3. Principles, Codes, and Standards Today
International Conference for Harmonization Guidelines for Good Clinical Practice (GCP)
Good Clinical Practice Guidelines were developed by the International Conference on Harmonization (ICH). Governments can use them to develop regulations governing clinical trials with humans. They include protection of human rights, standards for conduct of trials, and responsibilities and roles of sponsors, investigators, monitors and clinical research associates. When adhered to, the results of trials conducted multi-nationally should be acceptable for safety and efficacy decisions by all participating governments. In 2005, a Handbook for Good Clinical Practice was published and in 2009 an on-line course became available.
Standards and Operational Guidance for Health Related Research
The “Standards and Operational Guidance for Health Related Research” is a draft document released for comment in 2011 by the WHO. This document is more specific than general ethical guidelines and is intended to govern the establishment and operation of research ethics committees that review research with human subjects.