Art. 25 Review areas
The responsible ethics committee shall review: - a.
- the completeness of the application;
- b.
- the categorisation requested;
- c.
- the information intended for registration in accordance with Article 64;
- d.
- the protocol with regard to:
- 1.
- the scientific relevance of the topic (Art. 5 HRA), the suitability of the chosen scientific methodology and compliance with Good Clinical Practice,
- 2.
- the ratio between the likely risks and burdens and the expected benefits (Art. 12 para. 2 HRA),
- 3.
- the measures taken to minimise risks and burdens, and for the protection and follow-up of participants (Art. 15 HRA), including precautionary measures in the handling of personal data,
- 4.
- the need to involve persons, and in particular persons who are particularly vulnerable (Art. 11 HRA),
- 5.
- the criteria for the selection of participants,
- 6.
- the proposed procedure for providing information and obtaining consent, including the appropriateness of the period for reflection,
- 7.
- the appropriateness of the remuneration for participants,
- 8.
- compliance with scientific integrity requirements;
- e.
- the completeness of the documentation for recruitment, information and consent, and its comprehensibility, especially with regard to the possible involvement of particularly vulnerable persons;
- f.
- the guaranteeing of the right to compensation in the event of damage (Art. 20 HRA);
- g.
- the adequacy of the knowledge and experience of the investigator and of the other persons conducting the clinical trial, in relation to the discipline concerned and the conduct of a clinical trial;
- h.
- the suitability of the infrastructure at the trial site;
- i.
- the financing of the clinical trial and the agreements between the sponsor, third parties and the investigator concerning the allocation of tasks, remuneration and publication;
- j.
- for Category A clinical trials of medicinal products or products under Article 2a paragraph 2 TPA capable of emitting ionising radiation: additionally, compliance with radiological protection legislation and the dose estimation;
- k.
- for investigations involving radiation sources31: additionally, compliance with radiological protection legislation and the dose estimation, in cases where an opinion does not have to be sought from the FOPH in accordance with Article 28;
- l.
- other areas, where this is necessary to assess the protection of participants.
31 German text amended by Annex 11 No 6 of the Radiological Protection Ordinance of 26 Apr. 2017, in force since 1 Jan. 2018 (AS 2017 4261). This amendment is not relevant to the English text.
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