Resources: Biospecimen Research
On January 19, 2017, federal regulators published the Final Rule to amend and update the Federal Policy for the Protection of Human Subjects (“the Common Rule”). Key provisions govern research with identifiable private information, identifiable biospecimens, broad consent, new exemption categories, and single IRB review of multi-site research.
HHS Announces Proposal to Improve Rules Protecting Human Research Subjects
Changes proposed to ensure the highest standards of protections for human subjects involved in research, while enhancing effectiveness of oversight
The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies have announced proposed revisions to the regulations for protection of human subjects in research. A Notice of Proposed Rulemaking (NPRM) was published in the Federal Register on September 8, 2015. The NPRM seeks comment on proposals to better…
Many important advances in human health depend on the effective collection, storage, use, and sharing of biological specimens and their associated data. However, recent controversies involving specimen-based research have raised important questions about ownership, data-sharing, privacy considerations, group harms, and standards for responsible specimen stewardship.
This November 2016 symposium addressed key…
A survey of many of the recent legal developments related to biospecimens, including research regulation, state developments, and proposed amendments to HIPAA.
This document seeks to explain when research involving biospecimens constitutes human subjects research for the purpose of federal regulations.
This list includes international laws, regulations, and guidelines governing the use of human biological materials.
This resource provides best practices related to biospecimen resources, covering responsible custodianship, informed consent, privacy, access, intellectual property, and conflict of interest.
This Guideline is intended to assist researchers in dealing with the ethical issues relating to how clinical research materials are obtained, used and eventually disposed of, and the corresponding informed consent requirements.
This article reviews the available literature to conclude that although consent ought to be required for biospecimen research, one-time general consent is sufficient.
This essay describes some of the privacy issues associated with biospecimen research, with reference to two additional resources: a study by Gymrek et al. in which supposedly deidentified specimens were able to be re-identified, and a report on privacy and security concerns related to whole genome sequencing by…
This short article provides a synopsis of a key case regarding what constitutes adequate informed consent for biospecimens collected for research to be stored and used in future, possibly unrelated studies.
After newborn screening has been completed, many states retain residual newborn screening dried blood samples for various purposes, including program evaluation, quality assurance, and biomedical research. The extent to which states possess legal authority to retain residual dried blood samples and use them for purposes unrelated to newborn screening is…