[Critical evaluation of the new legal regulation of pharmaceutical trials with adults who lack decision-making capacity: a survey of human research ethics committees in Germany].

BACKGROUND

In Germany, the drug law was revised in 2016 to include new regulations on clinical drug trials with adults who lack decision-making capacity. For the first time, trials with a merely indirect benefit (benefit for other patients with similar characteristics) will be possible if several safeguards are respected. The ethical justification and practicality of this regulation are controversially discussed.

OBJECTIVES

(1) Eliciting the current pertinent practice of research ethics committees in Germany regarding research with indirect benefit on adults without decision-making capacity; (2) exploring the possibilities and difficulties of implementing the new law.

METHODS

Semiquantitative, anonymous questionnaire among 249 members of all 53 human research ethics committees in Germany.

RESULTS

Eighty-four questionnaires were analyzed (response rate 34%). The participants disagreed on assigning research projects to the categories of research with direct benefit to the subject, with an indirect benefit, and without any benefit. Moreover, the criteria of minimum risk and minimum burden were interpreted heterogeneously. More than half of the participants judged the newly introduced research advance directive to be unnecessary, given the legal safeguards in place. The applicability of these directives was doubted because of the strict requirements for anticipatory informed consent and the restricted predictability of future research.

CONCLUSION

In spite of the new legal regulation, significant ethical uncertainties remain concerning research with indirect benefit on adults without decision-making capacity. It remains an open question whether we need a better explanation of the law, additional legal regulation, practice evaluation, or a completely new law.