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Article: Research in the Time of COVID-19: Challenges of Research Ethics Committees.

Reyes, Marita

Journal of the ASEAN Federation of Endocrine Societies

2020 Volume 35, Issue 1, Page(s) 29–32

Abstract: Compliance with ethics guidelines for research are even more critical in the time of emergency ... Standard Operating Procedures (SOPs) in research ethics committees may be revised to provide a quicker turn ... and timeliness. It is crucial to recognize that ethics review committees share responsibility ...

Abstract	Compliance with ethics guidelines for research are even more critical in the time of emergency public health situations such as a pandemic. Underpinned by the principles laid out in the 1979 Belmont report, conduct of research at any time should focus on respect for persons, beneficence and justice. Certain Standard Operating Procedures (SOPs) in research ethics committees may be revised to provide a quicker turn-around and timely review. Key elements in effective review of studies include rigorousness, responsiveness and timeliness. It is crucial to recognize that ethics review committees share responsibility with researchers and its institutions, funding agencies and regulatory agencies for upholding ethical principles in research at all times.
Language	English
Publishing date	2020-05-23
Publishing country	Thailand
Document type	Journal Article
ZDB-ID	2893162-2
ISSN	2308-118X ; 0857-1074
ISSN (online)	2308-118X
ISSN	0857-1074
DOI	10.15605/jafes.035.01.07
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article: Research in the time of covid-19: Challenges of research ethics committees

Reyes, Marita

J. ASEAN Fed. Endocr. Soc.

Abstract	Compliance with ethics guidelines for research are even more critical in the time of emergency public health situations such as a pandemic. Underpinned by the principles laid out in the 1979 Belmont report, conduct of research at any time should focus on respect for persons, beneficence and justice. Certain Standard Operating Procedures (SOPs) in research ethics committees may be revised to provide a quicker turn-around and timely review. Key elements in effective review of studies include rigorousness, responsiveness and timeliness. It is crucial to recognize that ethics review committees share responsibility with researchers and its institutions, funding agencies and regulatory agencies for upholding ethical principles in research at all times.
Keywords	covid19
Publisher	WHO
Document type	Article
Note	WHO #Covidence: #678596
Database	COVID19

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Article ; Online: Informed Consent in COVID-19-Research

Katja Voit / Tobias Skuban-Eiseler / Marcin Orzechowski / Florian Steger

Healthcare, Vol 11, Iss 1793, p

An Ethical Analysis of Clinical Studies Performed during the Pandemic

2023 Volume 1793

Abstract: ... with COVID-19 that the Research Ethics Committee of Ulm University has reviewed and voted on in the years ... Health crises such as the current COVID-19 pandemic pose challenges to the conduct of clinical ... studies. Aspects of research ethics, such as obtaining informed consent (IC), can be complicated. We are ...

Abstract	Health crises such as the current COVID-19 pandemic pose challenges to the conduct of clinical studies. Aspects of research ethics, such as obtaining informed consent (IC), can be complicated. We are concerned with whether or not the proper IC procedures were followed in the context of clinical studies at Ulm University in the years 2020 to 2022. We identified all protocols of clinical studies dealing with COVID-19 that the Research Ethics Committee of Ulm University has reviewed and voted on in the years 2020 to 2022. We then performed a thematic analysis regarding the following aspects: study type, handling of IC, type of patient information, means of communication, applied security precautions, and the approach to participants from vulnerable groups. We identified n = 98 studies that dealt with COVID-19. In n = 25 (25.51%), IC was obtained traditionally in written form, in n = 26 (26.53%) IC was waived, in n = 11 (11.22%) IC was obtained delayed, and in n = 19 (19.39%) IC was obtained by proxy. No study protocol was accepted that waived IC in case IC would have been required in times outside of pandemics. It is possible to obtain IC even in times of severe health crises. In the future, it is necessary to address in greater detail and with legal certainty which alternative methods of obtaining IC are possible and under which circumstances IC can be waived.
Keywords	informed consent ; COVID-19 ; clinical study ; ethics ; Medicine ; R
Subject code	170
Language	English
Publishing date	2023-06-01T00:00:00Z
Publisher	MDPI AG
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Pandemic preparedness and responsiveness of research review committees

Alex Hinga / Marianne Munene / Jane Kahindi / Esther Awuor / Dorcas Kamuya / Lisha Jeena / Sassy Molyneux / Samson Kinyanjui / Vicki Marsh

Wellcome Open Research, Vol

lessons from review of COVID-19 protocols at KEMRI Wellcome Trust Research Programme in Kenya [version 2; peer review: 2 approved]

2022 Volume 7

Abstract: ... challenges in the review of COVID-19 protocols. We investigated how research at the KEMRI Wellcome Trust ... feedback letters from review committees for 10 new COVID-19 protocols (n=42), and minutes from 35 COVID-19 ... ethics questions centred on: virtual informed consent and data collection; COVID-19 prevention, screening ...

