Research-ethical legislation and guidelines

Finnish ethical expert bodies

• National Advisory Board on Research Ethics
• National Advisory Board on Health Care Ethics (ETENE)
• ETENE's Sub-Committee on Medical Research Ethics (TUKIJA)
• Cooperation Group for Laboratory Animal Sciences
• Finnish National Advisory Board on Biotechnology
• Board for Gene Technology

Research-ethical legislation

• Finnish legislation
• Medical Research Act
  - key act on research
  - regulations on e.g. general conditions of the research, research on humans, clinical trials on medicinal products, research involving embryos and foetuses
• decree on clinical trials on medicinal products (in Finnish)
• Act on the Status and Rights of Patients
  - regulations on e.g. the research plan and the supplying of information contained in patient documents
• Act of the Medical Use of Human Organs and Tissues
  - regulations on e.g. research in connection with post-mortem examination and changes in purpose for which tissue samples will be used
• Act on the Use of Laboratory Animals (in Finnish) 
  - regulations on e.g. general conditions of animal testing, supervisory authorities, required permits and research procedures
• Act on the Openness of Government Activities 
  -  regulations on e.g. the openness of official documents, document secrecy and granting access to documents for purposes of research
• Personal Data Act
  - general act on the processing of personal data, with regulations on e.g. prerequisites for processing personal data for purposes of research
• Legal guide on genetic engineering (in Finnish)
  - published by Finnish Bioindustries FIB
  - obligations and regulations in the legislation on genetic engineering

International ethical guides and recommendations

• ETENE's list on national and international actors as well as agreements
• European Commission/bioethics

Ethical rules in FP7   

• participants in FP projects must first of all conform to current ethical legislation and regulations in the countries where the research will be carried out, but they must also conform to relevant EU legislation
• European Union law
• Convention on Human Rights and Biomedicine (164)
• Additional protocol with regard to the prohibition of cloning human beings (168)
• World Medical Association/Declaration of Helsinki
  - not legally binding
  - declaration of principle on medical research involving human subjects
• WHO: Operational Guidelines for Ethics Committees That Review Biomedical Research (2000)