The European ethical review committee.

The European Ethical Review Committee, which concerns itself with the standards applicable to clinical trials with medicinal products, was established in 1977 and, as the name suggests, draws its membership from the countries of Europe. Its structure comprises a Board and panels of experts representing internal medicine, clinical pharmacology, general practice, nursing, legal and lay persons. Board members attend all meetings and indeed the structure of the Board is such that it constitutes an ethics committee in FDA terms in its own right. Full meetings normally comprise the Board and a member drawn from each of the consultant panels, the members of which are often selected in recognition of their particular expertise in the area of the protocols to be reviewed. In the main, the EERC reviews protocols for multi-centre clinical trials, usually within Europe and sponsored by pharmaceutical companies. EERC standard operating procedures require the sponsoring company's representative and/or the clinical investigator to be present at its meeting to present the protocol and receive comments on it in person. This dialogue between the Committee and pharmaceutical companies is an especially valuable feature, since amendments to the protocol can be agreed at the meeting and the assessment of protocols is facilitated. At the end of the meeting, protocols are either accepted as they stand or, more commonly, accepted with amendments and a certificate of approval is issued. Less commonly, a protocol is referred back to the pharmaceutical company and a certificate is not given. The Committee meets at the University of Leuven, Belgium, every six weeks and occasionally in London. In the thirteen years of its existence, the EERC has met 96 times to review 530 protocols from 23 different pharmaceutical companies. Its procedures require it to hold a general meeting annually at which all companies