title: Informed consent in clinical research: Consensus recommendations for reform identified by an expert interview panel.
abstract: BACKGROUND
  Informed consent is the cornerstone for protection of human subjects in clinical trials. However, a growing body of evidence suggests that reform of the informed consent process in the United States is needed.
  
  
  METHODS
  The Clinical Trials Transformation Initiative conducted interviews with 25 experienced observers of the informed consent process to identify limitations and actionable recommendations for change.
  
  
  RESULTS
  There was broad consensus that current practices often fail to meet the ethical obligation to inform potential research participants during the informed consent process. The most frequent single recommendation, which would affect all participants in federally regulated clinical research, was reform of the informed consent document. The interviews also identified the need for reform of clinical research review by institutional review boards, including transitioning to a single institutional review board for multi-site trials.
  
  
  CONCLUSIONS
  The consensus recommendations from the interviewees provide a framework for meaningful change in the informed consent process. Although some proposed changes are feasible for rapid implementation, others such as substantive reform of the informed consent document may require change in federal regulations.
authors.affiliation: FDA & Life Sciences Group, King & Spalding LLP, Washington, DC, USA blorell@kslaw.com.
authors.forename: Beverly H
authors.initials: BH
authors.lastname: Lorell
authors.affiliation: Patient Representative, Clinical Trials Transformation Initiative (CTTI), Salt Lake City, UT, USA.
authors.forename: J Stephen
authors.initials: JS
authors.lastname: Mikita
authors.affiliation: The Center for Information and Study on Clinical Research Participation (CISCRP), Boston, MA, USA.
authors.forename: Annick
authors.initials: A
authors.lastname: Anderson
authors.affiliation: The Center for Information and Study on Clinical Research Participation (CISCRP), Boston, MA, USA.
authors.forename: Zachary P
authors.initials: ZP
authors.lastname: Hallinan
authors.affiliation: Clinical Trials Transformation Initiative (CTTI), Durham, NC, USA.
authors.forename: Annemarie
authors.initials: A
authors.lastname: Forrest
mesh_terms: D026683:Advisory Committees; D035843:Biomedical Research / Q000941:ethics*; D032921:Consensus; D006801:Humans; D007258:Informed Consent / Q000941:ethics / Q000592:standards*; D007407:Interviews as Topic; D036301:Qualitative Research; D014481:United States
keywords: Informed consent; clinical research; decision-making; health policy; institutional review board; research ethics