Evidence map›Paper›PMID 30744313›Full record

ArticleEthics & human research2019

Advancing Ethics and Policy for Healthy-Volunteer Research through a Model-Organism Framework.

Jill A Fisher, Rebecca L Walker

Open access · hybridAbstract read
In one paragraph

Article in Ethics & human research, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
2.2field-weighted citation impact, top 13% of its field
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

10 citing papers in PubMed, 18 citations in OpenAlex.

  1. Article
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  7. Appraising Harm in Phase I Trials: Healthy Volunteers' Accounts of Adverse Events.The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics · 2019
    Article
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

2 authors at 1 institution in 1 country.

Jill A FisherAssociate professor in the Department of Social Medicine and the Center for Bioethics at the University of North Carolina at Chapel Hill.
Rebecca L WalkerProfessor in the Department of Social Medicine and the Center for Bioethics at the University of North Carolina at Chapel Hill.
University of North Carolina at Chapel Hill · US

Funding

Healthy Volunteers as Model Organisms: Comparative Research Ethics and Policy for Phase I trialsR01GM099952 · NIGMS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI FISHER, JILL A, WALKER, REBECCA · 2012 to 2020
$3.6M
NIGMS NIH HHS R01 GM099952
6 · The paper itself

Abstract

Nonhuman animal research and phase I healthy-volunteer clinical trials are both critical components of testing the safety of investigational drugs as part of the development of new pharmaceuticals. In addition, these types of research share important structural features, as both take place in confinement and both use subjects that are dissimilar to the target population. By mobilizing a model-organism framework for phase I trials, we employ concepts and mechanisms typical to animal research to query gaps in the human subjects ethics and policy framework. By bringing these two research worlds together, we aim to illustrate how the model-organism framework can enhance healthy volunteers' welfare during trials, improve research oversight, and more critically assess the science value of current phase I trials.

Indexed as

Ethics, ResearchHealthy VolunteersAdultAnimal ExperimentationAnimalsDrugs, InvestigationalHumansPolicyDrugs, Investigationalanimal research ethicshealthy‐volunteer researchhuman research ethicsphase I clinical trialsresearch oversight

Identifiers

PMID30744313
PMCPMC6410705
OpenAlexW2911720550

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.