Ramachandran A J
J Biolaw Bus. 2003;6(1):65-75.
The policies and practices for obtaining informed consent from research subjects in clinical research play a vital role in determining a nation's success as a center for clinical research. The difficulty lies in the fact that while on the one hand, informed consent is a necessary pre-condition for ethical clinical research, a scrupulous observance of the guidelines for informed consent could, on the other hand, cripple medical research. Crippling of ethical medical research can be adverse to public interest, and consequently, unethical. Hence, a fine balance must be struck in the application of the guidelines for obtaining informed consent. This, in turn, would depend on the constitution and skill of research ethics committees who are appointed to consider and approve clinical research proposals. The discussion below addresses the above difficulty with recommendations that could further enhance Singapore's image as a regional clinical trial hub.
在临床研究中，从研究对象处获得知情同意的政策和做法对于一个国家成为临床研究中心的成功与否起着至关重要的作用。困难在于，一方面，知情同意是符合伦理的临床研究的必要前提条件；另一方面，严格遵守知情同意准则可能会阻碍医学研究。阻碍符合伦理的医学研究可能不利于公众利益，因此是不道德的。所以，在应用获取知情同意的准则时必须达成微妙的平衡。这反过来又取决于被任命来审议和批准临床研究提案的研究伦理委员会的组成和能力。以下讨论将针对上述困难提出建议，这些建议可能会进一步提升新加坡作为区域临床试验中心的形象。
