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Moral reasoning in biomedical research protocols

S Holm1

  • 1Institute of Biostatistics and Theory of Medicine, University of Copenhagen, Denmark.

Scandinavian Journal of Social Medicine
|June 1, 1994
PubMed
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Many biomedical research protocols lack essential ethics sections, indicating a potential perception of ethics review as merely formal. This study analyzed ethics content in Danish research protocols from 1990.

Area of Science:

  • Biomedical research ethics
  • Research protocol review

Background:

  • Ethical considerations are paramount in biomedical research.
  • The Helsinki-II declaration mandates specific ethics sections in research protocols.
  • Danish Research Ethical Committees (RECs) require adherence to ethical guidelines.

Purpose of the Study:

  • To analyze the content and completeness of ethics sections in biomedical research protocols submitted to a Danish REC in 1990.
  • To assess the proportion of protocols lacking required ethics sections.
  • To evaluate the nature and extent of ethical statements within submitted protocols.

Main Methods:

  • Analysis of 134 biomedical research protocols submitted to a Danish REC in 1990.
  • Identification and classification of statements within the ethics sections.
Keywords:
Biomedical and Behavioral ResearchEmpirical ApproachJutland

Related Experiment Videos

  • Quantitative assessment of ethics section length and content.

    • Main Results:

    • 20% of protocols lacked an ethics section, despite requirements.
    • Ethics sections had a median length of 6 lines and 3 statements, comprising 1.13% of protocols.
    • 32% of statements were formal, 30% addressed information, consent, and voluntariness.

    Conclusions:

    • The findings suggest a perception of ethics review as a formal procedure among researchers.
    • A significant portion of protocols failed to meet basic ethical documentation standards.
    • Further investigation into researcher perceptions and the effectiveness of ethics review processes is warranted.