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August 15, 2018

The Legal, Ethical and Regulatory Landscape for the Use of Human Biospecimens In our Research Sample Biobank.


Discovery Life Sciences, Inc.

The legal, ethical and scientific basis for aggregating, sequestering and distribution of human biospecimens for research purposes has been well debated for the past 50 years and most recently re-visited by an HHS rulemaking committee in 2016. Any modifications to existing rules were firmly argued against by nearly every academic, industrial and private research group in the United states.

The founding core philosophy for developing Biobanks and utilizing archival human biospecimens for research purposes can be found contained in a report delivered to the National Bioethics Advisory Committee in 1998 by David Korn MD, titled “Contributions of the Human Tissue Archive to the Advancement of Medical Knowledge and the Public Health” where he describes them as the “intellectual foundation of modern medicine”. Certainly, since this publication, significant additional advances in medical care have been based on research using human specimens. Included are many major advances that have not only changed treatments for disease, but also have resulted in fundamental new concepts of human biology.

In Summary, here is the landscape:

1. Recent Attempt to Modify: 
HHS abandons controversial consent proposal on using human research samples:

2. What’s New with the Rule?

3. FDA Guidance on Use of “leftover’ diagnostic specimens 2006:
Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not individually identifiable

4. HHS/OHRP does not consider the use of anonymized (de-identified) remnant biospecimens to be Human Subjects research
(as defined under 45 CFR 46.102(f)):

5. The Common Rule.
The Common Rule has been codified by 15 US federal departments and agencies and applies to all research involving human subjects that is “conducted, supported or otherwise subject to regulation by any federal department or agency which takes appropriate administrative action to make this policy applicable to such research.” Each of these 15 federal department or agencies has a codification of the Common Rule which is equivalent to 45 CFR 46, Subpart A1. The Rule includes requirements for Institutional Review Board (IRB) review and informed consent for human subjects research.

6. FDA Human Subjects Regulations:
The second set of significant US federal regulations that may apply to the collection and use of human specimens for research are the Food and Drug Administration (FDA) regulations, 21 CFR 50, 56, and 812. The FDA regulations apply to all clinical investigations regulated by the FDA under sections 505(i) and 520(g) of the Federal Food, Drug, and Cosmetic Act, as well as clinical investigations that support applications for research or marketing permits for products regulated by the FDA. Among other products included within the scope are drugs for human use, medical devices for human use and biological products for human use. 21 CFR 50 covers informed consent requirements and 21 CFR 56 covers IRB review requirements. 21 CFR 812.2(a) applies to all clinical investigations of devices to determine safety and effectiveness unless the device investigation is exempt under 812.2(c).

The FDA regulations define a human subject differently than the Common Rule. The FDA regulations at 21 CFR 50.3(g) and 56.102(e) define a human subject as an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient. (See 21 CFR 50.3(g) and 56.102(e)). The device regulations define a subject as an individual on whom or on whose specimen an investigational device is used. (See 21 CFR part 812).

7. The Health Insurance Portability and Accountability Act, Privacy and Security Rules:
The third major set of US federal regulations that may be relevant to some human specimen research is the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules. The Privacy Rule regulates the uses and disclosures of individually identifiable health information by “covered entities” (health care providers, health plans, and health care clearinghouses). While the Privacy Rule does not apply to the use of human specimens per se, it may apply to uses and disclosures of the health information that may be associated with the specimens. The Privacy Rule generally requires patient authorization for uses and disclosures of health information that is individually identifiable. [See 45 CFR part 164.508]. Authorization is a similar but not identical concept to informed consent. Informed consent is the process by which subjects are informed about the risks and benefits of participating in research whereas authorization is solely a permission to allow researchers to use or disclose defined protected health information.

8. Traceability and Transparency for All Biospecimen Trials.

9. Property Rights and the Human Body

10. New England Journal of Medicine – Who owns tissue?

11. Journal of Ethics

12Why we need Human Biospecimens for Human Research.

Discovery Life Sciences, Inc., July 2018.