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1.
J Med Internet Res ; 23(12): e25414, 2021 12 22.
Article in English | MEDLINE | ID: covidwho-1591572

ABSTRACT

Digital technologies offer unique opportunities for health research. For example, Twitter posts can support public health surveillance to identify outbreaks (eg, influenza and COVID-19), and a wearable fitness tracker can provide real-time data collection to assess the effectiveness of a behavior change intervention. With these opportunities, it is necessary to consider the potential risks and benefits to research participants when using digital tools or strategies. Researchers need to be involved in the risk assessment process, as many tools in the marketplace (eg, wellness apps, fitness sensors) are underregulated. However, there is little guidance to assist researchers and institutional review boards in their evaluation of digital tools for research purposes. To address this gap, the Digital Health Checklist for Researchers (DHC-R) was developed as a decision support tool. A participatory research approach involving a group of behavioral scientists was used to inform DHC-R development. Scientists beta-tested the checklist by retrospectively evaluating the technologies they had chosen for use in their research. This paper describes the lessons learned because of their involvement in the beta-testing process and concludes with recommendations for how the DHC-R could be useful for a variety of digital health stakeholders. Recommendations focus on future research and policy development to support research ethics, including the development of best practices to advance safe and responsible digital health research.


Subject(s)
COVID-19 , Checklist , Ethics Committees, Research , Humans , Retrospective Studies , SARS-CoV-2
2.
J Int AIDS Soc ; 24 Suppl 7: e25796, 2021 11.
Article in English | MEDLINE | ID: covidwho-1525464

ABSTRACT

INTRODUCTION: A major change in the ethics framework for preventive HIV vaccine trials worldwide is the release of the UNAIDS 2021 ethical considerations in HIV prevention trials. This new guidance comes at an exciting time when there are multiple HIV vaccine efficacy trials in the field. Research Ethics Committees (RECs) or Institutional Review Boards are a most likely audience for these guidelines. Our objective is to highlight shifts in ethics recommendations from the earlier 2012 UNAIDS guidance. DISCUSSION: We review recommendations related to four key issues, namely standard of prevention, post-trial access to safe and effective vaccines, enrolment of adolescents and enrolment of pregnant women. We outline implications and make recommendations for the ethics review process, including suggested lines of inquiry by RECs and responses by applicants. CONCLUSIONS: There have been several shifts in the UNAIDS ethics guidance with implications for HIV vaccine researchers submitting applications for initial ethics review or re-certification, and for RECs conducting such reviews. This review may assist RECs in a more efficient and consistent application of ethics recommendations. However, additional tools and training may further help stakeholders comply with new UNAIDS ethics recommendations during protocol development and ethics review.


Subject(s)
AIDS Vaccines , HIV Infections , Adolescent , Ethics Committees, Research , Female , HIV Infections/prevention & control , Humans , Pregnancy , Research Design , Research Personnel
3.
BMC Med Ethics ; 22(1): 147, 2021 11 06.
Article in English | MEDLINE | ID: covidwho-1506573

ABSTRACT

BACKGROUND: Research has been an essential part of the COVID-19 pandemic response, including in Latin American (LA) countries. However, implementing research in emergency settings poses the challenge of producing valuable knowledge rapidly while upholding research ethical standards. Research ethics committees (RECs) therefore must conduct timely and rigorous ethics reviews and oversight of COVID-19 research. In the LA region, there is limited knowledge on how countries have responded to this need. To address this gap, the objective of our project is to explore if LA countries developed policies to streamline ethics review and oversight of research in response to the pandemic while ensuring its adherence to ethical standards, and to analyze to what extent these governance frameworks are in accordance with international guidance. METHODS: We conducted a descriptive and exploratory study assessing the COVID-19 research ethics governance frameworks of 19 LA countries, considering 4 dimensions based on international COVID-19 ethics guidance documents: (i) ethics review organizational model adopted, (ii) measures to coordinate between RECs and other research stakeholders, (iii) operational guidance for RECs, and (iv) key ethical issues for review and oversight of COVID-19 research. RESULTS: 10 out of 19 LA countries have some policy to streamline ethics review of COVID-19 research. Of these countries only 6 issued comprehensive documents following international guidance that contemplate strategies with recommendations for concrete actions for a timely and rigorous review. CONCLUSION: LA countries adopted partial strategies and operational guidance that may demonstrate a lack of a comprehensive view of research ethics for the review and oversight of COVID-19 research. Continuing efforts should be directed to strengthen LA countries' research capacity to respond timely and ethically to future health emergencies. Past lessons and the ones from this pandemic should be the basis to develop international standards and operational guidelines for ethics review and oversight of any research for public health emergencies.


Subject(s)
COVID-19 , Ethics Committees, Research , Ethics, Research , Humans , Latin America , Pandemics , SARS-CoV-2
6.
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
8.
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
9.
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
10.
Narrat Inq Bioeth ; 11(1): 95-99, 2021.
Article in English | MEDLINE | ID: covidwho-1337555

ABSTRACT

This commentary discusses twelve stories in which people who are involved in institutional review board (IRB) administration or serve as IRB members tell the stories of how the COVID-19 pandemic affected their work and lives. Among the aspects of these stories it highlights are the need to focus on the well-being of the institution's employees, and how issues involving protecting vulnerable subjects might relate to current policy debates about underserved communities. The final portion of this commentary focuses in particular on how one might measure success for a program in protecting its research subjects during a pandemic.


Subject(s)
COVID-19 , Ethics Committees, Research , Occupational Health , Pandemics , Research Subjects , Safety , Humans , Narration , Policy , SARS-CoV-2 , Vulnerable Populations
11.
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
14.
Narrat Inq Bioeth ; 11(1): 84-87, 2021.
Article in English | MEDLINE | ID: covidwho-1337551
19.
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
20.
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
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