Evidence map›Paper›PMID 35435790›Full record

ArticleThe American journal of bioethics : AJOB2023

Think Pragmatically: Investigators' Obligations to Patient-Subjects When Research is Embedded in Care.

Stephanie Morain, Emily Largent

Abstract read
In one paragraph

Article in The American journal of bioethics : AJOB, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing 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

17 citing papers in PubMed.

  1. A Framework of Institutional Obligations for Pragmatic Clinical Trials.The American journal of bioethics : AJOB · 2026
    Article
  2. Article
  3. Article
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  6. Recurring and Emerging Ethical Issues in Pragmatic Clinical Trials.Circulation. Cardiovascular quality and outcomes · 2024
    Article
  7. Article
  8. Review
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Is There a Doctor in the House?The American journal of bioethics : AJOB · 2023
    Article
  15. Article
  16. Progressing from "Whether to" to "How to" Conduct Pragmatic Trials.The American journal of bioethics : AJOB · 2023
    Article
  17. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

2 authors.

Stephanie MorainJohns Hopkins University.ORCID 0000-0001-7278-7517
Emily LargentUniversity of Pennsylvania.ORCID 0000-0002-7536-5077

Funding

Training Core (I)U54AG063546 · NIA · BROWN UNIVERSITY · PI Alexia Mary Torke · 2019 to 2026
$125.9M
NIH Health Care Systems Research Collaboratory-Coordinating Center (U24)U24AT009676 · NCCIH · DUKE UNIVERSITY · PI LESLEY H CURTIS, Adrian Hernandez · 2017 to 2026
$21.5M
UNDERSTANDING HOW THE STUDY PARTNER REQUIREMENT IMPACTS THE DISCOVERY AND TRANSLATION OF PRECLINICAL ALZHEIMERS DISEASEK01AG064123 · NIA · UNIVERSITY OF PENNSYLVANIA · PI LARGENT, EMILY · 2019 to 2023
$637k
NCCIH NIH HHS U24 AT009676NIA NIH HHS K01 AG064123NIA NIH HHS U54 AG063546
6 · The paper itself

Abstract

Growing interest in embedded research approaches-where research is incorporated into clinical care-has spurred numerous studies to generate knowledge relevant to the real-world needs of patients and other stakeholders. However, it also has presented ethical challenges. An emerging challenge is how to understand the nature and extent of investigators' obligations to patient-subjects. Prior scholarship on investigator duties has generally been grounded upon the premise that research and clinical care are distinct activities, bearing distinct duties. Yet this premise-and its corresponding implications-are challenged when research and clinical care are deliberately integrated. After presenting three case studies from recent pragmatic clinical trials, we identify six differences between explanatory trials and embedded research that limit the application of existing scholarship for ascertaining investigator duties. We suggest that these limitations indicate a need to account for the implications of usual care and to move beyond a narrow focus on the investigator-subject dyad, one that better reflects the team- and institution-based nature of contemporary health systems.

Indexed as

Biomedical ResearchResearch PersonnelHumanshealth services researchhuman subjects researchprofessional ethicsResearch ethics

Identifiers

PMID35435790
PMCPMC9576818

What OpenQuestion holds

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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 OpenQuestion graph.