Information sheets and informed consent forms for clinical study participants: towards standardised recommendations?
Subjects taking part in biomedical research must be provided with legible and intelligible information enabling them to freely give their informed consent. At present, sponsors tend to provide many different types of information, not all of which is directly connected with or indeed really informative about studies for those taking part.As a result of this observation, a round table was convened during the Clinical Pharmacology meetings to deliberate on the creation of a charter concerning the drafting of information documents for biomedical research participants as well as a code of good practice for the preparation of such documents.Recommendations were made based on the efforts of the various working groups concerned, such as the French National Conference of Ethics Committees (CNCP), users' representatives, patients associations and the French industrial and institutional sponsors association (CPI), together with proposals contained in the literature.The deliberations of the round table may be subsumed under the following 3 categories and 14 points: 1) Format: design, drafting rules, layout, table of contents, glossary. 2) CONTENT: introductory page, description of the study, risks, benefits. 3) Regulatory aspects: legal aspects, CNIL message (data protection), financial aspects, conflict of interests, model and varied signatures. This document should help make research in France more attractive and it was decided after the Clinical Pharmacology meeting to submit the charter and related documents for approval by the various actors involved: DGS (Direction Générale de la Santé), Afssaps (Agence Française de Sécurité Sanitaire des Produits de Santé), CNCP, CPI and LEEM (Les entreprises du médicament). Once the charter has been validated, it will be made available to Sponsors and Ethics Committees in order to ensure greater uniformity and legibility regarding information given to study subjects.
Chassany
Olivier
O
DRRC, PH-HP, Hôpital Saint Louis, Paris, France.
Bernard-Harlaut
Micheline
M
Guy
Gilles
G
Billon
Nathalie
N
D016265:Conflict of Interest; D032962:Consent Forms / Q000592:standards*; D004358:Drug Therapy; D064420:Drug-Related Side Effects and Adverse Reactions; D005602:France; D017408:Guidelines as Topic; D006801:Humans; D007258:Informed Consent / Q000592:standards*; D005791:Patient Care; D010353:Patient Education as Topic / Q000592:standards*; D012106:Research; D018570:Risk Assessment