American Journal of Epidemiology Vol. 152, No. 4 : 371-378
Copyright © 2000 by The Johns Hopkins University School of Hygiene and Public Health
ORIGINAL CONTRIBUTIONS |
Current Medicolegal and Confidentiality Issues in Large, Multicenter Research Programs
1 Norris Cotton Cancer Center/Dartmouth-Hitchcock Medical Center/Department of Community and Family Medicine, Dartmouth Medical School, Hanover/Lebanon, NH.
2 Office of Health Promotion Research, University of Vermont, College of Medicine, Burlington, VT.
3 Orr and Reno, Professional Association, Concord, NH.
4 Center for Health Studies, Group Health Cooperative of Puget Sound, Seattle, WA.
5 Office of Sponsored Programs, University of Vermont, Burlington, VT.
6 Department of Epidemiology and Biostatistics, University of California, San Francisco, CA.
7 Department of Radiology, University of North Carolina at Chapel Hill, Chapel Hill, NC.
8 Fred Hutchinson Cancer Research Center, Seattle, WA.
9 Department of Preventive Medicine, University of Iowa College of Medicine, Iowa City, IA.
10 Department of Radiology, University of New Mexico, Albuquerque, NM.
11 Cancer Prevention and Control Program, Colorado Department of Public Health and Environment, Denver, CO.
12 General Counsel, University of Vermont, Burlington, VT.
13 Applied Research Branch, Cancer Control Program, National Cancer Institute, Bethesda, MD.
The convenience of fast computers and the Internet have encouraged large collaborative research efforts by allowing transfers of data from multiple sites to a single data repository; however, standards for managing data security are needed to protect the confidentiality of participants. Through Dartmouth Medical School, in 1996–1998, the authors conducted a medicolegal analysis of federal laws, state statutes, and institutional policies in eight states and three different types of health care settings, which are part of a breast cancer surveillance consortium contributing data electronically to a centralized data repository. They learned that a variety of state and federal laws are available to protect confidentiality of professional and lay research participants. The strongest protection available is the Federal Certificate of Confidentiality, which supersedes state statutory protection, has been tested in court, and extends protection from forced disclosure (in litigation) to health care providers as well as patients. This paper describes the careful planning necessary to ensure adequate legal protection and data security, which must include a comprehensive understanding of state and federal protections applicable to medical research. Researchers must also develop rules or guidelines to ensure appropriate collection, use, and sharing of data. Finally, systems for the storage of both paper and electronic records must be as secure as possible. Am J Epidemiol 2000;152:371–8.
confidentiality; liability; legal; privacy
Abbreviations: IRB, institutional review board; NCI, National Cancer Institute; QA, quality assurance.
CiteULike 
Connotea 
Del.icio.us What's this?
This article has been cited by other articles:
|
|
 |
|
  M. J. Schell, B. C. Yankaskas, R. Ballard-Barbash, B. F. Qaqish, W. E. Barlow, R. D. Rosenberg, and R. Smith-Bindman Evidence-based Target Recall Rates for Screening Mammography Radiology, June 1, 2007; 243(3): 681 - 689. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 P. A. Carney, L. A. Abraham, D. L. Miglioretti, K. R. Yabroff, E. A. Sickles, D. S. M. Buist, C. J. Kasales, B. M. Geller, R. D. Rosenberg, M. B. Dignan, et al. Factors Associated with Imaging and Procedural Events Used to Detect Breast Cancer After Screening Mammography Am. J. Roentgenol., February 1, 2007; 188(2): 385 - 392. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
