Evidence map›Paper›PMID 12822049›Full record

ArticleWorld journal of surgery2003

Introducing new technologies: protecting subjects of surgical innovation and research.

Martin F McKneally, Abdallah S Daar

Abstract read
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In one paragraph

Article in World journal of surgery, 2003. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 2 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

14 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Article
  5. [Innovations in surgery-How can new technologies be safely implemented in the clinical practice?]Der Chirurg; Zeitschrift fur alle Gebiete der operativen Medizen · 2020
    Review
  6. Article
  7. Article
  8. Surgical innovation as sui generis surgical research.Theoretical medicine and bioethics · 2013
    Article
  9. Review
  10. Innovation as the core strategy for the future success of academic health centres.Canadian journal of surgery. Journal canadien de chirurgie · 2011
    Article
  11. How should accredited specialists be trained to do new procedures?Annals of the Royal College of Surgeons of England · 2009
    Review
  12. Article
  13. Article
  14. 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

2 authors.

Martin F McKneallyDepartment of Surgery, University of Toronto, 88 College Street, Toronto, Ontario, Canada M5G 1L4. martin.mckneally@utoronto.ca
Abdallah S Daar

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The system for protecting human research subjects is under increasing pressure. Under the currently dominant Regulatory Ethics Paradigm, clinical research protocols must be reviewed and approved by an institutional review board (IRB) or equivalent. Although the IRB was introduced into health care in part to protect patients and investigators from the inherent conflict between the best clinical interest of the individual patient and the interest of science and society in answering a clinical question, its rigorous standards and rigid framework discourage surgeons from seeking potentially valuable early IRB consultation. Most of the important advances in the history of medicine, such as anesthesia, appendectomy, antibiotics, intensive care, and immunization, were introduced through an informal, unregulated innovation process that has been enormously productive but can lead to ratification of ineffective or harmful treatment by credulous physicians and patients. We propose a surgical innovation ethics paradigm that is a more nimble, flexible source of institutional and public oversight and approval of innovations that are in the gray zone prior to their conversion to formal protocols that then require IRB approval. We also discuss the management of personal and institutional conflicts of interest.

Indexed as

Ethics Committees, ResearchBiomedical ResearchClinical Trials Data Monitoring CommitteesGeneral SurgeryHumansMedical AuditOrganizational InnovationSurgical Procedures, OperativeTherapeutic Human ExperimentationBiomedical and Behavioral Research

Identifiers

What OpenQuestion holds

Textmetadata
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.