Abstract	Background: The scale of the COVID-19 pandemic and novelty of SARS-CoV-2 presented unprecedented challenges in the review of COVID-19 protocols. We investigated how research at the KEMRI Wellcome Trust Research Programme (KWTRP) was reviewed, including by institutional and national level committees. Methods: A document review and in-depth interviews with researchers, regulators and research reviewers were conducted. Documents reviewed included research logs of all protocols submitted between April-1-2020 and March-31-2021, feedback letters from review committees for 10 new COVID-19 protocols (n=42), and minutes from 35 COVID-19 research review meetings. Fifteen in-depth interviews were conducted with respondents purposively selected because of their experience of developing or reviewing COVID-19 protocols at the institution level (n=9 researchers, engagement officers and regulators) or their experience in reviewing proposals at a national-level (n=6 committee members). Data were managed and analyzed using MS Excel and NVivo12. Results: Between April-1-2020 and March-31-2021, 30 COVID-19-related submissions by KWTRP researchers were approved. Changes to the review system included strengthening the online system for protocol submission and review, recruiting more reviewers, and trialing a joint review process where one protocol was submitted to multiple review committees simultaneously . The turnaround time from submission to national approval/rejection over this period was faster than pre-pandemic, but slower than the national committee’s target. COVID-19-specific ethics questions centred on: virtual informed consent and data collection; COVID-19 prevention, screening and testing procedures; and the challenges of study design and community engagement during the pandemic. Conclusions: The unprecedented challenges of the pandemic and added bureaucratic requirements created a more complex review process and delayed final approval of research protocols. The feasibility of conducting joint review of research during ...
Keywords	research review ; ethics committee ; COVID-19 ; Kenya ; eng ; Medicine ; R ; Science ; Q
Subject code	306
Language	English
Publishing date	2022-06-01T00:00:00Z
Publisher	Wellcome
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article: Informed Consent in COVID-19-Research: An Ethical Analysis of Clinical Studies Performed during the Pandemic.

Voit, Katja / Skuban-Eiseler, Tobias / Orzechowski, Marcin / Steger, Florian

Healthcare (Basel, Switzerland)

2023 Volume 11, Issue 12

Abstract	Health crises such as the current COVID-19 pandemic pose challenges to the conduct of clinical studies. Aspects of research ethics, such as obtaining informed consent (IC), can be complicated. We are concerned with whether or not the proper IC procedures were followed in the context of clinical studies at Ulm University in the years 2020 to 2022. We identified all protocols of clinical studies dealing with COVID-19 that the Research Ethics Committee of Ulm University has reviewed and voted on in the years 2020 to 2022. We then performed a thematic analysis regarding the following aspects: study type, handling of IC, type of patient information, means of communication, applied security precautions, and the approach to participants from vulnerable groups. We identified n = 98 studies that dealt with COVID-19. In n = 25 (25.51%), IC was obtained traditionally in written form, in n = 26 (26.53%) IC was waived, in n = 11 (11.22%) IC was obtained delayed, and in n = 19 (19.39%) IC was obtained by proxy. No study protocol was accepted that waived IC in case IC would have been required in times outside of pandemics. It is possible to obtain IC even in times of severe health crises. In the future, it is necessary to address in greater detail and with legal certainty which alternative methods of obtaining IC are possible and under which circumstances IC can be waived.
Language	English
Publishing date	2023-06-17
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2721009-1
ISSN	2227-9032
ISSN	2227-9032
DOI	10.3390/healthcare11121793
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Article ; Online: Human Research During the COVID-19 Pandemic: Insights From Behind-the-Scenes.

Iltis, Ana S

Narrative inquiry in bioethics

2021 Volume 11, Issue 1, Page(s) 47–53

Abstract: ... routinely associated with conducting human research were amplified during the COVID-19 pandemic ... integrity, managing budget constraints, and finding time to fulfill research obligations along ... The researchers' stories collected here demonstrate how many ethical and practical challenges ...

