Use of human specimens in research: the evolving United States regulatory, policy, and scientific landscape
Open accessAbstract
The use of human specimens in research has contributed to significant scientific and medical advancements. However, the development of sophisticated whole genome and informatics technologies and the increase in specimen and data sharing have raised new questions about the identifiability of specimens and the protection of participants in human specimen research. In the US, new regulations and policies are being considered to address these changes. This review discusses the current and proposed regulations as they apply to specimen research, as well as relevant policy discussions. It summarizes the ways that researchers and other stakeholders can provide their input to these discussions and policy development efforts. Input from all the stakeholders in specimen research will be essential for the development of policies that facilitate such research while at the same time protecting the rights and welfare of research participants.
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Human biospecimens have played a crucial role in scientific and medical advances, and their continued widespread availability for research is vital to realizing the goals of precision medicine.
“Human biospecimens have played a crucial role in scientific and medical advances.”
From Lessons from HeLa Cells: The Ethics and Policy of Biospecimens (2016) · cites this paper as [13]
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Ethical Practices: Institutional Oversight and Enforcement
Dziegielewski, S. (2015) · doi:10.1016/b978-0-08-097086-8.11014-1
- Authors
- Bledsoe, M. J., & Grizzle, W. E.
- Affiliations
- University of Alabama at Birmingham (US)
- ORCID
- Grizzle, William E.
- Venue
- Diagnostic Histopathology
- Publisher
- Elsevier BV
- Published
- 2013-09
- Volume
- 19
- Issue
- 9
- Pages
- 322-330
- ISSN
- 1876-7621 (ISSN-L)
- 1756-2317
- PMC
- PMC3954467
- OpenAlex
- W2064667208
- Cited by
- 39
- References
- 72
- Citations by year
- 2026: 1 · 2025: 4 · 2023: 9 · 2022: 5 · 2021: 3 · 2020: 3 · 2019: 3 · 2018: 3 · 2017: 4 · 2016: 2 · 2015: 2
- FWCI
- 1.36
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Diagnostic histopathology (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- Cardiovascular Medical Research and Education Fund
- National Cancer Institute (P20CA101955, P50CA101955, U01CA044968, P50CA089019, U54CA118623, P30CA013148, U54CA118948)
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (P30AR050948)
- National Institute on Minority Health and Health Disparities (G12MD007585)
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Health Sciences › Medicine › Physiology › Biomedical Ethics and Regulation
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics and bioethics in healthcare
- Keywords
- human specimens, research regulation, science policy, research participant protection, identifiability, whole genome sequencing, research ethics, stakeholder feedback, United States
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