Evidence map›Paper›PMID 35048782›Full record

ArticleThe American journal of bioethics : AJOB2022

A Research Ethics Framework for the Clinical Translation of Healthcare Machine Learning.

Melissa D McCradden, James A Anderson, Elizabeth A Stephenson, Erik Drysdale, Lauren Erdman, Anna Goldenberg, Randi Zlotnik Shaul

Abstract read
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In one paragraph

Article in The American journal of bioethics : AJOB, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 45 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed, 3 pooled it
–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

45 citing papers in PubMed, 3 syntheses or guidelines pooled it.

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  4. Ethics of Autonomous AI Clinical Trials: Delphi Study.Journal of medical Internet research · 2026
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors.

Melissa D McCraddenDepartment of Bioethics, The Hospital for Sick Children.ORCID 0000-0002-6476-2165
James A AndersonDepartment of Bioethics, The Hospital for Sick Children.
Elizabeth A StephensonLabatt Family Heart Centre, The Hospital for Sick Children.
Erik DrysdaleGenetics and Genome Biology, The Hospital for Sick Children, Peter Gilgan Centre for Research and Learning.
Lauren ErdmanGenetics and Genome Biology, The Hospital for Sick Children, Peter Gilgan Centre for Research and Learning.
Anna GoldenbergDepartment of Bioethics, The Hospital for Sick Children.
Randi Zlotnik ShaulDepartment of Bioethics, The Hospital for Sick Children.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The application of artificial intelligence and machine learning (ML) technologies in healthcare have immense potential to improve the care of patients. While there are some emerging practices surrounding responsible ML as well as regulatory frameworks, the traditional role of research ethics oversight has been relatively unexplored regarding its relevance for clinical ML. In this paper, we provide a comprehensive research ethics framework that can apply to the systematic inquiry of ML research across its development cycle. The pathway consists of three stages: (1) exploratory, hypothesis-generating data access; (2) silent period evaluation; (3) prospective clinical evaluation. We connect each stage to its literature and ethical justification and suggest adaptations to traditional paradigms to suit ML while maintaining ethical rigor and the protection of individuals. This pathway can accommodate a multitude of research designs from observational to controlled trials, and the stages can apply individually to a variety of ML applications.

Indexed as

Artificial IntelligenceEthics Committees, ResearchDelivery of Health CareEthics, ResearchHumansInformed ConsentMachine LearningProspective StudiesEthics committeeshealth care deliveryhuman subjects researchinformed consentIRB (Institutional Review Board)research ethics

Identifiers

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.