TY - CHAP M1 - Book, Section TI - Appendix D: Guiding Principles for Human and Animal Research1 A1 - Shargel, Leon A1 - Wu-Pong, Susanna A1 - Yu, Andrew B.C. Y1 - 2012 N1 - T2 - Applied Biopharmaceutics & Pharmacokinetics, 6e AB - The Declaration of Helsinki, first published in 1964 by the World Medical Association, established recommendations guiding medical doctors in biomedical research involving human subjects (www.wma.net/e/policy/b3.htm). The Declaration governs international research ethics and defines rules for “research combined with clinical care” and “non-therapeutic research.” The Declaration of Helsinki has been revised periodically and is the basis of Good Clinical Practices used today. A copy of the latest revision is reproduced in this Appendix. The Declaration of Helsinki addressed the following issues: “Medical research is subject to ethical standards that promote respect for all human beings and protect their health and rights.”Research protocols should be clearly formulated into an experimental protocol and reviewed by an independent committee prior to initiation.Informed consent from all research participants is necessary.Research should be conducted by medically/scientifically qualified individuals.Risks should not exceed benefits. SN - PB - The McGraw-Hill Companies CY - New York, NY Y2 - 2024/04/19 UR - accesspharmacy.mhmedical.com/content.aspx?aid=56609131 ER -