Throughout the years, there have been major changes in the research industry due to alterations to policies and regulations that affect biobanking. Additionally, there has been various evolving ethical issues and significant shifts in ethics. In the last 20 years, the International Society for Biological and Environmental Repositories (ISBER) made significant strides by publishing guidelines such as “Best Practices for Repositories I: Collection, Storage, and Retrieval of Human Biological Materials for Research” in 2005. Subsequently, the second and third editions were published in 2008 and 2012. These guidelines cover ethical and technical best practices for the collection, storage, distribution, and use of biospecimens in research. The United States National Cancer Institute (NCI) also released the NCI Best Practices for Biospecimen Resources (NCI Best Practices) with subsequent versions in 2011 and 2016. This document covers the ethical, operational, technical, legal, and policy best practices which are limited to human specimen resource collections. Other guidelines such as the Organization for Economic Cooperation and Development (OECD) Guidelines for Biological Resource Centers and OECD Guidelines for Human Biobanks and Human Genetic Database were also published.
To address ongoing and new ethical issues that are related to human biospecimens in research, the Council of Europe adopted the Recommendation of the Committee of Ministers to Member States on Research on Biological Material of Human Origin in 2006, updated in 2016. The World Medical Association (WMA) also issued the WMA Declaration of Taipei on Ethical Considerations in 2016 regarding biobanks and health databases.
New privacy rules have also been established due to concerns about privacy in health records. In the United States, the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule was founded to help provide protect information from health providers, healthcare clearinghouses, and health plans. Although the rule may not apply to biospecimens, it applies to the disclosure and use of health information that is associated with the specimen. In 2016, the European Union General Data Protection Regulation was adopted to protect personal data. Throughout the years, more regulations have been added or modified to suit the changing times.
Evolving Ethical Issues
Over the last two decades, new ethical issues and been highlighted. This includes important existing issues related to the biospecimens and their associated data. The increasing use of genetic technologies and their data led to increasing concerns regarding the identifiability of data, biospecimens, and how to protect the research. Ethical issues have led to the establishment of the Human Tissue Act of 2004. In 2010, a book was published highlighting the issue of Henrietta Lacks where biospecimens were obtained from her without her knowledge and used commercially. This has brought attention to issues such as informed consent and the use of biospecimens commercially. Other cases were focused on the ownership of biospecimens and claims of private ownership of the biospecimens in research. There were also several other court cases that have resulted in the destruction of newborn bloodspots that have been retained due to unobtained parental consent. Other issues to consider include cultural perspectives, transparency, accountability in research, and changes in policies and regulations. These changes suggest that the broad consent models can be acceptable under specific circumstances due to the recognition of the importance of the biospecimens. Recently, some have proposed the use of dynamic consent models where participants can decide if they want to provide a broad or case-by-case basis consent. These models are promising as it allows research participants more choices and a medium for ongoing communication along with possible access to results from the research. Limitations of dynamic consent models include decreased access for populations who are unable to access the necessary equipment or for those who choose not to adopt it due to higher costs required to implement. Another popular issue would be the return of individual research results to biobank participants as challenges include feasibility, costs, and participant responses when returning these data.
As the industry progresses, increasing debate and dialogue regarding existing and new ethical issues become more important. A good example would be the necessity to rethink concepts of identifiability as more advanced technologies are developed and continued proliferation of databases that contain unique data to the participant. It is also important to clarify the rights participants may have regarding their specimens. This issue has prompted donors to call for some benefit such as financial compensation, control over how their specimens are used, and return of individual research results. Increasingly important will be the governance systems used in biobanks to ensure that the biospecimens and associated data are used appropriately. The ISBER will also need to continue ensuring that policies and regulations are followed and providing input to modify policies and regulations to help protect research participants while facilitating research. Last but not least, public education and participant engagement are also key to ensure the future of the industry.
Bledsoe MJ. The final common rule: implications for biobanks. Biopreservation and Biobanking. 2017; 15(4): 283-284.
Bledsoe MJ. Ethical legal and social issues of biobanking: past, present, and future. Biopreservation and Biobanking. 2017; 15(2): 142-147.