Current medicolegal and confidentiality issues in large, multicenter research programs

Patricia (Patty) Carney, Berta M. Geller, Howard Moffett, Molly Ganger, Matson Sewell, William E. Barlow, Nancy Stalnaker, Stephen H. Taplin, Cynthia Sisk, Virginia L. Ernster, Heather A. Wilkie, Bonnie Yankaskas, Steven P. Poplack, Nicole Urban, Michele M. West, Robert D. Rosenberg, Sharon Michael, Thomas D. Mercurio, Rachel Ballard-Barbash

Research output: Contribution to journalArticle

68 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)371-378
Number of pages8
JournalAmerican Journal of Epidemiology
Volume152
Issue number4
DOIs
StatePublished - Aug 15 2000
Externally publishedYes

Fingerprint

Confidentiality
Computer Security
Research
Organizational Policy
Information Dissemination
Disclosure
Jurisprudence
Medical Schools
Legislation
Health Personnel
Internet
Biomedical Research
Research Personnel
Guidelines
Breast Neoplasms
Delivery of Health Care

Keywords

  • Confidentiality
  • Legal
  • Liability
  • Privacy

ASJC Scopus subject areas

  • Epidemiology

Cite this

Carney, P. P., Geller, B. M., Moffett, H., Ganger, M., Sewell, M., Barlow, W. E., ... Ballard-Barbash, R. (2000). Current medicolegal and confidentiality issues in large, multicenter research programs. American Journal of Epidemiology, 152(4), 371-378. https://doi.org/10.1093/aje/152.4.371

Current medicolegal and confidentiality issues in large, multicenter research programs. / Carney, Patricia (Patty); Geller, Berta M.; Moffett, Howard; Ganger, Molly; Sewell, Matson; Barlow, William E.; Stalnaker, Nancy; Taplin, Stephen H.; Sisk, Cynthia; Ernster, Virginia L.; Wilkie, Heather A.; Yankaskas, Bonnie; Poplack, Steven P.; Urban, Nicole; West, Michele M.; Rosenberg, Robert D.; Michael, Sharon; Mercurio, Thomas D.; Ballard-Barbash, Rachel.

In: American Journal of Epidemiology, Vol. 152, No. 4, 15.08.2000, p. 371-378.

Research output: Contribution to journalArticle

Carney, PP, Geller, BM, Moffett, H, Ganger, M, Sewell, M, Barlow, WE, Stalnaker, N, Taplin, SH, Sisk, C, Ernster, VL, Wilkie, HA, Yankaskas, B, Poplack, SP, Urban, N, West, MM, Rosenberg, RD, Michael, S, Mercurio, TD & Ballard-Barbash, R 2000, 'Current medicolegal and confidentiality issues in large, multicenter research programs', American Journal of Epidemiology, vol. 152, no. 4, pp. 371-378. https://doi.org/10.1093/aje/152.4.371
Carney, Patricia (Patty) ; Geller, Berta M. ; Moffett, Howard ; Ganger, Molly ; Sewell, Matson ; Barlow, William E. ; Stalnaker, Nancy ; Taplin, Stephen H. ; Sisk, Cynthia ; Ernster, Virginia L. ; Wilkie, Heather A. ; Yankaskas, Bonnie ; Poplack, Steven P. ; Urban, Nicole ; West, Michele M. ; Rosenberg, Robert D. ; Michael, Sharon ; Mercurio, Thomas D. ; Ballard-Barbash, Rachel. / Current medicolegal and confidentiality issues in large, multicenter research programs. In: American Journal of Epidemiology. 2000 ; Vol. 152, No. 4. pp. 371-378.
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