1. ETHICAL ISSUES OF RESEARCH ON HUMAN BIOLOGICAL MATERIALS
Aime Keis
Department of Public Health, University of Tartu
Research ethic Committee of University of Tartu

2. Privacy Informational Physical Desicional Identical A.V. Campbell
Director Centre for Biomedical Ethics, Yong Loo
Lin School of Medicine, NUS, Singapore

3. Biological material Can be stored for a very long time
Can used repeatedly
Can be used differently from the first intention

4. Biological material Conteins identifiable information
May lead to violation of privacy
With personal data = sensitive data
May lead to stigmatization and discrimination

5. Different types of biological material
Medical waste – body parts, organs, body fluids, ordinary we know the source
Archived – we may have coded, anonymous or personal data
Biobank research – typically data are in coded or anonymous
Material from deceased – personal data but we cannot ask permission.

6. Medical waste Donor must to be informed
Donor must to be informed about goals
Donor must to give an assent
Based on the Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research
Article 13 (VII – any foreseen potential further uses, including commercial uses, of the research results, data or biological materials)

7. Archived material Personal data + biological material
Personal data protection act of the Republic of Estonia (2008)
§ 16. Processing of personal data for scientific research or official statistics needs
Processing of personal data for scientific research or official statistics purposes without the consent of the data subject is permitted if the processor of the personal data has taken sufficient organisational, physical and information technology measures for the protection of the personal data, has registered the processing of sensitive personal data and the Data Protection Inspectorate has verified, before the commencement of the processing of the personal data, compliance with the requirements set out in this section and, if an ethics committee has been founded based on law in the corresponding area, has also heard the opinion of such committee.
In case if the material is stored from very long time – then only REC approval is needed

8. Biobank-research Estonian Genome Center
Human Genes Research Act – reflection of the Universal Declaration on the Human Genome and Human Rights (1997)
Broad consent = open consent ≠ informed consent
Data Collection era has finished
Research projects era has begun
Problem with decoding and reconatcting for the follow up and new research projects

9. Biobank-research
The aim of the Estonian Genome Project is to establish the Gene Bank, a database that contains data on the health and genes of the people of Estonia. The Gene Bank enables scientific and applied gene and health research to be carried out in order to determine genes that influence the development of diseases. Research carried out with the help of the Gene Bank shall not be limited to the present scientific level.
Gene Donor Consent Form

10. Human Genes Research Act
§ 24. Decoding
4) in order to identify a gene donor on the proposal of the chief processor and with the consent of the Ethics Committee, to contact the gene donor and to renew, supplement or verify a description of his or her state of health with his or her written consent;

11. Biological materials from the deceased
The idealistic approach – subject has express his/hers intention
Consequences of removal of biological material – destroy a body shape or not?
Keep in mind human dignity and restore body
To inform relatives and ask for a consent
Size of material is not significant – then what? Do the relatives have really know?

12. ROLE OF THE ETHICS COMMITTEES
The ethics committee on human research is an institution which includes medical and nonmedical specialists whose responsibility is to protect human rights, assure safety and welfare of humans in biomedical and non- biomedical research projects.

13. Thank You