Biobanking in a Global Society: Awareness of International Laws & Guidance

Dr. Wendy Tate
Director, Analytics, Forte
May 19th, 2016

Biobanks are large holders of both specimens and data. Thus, a biobank has a wealth of private information regarding people’s health. Such quantities of personal information require oversight to maintain privacy and confidentiality as well as to ensure the ethical and responsible use of these materials. The United States and the European Union, as well as other countries worldwide, have regulations surrounding biospecimens and human subjects research.

My last article discussed good governance and transparency to maximize quality in a biobank. Another important part of good governance is compliance with biobanking regulations and adherence to ethical standards. The foundation of ethical human biobanking is the recognition that samples are really a person. A donor has given a part of themselves, a limited resource, for the purposes of research. These people have rights and the rights of the donor must come first. This perspective is socially responsible and based on global ethical expectations presented by the Declaration of Helsinki, the EU Bioethics Convention, the UN Guiding Principles on Business and Human Rights, and the U.S. Belmont Report. Due to the weight of this social responsibility and the rapid advancement of technology associated with biospecimens, regular assessment of standards for the use of these resources must be performed.

Changes to the regulatory landscape

Currently, regulations and guidance surrounding the collection and use of biospecimens are being revised in both the United States and the European Union. This was the topic of multiple sessions at the ISBER conference. Biospecimens regulation experts anticipate changes in the EU General Data Protection Regulation and the US Common Rule (human subjects regulations) before the end of 2017. These regulations are legally enforceable by government entities and affect research conducted within the country, even if just a sub-contractor. The major change is in the United States, where notable revisions to what specimens are considered exempt from informed consent are expected. This change would require all prospective samples to be used in biobanking to have informed consent, even if they were originally obtained for clinical purposes. This is a standard that has been in place in the EU for approximately a decade.

Other anticipated changes affect internationally recognized guidance and best practices in biobanking ethics. These include the World Medical Association Declaration on Databases and Biobanks (a supplement to the Declaration of Helsinki), the Council of Europe DH-BIO (a working document regarding research on biological materials of human origin), and the CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects (a revision of their 2002 guidelines). According to the international panel of speakers at the ISBER session on the expected regulatory changes, all of these regulations and guidance documents are fairly supportive of the concept of broad consent, a concept critical to the efficiency of repositories.

Broad consent is essentially the consent to the governance of the biobank. In the case where it is unknown exactly what will be done with a specimen, consent of the donor, who is subject to the parameters of what may be done with the specimen and/or data, can be performed without specifics. This allows the donor subjects to give informed consent after they are essentially informed that they don’t have all of the information on what will happen.

Guidance revisions

Revisions to guidance documents focusing on the technical end of biobanking are also expected. The International Conference on Harmonisation (ICH) is in the process of revising ICH E18: Genomic Sampling Methodologies for Future Use, a legally enforceable document. Two additional documents under revision, neither legally enforceable but seen as best practice, are the ISO Technical Committee 276 document on the quality management system requirements of biobanks and the NCI Best Practices for Biospecimen Resources.

Even if a document is not seen as legally enforceable, it can be highly influential in the development of national laws and regulations, as they provide a forum for standardization and/or provide industry best practice. Additionally, funding entities can require adherence to guidance documents above and beyond federal and international regulations as a stipulation for award funding. Regardless of how large your biobank may be, if you plan to do research on biospecimens, whether it be for one study or one thousand studies, you would be wise to research these anticipated changes further and educate yourself on what may come. If your career is rooted in biospecimens, or any other aspect of research, joining a community (such as ISBER for repositories) can provide a forum for obtaining up-to-date information on changes as well as continuing education and networking opportunities.

Related article: Biobanking in a Global Society: The Importance of Governance


Compliance and Regulatory Study Coordination

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