Evidence map›Paper›PMID 26282436›Full record

ReviewMethods (San Diego, Calif.)2016

Ethical considerations in tissue engineering research: Case studies in translation.

Hannah B Baker, John P McQuilling, Nancy M P King

Open access · greenAbstract readReview
In one paragraph

Review in Methods (San Diego, Calif.), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 3 pooled it
1.3field-weighted citation impact, top 21% 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

19 citing papers in PubMed, 3 syntheses or guidelines pooled it, 46 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Early-Phase Clinical Trials of Bio-Artificial Organ Technology: A Systematic Review of Ethical Issues.Transplant international : official journal of the European Society for Organ Transplantation · 2022
    Pooled it
  4. Human cardiovascular organoids: Biomedical applications and ethical challenges.American heart journal plus : cardiology research and practice · 2026
    Review
  5. Article
  6. Review
  7. Article
  8. Article
  9. Review
  10. Review
  11. Emerging Paradigms in Bioengineering the Lungs.Bioengineering (Basel, Switzerland) · 2022
    Review
  12. Article
  13. Review
  14. Article
  15. Article
  16. Ethics and Policy for Bioprinting.Methods in molecular biology (Clifton, N.J.) · 2020
    Article
  17. Engineering geometrical 3-dimensional untethered in vitro neural tissue mimic.Proceedings of the National Academy of Sciences of the United States of America · 2019
    Article
  18. Review
  19. 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 2 institutions in 1 country.

Hannah B BakerDepartment of Biomedical Engineering, Virginia Tech-Wake Forest School of Biomedical Engineering and Sciences, Wake Forest Institute for Regenerative Medicine, 391 Technology Way, Winston-Salem, NC 27103, United States.
John P McQuillingDepartment of Biomedical Engineering, Virginia Tech-Wake Forest School of Biomedical Engineering and Sciences, Wake Forest Institute for Regenerative Medicine, 391 Technology Way, Winston-Salem, NC 27103, United States.
Nancy M P KingDepartment of Social Sciences and Health Policy and Wake Forest Institute for Regenerative Medicine, Wake Forest School of Medicine, Center for Bioethics, Health, and Society and Graduate Program in Bioethics, Wake Forest University, Medical Center Blvd, Winston-Salem, NC 27157, United States. Electronic address: nmpking@wakehealth.edu.
Forest Institute · USWake Forest University · US

Funding

Studies in Translational Regenerative MedicineT32EB014836 · NIBIB · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI ANTHONY ATALA, Victoria Weis · 2013 to 2026
$1.7M
NIBIB NIH HHS T32 EB014836NIBIB NIH HHS T32EB014836
6 · The paper itself

Abstract

Tissue engineering research is a complex process that requires investigators to focus on the relationship between their research and anticipated gains in both knowledge and treatment improvements. The ethical considerations arising from tissue engineering research are similarly complex when addressing the translational progression from bench to bedside, and investigators in the field of tissue engineering act as moral agents at each step of their research along the translational pathway, from early benchwork and preclinical studies to clinical research. This review highlights the ethical considerations and challenges at each stage of research, by comparing issues surrounding two translational tissue engineering technologies: the bioartificial pancreas and a tissue engineered skeletal muscle construct. We present relevant ethical issues and questions to consider at each step along the translational pathway, from the basic science bench to preclinical research to first-in-human clinical trials. Topics at the bench level include maintaining data integrity, appropriate reporting and dissemination of results, and ensuring that studies are designed to yield results suitable for advancing research. Topics in preclinical research include the principle of "modest translational distance" and appropriate animal models. Topics in clinical research include key issues that arise in early-stage clinical trials, including selection of patient-subjects, disclosure of uncertainty, and defining success. The comparison of these two technologies and their ethical issues brings to light many challenges for translational tissue engineering research and provides guidance for investigators engaged in development of any tissue engineering technology.

Indexed as

AnimalsBiomedical ResearchClinical Trials as TopicHumansInformed ConsentOrgan TransplantationPatient SelectionTissue EngineeringTranslational Research, BiomedicalAnimal research ethicsBioartificial pancreasHuman research ethicsTissue-engineered skeletal muscleTranslational research ethics

Identifiers

PMID26282436
PMCPMC4869966
OpenAlexW1168893453

What OpenQuestion holds

Textmetadata
LicenceTDM
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.