RACE
to Karolinska Institutet

Ethical Issues

A major ethical concern in biomedical research is the use of animals and human subjects in experiments. In RACE, there are no experiments involving animals.

The Coordinator who is a member of the Karolinska Institutional Review Board since fours years back will oversee ethical issues involved in this project. The Coordinator will consult external bodies including local ethical committees, as required, to solve specific ethical issues.

The Coordinator will ensure compliance with:

  • Ethical standards of FP6.
  • The Charter of Fundamental Rights of the EU.
  • Local ethical boards decisions and requirements.
  • 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.
  • The Helsinki Declaration and its amendments.
  • The Convention of the Council of Europe on Human Rights and Biomedicine (Oviedo, April 1997).
  • Universal Declaration on the Human Genome and Human Rights adopted by UNESCO, 1997.

In addition, each researcher must be aware of the ethical requirements of the project and must be trained to follow such experimental requirements.

Human experiments

We will strictly comply with widely recognised international texts and codes of practice (the Helsinki agreement, the Convention of the Council of Europe on Human Rights and Biomedicine, The UNESCO Declaration on the Human Genome). The projects will respect all ethical requirements in objectives and methodology, and there are no known negative ethical implications of the results to be obtained. No patient tissues, or blood samples will be collected. Patients will be recruited in a consecutive manner without regard to race or other exclusion considerations. Patient data will be obtained through medical record chart review and interviews. Confidentiality will be assured by using codes for patient identification, and confidentially laws will be strictly observed when processing human clinical information. No patient identifying information will be published or available after the requisite clinical data have been collected, and consent will be obtained for the use of all data and tissues. Data will be accessible only to members and coordinators of the tissue procurement facility and research team, which will include surgical, pathological, and medical personnel under approved guidelines.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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