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1.
PLoS One ; 17(2): e0263750, 2022.
Article in English | MEDLINE | ID: covidwho-1674021

ABSTRACT

PURPOSE: To identify meanings of and challenges to enacting equitable diversification of genomics research, and specifically precision medicine research (PMR), teams. METHODS: We conducted in-depth interviews with 102 individuals involved in three U.S.-based precision medicine research consortia and conducted over 400 observation hours of their working group meetings, consortium-wide meetings, and conference presentations. We also reviewed published reports on genomic workforce diversity (WFD), particularly those relevant to the PMR community. RESULTS: Our study finds that many PMR teams encounter challenges as they strive to achieve equitable diversification on scientific teams. Interviewees articulated that underrepresented team members were often hired to increase the study's capacity to recruit diverse research participants, but are limited to on-the-ground staff positions with little influence over study design. We find existing hierarchies and power structures in the academic research ecosystem compound challenges for equitable diversification. CONCLUSION: Our results suggest that meaningful diversification of PMR teams will only be possible when team equity is prioritized as a core value in academic research communities.


Subject(s)
Biomedical Research/ethics , Cultural Diversity , Laboratory Personnel/ethics , Precision Medicine/ethics , Adolescent , Adult , Aged , Female , Genomics/ethics , Health Workforce/ethics , Humans , Laboratory Personnel/organization & administration , Male , Middle Aged , Patient Care Team/ethics , Patient Care Team/organization & administration , United States , Young Adult
2.
PLoS One ; 17(1): e0262609, 2022.
Article in English | MEDLINE | ID: covidwho-1643269

ABSTRACT

BACKGROUND: The use of linked healthcare data in research has the potential to make major contributions to knowledge generation and service improvement. However, using healthcare data for secondary purposes raises legal and ethical concerns relating to confidentiality, privacy and data protection rights. Using a linkage and anonymisation approach that processes data lawfully and in line with ethical best practice to create an anonymous (non-personal) dataset can address these concerns, yet there is no set approach for defining all of the steps involved in such data flow end-to-end. We aimed to define such an approach with clear steps for dataset creation, and to describe its utilisation in a case study linking healthcare data. METHODS: We developed a data flow protocol that generates pseudonymous datasets that can be reversibly linked, or irreversibly linked to form an anonymous research dataset. It was designed and implemented by the Comprehensive Patient Records (CPR) study in Leeds, UK. RESULTS: We defined a clear approach that received ethico-legal approval for use in creating an anonymous research dataset. Our approach used individual-level linkage through a mechanism that is not computer-intensive and was rendered irreversible to both data providers and processors. We successfully applied it in the CPR study to hospital and general practice and community electronic health record data from two providers, along with patient reported outcomes, for 365,193 patients. The resultant anonymous research dataset is available via DATA-CAN, the Health Data Research Hub for Cancer in the UK. CONCLUSIONS: Through ethical, legal and academic review, we believe that we contribute a defined approach that represents a framework that exceeds current minimum standards for effective pseudonymisation and anonymisation. This paper describes our methods and provides supporting information to facilitate the use of this approach in research.


Subject(s)
Biomedical Research/methods , Confidentiality , Data Anonymization , Biomedical Research/ethics , Datasets as Topic , Electronic Data Processing/ethics , Electronic Data Processing/methods , Electronic Health Records/organization & administration , Humans , Information Storage and Retrieval , United Kingdom
4.
Ethics Hum Res ; 43(5): 42-44, 2021 Sep.
Article in English | MEDLINE | ID: covidwho-1396864

ABSTRACT

With the rapid spread of SARS-CoV2 has come a rapid proliferation of clinical research studies, resulting in considerable strain on research ethics committees (RECS), which need to review study proposals. RECs are pressured to move through the review process quickly so that studies can get underway to address the pandemic. These committees are also asked to increase efficiency without relaxing the standards for ethical review. RECs are accustomed to external pressure for approval from investigators; however, in the Covid-19 era, this pressure is coming from not only the sponsors and investigators but also many other stakeholders, including world leaders, the community, the media, and professional organizations. Drawing on the authors' experiences on a central REC reviewing complex multicenter Covid-19 studies, this commentary describes challenges that are inherent to Covid-19 research studies, such as the difficulty of obtaining informed consent from patients ill with the highly infectious virus. The commentary recommends several steps that RECs can take to ensure ethical review of research studies during the Covid-19 pandemic and future infectious disease outbreaks.


