RESPO

NSIBILITIES

The platform is a committee of ethics commissions responsible for the assessment of clinical trials of medicinal products.

It aims to ensure a common, unified approach by the ethics commissions and serves as the point of contact for matters concerning the assessment of clinical trials of medicinal products.

Its legal basis is found in the Medicinal Products Act (§ 29 AMG Federal Law Gazette No. 8/2022).

"The tasks of the platform are regulated in § 34 AMG Federal Law Gazette No. 8/2022.

1. Development of an agreement with the Federal Office for Safety in Health Care
2. Adoption of the platform's Rules of Procedure
3. Adoption of the common Rules of Procedure for the announced ethics commissions
4. Determination of the distribution of tasks for the applications
5. Representation of the announced ethics commissions externally
6. Determination of the fee share for the ethics commissions for the assessment of clinical trials
7. Reporting to the Federal Ministry of Social Affairs, Health, Care, and Consumer Protection, while simultaneously notifying the Federal Office for Safety in Health Care, when it becomes known to the platform that an ethics commission no longer meets the legal requirements.