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Burdensome Research Procedures in Trials: Why Less Is More.
Jonathan Kimmelman1, David B Resnik2, Jeffrey Peppercorn3
1Studies of Translation, Ethics and Medicine (STREAM), Biomedical Ethics Unit, Social Studies of Medicine, McGill University, Montréal, Canada.
Journal of the National Cancer Institute
|April 5, 2017
Summary
Clinical trials often use invasive, nontherapeutic procedures that carry risks without direct participant benefit. Stricter scientific standards are needed for the design and reporting of these burdensome research methods.
Area of Science:
- Clinical Research Ethics
- Medical Research Methodology
Background:
- Invasive, nontherapeutic research procedures (e.g., organ biopsy, sham surgeries) are common in clinical trials.
- These procedures pose risks comparable to experimental treatments but offer no direct benefit to participants.
- Concerns exist regarding the planning, reporting, and utilization of results from such studies.
Purpose of the Study:
- To provide recommendations for improving the evaluation and implementation of studies involving invasive, nontherapeutic procedures.
- To advocate for enhanced scientific standards in the design and reporting of these research methods.
Main Methods:
- This commentary synthesizes current literature and expert opinion.
- It proposes actionable recommendations for investigators, sponsors, and ethics committees.
- Focuses on improving the scientific rigor and ethical oversight of nontherapeutic procedures.
Main Results:
- Many studies involving invasive, nontherapeutic procedures are inadequately planned and reported.
- Results from these studies are often underutilized in subsequent research.
- There is a need for better justification and risk-benefit assessment.
Conclusions:
- More demanding scientific standards are crucial for the rationale, design, and reporting of burdensome, nontherapeutic research procedures.
- Particular attention should be paid to procedures with a risk of serious complications.
- Improving these standards will enhance the ethical conduct and scientific value of clinical investigations.