title: The Impact of Institutional Review Boards (IRBs) on Clinical Innovation: A Survey of Investigators and IRB Members.
abstract: We conducted a survey to assess the perspectives of principal investigators and Institutional Review Board (IRB) members on the impact of the IRB structure on the conduct of research and innovative therapy, defined as a nonstandard treatment intended to enhance the well-being of an individual patient. Although investigators and IRB members agreed that the IRB provides adequate protection to study subjects (97% vs. 100%) and an ethically insightful review (88% vs. 100%), a third of clinical investigators felt that the IRB review process limits clinical innovation, in comparison with only 4% of IRB representatives. Limitations of the current IRB review process were explored. We propose several measures to improve the IRB review process while maintaining the protection of human research subjects, including the use of centralized IRBs, the opening of IRB meetings to investigators, the development of metrics and outcome measures for the IRB, and the promotion of guidelines that distinguish research and innovative therapy.
authors.affiliation: Massachusetts Eye and Ear Infirmary, Boston, USA Harvard Medical School, Boston, MA, USA.
authors.forename: Tomasz P
authors.initials: TP
authors.lastname: Stryjewski
authors.affiliation: Harvard Medical School, Boston, MA, USA Boston Children's Hospital, MA, USA.
authors.forename: Brian T
authors.initials: BT
authors.lastname: Kalish
authors.affiliation: Harvard Medical School, Boston, MA, USA McLean Hospital, Boston, MA, USA.
authors.forename: Benjamin
authors.initials: B
authors.lastname: Silverman
authors.affiliation: Harvard Medical School, Boston, MA, USA Brigham and Women's Hospital, Boston, MA, USA llehmann1@partners.org.
authors.forename: Lisa Soleymani
authors.initials: LS
authors.lastname: Lehmann
mesh_terms: D001290:Attitude; D035843:Biomedical Research / Q000941:ethics*; D026724:Ethical Review; D028744:Ethics Committees, Research; D006801:Humans; D012108:Research Personnel; D011795:Surveys and Questionnaires; D035703:Therapies, Investigational / Q000941:ethics*
keywords: IRB; compliance; human subjects; investigator; multisite; protection