Medical Ethics Case 2 Informed Consent

According to Nuremberg Code, research subject should give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved, as to enable him to make an understanding and enlightened decision (1). WMA Declaration of Helsinki indicates that study participants should be able to agree willingly and freely before enrolling in a research, he or she is also free to consult family members if the need arises and must be sufficiently educated on the aims, methods, expected benefits and future risk involved

A respect for autonomy, beneficence and justice are ethical principles that guide the conduct of research involving human subjects. Regulations and policy require that this information be provided as part of the consent process. Any consent that lacks these major guidelines might be regarded invalid. Case 2 “Informed Consent “ has some ethical problems which are lack of ethical review and inadequate consent. The study did not receive an ethical review before it was started because there were few research institutions in the country. Consequently, this act violates guideline 23 of CIOMS which states that all proposals to conduct research involving human subjects must be submitted for ethical review of their scientific merit and ethical acceptability depending on the nature of the research and application of law (5). The inability of a researcher to give in research proposal for competent review leads to a serious breach of ethical principles. Ordinarily, If this study was submitted to the ethics committee before it was conducted, it might not be ethically acceptable considering the fact that the researcher withheld basic information from the patients. Although, there are