"If It's Ethical During a Pandemic…": Lessons from COVID-19 for Post-Pandemic Biobanking.
"If It's Ethical During a Pandemic…": Lessons from COVID-19 for Post-Pandemic Biobanking.
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DOI：
10.1080/15265161.2021.1991034
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发表时间：
2021-12
影响因子：
13.4
通讯作者：
Cadigan, R. Jean
中科院分区：
文献类型：
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作者：
Brothers, Kyle B.;Goldenberg, Aaron J.;Cadigan, R. Jean
COVID-19 大流行对典型的做事方式造成了广泛的破坏。几乎在每个行业，对这一流行病的应对措施都导致了标准操作程序的背离和前所未有的做法的采用。正如 Holly Fernandez Lynch 及其同事（2021）所详述的那样，美国食品和药物管理局 (FDA) 采取了一系列非常规措施，努力加快治疗方法和疫苗的供应，希望减轻甚至结束疫情。在其他行业，做出偏离典型做法的决定是出于保护员工和其他利益相关者免于接触 SARS-CoV-2 病毒的愿望，这一目标是由公共卫生优先事项和个人安全问题驱动的。无论推动因素是科学的加速发展还是减少科学团队的风险，这场流行病都给研究政策和实践带来了前所未有的改变和修改。正如 Lynch 及其同事 (2021) 所指出的，鉴于 COVID-19 已经“颠覆了现状”，评估这些变化或适应可能如何影响后 COVID 环境中的研究，以及我们可以从 COVID-19 研究经验中吸取哪些经验教训，以潜在地创建新的研究范式，以维持强有力的人类受试者保护，至关重要。受这些双重且有些相反的激励因素影响的研究领域之一是生物样本库或生物样本库研究（Singh 等人，2021）。与其他生物医学研究活动一样，生物银行家同时被要求“加强”他们的研究，同时还需要保持严格的安全和疏远协议。自大流行开始以来，生物样本库成为收集和分析患者生物样本以进行 COVID-19 相关研究的重要资源。与此同时，在临床研究的研究招募基本上被搁置的情况下，它们成为维持其他类型生物医学研究的日益重要的资源。与 FDA 一样，生物样本库必须采用新的工作方法，以满足广泛的临床和公共卫生研究的需求。为了探索这些变化，我们与国际生物与环境储存库协会 (ISBER) 合作，对世界各地的生物银行家进行调查，了解大流行对其运营的影响。我们关注伦理和监管问题，例如招募、知情同意、数据和样本共享、研究结果返还以及资金和可持续性。这项调查的详细结果将出现在未来的出版物中，但为了讨论的目的，注意到生物银行家报告了广泛的影响就足够了。对于一些人来说，COVID-19 大流行提高了他们在较大机构中的可持续性和知名度，因为他们有助于收集和储存可用于 SARS-CoV-2 病毒研究的样本。他们还报告说，他们采取了新的做法来保护员工并遵守机构和政府的公共卫生指令。除其他离职外，他们报告首次引入电话和/或电子同意，通过视频会议开展社区参与活动，以及加强与机构审查委员会（IRB）和研究伦理委员会（REC）的合作和直接讨论，以排除成功执行研究任务的障碍。
The COVID-19 pandemic has resulted in widespread disruption of the typical way of doing things. In nearly every industry, responses to the pandemic have brought about departures from standard operating procedures and the adoption of unprecedented practices. As Holly Fernandez Lynch and colleagues (2021) detail, the Food and Drug Administration (FDA) adopted a range of extraordinary measures in their efforts to accelerate the availability of treatments and vaccines, with the hope of mitigating and even ending the pandemic. In other industries, decisions to depart from typical practices were driven by a desire to protect employees and other stakeholders from exposure to the SARS-CoV-2 virus, a goal driven by both public health priorities and individual safety concerns. Whether the motivating factor was acceleration of science or reducing risks to scientific teams, the pandemic has seen unprecedented alterations and modifications to research policies and practices. As Lynch and colleagues (2021) note, given that COVID-19 has “upended the status quo,” it is crucial to assess how these changes or adaptations may impact research in a post-COVID environment, and what lessons we can take from our COVID-19 research experience to potentially create new research paradigms that maintain robust human subjects protections. One area of research impacted by these dual and somewhat opposing motivating factors is biobanking or biorepository research (Singh et al. 2021). Like other biomedical research pursuits, biobankers were simultaneously asked to “step up” their research while also needing to maintain strict safety and distancing protocols. Since the beginning of the pandemic, biobanks became a vital resource for collecting and analyzing biospecimens from patients for COVID-19 related research. Simultaneously, they became an increasingly important resource to maintain other kinds of biomedical research at a time when research recruitment for clinical studies was largely put on hold. Like the FDA, biobanks had to adopt new approaches to their work to meet the needs of a wide array of clinical and public health studies. To explore these changes, we partnered with the International Society for Biological and Environmental Repositories (ISBER) to survey biobankers around the world on ways the pandemic has impacted their operations. We focused on ethical and regulatory issues such as recruitment, informed consent, sharing of data and samples, return of research results, and funding and sustainability. The detailed findings of this survey will appear in a future publication, but for the sake of this discussion it is sufficient to note that biobankers reported a wide range of impacts. For some, the COVID-19 pandemic led to an increase in their sustainability and visibility in their larger institution, as they contributed to the collection and storage of samples useful for research on the SARS-CoV-2 virus. They also reported that they adopted new practices to protect their staff and to comply with institutional and governmental public health directives. Among other departures, they reported introducing phone and/or econsent for the first time, conducting community engagement activities via videoconference, and increasing collaboration and direct discussion with Institutional Review Boards (IRBs) and Research Ethics Committees (RECs) in order to troubleshoot barriers to successfully carrying out their research missions.
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DOI：
10.1177/15562646211038819
发表时间：
2022-03
期刊：
Journal of empirical research on human research ethics : JERHRE
影响因子：
--
作者：
Simon CM;Wang K;Shinkunas LA;Stein DT;Meissner P;Smith M;Pentz R;Klein DW
通讯作者：
Klein DW
影响因子：
13.4
作者：
Lynch, Holly Fernandez;Caplan, Arthur;Bateman-House, Alison
通讯作者：
Bateman-House, Alison
影响因子：
4.1
作者：
Singh S;Cadigan RJ;Moodley K
通讯作者：
Moodley K
影响因子：
--
作者：
Berkman, Benjamin E;Mastroianni, Anna C;Hull, Sara Chandros
通讯作者：
Hull, Sara Chandros