Regulation (EU) No 536/2014 of the European Parliament and of the CouncilDangos y teitl llawn

Article 30 U.K. Informed consent in cluster trials

1. Where a clinical trial is to be conducted exclusively in one Member State, that Member State may, without prejudice to Article 35, and by way of derogation from points (b), (c), and (g) of Article 28(1), Article 29(1), point (c) of Article 29(2), Article 29(3), (4) and (5), points (a), (b) and (c) of Article 31(1) and points (a), (b) and (c) of Article 32(1), allow the investigator to obtain informed consent by the simplified means set out in paragraph 2 of this Article, provided that all of the conditions set out in paragraph 3 of this Article are fulfilled.

2. For clinical trials that fulfil the conditions set out in paragraph 3, informed consent shall be deemed to have been obtained if:

(a) the information required under points (a), (b), (d) and (e) of Article 29(2) is given, in accordance with what is laid down in the protocol, prior to the inclusion of the subject in the clinical trial, and this information makes clear, in particular, that the subject can refuse to participate in, or withdraw at any time from, the clinical trial without any resulting detriment; and

(b) the potential subject, after being informed, does not object to participating in the clinical trial.

3. Informed consent may be obtained by the simplified means set out in paragraph 2, if all the following conditions are fulfilled:

(a) the simplified means for obtaining informed consent do not contradict national law in the Member State concerned;

(b) the methodology of the clinical trial requires that groups of subjects rather than individual subjects are allocated to receive different investigational medicinal products in a clinical trial;

(c) the clinical trial is a low-intervention clinical trial and the investigational medicinal products are used in accordance with the terms of the marketing authorisation;

(d) there are no interventions other than the standard treatment of the subjects concerned;

(e) the protocol justifies the reasons for obtaining informed consent with simplified means and describes the scope of information provided to the subjects, as well as the ways of providing information.

4. The investigator shall document all refusals and withdrawals and shall ensure that no data for the clinical trial are collected from subjects that refuse to participate in or have withdrawn from the clinical trial.