The Use of Human Tissues for Research: What Investigators Need to Know.

While laboratory animals are necessary for some aspects of the development of scientific and biomedical advances, including those of precision medicine, the use of human tissues is necessary in order to explore the findings and ensure that they are relevant to human systems. Many sources of human tissues exist, but researchers - particularly those making the transition from animal to human systems - may not be aware of how best to find quality sources of human tissues or how best to use them in their research. In this article, we discuss the advantages of using human tissues in research. In addition, we highlight some of the major advances made possible through the use of human tissue, and describe how human tissue is collected for research. We discuss the various types of bioresources that make human tissue available, and advise on how investigators can find and use appropriate bioresources to support their research - with the hope that this information will help facilitate the transition from research on animals to research using human tissues, as rapidly as is practicable.

Returning Individual Research Results to Vulnerable Individuals.

Although issues associated with returning individual research results to study participants have been well explored, these issues have been less thoroughly investigated in vulnerable individuals and populations. Considerations regarding return of research results to these individuals and populations, including how best to ensure truly informed consent, how to minimize the risks and benefits of the return of research results, and how best to ensure justice may differ from those of the population at large. This article discusses the issues and challenges associated with the return of individual research results (such as genomic, proteomic, or other biomarker data) to potentially vulnerable individuals and populations, including those who may be vulnerable for cognitive, communicative, institutional, social, deferential, medical, economic, or social reasons. It explores factors that should be considered in the design, conduct, and oversight of ethically responsible research involving the return of research results to vulnerable individuals and populations and discuss recommendations for those engaged in this work.

Analysis of Biospecimen Demand and Utilization of Samples from the National Amyotrophic Lateral Sclerosis Biorepository.

Amyotrophic lateral sclerosis (ALS) is a rare neurological condition affecting upper and lower motor neurons. The National ALS Biorepository (referred to as the Biorepository) was initiated in 2015, with biospecimen collection beginning in 2017, as a repository for biospecimens for future ALS research. To help ensure the usefulness of the Biorepository, a biospecimen demand analysis is conducted on an annual basis, as well as an analysis of the utilization of the Biorepository. To determine the types of biospecimens to be collected for the Biorepository, an in-depth initial examination occurred followed by ongoing biospecimen demand and utilization analyses. The initial examination included input from an expert panel, discussions with ALS research experts, review of other ALS biorepositories, assessment of biospecimen demand, and analysis of the biospecimen types historically used in ALS research. Of all biospecimen types reported in the literature, the most frequently used were DNA, postmortem spinal cord, blood, and cerebrospinal fluid; while the frequently reported types of biospecimens used in ALS-related grants were induced pluripotent stem cells, brain, blood, and spinal cord. Continuous analysis of potential sample demand and tissues collected, based on an analysis of the literature and funded grants, and actual sample requests can assist the Biorepository in ensuring that the appropriate samples are available for researchers when they are needed.

Biobanking in the COVID-19 Era and Beyond: Part 2. A Set of Tool Implementation Case Studies.

The COVID-19 era has brought about a number of novel challenges for the global biobanking community. An array of diverse tools (e.g., standards, best practices, and plans) exists to support quality and fitness-for-purpose in biobank operations. The International Society for Biological and Environmental Repositories (ISBER) COVID-19 Response Task Force has set out to identify needs and gaps in these tools and make recommendations for the next generation of available tools, having closely examined the COVID-19-related challenges. While conducting this work to examine the relationships between tools and biobank adaptability, a subgroup of the task force conducted a parallel effort to develop and describe individual COVID-19 era case studies based on a number of operating biobanks. Each case study presents a different combination of implemented tools. Observations and lessons learned from these case studies are provided, and experiences with tool implementation are discussed. This information is supplemented by data relating to tool usefulness that was obtained through an ISBER survey discussed in a companion article. The knowledge gained from this study will be combined with other task force efforts to make recommendations to better position the biobanking community in their response to future emergencies.

Biobanking in the COVID-19 Era and Beyond: Part 1. How Early Experiences Can Translate into Actionable Wisdom.

