent measures taken to prevent ethical problems include funding organisations not approving a study unless it has been cleared by the IRB, and requiring all investigators and IRB members to pass an ethics course. More measures will need to be taken to ensure the safety of the trial subjects involved in research studies.
The importance of ethics in research was highlighted in the USA when a healthy volunteer subject, 24-year-old Ellen Roche, died in a Johns Hopkins asthma study in 2002. Investigations showed that there had been serious deficiencies in the ethical review and research work was suspended in Johns Hopkins until recommendations by the Office for Human Research Protection were implemented.
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