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Redefining informed consent form in cell and gene therapy trials
Varsha Dalal1, Geeta Jotwani1, Munna Lal Yadav1
1Division of Basic Medical Sciences, Indian Council of Medical Research, New Delhi, India.
Perspectives in Clinical Research
|January 29, 2024
Summary
Informed consent forms for advanced cell and gene therapies need improvement, especially in India. Enhancing patient education on these complex treatments is crucial for ethical research and participant safety.
Area of Science:
- Regenerative Medicine
- Clinical Trial Ethics
- Advanced Therapeutic Medicinal Products
Background:
- Informed consent is fundamental to ethical human participant research.
- Regenerative therapies, including cell and gene therapy (GT), offer transformative potential for incurable diseases.
- These advanced therapies present unique challenges due to their complex and personalized nature.
Purpose of the Study:
- To highlight deficiencies in informed consent forms (ICFs) for cell and gene therapy clinical trials.
- To emphasize the need for improved patient and public education regarding these innovative treatments.
- To address essential elements of ICFs for advanced therapies, particularly in the context of India.
Main Methods:
- Review of existing cell and gene therapy clinical trials.
- Analysis of informed consent forms (ICFs) for completeness and clarity.
- Identification of challenges specific to advanced therapeutic medicinal products.
Main Results:
- Significant lacunae were identified in the informed consent process for cell and gene therapy trials.
- Limited patient understanding of clinical trials in India exacerbates consent challenges.
- Lapses in informed consent can compromise participant decision-making, safety, and national research reputation.
Conclusions:
- There is a critical need for enhanced patient and public education on cell and gene therapies.
- Informed consent forms must be adapted to address the complexities of advanced therapies.
- Improving the informed consent process is vital for ethical conduct and participant protection in regenerative medicine research.
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