Evidence map›Paper›PMID 39279821›Full record

ArticleOpen research Europe2024

Evolution of informed consent in research: From the Hippocratic Oath to the tailored consent.

Jaime Fons-Martinez, Carlos Murciano-Gamborino, Javier Diez-Domingo

Abstract read
In one paragraph

Article in Open research Europe, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Article
  2. Article
  3. 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

3 authors.

Jaime Fons-MartinezVaccine Research Area, Foundation for the Promotion of Health and Biomedical Research of Valencia Region, FISABIO, Valencia, Spain.ORCID https://orcid.org/0000-0002-8319-3658
Carlos Murciano-GamborinoVaccine Research Area, Foundation for the Promotion of Health and Biomedical Research of Valencia Region, FISABIO, Valencia, Spain.ORCID https://orcid.org/0009-0003-7794-8748
Javier Diez-DomingoVaccine Research Area, Foundation for the Promotion of Health and Biomedical Research of Valencia Region, FISABIO, Valencia, Spain.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Informed consent (IC) is essential in defending the autonomy of potential participants in clinical research. Despite the advances in research ethics, particularly in IC, the different guidelines and codes have not been fully implemented. Several studies have presented consent deficiencies that have resulted in unethical practices or poor understanding of the IC. Main body: This article reviews the evolution of IC, from its philosophical origins and initial use in the Ottoman Empire (16th century) to its use in clinical research today. It also presents the vision of the European project i-CONSENT (Grant Agreement number: 741856), whose main purpose is to improve the understanding of ICs in research and identifies the key components of a new paradigm to develop patient-centred ICs. Conclusions: In many cases, the IC has served to protect the investigator or sponsor from complaints. Different ethical guidelines have sought to make the IC a more useful tool, with little success. Today's IC is mainly a bureaucratic and legal process that fails to consider the patient's point of view. In this context, the Guidelines for Tailoring the Informed Consent Process in Clinical Studies provide alternatives to the current IC process, focusing on the patient's opinions and making them part of the process, thereby improving clinical research quality.

Indexed as

Belmont ReportDeclaration of HelsinkieConsenti-CONSENTInformed consentresearch ethicsThe Nuremberg Code

Identifiers

PMID39279821
PMCPMC11399764

What OpenQuestion holds

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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.