Evidence map›Paper›PMID 33506070›Full record

ArticleOpen forum infectious diseases2021

Human Challenge Studies With Wild-Type Severe Acute Respiratory Sydrome Coronavirus 2 Violate Longstanding Codes of Human Subjects Research.

Stanley M Spinola, Camilla Broderick, Gregory D Zimet, Mary A Ott

Open access · goldAbstract read
In one paragraph

Article in Open forum infectious diseases, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.2field-weighted citation impact, top 42% 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

1 citing paper in PubMed, 12 citations in OpenAlex.

  1. 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 at 2 institutions in 1 country.

Stanley M SpinolaDepartment of Microbiology and Immunology, Indiana University School of Medicine, Indiana University, Indianapolis, Indiana, USA.
Camilla BroderickThe John Jay College of Criminal Justice, New York, New York, USA.
Gregory D ZimetDepartment of Pediatrics, Indiana University School of Medicine, Indiana University, Indianapolis, Indiana, USA.
Mary A OttDepartment of Pediatrics, Indiana University School of Medicine, Indiana University, Indianapolis, Indiana, USA.
Indiana University School of MedicineJohn Jay College of Criminal Justice · US

Funding

Quality Assurance and Quality Control Project Management: Improving Submissions and Study Conduct in the Human Subjects Research Prior Approval ProcessUL1TR002529 · NCATS · INDIANA UNIVERSITY INDIANAPOLIS · PI MOE, SHARON M, WIEHE, SARAH ELIZABETH · 2018 to 2022
$27.2M
Determination of the Interactome between Haemophilus ducreyi and the Human Host.R01AI137116 · NIAID · INDIANA UNIVERSITY INDIANAPOLIS · PI SPINOLA, STANLEY M. · 2020 to 2024
$3.2M
NCATS NIH HHS UL1 TR002529NIAID NIH HHS R01 AI137116
6 · The paper itself

Abstract

This manuscript explores the ethics of human inoculation experiments in young healthy adults with wild-type severe acute respiratory sydrome coronavirus 2 (SARS-CoV-2) as a tool to evaluate vaccine efficacy in the context of the Nuremberg Code, the Declaration of Helsinki, and the Belmont Report, and in the context of dose-response relationships with infectious agents. Despite societal pressure to develop a SARS-CoV-2 challenge model to evaluate vaccines, we argue that there are substantial risks that cannot be adequately defined because the dose of SARS-CoV-2 that causes severe disease in young adults is unknown. In the absence of curative therapy, even if a volunteer consents, longstanding ethical codes governing human subjects research preclude the conduct of such experiments.

Indexed as

ethicshuman challenge experimentsSARS-CoV-2vaccines

Identifiers

PMID33506070
PMCPMC7798584
OpenAlexW3116156448

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.