Informed consent: Old and new challenges in the context of the COVID-19 pandemic

Rothwell, Erin; Brassil, Donna; Barton-Baxter, Marietta; Brownley, Kimberly A; Dickert, Neal W.; Ford, Daniel E.; Kraft, Stephanie A.; McCormick, Jennifer B.; Wilfond, Benjamin S.

doi:10.1017/cts.2021.401

Cited by 23 publications

(46 citation statements)

References 26 publications

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“…centers (AMCs). For example, electronic case report forms and consents are now standard operating procedures while regulatory processes have been streamlined and harmonized to maximize productivity and improve safety [12,13].…”

Section: A Phased Reopeningmentioning

confidence: 99%

Managing the risks and benefits of clinical research in response to a pandemic

Flume

Berbari

Viera

et al. 2021

J. Clin. Trans. Sci.

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Section: A Phased Reopeningmentioning

confidence: 99%

Managing the risks and benefits of clinical research in response to a pandemic

Flume

Berbari

Viera

et al. 2021

J. Clin. Trans. Sci.

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“…Some of the ethics issues identified in this study align with COVID-19 literature around virtual informed consent and the need to stay up to date with published data during an evolving pandemic to inform study designs 32,39 . During the Ebola outbreak, different ethics issues were raised in review of protocols such as on storage of blood samples for future use and the exclusion of pregnant women in clinical trials 30 .…”

Section: Discussionmentioning

confidence: 73%

Pandemic preparedness and responsiveness of research review committees: lessons from review of COVID-19 protocols at KEMRI Wellcome Trust Research Programme in Kenya

et al. 2022

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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 Kenya Medical Research Institute - 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. 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 public health emergencies in Kenya needs further investigation. Consideration of the unique COVID-19 ethics issues raised in this paper might aid expedience in current and future reviews.

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“…Use of eIC, including more platforms with interactive features, was increasing but accelerated during the COVID-19 pandemic [11,15], highlighting how well IRBs and study teams can work together to facilitate the transition from paper-based, in-person IC to a remote eIC process. Increased use of eIC likely will become a mainstay of research and provides an opportunity to better meet the expectations for IC outlined in the revised Common Rule, thus substantively improving participant experience by leveraging interactive features that enable the IC process to be tailored to individual participants' needs.…”

Section: Discussionmentioning

confidence: 99%

“…This is a convenient and effective way to engage more people and get them interested in participating in research because >85% of the US population owns a smartphone, with few differences seen across race, age, or socioeconomic status [14]. Further, the COVID-19 pandemic has underscored the need for research teams to conduct the IC process remotely to avoid in-person contact and potential exposure [15]. We expect that the trend toward eIC will continue post-pandemic.…”

Section: Introductionmentioning

confidence: 99%

From paper to screen: regulatory and operational considerations for modernizing the informed consent process

Cobb

Farrar-Edwards

Chin

et al. 2022

J. Clin. Trans. Sci.

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Electronic platforms provide an opportunity to improve the informed consent (IC) process by permitting elements shown to increase research participant understanding and satisfaction, such as graphics, self-pacing, meaningful engagement, and access to additional information on demand. However, including these elements can pose operational and regulatory challenges for study teams and institutional review boards (IRBs) responsible for the ethical conduct and oversight of research. We examined the experience of two study teams at Alzheimer's Disease Research Centers who chose to move from a paper-based IC process to an electronic informed consent (eIC) process to highlight some of these complexities and explore how IRBs and study teams can navigate them. Here, we identify the key regulations that should be considered when developing and using an eIC process as well as some of the operational considerations eIC presents related to IRB review and how they can be addressed.

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Informed consent: Old and new challenges in the context of the COVID-19 pandemic

Abstract: This version may be subject to change during the production process.

Cited by 23 publications

References 26 publications

Managing the risks and benefits of clinical research in response to a pandemic

Managing the risks and benefits of clinical research in response to a pandemic

Pandemic preparedness and responsiveness of research review committees: lessons from review of COVID-19 protocols at KEMRI Wellcome Trust Research Programme in Kenya

From paper to screen: regulatory and operational considerations for modernizing the informed consent process

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