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As science rapidly accelerates to address COVID-19 and other disease indications, we can’t lose sight of the importance of regulatory guidelines and requirements to ensure the safe, ethical treatment of patients participating in research studies.

Regulations governing the protection of human research subjects are based on the ethical principles identified in the Belmont Report, the Nuremberg Code, and the Declaration of Helsinki,1–3 with contributions
by the Council for the International Organization of Medical Sciences, the Nuffield Council on Bioethics, and Good Clinical Practice.4–6 The application of these principles in the use of human biospecimens for research is enforced by legal/ethical regulations. Many of these regulations relate to permission, which may come directly from the donor (informed consent) or be granted by others authorized to protect donor interests.

Legal and ethical oversight is country/region-specific. In the U.S., institutional review boards (IRBs) are responsible for the regulatory oversight of research involving human subjects, with the Office of Human Research Protection (OHRP) 45 CFR Part 46 regulations governing IRBs.7 In the U.K., consent or authorization is required for the collection of biospecimens for research, with a similar situation existing in European countries. However, in the U.K., the Health Research Authority determines if a research study requires ethical approval by an independent ethics committee (IEC). In other countries, the Ministries of Health (MOH) or authorized IECs may be responsible.

Types of Collections

The three main collection types vary in their regulations for consent. Prospective collections are obtained from excess material from a standard-of-care procedure or from samples collected specifically for research. In most countries, these research samples require the donor’s written informed consent. Retrospective or remnant specimens are left over after diagnostic tests and analyses have been conducted. Each country or region has its own regulations regarding the use of these samples. Likewise, postmortem/cadaveric samples have regulations that differ by region regarding their collection and use.

Quality Considerations

Originally, biobanks stored archival specimens from in-house longitudinal studies. As research focused on personalized medicine, scientists identified a need for high-quality, data-rich specimens due to differences in collection processes, sample storage, data capture, and regulatory documentation. Because of these issues, various groups were created to define processing standards that ensure reliable specimen quality.

  • The International Society for Biological and Environmental Repositories (ISBER) was established in 1999 to focus on identifying and harmonizing “quality standards, education, ethical principles and innovation in the science and management of biorepositories.” 8
  • The U.S. National Cancer Institute (NCI) Biorepository Coordinating Committee was established in 2004–2005 to identify and resolve biospecimen resource issues.9

The consensus of these two organizations, as well as contributions from other groups, provides the basis for current biorepository standards and principles that meet the global research needs for high-quality

Research frequently requires large numbers of samples with adequate specimen size and volume. Consistent sample quality is expected with a range of sample types that are representative of the condition(s) being studied. Additionally, researchers are looking for clinical data and demographics to accompany the samples and support their research. The reliability of data derived from human specimens depends on the quality and consistency of the analyzed samples.

For additional insight, please visit BioIVT.com and read BioIVT’s Recommendations to Consider When Sourcing Human Biospecimens and Questions to Ask Your Human Biological Specimens Provider.

1. hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html
2. Annas GJ and Grodin MA, The Nazi Doctors and the Nuremberg Code, 1995
3. www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects
4. cioms.ch
5. nuffieldbioethics.org/wp-content/uploads/2014/07/Human-tissue.pdf
6. ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf
7. hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html#46.102
8. www.isber.org/page/BPR
9. biospecimens.cancer.gov/bestpractices/2016-NCIBestPractices.pdf

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