title: Rational protection of subjects in research and quality improvement activities.
abstract: This Open Forum illuminates shortcomings with the basis for determining degree of oversight of health services research and quality improvement activities. Using a federally regulated definition of research rather than a direct appraisal of risk to patients can misallocate effort from activities with higher risk for patients to those with lower risk. The case of the Johns Hopkins multicenter study of central line safety checklists in intensive care units is cited. Definitions of research promulgated by the Office of Human Research Protection are reviewed, and an alternative model based on patient risk is proposed. Suggestions for how quality improvement work fits into the larger paradigm of research are made.
authors.affiliation: Blue Cross Blue Shield of Michigan, Detroit, USA. bgold0914@comcast.net
authors.forename: Beth
authors.initials: B
authors.lastname: Goldman
authors.forename: Lisa B
authors.initials: LB
authors.lastname: Dixon
authors.forename: David A
authors.initials: DA
authors.lastname: Adler
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Berlant
authors.forename: Rebecca A
authors.initials: RA
authors.lastname: Dulit
authors.forename: Ann
authors.initials: A
authors.lastname: Hackman
authors.forename: David W
authors.initials: DW
authors.lastname: Oslin
authors.forename: Samuel G
authors.initials: SG
authors.lastname: Siris
authors.forename: Marcia
authors.initials: M
authors.lastname: Valenstein
mesh_terms: D000046:Academic Medical Centers; D026661:Clinical Trials Data Monitoring Committees; D006302:Health Services Research / Q000331:legislation & jurisprudence*; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence*; D015337:Multicenter Studies as Topic; D018579:Patient Selection; D011785:Quality Assurance, Health Care / Q000331:legislation & jurisprudence*; D018570:Risk Assessment / Q000331:legislation & jurisprudence; D017751:Safety Management / Q000331:legislation & jurisprudence*; D036302:Therapeutic Human Experimentation / Q000331:legislation & jurisprudence*