Evidence map›Paper›PMID 36846360›Full record

ArticleIEEE open journal of engineering in medicine and biology2022

COVID-19 Test Us: A Case for Embedding Ethics and Regulatory Expertise.

Holly A Taylor, Janet F Hale, Michael Centola, Allison Blodgett

Abstract read
In one paragraph

Article in IEEE open journal of engineering in medicine and biology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Holly A TaylorDepartment of Bioethics, Clinical CenterNational Institutes of Health Bethesda MD 20892 USA.ORCID https://orcid.org/0000-0001-6811-9356
Janet F HaleUMass Chan Medical School Worcester MA 01655 USA.
Michael CentolaOffice of Research IntegrityUMass Lowell Lowell MA 01854 USA.ORCID https://orcid.org/0000-0001-6828-0844
Allison BlodgettUMass Chan Medical School Worcester MA 01655 USA.

Funding

The Center for Advancing Point of Care in Heart, Lung, Blood and Sleep DiseasesU54HL143541 · NHLBI · UNIV OF MASSACHUSETTS MED SCH WORCESTER · PI BRYAN O BUCHHOLZ, Nathaniel Scott Hafer · 2018 to 2026
$141.0M
NHLBI NIH HHS U54 HL143541
6 · The paper itself

Abstract

A key aspect of the National Institutes of Health (NIH) funded Rapid Acceleration of Diagnostics (RADx) Tech program was an active Clinical Studies Core including Committees with unique expertise to facilitate the development and implementation of studies to test novel diagnostic devices for Covid-19. The Ethics and Human Subjects Oversight Team (EHSO) was tasked to provide ethics and regulatory expertise to stakeholders in the RADx Tech effort. The EHSO developed a set of Ethical Principles to guide the overall effort and provided consultation on a wide range of ethical and regulatory concerns. Having access to a pool of experts with ethical and regulatory knowledge who met weekly to tackle issues of importance to the investigators was critical to the overall success of the project.

Indexed as

Covid-19device testingethicsRADx

Identifiers

PMID36846360
PMCPMC9955894

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.