Terveyden- ja hyvinvoinnin laitos, MERGO -tutkimusryhmän lakimiesjäsen.

Sandra Liede (Osallistuja)

Aktiviteetti: Muiden aktiviteettien tyypitTyypit: Muut aktiviteetit - Muut


Vastuullinen johtaja: tutkimusprofessori, Lääketieteen ja Kirurgian tohtori, Kansanterveystieteen dosentti Elina Hemminki.
Muut jäsenet: Piret Veerus (MD, PhD), Jorma Virtanen (DDS, PhD, adjunct professor).
Rahoitus: Suomen Akatemia.

Clinical research and its governance will be an important health service and research policy question in the future due to the increasing need for evidence in health care decision-making. Furthermore, in the future, it is likely that prior approval by ethics committees will also be required for all social research. The handling of non-medical research by medical ethics committees thus illustrates general problems to be faced in the future control of social research.
The aims of this study are:

to map the present regulation and practices of ethical control of medical (clinical) research in Finland
to provide suggestions for identifying and solving problems in the ethical control of firstly, medical (clinical), and secondly, social and behavioural research.
We want to answer the following questions:
1. What are the official medical research regulators, with the focus on ethics committees and gatekeepers in health service provider organizations in Finland?
2. How does the Finnish system compare with other European countries?
3. What do the official ethics committees do? Two time periods (2002 and 2007) will be compared.
3a. What is the share of drug trials of all clinical research, where and by whom are clinical trials done, who funds them, what is the role of CROs (contract research organizations)?
3b. How are clinical trials processed in ethics committees, what is the role of ethics committees in promoting or hindering clinical trials? How do ethics committees regulate drug trials as compared to other medical research and non-medical research? How do they deal with financial aspects? What is the role of international guidelines, particularly the EU good clinical trials directive which came into force in 2004?
4. How do health service provider organizations regulate research carried out by their staff or among their patients?
5. What are the criteria of the drug control agency (National Agency for Medicines) in regulating research, how are they applied, especially when compared to the rules of clinical care?
6. What types of non-medical projects are submitted to the ethics committees of hospital districts?
What criteria are used in deciding to review or not to review an application and what changes do ethics committees propose propose?

PidettyNational Institute for Health and Welfare (THL), Suomi