Evidence mapPaperPMID 35763201Full record

ArticleThe Hastings Center report2022

Toward Meeting the Obligation of Respect for Persons in Pragmatic Clinical Trials.

Stephanie R Morain, Stephanie A Kraft, Benjamin S Wilfond, Amy Mcguire, Neal W Dickert, Andrew Garland, Jeremy Sugarman

Abstract read
In one paragraph

Article in The Hastings Center report, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing 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

12 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Article
  5. Article
  6. Recurring and Emerging Ethical Issues in Pragmatic Clinical Trials.Circulation. Cardiovascular quality and outcomes · 2024
    Article
  7. Ethical considerations for respectful research participant payment processes.Journal of clinical and translational science · 2024
    Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. 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

7 authors.

Stephanie R Morain
Stephanie A Kraft
Benjamin S Wilfond
Amy Mcguire
Neal W Dickert
Andrew Garland
Jeremy Sugarman

Funding

NIH Health Care Systems Research Collaboratory-Coordinating Center (U24)U24AT009676 · DUKE UNIVERSITY · 2025 to 2025
$2.7M
Respect for Persons in the Genomics Research Enrollment Process: Incorporating Diverse Experiences and AttitudesK01HG010361 · NHGRI · SEATTLE CHILDREN'S HOSPITAL · PI Stephanie A Kraft · 2022 to 2023
$259k
National Institutes of Health Health Care Systems Research Collaboratory by the NIH Common Fund U24AT009676NCCIH NIH HHS U24 AT009676NCCIH NIH HHS U24 AT010961NHGRI NIH HHS K01 HG010361NHGRI NIH HHS K01HG010361NIH HEAL Initiative U24AT010961
6 · The paper itself

Abstract

Research ethics oversight systems have traditionally emphasized the informed consent process as the primary means by which to demonstrate respect for prospective subjects. Yet how researchers can best fulfill the ethical obligations of respect for persons in pragmatic clinical trials (PCTs)-particularly those that may alter or waive informed consent-remains unknown. We propose eight dimensions of demonstrating respect in PCTs: (1) engaging patients and communities in research design and execution, (2) promoting transparency and open communication, (3) maximizing agency, (4) minimizing burdens and promoting accessibility, (5) protecting privacy and confidentiality, (6) valuing interpersonal interactions with clinicians and study team members, (7) providing compensation, and (8) maximizing social value. While what respect requires in the context of PCTs will vary based on the nature of the PCT in question, the breadth of these dimensions demonstrates that respect obligations extend beyond informed consent processes.

Indexed as

Informed ConsentMoral ObligationsCommunicationHumansPragmatic Clinical Trials as TopicPrivacyProspective Studiesbioethicsclinical ethicsconsentPCTpragmatic clinical trialsresearch ethicsrespect

Identifiers

PMID35763201
PMCPMC9704739

What Socratic holds

Textmetadata
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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 Socratic graph.