title: Ethical aspects in tissue research: thematic analysis of ethical statements to the research ethics committee.
abstract: BACKGROUND
  Many studies have been published about ethics committees and the clarifications requested about the submitted applications. In Finland, ethics committees require a separate statement on ethical aspects of the research in applications to the ethics committee. However, little is known about how researchers consider the ethical aspects of their own studies.
  
  
  METHODS
  The data were collected from all the applications received by the official regional ethics committee in the Hospital District of Northern Savo during 2004-2009 (n = 688). These included a total of 56 studies involving research on tissue other than blood. The statements by the researchers about the ethics about their own research in these applications were analyzed by thematic content analysis under the following themes: recruitment, informed consent, risks and benefits, confidentiality and societal meaning.
  
  
  RESULTS
  The researchers tended to describe recruitment and informed consent process very briefly. Usually these descriptions simply stated who the recruiter was and that written consent would be required. There was little information provided on the recruitment situation and on how the study recruiters would be informed. Although most of the studies were clinical, the possibility was hardly ever discussed that patients could fail to distinguish between care and research.
  
  
  CONCLUSIONS
  The written guidelines, available on the webpages of the ethics committee, do not seem to be enough to help researchers achieve this goal. In addition to detailed guidelines for researchers, investigators need to be taught to appreciate the ethical aspects in their own studies.
authors.affiliation: Faculty of Health Sciences, University of Eastern Finland, Research Unit/Research Ethics Committee, University Hospital of Kuopio, PO Box 1777, 70210 , Kuopio, Finland. arja.halkoaho@kuh.fi
authors.forename: Arja
authors.initials: A
authors.lastname: Halkoaho
authors.forename: Anna-Maija
authors.initials: AM
authors.lastname: Pietilä
authors.forename: Mari
authors.initials: M
authors.lastname: Vesalainen
authors.forename: Kirsi
authors.initials: K
authors.lastname: Vähäkangas
mesh_terms: D002986:Clinical Trials as Topic / Q000941:ethics; D003219:Confidentiality / Q000941:ethics*; D028744:Ethics Committees, Research; D032984:Ethics, Research; D005387:Finland; D006805:Human Experimentation / Q000941:ethics*; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D018579:Patient Selection / Q000941:ethics; D012107:Research Design