Evidence map›Paper›PMID 29342285›Full record

ArticleThe Journal of medicine and philosophy2018

Serial Participation and the Ethics of Phase 1 Healthy Volunteer Research.

Rebecca L Walker, Marci D Cottingham, Jill A Fisher

Abstract read
In one paragraph

Article in The Journal of medicine and philosophy, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 1 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

18 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. The Ethics of Human Embryo Editing via CRISPR-Cas9 Technology: A Systematic Review of Ethical Arguments, Reasons, and Concerns.HEC forum : an interdisciplinary journal on hospitals' ethical and legal issues · 2025
    Pooled it
  2. Article
  3. Review
  4. Observational
  5. Article
  6. Article
  7. Paying for Fairness? Incentives and Fair Subject Selection.The American journal of bioethics : AJOB · 2021
    Article
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  17. Healthy Volunteers' Perceptions of the Benefits of Their Participation in Phase I Clinical Trials.Journal of empirical research on human research ethics : JERHRE · 2018
    Article
  18. 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.

Rebecca L WalkerUniversity of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
Marci D CottinghamUniversity of Amsterdam, Amsterdam, The Netherlands.
Jill A FisherUniversity of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.

Funding

Healthy Volunteers as Model Organisms: Comparative Research Ethics and Policy for Phase I trialsR01GM099952 · NIGMS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI FISHER, JILL A, WALKER, REBECCA · 2012 to 2020
$3.6M
NIGMS NIH HHS R01 GM099952
6 · The paper itself

Abstract

Phase 1 healthy volunteer clinical trials-which financially compensate subjects in tests of drug toxicity levels and side effects-appear to place pressure on each joint of the moral framework justifying research. In this article, we review concerns about phase 1 trials as they have been framed in the bioethics literature, including undue inducement and coercion, unjust exploitation, and worries about compromised data validity. We then revisit these concerns in light of the lived experiences of serial participants who are income-dependent on phase 1 trials. We show how participant experiences shift attention from discrete exchanges, behaviors, and events in the research enterprise to the ongoing and dynamic patterns of serial participation in which individual decision-making is embedded in collective social and economic conditions and shaped by institutional policies. We argue in particular for the ethical significance of structurally diminished voluntariness, routine powerlessness in setting the terms of exchange, and incentive structures that may promote pharmaceutical interests but encourage phase 1 healthy volunteers to skirt important rules.

Indexed as

CoercionEthics, ResearchAdultClinical Trials, Phase I as TopicFemaleHealthy VolunteersHumansInformed ConsentMaleMoralsRisk AssessmentVulnerable Populationsexploitationphase 1 healthy volunteersresearch risks and benefitsstructural coercionundue inducement

Identifiers

PMID29342285
PMCPMC5901090

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.