Ethical Challenges in COVID-19 Biospecimen Research

Lapid, Maria I.; Meagher, Karen M.; Giunta, Hannah; Clarke, B.L.; Ouellette, Yves; Armbrust, Tamyra L.; Wright, R. Scott

doi:10.1016/j.mayocp.2020.10.021

Cited by 5 publications

(4 citation statements)

References 29 publications

(33 reference statements)

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“…The debates center on alternative consent procedures such as “broad consent” [ 24 ]. Maria Lapid et al offer an analysis of the ethical challenges of biospecimen research during the pandemic together with some recommendations for IRB members that already can be of use but need further translation into practice under different local circumstances [ 25 ].…”

Section: Discussionmentioning

confidence: 99%

Challenges and proposed solutions in making clinical research on COVID-19 ethical: a status quo analysis across German research ethics committees

et al. 2021

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Background In the course of the COVID-19 pandemic, the biomedical research community’s attempt to focus the attention on fighting COVID-19, led to several challenges within the field of research ethics. However, we know little about the practical relevance of these challenges for Research Ethics Committees (RECs). Methods We conducted a qualitative survey across all 52 German RECs on the challenges and potential solutions with reviewing proposals for COVID-19 studies. We de-identified the answers and applied thematic text analysis for the extraction and synthesis of challenges and potential solutions that we grouped under established principles for clinical research ethics. Results We received an overall response rate of 42%. The 22 responding RECs reported that they had assessed a total of 441 study proposals on COVID-19 until 21 April 2020. For the review of these proposals the RECs indicated a broad spectrum of challenges regarding (1) social value (e.g. lack of coordination), (2) scientific validity (e.g. provisional study planning), (3) favourable risk–benefit ratio (e.g. difficult benefit assessment), (4) informed consent (e.g. strict isolation measures), (5) independent review (e.g. lack of time), (6) fair selection of trial participants (e.g. inclusion of vulnerable groups), and (7) respect for study participants (e.g. data security). Mentioned solutions ranged from improved local/national coordination, over guidance on modified consent procedures, to priority setting across clinical studies. Conclusions RECs are facing a broad spectrum of pressing challenges in reviewing COVID-19 studies. Some challenges for consent procedures are well known from research in intensive care settings but are further aggravated by infection measures. Other challenges such as reviewing several clinical studies at the same time that potentially compete for the recruitment of in-house COVID-19 patients are unique to the current situation. For some of the challenges the proposed solutions in our survey could relatively easy be translated into practice. Others need further conceptual and empirical research. Our findings together with the increasing body of literature on COVID-19 research ethics, and further stakeholder engagement should inform the development of hands-on guidance for researchers, funders, RECs, and further oversight bodies.

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Section: Discussionmentioning

confidence: 99%

Challenges and proposed solutions in making clinical research on COVID-19 ethical: a status quo analysis across German research ethics committees

et al. 2021

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“…35 In addition, proxy decision-makers may be understandably anxious and not wishing to engage in a research-informed consent process. 36 Finally, researchers or others involved in sample collection could be exposed to the virus if proper infection control measures are not in place, 37 and the availability and access to appropriate personal protective equipment (PPE) have been limited. 38 When PPE is available, its use, including the use of face masks, can preclude optimal face-to-face informed consent discussions.…”

Section: Biobanking For Covid-19 In Lmics: Ethical Considerationsmentioning

confidence: 99%

“… 38 When PPE is available, its use, including the use of face masks, can preclude optimal face-to-face informed consent discussions. 36 …”

Section: Biobanking For Covid-19 In Lmics: Ethical Considerationsmentioning

confidence: 99%

“…Biobankers should develop a plan to deidentify or anonymise collected samples and data prior to sharing to mitigate any possible risks to individuals. 36 Waived consent for sample storage during pandemics is arguably justifiable based on necessity provided that future research is COVID-related (or, perhaps, related to other infectious disease outbreaks), in the public interest and approved by an REC/IRB. In addition, existing collections of stored biosamples could be repurposed for research during a pandemic without the need for reconsent provided that studies using such biosamples are appropriately designed and that study benefits are equitably distributed.…”

Section: Biobanking For Covid-19 In Lmics: Ethical Considerationsmentioning

confidence: 99%

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Challenges to biobanking in LMICs during COVID-19: time to reconceptualise research ethics guidance for pandemics and public health emergencies?

2021

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Biobanking can promote valuable health research that may lead to significant societal benefits. However, collecting, storing and sharing human samples and data for research purposes present numerous ethical challenges. These challenges are exacerbated when the biobanking efforts aim to facilitate research on public health emergencies and include the sharing of samples and data between low/middle-income countries (LMICs) and high-income countries (HICs). In this article, we explore ethical challenges for COVID-19 biobanking, offering examples from two past infectious disease outbreaks in LMICs where biobanking activities contributed to the perpetuation of global inequities. We focus on how the ethical imperative to promote the common good during public health emergencies can conflict with protecting the interests of biobank participants. We discuss how conducting biobank research under a waiver of informed consent during public health emergencies is ethically permissible, provided guidance is in place to prevent biopiracy and exploitation of vulnerable communities. We also highlight the need for biobank collaborations between LMICs and HICs to promote capacity building and benefit sharing. Finally, we offer guidance to promote the ethical oversight of biobanks and biobank research during the COVID-19 pandemic or other future public health emergencies.

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The impact of COVID-19 on disease epidemiology, family dynamics, and social justice in Minnesota: All that you cannot see

Schleiss

Blazar

Chapman

et al. 2022

J. Clin. Trans. Sci.

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Objective: The COVID-19 pandemic presented a challenge to established seed grant funding mechanisms aimed at fostering collaboration in child health research between investigators at the University of Minnesota (UMN) and Children’s Hospitals and Clinics of Minnesota (Children’s MN). We created a “rapid response,” small grant program to catalyze collaborations in child health COVID-19 research. In this paper, we describe the projects funded by this mechanism and metrics of their success. Methods: Using seed funds from the UMN Clinical and Translational Science Institute, the UMN Medical School Department of Pediatrics, and the Children’s Minnesota Research Institute, a rapid response request for applications (RFAs) was issued based on the stipulations that the proposal had to: 1) consist of a clear, synergistic partnership between co-PIs from the academic and community settings; and 2) that the proposal addressed an area of knowledge deficit relevant to child health engendered by the COVID-19 pandemic. Results: Grant applications submitted in response to this RFA segregated into three categories: family fragility and disruption exacerbated by COVID-19; knowledge gaps about COVID-19 disease in children; and optimizing pediatric care in the setting of COVID-19 pandemic restrictions. A series of virtual workshops presented research results to the pediatric community. Several manuscripts and extramural funding awards underscored the success of the program. Conclusions: A “rapid response” seed funding mechanism enabled nascent academic-community research partnerships during the COVID-19 pandemic. In the context of the rapidly evolving landscape of COVID-19, flexible seed grant programs can be useful in addressing unmet needs in pediatric health.

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Ethical Challenges in COVID-19 Biospecimen Research

Cited by 5 publications

References 29 publications

Challenges and proposed solutions in making clinical research on COVID-19 ethical: a status quo analysis across German research ethics committees

Challenges and proposed solutions in making clinical research on COVID-19 ethical: a status quo analysis across German research ethics committees

Challenges to biobanking in LMICs during COVID-19: time to reconceptualise research ethics guidance for pandemics and public health emergencies?

The impact of COVID-19 on disease epidemiology, family dynamics, and social justice in Minnesota: All that you cannot see

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