title: Journalists, district attorneys and researchers: why IRBs should get in the middle.
abstract: BACKGROUND
  Federal regulations in the United States have shaped Institutional Review Boards (IRBs) to focus on protecting individual human subjects. Health services research studies focusing on healthcare institutions such as hospitals or clinics do not have individual human subjects. Since U.S. federal regulations are silent on what type of review, if any, these studies require, different IRBs may approach similar studies differently, resulting in undesirable variation in the review of studies focusing on healthcare institutions. Further, although these studies do not focus on individual human subjects, they may pose risks to participating institutions, as well as individuals who work at those institutions, if identifying information becomes public.
  
  
  CONCLUSIONS
  Using two recent health services research studies conducted in the U.S. as examples, we discuss variations in the level of IRB oversight for studies focusing on institutions rather than individual human subjects. We highlight how lack of IRB guidance poses challenges for researchers who wish to both protect their subjects and work appropriately with the public, journalists or the legal system in the U.S. Competing interests include the public's interest in transparency, the researcher's interest in their science, and the research participants' interests in confidentiality. Potential solutions that may help guide health services researchers to balance these competing interests include: 1) creating consensus guidelines and standard practices that address confidentiality risk to healthcare institutions and their employees; and 2) expanding the IRB role to conduct a streamlined review of health services research studies focusing on healthcare institutions to balance the competing interest of stakeholders on a case-by-case basis.
  
  
  CONCLUSIONS
  For health services research studies focusing on healthcare institutions, we outline the competing interests of researchers, healthcare institutions and the public. We propose solutions to decrease undesirable variations in the review of these studies.
authors.affiliation: Division of General Internal Medicine, San Francisco General Hospital, Department of Medicine, University of California, San Francisco 1001 Potrero Avenue, San Francisco, CA, USA. anna.chodos@ucsf.edu.|Division of Geriatrics, University of California and San Francisco VA Medical Center, 4150 Clement Street, San Francisco, CA, USA. anna.chodos@ucsf.edu.
authors.forename: Anna H
authors.initials: AH
authors.lastname: Chodos
authors.affiliation: Division of Geriatrics, University of California and San Francisco VA Medical Center, 4150 Clement Street, San Francisco, CA, USA. sei.lee@ucsf.edu.
authors.forename: Sei J
authors.initials: SJ
authors.lastname: Lee
mesh_terms: D003219:Confidentiality; D016265:Conflict of Interest; D003695:Delivery of Health Care; D030881:Disclosure; D026724:Ethical Review; D028744:Ethics Committees, Research; D033161:Government Regulation; D006268:Health Facilities; D006296:Health Services; D006302:Health Services Research / Q000941:ethics* / Q000331:legislation & jurisprudence; D006801:Humans; D007258:Informed Consent; D033241:Lawyers; D008402:Mass Media; D009938:Organizations; D012108:Research Personnel; D012586:Science; D014481:United States