title: Access to death certificates: what should research ethics committees require for approval?
abstract: OBJECTIVE
  To present and discuss the reactions of research ethics committees (RECs) in a number of countries when asked for approval of a study requiring access to death certificates to identify the physicians signing the certificates and to send them a four-page questionnaire about medical decisions made at the patient's end-of-life that could possibly have hastened death.
  
  
  METHODS
  A simple questionnaire were sent to the responsible national investigator in an international study (Australia, Belgium, Denmark, Italy, the Netherlands, Sweden, Switzerland) asking about the interactions between the national research group and the national/regional REC(s).
  
  
  RESULTS
  Different laws or guidelines were used by the RECs. Denmark, the Netherlands, and Switzerland did not require an application to a REC. In Australia and Sweden, the RECs wanted changes in the research protocol, and one national research group had to refrain from publishing its results because the attrition rate became too high, probably due to the required changes in the protocol.
  
  
  CONCLUSIONS
  Generally, similar demands from all RECs in relation to one project are strongly desirable. In epidemiological research, in which voluntary completion of an anonymous questionnaire demonstrates consent, additional prior informed consent about being approached should not be required.
authors.affiliation: Lund University, Department of Medical Ethics, Sweden. Tore.Nilstun@med.lu.se
authors.forename: Tore
authors.initials: T
authors.lastname: Nilstun
authors.forename: Colleen
authors.initials: C
authors.lastname: Cartwright
authors.forename: Rurik
authors.initials: R
authors.lastname: Löfmark
authors.forename: Luc
authors.initials: L
authors.lastname: Deliens
authors.forename: Susanne
authors.initials: S
authors.lastname: Fischer
authors.forename: Guido
authors.initials: G
authors.lastname: Miccinesi
authors.forename: Michael
authors.initials: M
authors.lastname: Norup
authors.forename: Agnes
authors.initials: A
authors.lastname: Van Der Heide
mesh_terms: D003644:Death Certificates / Q000331:legislation & jurisprudence; D003657:Decision Making; D028744:Ethics Committees, Research / Q000331:legislation & jurisprudence / Q000592:standards; D005060:Europe; D006801:Humans; D007258:Informed Consent; D010820:Physicians; D011795:Surveys and Questionnaires