Cologne - The Union parliamentary group has agreed on proposal under which conditions research on adults who are unable to give consent, such as dementia patients, can be permitted, even if they themselves do not benefit from the research results.
After If the CDU and CSU wish to do so, those affected must have agreed to research for the benefit of the group after medical advice at time when they were still in full possession of their intellectual powers, and this must be documented in test person's will that is independent of the living will. The proposal is similar to the one e. After that, the person concerned must, with their clear mind, agree to non-profit research on their person and be informed about the risks and benefits by doctor. The document should be kept together with health care proxy or care decree.
The debate about the group-useful research on those unable to consent was sparked by the draft of fourth law amending pharmaceutical law and other regulations, which the Bundestag originally approved on 9 June should vote. This allowed such studies within narrow limits, namely if the person concerned consents to group-useful research in full possession of his mental powers and had written corresponding living will.
The law adapts German law to the EU regulation on clinical trials (). This only provides for the consent of legal representative for people who are unable to give their consent to participate in group-profit studies. However, the regulation also makes it clear that the test subjects may only be exposed to low risk and minimal exposure.
Protection of the test subjects has top priority In question time of the Bundestag today, the Parliamentary State Secretary in, Ingrid Fischbach, said that only under pressure from the German side, the EU regulation allows the member states to issue stricter national regulations in the matter of research on those unable to consent. At the same time, she emphasized that discussions on compromise proposal were still ongoing in the political groups.
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During Question Time, some MPs criticized the Federal Government's will to allow group-useful research on those unable to consent within narrow limits.Katja Dörner (Bündnis 90 / Die Grünen) warned that with its draft law, the federal government was undermining resolution of the Bundestag from 2013 (), according to which direct individual benefit must be prerequisite for research on adults who are unable to consent and on people in emergency situations. Hubert Hüppe (CDU) fundamentally doubted the need for group-profit studies on those unable to consent.
Fischbach admitted that the Federal Government did not have any figures on clinical studies on those unable to consent in countries where these are permitted. That is not evident from the statistics. At the same time, she emphasized that the protection of the test subjects had top priority in any case. Clinical researchers have made it clear, however, that there are large research gaps in the late stages of the disease in the case of dementia, for example, which cannot be closed by research on those who are still capable of giving consent.
The Bundestag wants its last week of session before the parliamentary summer break Vote on the draft law in the Bundestag. This was confirmed by representatives of both coalition factions in Berlin. Since this is an ethically difficult question, the Union and the SPD want to approve the vote as decision of conscience. Today it became apparent that the Union and the SPD could jointly apply. However, it is to be expected that there will be dissenting votes in both groups. The last week of meetings before the summer break will take place from July 4th to 8th.