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.
MeSH term(s)	Biomedical Research/ethics ; COVID-19 ; Ethics Committees, Research ; Ethics, Research ; Humans ; Narration ; Pandemics ; Research Design ; Research Personnel/ethics ; SARS-CoV-2
Language	English
Publishing date	2021-07-21
Publishing country	United States
Document type	Journal Article
ZDB-ID	2632728-4
ISSN	2157-1740 ; 2157-1732
ISSN (online)	2157-1740
ISSN	2157-1732
DOI	10.1353/nib.2021.0020
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Article ; Online: Challenges and proposed solutions in making clinical research on COVID-19 ethical: a status quo analysis across German research ethics committees.

Faust, Alice / Sierawska, Anna / Krüger, Katharina / Wisgalla, Anne / Hasford, Joerg / Strech, Daniel

BMC medical ethics

2021 Volume 22, Issue 1, Page(s) 96

Abstract: ... 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 ... of literature on COVID-19 research ethics, and further stakeholder engagement should inform the development ...

Abstract	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.
MeSH term(s)	COVID-19 ; Ethics Committees, Research ; Ethics, Research ; Humans ; Pandemics ; SARS-CoV-2
Language	English
Publishing date	2021-07-19
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2041552-7
ISSN	1472-6939 ; 1472-6939
ISSN (online)	1472-6939
ISSN	1472-6939
DOI	10.1186/s12910-021-00666-8
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Article ; Online: Adapting the ethical review process for COVID-19 research: reviewers' perspectives from Pakistan.

Shekhani, Sualeha / Iqbal, Saima / Jafarey, Aamir

Eastern Mediterranean health journal = La revue de sante de la Mediterranee orientale = al-Majallah al-sihhiyah li-sharq al-mutawassit

2021 Volume 27, Issue 11, Page(s) 1045–1051

Abstract: ... timely reviews of research proposals in the wake of the COVID-19 pandemic. The REC of the National ... reviewers who reviewed COVID-19 research proposals while describing the newly instituted Rapid Turnaround ... interviews conducted with both groups; and document review related to COVID-19 research proposals.: Results ...

Abstract	Background: Research ethics committees (RECs) globally have adapted their responses to provide timely reviews of research proposals in the wake of the COVID-19 pandemic. The REC of the National Bioethics Committee (NBC) of Pakistan has followed suit. Aims: To explore perceptions of NBC-REC reviewers who reviewed COVID-19 research proposals while describing the newly instituted Rapid Turnaround Review (RTR) system. Methods: This cross-sectional study used 3 methods of data collection: a demographic questionnaire filled in by permanent members and co-opted reviewers; qualitative in-depth interviews conducted with both groups; and document review related to COVID-19 research proposals. Results: Eight permanent members and 3 co-opted members participated. Under the RTR system, the time for review was established as 72 hours after receipt of the proposal. The Committee reviewed 55 projects over 10 months. Participants described numerous strengths of the new system, including introduction of online discussions via Zoom as well as presence of co-opted members leading to learning opportunities, particularly for junior members. The RTR system also allowed NBC-REC to gain recognition it had not enjoyed previously. Challenges identified by respondents included initial difficulty in initiating the system and tighter deadlines that may have compromised review quality. Poor scientific quality of proposals, compounded by external pressures to provide rapid approval, added to reviewers' frustrations. While fruitful, the RTR system was considered unsustainable beyond a public health emergency. Conclusion: Adaptation of ethical review processes is essential in emergencies, however, existing guidelines have to be modified to suit contextual needs.
MeSH term(s)	COVID-19 ; Cross-Sectional Studies ; Ethical Review ; Humans ; Pakistan ; Pandemics ; SARS-CoV-2
Language	English
Publishing date	2021-12-01
Publishing country	Egypt
Document type	Journal Article
ZDB-ID	1291071-5
ISSN	1687-1634 ; 1020-3397
ISSN (online)	1687-1634
ISSN	1020-3397
DOI	10.26719/emhj.21.053
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Article ; Online: Mitigation strategies to safely conduct HIV treatment research in the context of COVID-19.

Henderson, Merle / Fidler, Sarah / Mothe, Beatriz / Grinsztejn, Beatriz / Haire, Bridget / Collins, Simon / Lau, Jillian S Y / Luba, Maureen / Sanne, Ian / Tatoud, Roger / Deeks, Steve / Lewin, Sharon R

Journal of the International AIDS Society

2021 Volume 25, Issue 2, Page(s) e25882

Abstract: ... challenges to conducting clinical research in PLWH. Guidelines regarding how best to implement HIV treatment ... strategies, the risk to PLWH in clinical trials will decline over time. However, with the emergence of more ... with HIV research from both PLWH and the research community despite the ongoing SARS-CoV-2 pandemic. How ...

