title: The experience of accommodating privacy restrictions during implementation of a large-scale surveillance study of an osteoporosis medication.
abstract: To explore whether privacy restrictions developed to protect patients have complicated research within a 15-year surveillance study conducted with US cancer registries.
  
  
  
  Data from enrolling 27 cancer registries over a 10-year period were examined to describe the amount of time needed to obtain study approval. We also analyzed the proportion of patients that completed a research interview out of the total reported by the registries and examined factors thought to influence this measure.
  
  
  
  The average length of the research review process from submission to approval of the research was 7 months (range, <1 to 24 months), and it took 6 months or more to obtain approval of the research at 41% of the cancer registries. Most registries (78%) required additional permission steps to gain access to patients for research. After adjustment for covariates, the interview response proportion was 110% greater (ratio of response proportion = 2.1; 95% confidence interval: 1.3, 3.3) when the least restrictive versus the most restrictive permission steps were required. An interview was more often completed for patients (or proxies) if patients were alive, within a year of being diagnosed, or identified earlier in the study.
  
  
  
  Lengthy research review processes increased the time between diagnosis and provision of patient information to the researcher. Requiring physician permission for access to patients was associated with lower subject participation. A single national point of entry for use of cancer registry data in health research is worthy of consideration to make the research approval process efficient. © 2016 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons Ltd.
authors.affiliation: Department of Pharmacoepidemiology and Risk Management, RTI Health Solutions, RTI International, Research Triangle Park, NC, USA.
authors.forename: Kirk D
authors.initials: KD
authors.lastname: Midkiff
authors.affiliation: Department of Pharmacoepidemiology and Risk Management, RTI Health Solutions, RTI International, Research Triangle Park, NC, USA.
authors.forename: Elizabeth B
authors.initials: EB
authors.lastname: Andrews
authors.affiliation: Department of Pharmacoepidemiology and Risk Management, RTI Health Solutions, RTI International, Research Triangle Park, NC, USA.
authors.forename: Alicia W
authors.initials: AW
authors.lastname: Gilsenan
authors.affiliation: Los Angeles Cancer Surveillance Program, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.
authors.forename: Dennis M
authors.initials: DM
authors.lastname: Deapen
authors.affiliation: Department of Pharmacoepidemiology and Risk Management, RTI Health Solutions, RTI International, Research Triangle Park, NC, USA.
authors.forename: David H
authors.initials: DH
authors.lastname: Harris
authors.affiliation: New York State Cancer Registry, New York State Department of Health, Albany, NY, USA.
authors.forename: Maria J
authors.initials: MJ
authors.lastname: Schymura
authors.affiliation: Center for Sarcoma and Connective Tissue Oncology, Massachusetts General Hospital, Boston, MA, USA.
authors.forename: Francis J
authors.initials: FJ
authors.lastname: Hornicek
mesh_terms: D000328:Adult; D000368:Aged; D050071:Bone Density Conservation Agents / Q000008:administration & dosage / Q000009:adverse effects*; D005260:Female; D006801:Humans; D007407:Interviews as Topic; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy*; D010024:Osteoporosis / Q000188:drug therapy; D018907:Privacy / Q000331:legislation & jurisprudence*; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D012042:Registries; D019379:Teriparatide / Q000008:administration & dosage / Q000009:adverse effects; D013997:Time Factors; D014481:United States
chemical_list: D050071:Bone Density Conservation Agents; D019379:Teriparatide
keywords: epidemiology; oncology; pharmacoepidemiology; postmarketing product surveillance; privacy; public health; retrospective studies; survey