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Is there an objective way to compare research risks?

John Rossi1, Robert M Nelson

  • 1Community Health and Prevention, Drexel University School of Public Health, 1505 Race Street, Bellet Building, 11th Floor, Philadelphia, PA 19102, USA. jar444@drexel.edu

Journal of Medical Ethics
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Summary
This summary is machine-generated.

Evaluating research risk acceptability is challenging. The systematic evaluation of research risks (SERR) framework has philosophical issues, suggesting a deliberative approach is better for risk assessment.

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Area of Science:

  • Bioethics
  • Risk Assessment
  • Regulatory Science

Background:

  • Assessing research risk against regulatory standards is complex.
  • The systematic evaluation of research risks (SERR) framework offers a structured method for risk comparison.
  • SERR aims for determinate judgments on whether research risks exceed acceptable standards.

Purpose of the Study:

  • To critically examine the philosophical underpinnings of determinate risk assessment frameworks like SERR.
  • To evaluate the suitability of SERR as a stand-alone method for determining research risk acceptability.
  • To propose alternative approaches for more nuanced risk evaluation in research.

Main Methods:

  • Philosophical analysis of the SERR framework and its assumptions.
  • Review of determinate approaches to risk comparison in regulatory science.
  • Conceptual exploration of deliberative approaches to risk assessment.

Main Results:

  • SERR, as a determinate approach, faces philosophical challenges that limit its applicability.
  • The framework's claim to provide definite risk comparisons is problematic.
  • Stand-alone use of SERR is not recommended due to its inherent limitations.

Conclusions:

  • Determinate frameworks like SERR should not be used exclusively for risk acceptability decisions.
  • A deliberative approach, informed by but not bound by methods like SERR, is a more viable path forward.
  • Future risk assessment methodologies should incorporate flexibility and nuanced judgment over rigid determination.