Evidence map›Paper›PMID 35324933›Full record

ArticlePloS one2022

Ethical, regulatory, and practical barriers to COVID-19 research: A stakeholder-informed inventory of concerns.

Bryan A Sisk, Kari Baldwin, Meredith Parsons, James M DuBois

Abstract read
In one paragraph

Article in PloS one, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Bryan A SiskDivision of Hematology/Oncology, Department of Pediatrics, Washington University School of Medicine, St. Louis, Missouri, United State of America.ORCID 0000-0002-2456-2476
Kari BaldwinDivision of General Medical Sciences, Bioethics Research Center, Department of Medicine, Washington University School of Medicine, St. Louis, Missouri, United States of America.
Meredith ParsonsDivision of General Medical Sciences, Bioethics Research Center, Department of Medicine, Washington University School of Medicine, St. Louis, Missouri, United States of America.
James M DuBoisDivision of General Medical Sciences, Bioethics Research Center, Department of Medicine, Washington University School of Medicine, St. Louis, Missouri, United States of America.ORCID 0000-0002-3712-7051

Funding

WU INSTITUTE OF CLINICAL AND TRANSLATIONAL SCIENCESUL1TR002345 · NCATS · WASHINGTON UNIVERSITY · PI William G. Powderly · 2017 to 2026
$97.8M
Understanding and addressing challenges to informed consent and research compliance during Covid-19 researchR01AG058254 · NIA · WASHINGTON UNIVERSITY · PI DUBOIS, JAMES M · 2018 to 2022
$2.8M
NCATS NIH HHS UL1 TR002345NIA NIH HHS R01 AG058254
6 · The paper itself

Abstract

introductionSARS-CoV-2 (COVID-19) has caused death and economic injury around the globe. The urgent need for COVID-19 research created new ethical, regulatory, and practical challenges. The next public health emergency could be worse than COVID-19. We must learn about these challenges from the experiences of researchers and Research Ethics Committee professionals responsible for these COVID-19 studies to prepare for the next emergency. MATERIALS AND

methodsWe conducted an online survey to identify the ethical, oversight, and regulatory challenges of conducting COVID-19 research during the early pandemic, and proposed solutions for overcoming these barriers. Using criterion-based, convenience sampling, we invited researchers who proposed or conducted COVID-19 research to complete an anonymous, online survey about their experiences. We administered a separate but related survey to Institutional Review Board (IRB) professionals who reviewed COVID-19 research studies. The surveys included open-ended and demographic items. We performed inductive content analysis on responses to open-ended survey questions.

resultsIRB professionals (n = 143) and researchers (n = 211) described 19 types of barriers to COVID-19 research, related to 5 overarching categories: policy and regulatory, biases and misperceptions, institutional and inter-institutional conflicts, risks of harm, and pressure of the pandemic. Researchers and IRB professionals described 8 categories of adaptations and solutions to these challenges: enacting technological solutions; developing protocol-based solutions; disposition and team management; establishing and communicating appropriate standards; national guidance and leadership; maintaining high standards; prioritizing studies before IRB review; and identifying and incorporating experts. DISCUSSION AND

conclusionsThis inventory of challenges represents ongoing barriers to studying the current pandemic, and they represent a risk to research during future public health emergencies. Delays in studies of a pandemic during a pandemic threatens the health and safety of the public. We urge the development of a national working group to address these issues before the next public health emergency arises.

Indexed as

COVID-19Ethics Committees, ResearchHumansPandemicsResearch PersonnelSARS-CoV-2

Identifiers

PMID35324933
PMCPMC8947496

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.