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Related Experiment Video

Updated: Dec 12, 2025

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Harm-Benefit Analyses Can Be Harmful.

Steven M Niemi1

  • 1Animal Law & Policy Program, Harvard Law School, Cambridge, Massachusetts, USA.

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|August 14, 2020
PubMed
Summary
This summary is machine-generated.

Harm-benefit analyses (HBAs) aim to balance animal suffering against research justification but are flawed. Predicting research benefits is difficult, potentially hindering scientific advancement and animal welfare.

Keywords:
bioethicsbiomedical researchharm-benefit analysisin vivo testinglaboratory animal regulationslaboratory animal suffering

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Area of Science:

  • Animal research ethics
  • Laboratory animal welfare
  • Scientific research policy

Background:

  • Harm-benefit analyses (HBAs) are increasingly used by regulatory agencies and animal care committees.
  • HBAs aim to weigh animal pain against scientific justification for research protocols.
  • Their adoption is partly driven by international accreditation standards.

Purpose of the Study:

  • To critically evaluate the utility and limitations of harm-benefit analyses in animal research.
  • To explore how HBAs might contribute to refining animal use in research.
  • To propose alternative assessment methods for research protocols.

Main Methods:

  • Conceptual analysis of harm-benefit assessment frameworks.
  • Review of the application of HBAs in regulatory and ethical review processes.
  • Discussion of the challenges in predicting research benefits, particularly for basic research.

Main Results:

  • HBAs face inherent difficulties in accurately predicting the benefits of basic research.
  • This predictive uncertainty can lead to the potential disapproval of valuable research proposals.
  • The current HBA framework may not adequately address the refinement of harm, irrespective of benefit.

Conclusions:

  • The premise of HBAs is flawed due to the unpredictable nature of research outcomes.
  • While intended to protect animals, HBAs may inadvertently impede scientific discovery.
  • Alternative approaches are needed to better assess research protocols and promote animal welfare.