Legislations
- Law No. 460 on the Ethical Review of Research Involving Humans (2003)
- Pharmaceuticals Act No. 1992: 859 (Swedish)
- Personal Data Act No. 204 (2002)
Regulations
CEPN:
- Ordinance No. 615 Concerning the Ethical Vetting of Research Involving Humans (2003)
- Statute No. 616 Containing Instructions for Regional Ethical Review Boards (2003)
- Statute No. 617 Containing Instructions for the Central Ethical Review Boards (2003)
Medical Products Agency
- Medical Products Agency’s Provisions and Guidelines on the Clinical Trials of Medicinal Products (1999)
- Medical Product Agency’s Provisions and Guidelines on Clinical Trials of Medicinal Products for Human Use, Code of Statutes No. 6 (2003)
Guidelines
CEPN:
- Information for Research Participants
SRC:
- Ethical Guidelines of Epidemiological Research (1994)
- Guidelines for Good Medical Research (1996)
- Guidelines for the Ethical Evaluation of Medical Research on Humans (2003)
- Policy Statement Regarding the Assessment of Scientific Studies in which Patients or Healthy Subjects are to Undergo Invasive Operations (2003)
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