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Umberfield EE, Kardia SLR, Jiang Y, et al. Regulations and Norms for Reuse of Residual Clinical Biospecimens and Health Data. West J Nurs Res. 2021;1939459211029296doi: 10.1177/01939459211029296.
Umberfield, E. E., Kardia, S. L. R., Jiang, Y., Thomer, A. K., & Harris, M. R. (2021). Regulations and Norms for Reuse of Residual Clinical Biospecimens and Health Data. Western journal of nursing research, 1939459211029296. https://doi.org/10.1177/01939459211029296
Umberfield, Elizabeth E, et al. "Regulations and Norms for Reuse of Residual Clinical Biospecimens and Health Data." Western journal of nursing research vol. (2021): 1939459211029296. doi: https://doi.org/10.1177/01939459211029296
Umberfield EE, Kardia SLR, Jiang Y, Thomer AK, Harris MR. Regulations and Norms for Reuse of Residual Clinical Biospecimens and Health Data. West J Nurs Res. 2021 Jul 08;1939459211029296. doi: 10.1177/01939459211029296. Epub 2021 Jul 08. PMID: 34238076.
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West J Nurs Res. 2021 Jul 08;1939459211029296. doi: 10.1177/01939459211029296. Epub 2021 Jul 08.

Regulations and Norms for Reuse of Residual Clinical Biospecimens and Health Data.

Western journal of nursing research

Elizabeth E Umberfield, Sharon L R Kardia, Yun Jiang, Andrea K Thomer, Marcelline R Harris

Affiliations

  1. Department of Health Policy & Management, Richard M Fairbanks School of Public Health, Indiana University, Indianapolis, IN, USA.
  2. Regenstrief Institute Inc., Center for Biomedical Informatics, Indianapolis, IN, USA.
  3. University of Michigan School of Public Health, Epidemiology, Ann Arbor, MI, USA.
  4. Department of Systems, Populations and Leadership, University of Michigan School of Nursing, Ann Arbor, MI, USA.
  5. University of Michigan School of Information, Ann Arbor, MI, USA.

PMID: 34238076 DOI: 10.1177/01939459211029296

Abstract

Nurse scientists are increasingly interested in conducting secondary research using real world collections of biospecimens and health data. The purposes of this scoping review are to (a) identify federal regulations and norms that bear authority or give guidance over reuse of residual clinical biospecimens and health data, (b) summarize domain experts' interpretations of permissions of such reuse, and (c) summarize key issues for interpreting regulations and norms. Final analysis included 25 manuscripts and 23 regulations and norms. This review illustrates contextual complexity for reusing residual clinical biospecimens and health data, and explores issues such as privacy, confidentiality, and deriving genetic information from biospecimens. Inconsistencies make it difficult to interpret, which regulations or norms apply, or if applicable regulations or norms are congruent. Tools are necessary to support consistent, expert-informed consent processes and downstream reuse of residual clinical biospecimens and health data by nurse scientists.

Keywords: biospecimen research; data sharing and reuse; health data; nursing research; residual clinical biospecimens

Publication Types

Grant support