@article{ref1,
title="The experience of accommodating privacy restrictions during implementation of a large-scale surveillance study of an osteoporosis medication",
journal="Pharmacoepidemiology and drug safety",
year="2016",
author="Midkiff, Kirk D. and Andrews, Elizabeth B. and Gilsenan, Alicia W. and Deapen, Dennis M. and Harris, David H. and Schymura, Maria J. and Hornicek, Francis J.",
volume="25",
number="8",
pages="960-968",
abstract="PURPOSE: To explore whether privacy restrictions developed to protect patients have complicated research within a 15-year surveillance study conducted with US cancer registries. <br><br>METHODS: 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. <br><br>RESULTS: 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. <br><br>CONCLUSIONS: 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.<br><br>© 2016 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons Ltd.<p /> <p>Language: en</p>",
language="en",
issn="1053-8569",
doi="10.1002/pds.4008",
url="http://dx.doi.org/10.1002/pds.4008"
}