Ethics

Ethics will be an underpinning foundation of the present project and ethical issues will be rigorously addressed. The general ethical principles followed throughout the project will be compliant with the Declaration of Helsinki and the Good Clinical Practices principles, in their most recent version, in order to uniform, on an international level, all ethical guidelines for the overall project.

The project will also respect the relevant EC legislation, as well as the appropriate international conventions and declarations, and more specifically the following:

  • The Charter of Fundamental Rights of the European Union and therefore all the regulations it is based on: the European Convention of Human Rights, the Council of Europe’s Social Charter, the Community Charter of Fundamental Social Rights of Workers and other international conventions to which the European Union or its Member States are parties;
  • The Convention of the Council of Europe on Human Rights and Biomedicine signed in Oviedo on April 4th, 1997, and the Additional Protocol on the Prohibition of Cloning Human Beings signed in Paris on January 12th, 1998 (Convention of the Council of Europe on Human Rights and Biomedicine);
  • Directive 1995/46/EC of the European Parliament and of the Council of October 24th, 1995, on the protection of individuals with regard to the processing of personal data and on the free movement of such data;
  • Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18th December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data;
  • Directive 2001/20/EC of the European Parliament and of the Council of April 4th, 2001, on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (and subsequent Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16th April 2014 on clinical trials on medicinal products for human use);
  • Directive 2005/28/EC of the European Parliament and of the Council of April 8th, 2005, laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products;
  • Directive 2001/83/EC of the European Parliament and of the Council of November 6th, 2001, on the Community code relating to medicinal products for human use;
  • Directive 2002/58/EC of the European Parliament and the Council of July 12th, 2002, concerning the processing of personal data and the protection of privacy in the electronic communications sector (Directive on privacy and electronic communications);
  • Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16th April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
  • Universal Declaration on the human genome and human rights adopted by UNESCO;
  • The opinions of the European Group of Advisers on the Ethical Implication of Biotechnology (1991-1997), the opinions of the European Group on Ethics in Science and New Technologies (as from 1998) and the opinions by the European Commission will also be taken into consideration.

These principles will apply to every project activity performed by any of the partners involved. Each country participating in the clinical pilot will be responsible of the submission and adherence to any additional legal and ethics requirements before the initiation of the pilot.

Further ethical rules shared by project partners are detailed for each pilot project with country-specific rules and best practices to manage activities involving patients.

Fondazione Don Carlo Gnocchi ONLUS

Additional ethical principles that will be followed are those laid down by the Board of Health and Regional Government of Lombardia, the Code of Ethics of the Italian Medical Association and the specific standards defined by the Scientific Direction of the Don Gnocchi Foundation. Before submission, the project has already been evaluated and approved by the Scientific Direction of the Foundation, which has assessed the scientific qualities of its procedures and the compliance in accordance with its Code of Ethics.

Västra Götalandsregionen 

Any clinical trial in Sweden, including the planning, approval, conduct, recording, and reporting thereof shall be carried out in due compliance with the provisions of the current Harmonized Tripartite Guideline for Good Clinical Practice (ICHGCP E6). Current ISO 14155-1, 14155-2 (2003): Clinical Investigation of Medical Devices for Human Subjects, as well as following regulations and guidelines published are to be followed. Rules for protection of individually identifiable health information are also compliant with US HIPAA – Health Insurance Portability and Accountability Act of 1996.

In addition, any clinical trial in Sweden should also be carried out in due compliance with the Swedish Law pertaining to Ethical Reviews on Research regarding Human Subjects (2003:460) as well as the Swedish collection of statutes; statutes no 2003:615, 2007:1068 and 2007:1069.

Hospital Universitario de Gefate – Servizio de Geriatrìa

Nothing to add to the general statement.

Maccabi Healthcare Services

Any clinical trial in Israel, including the planning, approval, conduct, recording, and reporting thereof shall be carried out in due compliance with the Public Health Regulations (Clinical Trials in Human Subjects) 1980, including all subsequent additions and amendments thereto until 1999 (hereinafter “the Regulations”), the Genetic Information Law 2000 (hereinafter: “the Genetic Information Law”), the provisions of these Ministry of Health guidelines, the provisions of the current Harmonized Tripartite Guideline for Good Clinical Practice (ICHGCP E6) and the provisions of the current ISO 14155-1, 14155-2 (2003): Clinical Investigation of Medical Devices for Human Subjects, as well as regulations and guidelines published. Rules for protection of individually identifiable health information are also compliant with US HIPAA – Health Insurance Portability and Accountability Act of 1996.