title: Assessment by human research ethics committees of potential conflicts of interest arising from pharmaceutical sponsorship of clinical research.
abstract: BACKGROUND
  Conflicts of interest arising from pharmaceutical industry sponsorship of clinical research have the potential to bias research outcomes and ultimately prejudice patient care. It is unknown how Australian Human Research Ethics Committees (HREC) assess and manage such conflicts of interest. We aimed to gain an understanding of how HREC approach the problem of potential conflicts of interest arising from pharmaceutical sponsorship of clinical research.
  
  
  METHODS
  We conducted a survey of HREC chairpersons in New South Wales.
  
  
  RESULTS
  HREC vary widely in their approaches to conflicts of interest, including in their use of National Health and Medical Research Council guidelines, which were often misinterpreted or overlooked. Many committees rely primarily on researchers disclosing potential conflicts of interest, whereas a majority of HREC use disclosure to research participants as the primary tool for preventing and managing conflicts of interest. Almost no HREC place limitations on researcher relationships with pharmaceutical companies.
  
  
  CONCLUSIONS
  These findings suggest reluctance on the part of HREC to regulate many potential conflicts of interest between researchers and pharmaceutical sponsors, which may arise from uncertainty regarding the meaning or significance of conflicts of interest in research, from ambiguity surrounding the role of HREC in assessing and managing conflicts of interest in research or from misinterpretation or ignorance of current National Health and Medical Research Council guidelines. Further review of policies and practices in this important area may prove beneficial in safeguarding clinical research and patient care while promoting continuing constructive engagement with the pharmaceutical industry.
authors.affiliation: Centre for Values Ethics and the Law in Medicine, University of Sydney, Sydney, New South Wales, Australia. jnewcomb@med.usyd.edu.au
authors.forename: J P
authors.initials: JP
authors.lastname: Newcombe
authors.forename: I H
authors.initials: IH
authors.lastname: Kerridge
mesh_terms: D002986:Clinical Trials as Topic / Q000191:economics / Q000941:ethics*; D016265:Conflict of Interest; D003625:Data Collection; D030881:Disclosure / Q000941:ethics; D004345:Drug Industry / Q000941:ethics; D028744:Ethics Committees, Research / Q000458:organization & administration; D017408:Guidelines as Topic; D006805:Human Experimentation / Q000941:ethics; D009517:New South Wales; D012108:Research Personnel / Q000941:ethics; D012109:Research Support as Topic / Q000941:ethics*