Consent and Information in Medical Research

Abstract

The present paper expounds and examines the requisites of information and consent to medical research interventions1 against the backdrop of the fundamental principles of informed consent to medical interventions generally and the relevant provisions of the current version of the World Medical Association Declaration of Helsinki (hereinafter referred to as the Helsinki Declaration) and the American Medical Association’s Proposed Revision of the World Medical Association Declaration of Helsinki (hereinafter referred to as the Proposed Revision). The reasons for the general background on informed consent are that (i) research interventions are but a species of the genus medical interventions; (ii) a sophisticated body of statutory law and/or judicial precedent pertinently addressing the issues of information and consent in medical research are largely absent; and (iii) hence, the fundamental principles of informed consent in standard medical interventions serve as an indispensible guideline for determining the nature, scope and application of the informed consent requisite in medical research interventions. For obvious reasons, the present paper focuses on the fundamental principles and minimum standards of informed consent in medical research in an international context rather than on detailed rules in specific jurisdictions.