Abstract	Introduction: The International AIDS Society convened a multidisciplinary committee of experts in December 2020 to provide guidance and key considerations for the safe and ethical management of clinical trials involving people living with HIV (PLWH) during the SARS-CoV-2 pandemic. This consultation did not discuss guidance for the design of prevention studies for people at risk of HIV acquisition, nor for the programmatic delivery of antiretroviral therapy (ART). Discussion: There is strong ambition to continue with HIV research from both PLWH and the research community despite the ongoing SARS-CoV-2 pandemic. How to do this safely and justly remains a critical debate. The SARS-CoV-2 pandemic continues to be highly dynamic. It is expected that with the emergence of effective SARS-CoV-2 prevention and treatment strategies, the risk to PLWH in clinical trials will decline over time. However, with the emergence of more contagious and potentially pathogenic SARS-CoV-2 variants, the effectiveness of current prevention and treatment strategies may be compromised. Uncertainty exists about how equally SARS-CoV-2 prevention and treatment strategies will be available globally, particularly for marginalized populations, many of whom are at high risk of reduced access to ART and/or HIV disease progression. All of these factors must be taken into account when deciding on the feasibility and safety of developing and implementing HIV research. Conclusions: It can be assumed for the foreseeable future that SARS-CoV-2 will persist and continue to pose challenges to conducting clinical research in PLWH. Guidelines regarding how best to implement HIV treatment studies will evolve accordingly. The risks and benefits of performing an HIV clinical trial must be carefully evaluated in the local context on an ongoing basis. With this document, we hope to provide a broad guidance that should remain viable and relevant even as the nature of the pandemic continues to develop.
MeSH term(s)	COVID-19 ; HIV Infections/drug therapy ; HIV Infections/epidemiology ; HIV Infections/prevention & control ; Humans ; Pandemics ; SARS-CoV-2
Language	English
Publishing date	2021-12-31
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2467110-1
ISSN	1758-2652 ; 1758-2652
ISSN (online)	1758-2652
ISSN	1758-2652
DOI	10.1002/jia2.25882
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Journal ; Article ; Online: Adapting the ethical review process for COVID-19 research

Sualeha Shekhani / Saima Iqbal / Aamir Jafarey

reviewers’ perspectives from Pakistan

2021

Abstract: ... timely reviews of research proposals in the wake of the COVID-19 pandemic. The REC of the National ... who reviewed COVID-19 research proposals while describing the newly instituted Rapid Turnaround Review (RTR ... with both groups; and document review related to COVID-19 research proposals.Results:Eight permanent members and 3 ...

Abstract	Background:Research ethics committees (RECs) globally have adapted their responses to provide timely reviews of research proposals in the wake of the COVID-19 pandemic. The REC of the National Bioethics Committee (NBC) of Pakistan has followed suit.Aims:To explore perceptions of NBC-REC reviewers who reviewed COVID-19 research proposals while describing the newly instituted Rapid Turnaround Review (RTR) system.Methods:This cross-sectional study used 3 methods of data collection: a demographic questionnaire filled in by permanent members and co-opted reviewers; qualitative in-depth interviews conducted with both groups; and document review related to COVID-19 research proposals.Results:Eight permanent members and 3 co-opted members participated. Under the RTR system, the time for review was established as 72 hours after receipt of the proposal. The Committee reviewed 55 projects over 10 months. Participants described numerous strengths of the new system, including introduction of online discussions via Zoom as well as presence of co-opted members leading to learning opportunities, particularly for junior members. The RTR system also allowed NBC-REC to gain recognition it had not enjoyed previously. Challenges identified by respondents included initial difficulty in initiating the system and tighter deadlines that may have compromised review quality. Poor scientific quality of proposals, compounded by external pressures to provide rapid approval, added to reviewers’ frustrations. While fruitful, the RTR system was considered unsustainable beyond a public health emergency.Conclusion:Adaptation of ethical review processes is essential in emergencies; however, existing guidelines have to be modified to suit contextual needs. 1045 1051
Keywords	Coronavirus Disease (COVID-19) ; COVID-19 ; Research Design ; Emergencies ; Public Health ; Bioethics ; Surveys and Questionnaires ; Demography ; physiopathology ; instrumentation ; education ; standards ; economics
Language	English
Publisher	World Health Organization. Regional Office for the Eastern Mediterranean
Document type	Journal ; Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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