Evidence map›Paper›PMID 18547191›Full record

ReviewThe Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics2008

Managing incidental findings in human subjects research: analysis and recommendations.

Susan M Wolf, Frances P Lawrenz, Charles A Nelson, Jeffrey P Kahn, Mildred K Cho, Ellen Wright Clayton, Joel G Fletcher, Michael K Georgieff, Dale Hammerschmidt, Kathy Hudson and 11 more

4 registry-linked trialsOpen access · greenAbstract readReview
In one paragraph

Review in The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 350 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
350citing papers in PubMed, 5 pooled it
30.4field-weighted citation impact, top 1% 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.

NCT02636712 completednot on this mapstarted 2015, after this paper: background citation

Observation of ImageReady™ MR Conditional Pacing System in China

TypeobservationalSponsorBoston Scientific CorporationRan2015 to 2017Enrolled10ConditionsArhythmia, Atrioventricular Heart-block, Chronic Bundle Branch or Branch Block, Carotid Sinus Hypersensitivity Reaction SyndromeArmsImageReady™ MR Conditional Pacing System
NCT03451721 nacompletednot on this mapstarted 2018, after this paper: background citation

Observation of ImageReady™ MR Conditional Defibrillation System in China (MR ICD)

TypeinterventionalSponsorBoston Scientific CorporationRan2018 to 2019Enrolled20ConditionsArrhythmiaArmsImageReady™ MR Conditional Defibrillation System
NCT03543644 nacompletednot on this mapstarted 2018, after this paper: background citation

A Randomized Controlled Trial of the Effect of Replacing Sugar-sweetened Beverages With Non-nutritive Sweetened Beverages or Water on Gut Microbiome and Metabolic Outcomes: STOP Sugars NOW Trial

TypeinterventionalSponsorUniversity of TorontoRan2018 to 2020Enrolled81ConditionsHealthy, Overweight and Obesity, Metabolic Syndrome, PreDiabetesArmsSugar-sweetened beverage (SSB), Non-nutritive sweetened beverages (NSB), Water
NCT04196374 nacompletednot on this mapstarted 2021, after this paper: background citation

Return of Genomic Results and Aggregate Penetrance in Population-Based Cohorts

TypeinterventionalSponsorBrigham and Women's HospitalRan2021 to 2025Enrolled7,603ConditionsSeemingly Healthy, Genetic Predisposition to DiseaseArmsGenomic Sequencing
3 · Its place in the literature

Who cites it

350 citing papers in PubMed, 5 syntheses or guidelines pooled it, 699 citations in OpenAlex.

  1. Pooled it
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  10. Provider and patient perceptions on the usage of whole-body magnetic resonance imaging in oncology: a scoping review.Cancer imaging : the official publication of the International Cancer Imaging Society · 2026
    Review
  11. Ethical Considerations in Transcranial Focused Ultrasound Neuromodulation for Disorders of Consciousness.Neuromodulation : journal of the International Neuromodulation Society · 2026
    Article
  12. Article
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  16. Observational
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  18. Review
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290 more citing papers are in PubMed but not listed here.

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

21 authors at 12 institutions in 2 countries.

Susan M WolfUniversity of Minnesota, MN, USA.
Frances P Lawrenz
Charles A Nelson
Jeffrey P Kahn
Mildred K Cho
Ellen Wright Clayton
Joel G Fletcher
Michael K Georgieff
Dale Hammerschmidt
Kathy Hudson
Judy Illes
Vivek Kapur
Moira A Keane
Barbara A Koenig
Bonnie S Leroy
Elizabeth G McFarland
Jordan Paradise
Lisa S Parker
Sharon F Terry
Brian Van Ness
Benjamin S Wilfond
University of Minnesota · USTwin Cities Orthopedics · USUniversity of Washington · USGenetic Alliance · USHarvard University Press · USJohns Hopkins University · USPennsylvania State University · USStanford University · USUniversity of British Columbia · CAUniversity of Pittsburgh · USVanderbilt University · USWinnMed · US

Funding

Managing Incidental Findings in Human Subjects ResearchR01HG003178 · NHGRI · UNIVERSITY OF MINNESOTA TWIN CITIES · PI WOLF, SUSAN M. · 2005 to 2010
$1.5M
NHGRI NIH HHS R01 HG 003178NHGRI NIH HHS R01 HG003178
6 · The paper itself

Abstract

No consensus yet exists on how to handle incidental findings (IFs) in human subjects research. Yet empirical studies document IFs in a wide range of research studies, where IFs are findings beyond the aims of the study that are of potential health or reproductive importance to the individual research participant. This paper reports recommendations of a two-year project group funded by NIH to study how to manage IFs in genetic and genomic research, as well as imaging research. We conclude that researchers have an obligation to address the possibility of discovering IFs in their protocol and communications with the IRB, and in their consent forms and communications with research participants. Researchers should establish a pathway for handling IFs and communicate that to the IRB and research participants. We recommend a pathway and categorize IFs into those that must be disclosed to research participants, those that may be disclosed, and those that should not be disclosed.

Indexed as

Incidental FindingsResearch SubjectsBiomedical ResearchGenomicsHumansReferral and ConsultationTruth Disclosure

Identifiers

PMID18547191
PMCPMC2575242
OpenAlexW1983973208

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

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.