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

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 biosp...

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Bibliographic Details
Published in:Western Journal of Nursing Research 2022-11, Vol.44 (11), p.1068-1081
Main Authors: Umberfield, Elizabeth E., Kardia, Sharon L. R., Jiang, Yun, Thomer, Andrea K., Harris, Marcelline R.
Format: Article
Language:English
Subjects:
Confidentiality
Data collection
Data integrity
Health information
Humans
Informed Consent
Privacy
Regulation
Regulatory agencies
Reuse
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Summary: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.
ISSN:0193-9459
1552-8456
1552-8456
DOI:10.1177/01939459211029296