Subject(s)
COVID-19 , Ethics Committees, Research/standards , Ethics, Research , Biomedical Research/ethics , Biomedical Research/standards , Humans , Informed Consent
5.
Narrat Inq Bioeth ; 11(1): 1-6, 2021.
Article in English | MEDLINE | ID: covidwho-1344143

ABSTRACT

This symposium is separated into two sections. The first includes twelve personal stories from IRB members, administrators, or staff about their experiences during the COVID-19 pandemic. The second section includes twelve personal stories from researchers. Six commentaries on these narratives are offered by experts in research ethics, regulatory oversite, IRB administration, the logistics of clinical research, and investigator responsibilities. These narratives and commentaries offer an inside look at how the COVID-19 pandemic affected the physical logistics of clinical research already underway, demanded immediate investment in scientific investigation of vaccines and treatments, and rerouted the usual decision pathways that guide ethical practice.


Subject(s)
Biomedical Research/ethics , COVID-19 , Ethics Committees, Research , Pandemics , COVID-19 Vaccines , Committee Membership , Ethics, Research , Humans , Narration , Research Personnel , SARS-CoV-2
6.
Narrat Inq Bioeth ; 11(1): 101-105, 2021.
Article in English | MEDLINE | ID: covidwho-1337556

ABSTRACT

In early 2020, clinicians and researchers rushed to understand the SARS-CoV-2 virus and how to go about treating and preventing it. Caring for patients while simultaneously learning about a disease not seen before created challenges on several levels. Much of the spotlight was on the researchers doing this critical work; however, these narratives remind us of the enormous effort and commitment shown by IRB members and research administrators responsible for research infrastructure. Despite the sense of urgency and obligation to plan and conduct clinical research during the pandemic, IRBs guaranteed that researchers still adhered to the core ethical principles that protect the rights and welfare of human subjects so that critical research could continue. Many themes emerge in these stories, including the need for flexibility in processes for both staff and research participants and the perception that IRB members serve as "research gatekeepers." With approaches to clinical research evolving, the SARS-CoV-2 pandemic may be the catalyst needed to make sustainable improvements to our research processes, roles, and goals.


Subject(s)
Biomedical Research/ethics , COVID-19 , Ethics Committees, Research , Pandemics , Ethics, Research , Gatekeeping , Humans , Narration , Research Personnel , Research Subjects , SARS-CoV-2
7.
Narrat Inq Bioeth ; 11(1): 89-94, 2021.
Article in English | MEDLINE | ID: covidwho-1337554

ABSTRACT

The COVID-19 pandemic threw health care logistics and clinical research processes into disarray. This collection of narratives describes the challenges faced by IRB administrators, staff, and committee members as they navigated the SARS-CoV-2 pandemic. The authors transitioned to remote meetings, adjusted to ever-changing information, and untangled the ethical implications of supporting open studies while making room for an influx of new protocols that addressed the pressing public health emergency.


Subject(s)
Biomedical Research/ethics , COVID-19 , Ethics Committees, Research , Pandemics , Ethical Review , Humans , Narration , SARS-CoV-2
12.
Narrat Inq Bioeth ; 11(1): 55-59, 2021.
Article in English | MEDLINE | ID: covidwho-1337545

ABSTRACT

The COVID-19 pandemic disrupted and displaced the old normal, necessitating adaptation. The narratives in this issue of NIB give us a glimpse into the experience of conducting research during a pandemic. The authors were on a mission to pursue research despite the challenges the pandemic imposed. They described difficulties of the Institutional Review Board process and the necessity of asking for accelerated IRB approval. The authors also discussed challenges they faced with research participant recruitment during a pandemic and concerns about keeping staff safe from the risk of transmission. The authors adapted and adjusted to the personal and professional restraints the COVID-19 pandemic placed upon them. Despite these difficulties, the authors remained committed to maintaining the integrity of their research.


