title: Principal investigator views of the IRB system.
abstract: We undertook a qualitative e-mail survey of federally-funded principal investigators of their views of the US human subjects protection system, intended to identify the range of investigator attitudes. This was an exploratory study with a 14% response rate. Twenty-eight principal investigators responded; their comments were analyzed to show underlying themes, which are here presented along with supporting quotations.There was consensus that it is important to protect human subjects from research abuse, but disagreement over how well the IRB system is functioning. Some researchers felt that the system is effective and serves its purpose well. Of those who support the system, some endorse its methods, purpose, and daily functioning, as they experience it, without reservation. Others, while expressing some frustration, feel that the purpose is important and their local IRB does its best to make a difficult system work well.Those investigators who were more harshly critical commented on multiple flaws in the system, including (1) consent forms that are inappropriate and incomprehensible, (2) an emphasis on minutiae, and (3) concern with protecting the institution more than research subjects. Respondents told us that the IRB system is a particular burden for research in neurology, emergency medical conditions, repositories, and social sciences in general; a more comprehensive study might identify other problematic areas. Significant concern was expressed about the cost, inefficiency, and irrationality of IRB review. The IRB system works well for some researchers, but our results indicate that other investigators feel the costs outweigh the benefits.
authors.affiliation: Department of Family, Community Medicine, Houston Center for Education, Research on Therapeutics, Baylor College of Medicine, Houston, TX 77098-3926, USA. swhitney@bcm.edu
authors.forename: Simon N
authors.initials: SN
authors.lastname: Whitney
authors.forename: Kirsten
authors.initials: K
authors.lastname: Alcser
authors.forename: Carl
authors.initials: C
authors.lastname: Schneider
authors.forename: Laurence B
authors.initials: LB
authors.lastname: McCullough
authors.forename: Amy L
authors.initials: AL
authors.lastname: McGuire
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Volk
mesh_terms: D001291:Attitude of Health Personnel; D028744:Ethics Committees, Research / Q000331:legislation & jurisprudence*; D006805:Human Experimentation / Q000941:ethics / Q000592:standards*; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence; D009316:National Institutes of Health (U.S.); D012108:Research Personnel / Q000523:psychology*; D035844:Researcher-Subject Relations / Q000941:ethics; D011795:Surveys and Questionnaires; D014481:United States