Title
Informed consent: Navigating the bioethical complexities of clinical research
Authors
Ravindra Waykar1,* & Yogesh A. Kulkarni2,*
Affiliation
1Caspersen School of Graduate Studies, Drew University, 36 Madison Ave, Madison, NJ 07940, United States; 2Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management, SVKM's Narsee Monjee Institute of Management Studies (NMIMS) Deemed to be University, Mumbai, India; *Corresponding author
Ravindra Waykar - E-mail: rwaykar@drew.edu
Yogesh A. Kulkarni - E-mail: yogesh.kulkarni@nmims.edu
Article Type
Review
Date
Received September 1, 2025; Revised September 30, 2025; Accepted September 30, 2025, Published September 30, 2025
Abstract
Informed consent (IC) has traditionally been regarded as the fundamental principle of ethical clinical research involving human subjects. This article explores the limitations of the IC, assesses the need for a comprehensive ethical framework and proposes a roadmap for developing a framework that holistically safeguards participants' rights, safety and well-being. The evolving nature of medical technology and complex decision-making situations necessitate a more comprehensive approach to research ethics. This review emphasizes the need for a procedural plan to structure moral deliberations and address potential conflicts between ethical values. By integrating ethical values and benchmarks, a systematic and consistent approach is required to uphold ethical integrity in clinical research beyond the limitations of informed consent.
Keywords
Informed consent, clinical trials, ethical framework, belmont report, nuremberg code, declaration of helsinki, research ethics
Citation
Waykar & Kulkarni, Bioinformation 21(9): 2950-2955 (2025)
Edited by
P Kangueane
ISSN
0973-2063
Publisher
License
This is an Open Access article which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. This is distributed under the terms of the Creative Commons Attribution License.
