1. 2.World Medical Association. Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. 2000. Available at http://www.wma.net/e/policy/b3.htm (accessed October 3, 2006).
2. 3.Department of Health and Human Services. Rules and Regulations. Title 45, part 46; revised as of March 1983.
3. 4.ICH Steering Committee. ICH Harmonized Tripartite Guideline. May 1, 1996.