R. D. Rosenberg, B. C. Yankaskas, L. A. Abraham, E. A. Sickles, C. D. Lehman, B. M. Geller, P. A. Carney, K. Kerlikowske, D. S. M. Buist, D. L. Weaver, et al. Performance Benchmarks for Screening Mammography Radiology, October 1, 2006; 241(1): 55 - 66. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
B. M. Geller, L. E. Ichikawa, D. S. M. Buist, E. A. Sickles, P. A. Carney, B. C. Yankaskas, M. Dignan, K. Kerlikowske, K. R. Yabroff, W. Barlow, et al. Improving the Concordance of Mammography Assessment and Management Recommendations Radiology, October 1, 2006; 241(1): 67 - 75. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 W. E. Barlow, E. White, R. Ballard-Barbash, P. M. Vacek, L. Titus-Ernstoff, P. A. Carney, J. A. Tice, D. S. M. Buist, B. M. Geller, R. Rosenberg, et al. Prospective breast cancer risk prediction model for women undergoing screening mammography. J Natl Cancer Inst, September 6, 2006; 98(17): 1204 - 1214. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 E. H. Wagner, S. M. Greene, G. Hart, T. S. Field, S. Fletcher, A. M. Geiger, L. J. Herrinton, M. C. Hornbrook, C. C. Johnson, J. Mouchawar, et al. Building a Research Consortium of Large Health Systems: The Cancer Research Network J Natl Cancer Inst Monographs, November 1, 2005; 2005(35): 3 - 11. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
E. A. Sickles, D. L. Miglioretti, R. Ballard-Barbash, B. M. Geller, J. W. T. Leung, R. D. Rosenberg, R. Smith-Bindman, and B. C. Yankaskas Performance Benchmarks for Diagnostic Mammography Radiology, June 1, 2005; 235(3): 775 - 790. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
B. C. Yankaskas, S. H. Taplin, L. Ichikawa, B. M. Geller, R. D. Rosenberg, P. A. Carney, K. Kerlikowske, R. Ballard-Barbash, G. R. Cutter, and W. E. Barlow Association between Mammography Timing and Measures of Screening Performance in the United States Radiology, February 1, 2005; 234(2): 363 - 373. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 P. A. Carney, J. G. Elmore, L. A. Abraham, M. S. Gerrity, R. E. Hendrick, S. H. Taplin, W. E. Barlow, G. R. Cutter, S. P. Poplack, and C. J. D'Orsi Radiologist Uncertainty and the Interpretation of Screening Med Decis Making, June 1, 2004; 24(3): 255 - 264. [Abstract] [PDF]
|
|
|
|
 |
|
 P. A. Carney, D. L. Miglioretti, B. C. Yankaskas, K. Kerlikowske, R. Rosenberg, C. M. Rutter, B. M. Geller, L. A. Abraham, S. H. Taplin, M. Dignan, et al. Individual and Combined Effects of Age, Breast Density, and Hormone Replacement Therapy Use on the Accuracy of Screening Mammography Ann Intern Med, February 4, 2003; 138(3): 168 - 175. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
V. L. Ernster, R. Ballard-Barbash, W. E. Barlow, Y. Zheng, D. L. Weaver, G. Cutter, B. C. Yankaskas, R. Rosenberg, P. A. Carney, K. Kerlikowske, et al. Detection of Ductal Carcinoma In Situ in Women Undergoing Screening Mammography J Natl Cancer Inst, October 16, 2002; 94(20): 1546 - 1554. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
W. E. Barlow, C. D. Lehman, Y. Zheng, R. Ballard-Barbash, B. C. Yankaskas, G. R. Cutter, P. A. Carney, B. M. Geller, R. Rosenberg, K. Kerlikowske, et al. Performance of Diagnostic Mammography for Women With Signs or Symptoms of Breast Cancer J Natl Cancer Inst, August 7, 2002; 94(15): 1151 - 1159. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
B. M. Geller, W. E. Barlow, R. Ballard-Barbash, V. L. Ernster, B. C. Yankaskas, E. A. Sickles, P. A. Carney, M. B. Dignan, R. D. Rosenberg, N. Urban, et al. Use of the American College of Radiology BI-RADS to Report on the Mammographic Evaluation of Women with Signs and Symptoms of Breast Disease Radiology, February 1, 2002; 222(2): 536 - 542. [Abstract] [Full Text] [PDF]
|
|