Manual for Research Ethics Committees
Centre of Medical Law and Ethics, King's College London
Edited by Sue Eckstein
Publisher: Cambridge University Press
Print Publication Year: 2003
Online Publication Date:January 2010
Chapter DOI: http://dx.doi.org/10.1017/CBO9780511550089.067
See the CIOMS website for the complete text of the publication. http://www.cioms.ch/
Guideline 1: Ethical justification and scientific validity of biomedical research involving human beings
The ethical justification of biomedical research involving human subjects is the prospect of discovering new ways of benefiting people's health. Such research can be ethically justifiable only if it is carried out in ways that respect and protect, and are fair to, the subjects of that research and are morally acceptable within the communities in which the research is carried out. Moreover, because scientifically invalid research is unethical in that it exposes research subjects to risks without possible benefit, investigators and sponsors must ensure that proposed studies involving human subjects conform to generally accepted scientific principles and are based on adequate knowledge of the pertinent scientific literature.
Commentary on Guideline 1
Among the essential features of ethically justified research involving human subjects, including research with identifiable human tissue or data, are that the research offers a means of developing information not otherwise obtainable, that the design of the research is scientifically sound, and that the investigators and other research personnel are competent. The methods to be used should be appropriate to the objectives of the research and the field of study. Investigators and sponsors must also ensure that all who participate in the conduct of the research are qualified by virtue of their education and experience to perform competently in their roles. These considerations should be adequately reflected in the research protocol submitted for review and clearance to scientific and ethical review committees (Appendix I).
30 - EU Clinical Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations, and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use:
69 - International guidelines on bioethics (informal listing of selected international codes, declarations, guidelines etc. on medical ethics/bioethics/health care ethics/human rights aspects of health):