Subject(s)
Attitude of Health Personnel , Biomedical Research , COVID-19 , Pandemics , Research Personnel , Biomedical Research/ethics , Ethics Committees, Research , Ethics, Research , Humans , Narration , Patient Selection , SARS-CoV-2 , Safety
13.
Narrat Inq Bioeth ; 11(1): 47-53, 2021.
Article in English | MEDLINE | ID: covidwho-1337544

ABSTRACT

The researchers' stories collected here demonstrate how many ethical and practical challenges routinely associated with conducting human research were amplified during the COVID-19 pandemic. These challenges include designing studies to minimize risks and maximize potential benefits, working with institutional review boards (IRBs), recruiting and enrolling participants, obtaining valid informed consent, promoting data integrity, managing budget constraints, and finding time to fulfill research obligations along with other duties. By offering insights about not only the barriers and challenges researchers encountered but also the creative solutions they and their colleagues found to conduct research, this behind-the-scenes peek at researchers' experiences helps us to identify barriers and potential lasting improvements for human subjects research even in the best of times.


Subject(s)
Biomedical Research/ethics , COVID-19 , Pandemics , Research Personnel/ethics , Ethics Committees, Research , Ethics, Research , Humans , Narration , Research Design , SARS-CoV-2
14.
Narrat Inq Bioeth ; 11(1): 39-45, 2021.
Article in English | MEDLINE | ID: covidwho-1337543

ABSTRACT

The SARS-CoV-2 pandemic has affected practically every aspect of life across the globe for the past year or more; the practice of clinical research not the least. Clinician scientists attempting to start or continue work both related and unrelated to the disease itself have faced ethical, oversight, or regulatory challenges. No aspect of the clinical trial enterprise was unaffected. These narratives detail some of the barriers encountered and how the investigators coped (or didn't cope). Common themes emerged, ranging from a need to contribute, which drove the researchers to frustration with real and perceived obstructions (both old and new). The narratives disclose common ethical issues related to research during a pandemic: issues both qualitatively and quantitatively different from other human subject research; challenges both new and novel, as well as those previously seen, but writ large in the face of the crisis. The narratives also offer words of advice from the trenches and speak to successes, both large and small, and to the value of teamwork and focus on a common goal.


Subject(s)
Attitude of Health Personnel , Biomedical Research/ethics , COVID-19 , Pandemics , Research Personnel/ethics , Ethics, Research , Humans , Narration , Research Personnel/psychology , SARS-CoV-2
18.
Indian J Med Ethics ; VI(1): 1-12, 2021.
Article in English | MEDLINE | ID: covidwho-1257359

ABSTRACT

The world currently faces an unprecedented pandemic outbreak of coronavirus disease (Covid-19). The novel nature of the virus and very high infection rates have not only increased the urgency to find a vaccine or cure but have also led to drastic changes in the mode of conduct of research. Thus, the Indian Council of Medical Research has developed the "National Guidelines for Ethics Committees Reviewing Biomedical & Health Research during Covid-19 Pandemic" for guidance during the review of research. Here, we attempt to analyse the strengths and limitations of these guidelines to assess if the unique ethical challenges faced during research in the current situation are adequately identified and addressed and if foundational values and principles of research ethics have been taken into account in these guidelines.


Subject(s)
Biomedical Research/ethics , Biomedical Research/standards , COVID-19/prevention & control , Codes of Ethics , Ethics Committees, Research/standards , Health Policy , Adult , Aged , Aged, 80 and over , COVID-19/epidemiology , Ethics, Research , Female , Humans , India/epidemiology , Male , Middle Aged , Pandemics , SARS-CoV-2
19.
Indian J Med Ethics ; VI(1): 1-5, 2021.
Article in English | MEDLINE | ID: covidwho-1257358

ABSTRACT

The Covid-19 pandemic is raging, taking heavy toll of lives and livelihoods. The need for safe and effective vaccine(s) is urgent. Vaccine research has progressed rapidly and a few vaccine candidates have passed trial Phases 1 and 2, confirming reasonable safety and immunogenicity parameters. They are ready for large scale Phase 3 trials to quantify protective efficacy, if any, and to detect uncommon but serious adverse effects, if any. These developments present unprecedented opportunities and challenges, scientific and ethical. Globally hundreds die every day due to Covid-19, and emergency/compassionate use of vaccine candidates that are ready for Phase 3 trials are likely to save lives. We perceive an ethical imperative to allow such vaccination for those at high risk of death and voluntarily make such informed choice - for them protection delayed will be tantamount to protection denied.


Subject(s)
Biomedical Research/ethics , Biomedical Research/standards , COVID-19 Vaccines/standards , COVID-19/prevention & control , Pandemics/prevention & control , Vaccination/ethics , Vaccination/standards , Humans , India , Practice Guidelines as Topic , SARS-CoV-2 , Time Factors
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