1. Research on human biological materials: Lithuanian perspective
Jurate Serepkaite
LITHUANIAN BIOETHICS COMMITTEE
The annual meeting of the Baltic research ethics committees, May 13-14, 2011 Vilnius

2. 5 types of research on human biological materials
Research on human biological materials that are:
1) obtained for specifically defined research project
2) already archived for other than research purposes
(e.g. archived diagnostic samples in pathology clinics)
3) prospectively collected for other than research purposes with a possibility to store them into disease-orientated biobank (e.g. diagnostic samples, leftovers)
4) obtained for population biobank
5) procured from the deceased for research

3. The issues to be discussed
Legal regulation
Consent
Anonymization
REC approval

4. 1st type: for specifically defined research project (1)
Legal regulation:
Law on Ethics of Biomedical Research
Law on Protection of Personal Data
REC approval:
Always required
3 RECs in Lithuania responsible for the ethical review
of biomedical research projects:
Lithuanian Bioethics Committee
2 Regional Biomedical Research Ethics Committees:
based at Vilnius University
based at Lithuanian University of Health Sciences (in Kaunas)

5. 1st type: for specifically defined research project (2)
Consent:
Law on Ethics of Biomedical Research describes consent as “an explicit and knowing written consent by the subject to participate in a biomedical research”
it must contain certain elements of information related to the particular research project:
aims
plans of the research
methods applied
decisions of the relevant RECs etc.

6. 1st type: for specifically defined research project (3)
Anonymisation:
Law on Ethics of Biomedical Research:
[health-related personal] information obtained in the course of a biomedical research […] shall be confidential and may be provided only in accordance with the procedure laid down by the Law on the Rights of Patients and Compensation of the Damage to Their Health (Article 9)
Law on Protection of Personal Data:
personal data shall be adequate and not excessive in relation to the purposes for which they are collected and further processed and they shall not be stored longer than it is necessary for data processing purposes

7. 2nd type: already archived for other than research purposes (1)
Lithuania has numerous different collections of human biological materials (e.g., over 180,000 tissue samples are stored in the National Centre of Pathology annually)
Research on archived samples can be conducted under 3 kinds of circumstances:
(a) during the minimal term (10 years) of storage of sample for diagnostics
(b) after the minimal term of tissue sample’s storage for diagnostics ends
(c) during the fixed term of storage of human residual material that is left after the primary tissue sample is taken for diagnostics

8. 2nd type: already archived for other than research purposes (2)
An example of the flow of samples in a pathology laboratory in Lithuania:

9. 3rd type: prospectively collected for other than research purposes with possibility to store in disease-orientated biobank (1)
Legal regulation:
Lithuania does not have specific regulations
Consent:
It must contain certain elements of information:
aims
plans of the research
methods applied
decisions of the relevant RECs etc. ↓
Possibility of not specific consent?
REC has to decide whether consent is acceptable in particular case

10. 3rd type: prospectively collected for other than research purposes with possibility to store in disease-orientated biobank (2)
The draft amendment of the Law on Protection of Personal Data is being prepared to set the legal basis for collecting residual materials for research purposes
Proposals of the model of consent:
1. Broad consent (e.g. Sweden)
2. Presumed consent
For all residual materials (e.g. Denmark, Netherlands)
Only for left-over (e.g. Belgium)

11. 4th type: collected for population biobank
Legal regulation:
Lithuania does not have specific regulations regarding research biobanks
Consent:
Implementation of informed consent as it is defined in the Law regulating biomedical research is problematic
Anonymization:
There are no specific regulations as of different levels of anonymization
REC approval:
Each surrender of samples for research has to be approved by REC

12. 5th type: obtained from the deceased for research
Legal regulation:
No clear regulations regarding this type of research
Consent:
it seems that in practice it is impossible to obtain materials (either identifiable or anonymous) for research from the deceased unless consent was secured while still alive
Anonymization:
There are no specific regulations as of different levels of anonymization
REC approval:
Always required

13. Summary
Even though Lithuania has a specific law regulating biomedical research (Law on Ethics of Biomedical Research) a number of issues remain unclear:
how broad consent is compatible with consent provisions in the said law
whether obtaining samples from the deceased for research purposes is possible at all
only very general regulations exist in relation to anonymization (the same strict regulations apply to both identifiable and anonymous human biological materials)

14. Discussion
3th type: prospectively collected for other than research purposes with a possibility to store samples in disease-orientated biobank
The draft amendment of the Law on Protection of Personal Data
Proposals of the model of consent:
Broad consent (e.g. Sweden)
Presumed consent
For all residual materials (e.g. Denmark, Netherlands)
Only for left-over (e.g. Belgium) ↓
Which consent model would you suggest?