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Understanding Regulatory Guidelines for Sourcing Human Biospecimens

By Cathie Miller, Ph.D. / Dec 26, 2019

Sourcing human biospecimens isn’t easy, as various government and medical professional societies have instituted regulations and accreditation programs to ensure that specimens are collected according to the best practices developed over many years. To make matters more complicated, those regulations and best practices are change.

That’s why it’s vital to work with a human biospecimen (HBS) provider that has an in-depth understanding of the ever-evolving regulatory landscape.

The foundation for protecting human research subjects came from The Belmont Report, issued by the United States’ Department of Health, Education and Welfare in 1979. This report states that the most important aspect of using HBS in research is ensuring that the sample was collected with the informed consent of the donor.

Informed consent is the understanding and written acceptance of the research that will be done on the HBS. In order for participants to make an informed decision, they need to be told the purpose of the study, study procedures, risks and discomforts, the benefits and compensation of participation, the use of their health data and information about voluntarily withdrawing from the research.

It’s also critical that participants are aware of the potential commercial use of their samples and data. They must be informed if their specimens could lead to new products, tests or discoveries that may have commercial value, and that the participants will not receive any monetary benefits from such discoveries. The participants must also be told about the potential publishing of study results in journals and academic papers, and they must be assured that no identifying data will be published.  

Additionally, participants must be notified if their samples will undergo genetic testing and if that testing is optional. They must also be assured that if a link is made between the samples and the donor that researchers will not identify the donor.

And that’s just scratching the regulatory surface. In the U.S., Institutional Review Boards (IRBs) are responsible for the regulatory oversight of research involving human research subjects. The Human Tissue Authority was established in the United Kingdom to regulate organizations that use human tissue for research. There’s the International Society for Biological and Environmental Repositories (ISBER), the National Cancer Institute (NCI), the Biobanking and Biomolecular Resources Research Infrastructure (BBMRI) and the European, Middle Eastern and African Society for Biopreservation and Biobanking (ESBB), not to mention countries that rely on Ministries of Health (MOH) or Independent Ethics Committees (IECs).

How can you keep it all straight?

Luckily, you don’t have to.

At BioIVT, we are committed to staying current and adopting new standards as they are established to achieve consistent compliance and the highest biospecimen quality.

For more information, download our Recommendations to Consider When Sourcing Human Biospecimens white paper and our Questions to Ask Your Human Biological Specimen Provider guide. If you have further questions concerning the ethical and quality-ensured collection of human specimens, or to learn more about our capabilities, reach out to our Quality team here. 

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