The World Medical Association in its Declaration of Helsinki states in paragraph B13:
"The design and performance of each experimental procedure involving human subjects should be clearly formulated in an experimental protocol. This protocol should be submitted for consideration, comment, guidance, and where appropriate, approval to a specially appointed ethical review committee, which must be independent of the investigator, the sponsor or any other kind of undue influence. This independent committee should be in conformity with the laws and regulations of the country in which the research experiment is performed. The committee has the right to monitor ongoing trials. The researcher has the obligation to provide monitoring information to the committee, especially any serious adverse events. The researcher should also submit to the committee, for review, information regarding funding, sponsors, institutional affiliations, other potential conflicts of interest and incentives for subjects."
In the UK, ethics review is one of a series of safeguards intended to protect individuals. The primary function of an ethics committee (REC)when considering a proposed study is to protect the rights, safety, dignity and well being of all actual or potential participants. The remit of Research Ethics Committees is described in the Department of Health guidance, Governance Arrangements for Research Ethics Committees (GAfREC).
The PTC online will be examining in depth a number of ethics issues, this will cover up-to-date standards and practices, together with links to useful sites.
We would also like suggestions of what you would topics or themes you would like covered, so please contact the PTC with your ideas.
WEB DIRECTIONS:
For more information:-
Central Office for Research Ethics Committee
http://www.corec.org.uk/
Ethics Book
Reference books such as the 'Manual for Research Ethics Committees' can be a useful reference tool. This text has received positive reviews including one by The Psychologist who stated that it was 'a timely and important publication that should be an invaluable aid for applied psychologists, or anyone planning joint research with the NHS' The Psychologist.
Manual for Research Ethics Committees, Centre of Medical Law and Ethics, King's College London, 6th Edition, Edited by Sue Eckstein, Cambridge Publishers
The sixth edition of the Manual for Research Ethics Committees is a unique compilation of legal and ethical guidance which will prove invaluable for members of research ethics committees, researchers involved in research with humans, members of the pharmaceutical industry and students of law, medicine, ethics and philosophy. Presented in a clear and authoritative form, it incorporates the key legal and ethical guidelines and specially written chapters on major topics in bioethics by leading academic authors and practitioners, pharmaceutical industry associations and professional bodies. In the sixth edition there are fifteen new chapters covering key issues from participation in clinical trials to cloning, and for the first time the manual has been produced in one easy-to-search hardback volume.
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