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Ethical issues

All research performed by the CML-Alliance will conform to relevant EU legislation such as:

  • The Charter of Fundamental Rights of the EU
  • Directive 2001/20/EC of the European Parliament and of the Council of 4 April 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
  • Commission directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medical products for human use, as well as the requirements for authorization of the manufacturing or importation of such products
  • Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data
  • Council Directive 83/570/EEC of 26 October 1983 amending Directives 65/65/EEC,75/318/EEC and 75/319/EEC on the approximation laid down by law, regulation or administrative action relating to proprietary medicinal products
  • Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions
  • Directive 90/219/EEC of 23 April 1990 on the contained use of genetically modified micro-organisms
  • Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC and to International conventions and declarations such as:
  • Helsinki Declaration in its latest version
  • Convention of the Council of Europe on Human Rights and Biomedicine signed in Oviedo on 4 April 1997, and the Additional Protocol on the Prohibition of Cloning Human Beings signed in Paris on 12 January 1998
  • UN Convention on the Rights of the Child
  • Universal Declaration on the human genome and human rights adopted by UNESCO

The opinions of the European Group of Advisers on the Ethical Implications of Biotechnology (1991 -1997) and the opinions of the European Group on Ethics in Science and New technologies (as from 1998) will be taken into account.
Also new protocols to the convention on human rights and biomedicine that are in force when the research project starts will be respected.

Data protection issues

Informed consent

Human samples will only be taken and stored after prior written consent by the research subject. There will be complete prior information concerning the purpose (e.g. the type of analyses that will take place) of taking and storage of the human samples including the planned duration of the storage and what happens thereafter. In addition, for non-anonymized human samples the research subject has the right to withdraw his/her consent and to ask for destruction of his/her sample without giving a reason. In clinical trials there will be a separate informed consent form for human samples, and the access to clinical trials will not be limited to those, who have given informed consent to the collection of human samples.
We will take care that the rights of the research participants will be protected at the highest level. The EU and the ICH GCP provides in detail how research protocols have to be drafted and how ethical issues have to be addressed. As practically all lead participants and principal investigators have taken part in a responsible position in multinational biomedical research projects including the collection of human samples there is considerable experience available with these ethical issues. As previously mentioned, all biomedical research and all epidemiological research with person-related data will not be started without prior written approval of the competent IECs/IRBs. To check in detail informed consent forms and the procedures for attaining informed consent is one of the major tasks of IECs/IRBs. This refers to the informed consent for collecting human samples, too. Thus it is impossible that within this project any ethically questionable research takes place.
The duration of storage of human samples depends on the research questions. All necessary information concerning duration of storage and thereafter will be provided in the respective informed consent form. These informed consent forms for human samples will be reviewed by the IEC/IRB, too.
The project coordinator will enforce and control the compliance with all relevant ethical and regulatory review necessities.

Created by: A. Hellenbrecht , generated 2007/12/20 , last changed: 2008/07/08


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