[Protection of study participants through standardised information--proposal of a unified criterion catalogue for the activities of ethics committees--results of an expert survey].
BACKGROUND
The main task of the ethics committees is the protection of study participants against unethical research. The international consensus on ethical aspects, however, is only partially considered in legal regulations. In Germany, the regulations for approval procedures of clinical studies have been increasingly standardised, but this does not apply to information for study participants. The aim of this study was to propose a list of criteria for information for study participants based on comparisons of existing resources and international standards.


METHODS
The available criteria for the development of information for study participants and consent forms of the ethics committees of the German State Medical Chambers (n = 16) were analysed and compared. The criteria identified were complemented with indications provided in international guidelines and compiled in a catalogue. This first version of a list of criteria (58 items) was submitted to an expert panel of members of the ethics committees (n = 16) and patient and consumer representatives (n = 18), and subjected to corresponding revision.


RESULTS
In Germany, the guidelines for the development of information for study participants are not standardised. The list of criteria resulting from international guidelines and the available criteria of the State Medical Chambers consisted of 58 items. The expert panel agreed on most of the items, and a revised version of the catalogue is now available.


CONCLUSIONS
The list of criteria may contribute to standardisation of information for study participants in clinical studies for the activities of the ethics committees.
Berger
Bettina
B
Universität Hamburg, Fachwissenschaft Gesundheit. bettina.berger@uni-hamburg.de
Studt
Kerstin
K
Krause
Kay
K
Seyfert
Rebecca
R
Klemme
Jörg
J
Steckelberg
Anke
A
D001294:Attitude to Health; D002986:Clinical Trials as Topic / Q000941:ethics* / Q000592:standards*; D005858:Germany; D006306:Health Surveys; D006801:Humans; D007258:Informed Consent; D011785:Quality Assurance, Health Care