Journal article
Current Medicolegal and Confidentiality Issues in Large, Multicenter Research Programs
American journal of epidemiology, Vol.152(4), pp.371-378
08/15/2000
DOI: 10.1093/aje/152.4.371
PMID: 10968382
Abstract
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.
Details
- Title: Subtitle
- Current Medicolegal and Confidentiality Issues in Large, Multicenter Research Programs
- Creators
- Patricia A. Carney - Dartmouth CollegeBerta M. Geller - University of VermontHoward Moffett - Orr and RenoMolly Ganger - Orr and RenoMatson Sewell - Dartmouth CollegeWilliam E. Barlow - Group Health CooperativeNancy Stalnaker - University of VermontStephen H. Taplin - Group Health CooperativeCynthia Sisk - Group Health CooperativeVirginia L. Ernster - University of California, San FranciscoHeather A. Wilkie - University of California, San FranciscoBonnie Yankaskas - University of North Carolina at Chapel HillSteven P. Poplack - Dartmouth CollegeNicole Urban - Fred Hutch Cancer CenterMichele M. West - University of IowaRobert D. Rosenberg - University of New MexicoSharon Michael - Colorado Department of Public Health and EnvironmentThomas D. Mercurio - University of VermontRachel Ballard-Barbash - National Institutes of Health
- Resource Type
- Journal article
- Publication Details
- American journal of epidemiology, Vol.152(4), pp.371-378
- Publisher
- Oxford University Press
- DOI
- 10.1093/aje/152.4.371
- PMID
- 10968382
- ISSN
- 0002-9262
- eISSN
- 1476-6256
- Language
- English
- Date published
- 08/15/2000
- Academic Unit
- Epidemiology
- Record Identifier
- 9984368212202771
Metrics
3 Record Views