1. Joint meeting of Baltic HRECs Riga, May 9-10, 2008 Some Remarks on Biomedical Research Ethics in Estonia Andres Soosaar Universtity of Tartu

2. Clinical trials in Estonia 2007 http://www.ravimiamet.ee/1119

3. http://www.ravimiamet.ee/1121

4. http://www.ravimiamet.ee/1123

5. Problems from statistics Are 93 clinical trials per one year for Estonia too much? They are quite unequally distributed between fields and research centres, there top centres have had over 10 clinical trials at the same time. Some researchers and represenatives of sponsors tend to say that clinical trials are important part of our economy and quality label of medicine.

6. Workload of the committee in 2007 11 meetings 42 clinical trials 137 academic research projects, including 58 applications from students 811 letters and documents, mostly changes of protocol and informed consent forms, also safety information from running projects.

7. Can we realize realize some Baltic standard in research ethics? Level and requirements of research ethics should be nationally and why not regionally (Baltic or Nordic region) more or less similar therefore HRECs involved should have certain comon standards. An example: Can we estimate common insurance conditions for research subjects

8. Some issues of that possible standard Regular exchange of information about projects (at least titles and names of researchers) between committees and SAM. Joint educational activities; Modernization of managements of documents; Some agreement of data protection requirements in research proposals; What to do with rapidly increasing number of collections of biological samples and related data; Issues related to e-health projects; Legal framework for biomedical research.

9. Regular excahnge of information We in fact didn’t have such exchange in Estonia until now, therefore it possible to reapply with failed project to another committee. We decided just few weeks ago to start with such exchange on a meeting basis.

10. Education At least in our HREC the education of committe members has been quite sporadic. To use resources in more efficient way we may think again about possibility to organize more focused joint Baltic seminars. An option is to develop the program of this event keeping more in mind research ethics education. Using of existing online resources.

11. Management of documents Until now all documents management runs on paper and in many copies (14 ). An option is to change the review method from “all read all” style to for example the way of few close readers. An option is to introduce some online data management system. As Tartu University has plan to finish with paper documents within next few years, we should follow such trends. Committee members are not so enthusiastic with such trends.

12. Different styles in international clinical trials and academic research. Extremely different style of consent forms in clinical trials and academic research. Why not to implement the requirement for shorter up to 4 pages information sheets for clinical trials? The quality of applications from academic researchers is quite unequal. Insurance is not the case in academic research. Some academic people try arrange big pharma sponsored research as academic research

13. Issues of data protection Estonian medical community is not happy with strong data protection practice in epidemiological research and data collection. We have started to ask more detailed description of data protection methods in application and information.

14. New collections of samples and data Almost every research project will be resulted with some sample and data collection. What will happen with them when project is completed. We have met situations where academic researchers have collected material and want to use samples again in other purposes. How to use biological materials and information of clinical practice in purposes of research? Do we need to ask special informed consent for gene studies also in academic research?

15. Some interesting cases Phase II emergency study to treat severe neurotrauma with a new bioactive compound. Initial consent due to lack of abilility and time was obtained from medical doctors. Academic studies to study psychological effects of alcohol. Participants were psychology students, they were compensated with small amount money (15 euros) and they can get credit points for participation.