Evidence map›Paper›PMID 35203974›Full record

ArticleBrain sciences2022

Ethical Considerations in Clinical Trials for Disorders of Consciousness.

Michael J Young, Yelena G Bodien, Brian L Edlow

Open access · goldAbstract read
In one paragraph

Article in Brain sciences, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
4.1field-weighted citation impact, top 5% 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.

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

22 citing papers in PubMed, 30 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Review
  5. Article
  6. Review
  7. Ethical Challenges in Research Involving Hospitalized Patients: A Phenomenological Study.Health care analysis : HCA : journal of health philosophy and policy · 2025
    Article
  8. Article
  9. Article
  10. Review
  11. Review
  12. Disorders of Consciousness Rehabilitation: Ethical Dimensions and Epistemic Dilemmas.Physical medicine and rehabilitation clinics of North America · 2024
    Review
  13. Article
  14. Article
  15. Covert consciousness.NeuroRehabilitation · 2024
    Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. Review
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 at 1 institution in 1 country.

Michael J YoungCenter for Neurotechnology and Neurorecovery, Department of Neurology, Harvard Medical School, Massachusetts General Hospital, Boston, MA 02114, USA.ORCID 0000-0001-6661-0811
Yelena G BodienCenter for Neurotechnology and Neurorecovery, Department of Neurology, Harvard Medical School, Massachusetts General Hospital, Boston, MA 02114, USA.
Brian L EdlowCenter for Neurotechnology and Neurorecovery, Department of Neurology, Harvard Medical School, Massachusetts General Hospital, Boston, MA 02114, USA.ORCID 0000-0001-7235-8456
Harvard University · US

Funding

An Ethical Approach to Detecting Covert ConsciousnessF32MH123001 · NIMH · MASSACHUSETTS GENERAL HOSPITAL · PI YOUNG, MICHAEL J · 2020 to 2022
$159k
NIH HHS F32MH123001NIMH NIH HHS F32 MH123001
6 · The paper itself

Abstract

As the clinical trial landscape for patients with disorders of consciousness (DoC) expands, consideration of associated ethical challenges and opportunities is of ever-increasing importance. Responsible conduct of research in the vulnerable population of persons with DoC, including those with coma, vegetative state/unresponsive wakefulness syndrome (VS/UWS), minimally conscious state (MCS), covert cortical processing (CCP), and cognitive motor dissociation (CMD), demands proactive deliberation of unique ethical issues that may arise and the adoption of robust protections to safeguard patients, surrogates, and other key stakeholders. Here we identify and critically evaluate four central categories of ethical considerations in clinical trials involving participants with DoC: (1) autonomy, respect for persons and informed consent of individuals with liminal consciousness; (2) balancing unknown benefits and risks, especially considering the epistemological gap between behavior and consciousness that complicates ordinary ascription of subjective states; (3) disclosure to surrogates and clinical teams of investigational results pertaining to consciousness; and (4) justice considerations, including equitable access to clinical trial enrollment across communities and geographies. We outline guiding principles and research opportunities for clinicians, neuroethicists, and researchers engaged in DoC clinical trials to advance ethical study design and deployment in this complex yet crucial area of investigation.

Indexed as

clinical trialscomaconsciousnessminimally conscious stateneuroethicsphilosophy

Identifiers

PMID35203974
PMCPMC8870384
OpenAlexW4210245200

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.