Judgement by Chairpersons of German Ethics Commissions Regarding Group Beneficial Research
In 2004 the Central Ethics Committee for the Observance of Ethical Principles in Medicine and Adjacent Fields (Zentrale Ethikkommission zur Wahrung ethischer Grundsätze in der Medizin und ihren Grenzgebieten - ZEKO) set up by the German Medical Association published an opinion on research involving minors. The ZEKO stipulates determination and evaluation of the possible benefits and possible risks or burdens, the lack of an alternative research method (§ 4.3) and the assent of the minor subject's parents (§ 4.4) as preconditions for the acceptability of research beneficial to group interests that involves minors. Research projects may only be conducted, the ZEKO continues, if the proportionality of benefits and risks is "commensurate" and the risks and burdens are (normally) only minimal (§§ 4.5, 4.6). For the purpose of minimizing psychological risks and burdens, the ZEKO recommends the participation of independent persons who are experienced in dealing with minors, enjoy the trust of the minor in question and can safeguard the latter's interests (§ 4.7). Furthermore, the ZEKO requires that minors be integrated into the decision-making process to the extent permitted by their level of comprehension (§ 4.8). Finally, once a project has been completed, the participants and legal guardians should be informed of the results in an appropriate manner (§ 4.9).
In concrete application, the work of the ethics committees presents a somewhat different picture.
In 2006, Kathrin Radenbach presented a survey concerning "Group beneficial research on children and teenagers". In this survey, she arrives at the conclusion that group beneficial research on children and teenagers with more than a minimal risk and minimal stress is being judged very differently by chairpersons of German ethics commissions. The study yielded the fact that, for some of the chairpersons, a minimal risk and minimal stress did not pose substantial conditions for the reliability of group beneficial research on minors. Most of the time, the approval of a study project in a case such as this was, however, linked to the positive attitude of the minor to their participation in the study. Nevertheless, the volition of infants and preschoolers was assigned a lower importance than that of older children. The author held the current legal situation of imprecise laws responsible for this situation, which she personally deems problematic; she thus calls for a specification and concretization of the terms "risk" and "stress" in the pertinent German laws.
Radenbach, K. E. (2006): Gruppennützige Forschung an Kindern und Jugendlichen. Online Version (German)
Zentrale Ethikkommission zur Wahrung ethischer Grundsätze in der Medizin und ihren Grenzgebieten bei der Bundesärztekammer (ZEKO) (2004): Forschung mit Minderjährigen. In: Deutsches Ärzteblatt 101(22), A1613–1617. Online Version (German)
Braun, K. (2013): Bioethik, Öffentlichkeit, Politik. Bundeszentrale für Politische Bildung, Dossier Bioethik. Online Version (German)