The era of COVID-19 has brought about a number of novel challenges for the global biobanking community. To better position the biobanking community to cope with current and future challenges, the International Society for Biological and Environmental Repositories (ISBER) COVID-19 Response Task Force was convened to identify needs and gaps in biobanking tools (existing resources that support good practice), for example, standards, best practices, business, etc. and to make recommendations to benefit the community. Toward these goals, the Task Force assembled a set of questions to explore individual biobanks' experiences, with emphasis on identification of key challenges and approaches, including tools employed. A survey was designed with the use of these questions and administered by ISBER. This article presents a summary of the aggregated data obtained from the survey responses, illustrating some of the major issues encountered and identifying which tools the survey respondents found most useful. In particular, this article focuses on the challenges identified during the early months of the COVID-19 era. Recommendations are provided to support biobank emergency preparedness for the future, address lessons learned, and propose solutions to bridge identified gaps. The analysis and the complete survey dataset will also inform the larger Task Force goal to develop specific tool recommendations.

Ensuring Effective Utilization of Biospecimens: Design, Marketing, and Other Important Approaches.

A number of studies have shown that underutilization of biospecimens from bioresources (biobanks and biorepositories) is a significant concern. In addition, biospecimen underutilization has been identified as an ethical as well as practical concern. The utilization of biospecimens is affected by many factors, including the establishment of a scientific need for the biospecimens, the design of the bioresource, strategic planning, biospecimen quality and fitness for purpose, informed consent considerations, access policies and procedures, and marketing. This article discusses the impact of these factors on biospecimen utilization and provides suggestions for how bioresources can optimize biospecimen utilization from their collections.

The Utilization of Biospecimens: Impact of the Choice of Biobanking Model.

The term research "biobank" is one of multiple names (e.g., bioresource, biorepository,) used to designate an entity that receives, collects, processes, stores, and/or distributes biospecimens or other biospecimen-related products (e.g., data) to support research. There are multiple organizational models of biobanking used by bioresources, but the primary goal of all bioresources should not be simply to collect biospecimens, but ultimately to distribute almost all collected biospecimens and/or data to support scientific research; bioresources should serve as "biodistributors" rather than "biovaults." The appropriate choice of model is the first step in ensuring optimal biospecimen utilization by a bioresource. This article discusses some of the different models that may be used alone or in combination by a bioresource providing biospecimens for research; it describes the factors affecting the choice of the most appropriate model or models, the advantages and disadvantages of the various models, and a discussion of the impact of the choice of the model on biospecimen utilization. Frequently, problems with biospecimen utilization are not caused by any single model, but rather a mismatch between the choice of model and goals of the bioresource, and/or problems with the subsequent design, goals, operations, and management of the bioresource after a model is selected.

Standardization and Innovation in Paving a Path to a Better Future: An Update of Activities in ISO/TC276/WG2 Biobanks and Bioresources.

Recent advances in biotechnology are making it possible to advance science and improve healthcare with increasing speed and precision. Biobanking, as a foundation of the biotechnology infrastructure, is critical to the assurance of quality for many of the key components for these advancing technologies in both the human and nonhuman domains. Biobanking must advance to support the increased complexity and required precision needs of biological resources. Standards development can provide an important link for the research and development community by providing tools to ensure quality, fitness-for-purpose, and reproducibility in biobanking. ISBER has been developing the ISBER Best Practices revision. At the same time, ISO/TC276/ WG2 has been developing an International Standard (IS) ISO/DIS 20387 General requirements for biobanking standard. It is important that ISBER and ISO/TC276/WG2 harmonize and/or align their products to enable members of the diverse biobanking community to tailor their own suite of tools to support their specific needs. The availability of both standards and best practices that are complementary will maximize available support for all biobanks. The increased availability of complementary standards, tools, and best practices will facilitate the path to new biotechnology advances and a better future.

Ethical Legal and Social Issues of Biobanking: Past, Present, and Future.

The past 15 years has seen considerable changes in the research environment. These changes include the development of new sophisticated genetic and genomic technologies, a proliferation of databases containing large amount of genotypic and phenotypic data, and wide-spread data sharing among many institutions, nationally and internationally. These changes have raised new questions regarding how best to protect the participants of biobanking research. In response to these questions, best practices for addressing the legal, ethical, and social issues of biobanking have been developed. In addition, new ethical guidelines related to biobanking have been established, as well as new regulations regarding privacy and human subject protections. Finally, changes in the science and the research environment have raised complex ethical issues related to biobanking, such as questions about the most appropriate consent models to use for biobanking research, commercial use and ownership issues, and whether and how to return individual research results to biobank participants. This article reviews some of the developments over the past 15 years related to the ELSI of biobanking with a look toward the future.