[Willingness to participate in group beneficial dementia research]. / Bereitschaft zur Teilnahme an gruppennütziger Demenzforschung.

ABSTRACT

BACKGROUND: With the fourth Act on the amendment of pharmaceutical legal and other regulations it became law in Germany from the beginning of 2017 that under certain conditions, pharmaceutical research will be allowed with persons incapable of giving consent, even if this research may only be beneficial to other sufferers of the same disease, i. e. group beneficial research. OBJECTIVE: We conducted a semistructured, non-representative survey among psychiatric patients and their relatives. PARTICIPANTS AND METHODS: This survey was done for a period of 3 months until the end of September 2017 in the practice of M. H. with successively examined patients and their relatives. Patients incapable of giving consent related to dementia, depression and emergency cases, were excluded. Participants were asked about their attitudes related to evaluation of a) group beneficial research in principle, b) pharmaceutical withdrawal studies and c) research authorization. Sociodemographic and clinical variables were collected. RESULTS AND DISCUSSION: This study included 85 persons and all of them gave their informed consent to participation. The mean age was 70 years, 47% were male, 61% had a university degree and 46% an independent profession. Mild cognitive impairment was diagnosed in 26%. This survey revealed a relatively high basic approval of group beneficial dementia research as well as of pharmaceutical withdrawal studies. In addition, research authorization gained a substantially positive evaluation. Only a few participants were informed about the new law in force since 2017. The present results were drawn from an explorative study with an unrepresentative sample and, therefore, have to be interpreted with caution. They show, however, that in the general population more information and awareness about group beneficial research with persons incapable of giving informed consent should be achieved. The relatively high rate of approval in this study may reveal a widespread feeling of social responsibility; however, reported objections of the participants should also be seriously considered.