Adv. Pradnya Nakhate, B.A.L.L.B., D.C.L, L.L.M, DES Shri. Navalmal Firodia Law College, Pune
ABSTRACT
Informed Consent: The Heartbeat of CTAs. The concept of informed consent has a historical narrative that can be traced back to important events like the Nuremberg Code and the Declaration of Helsinki. These events played a significant role in shaping research ethics. Over time, the concept has evolved and been influenced by landmark cases and changing ethical frameworks. Informed consent remains a fundamental requirement in clinical trial agreements worldwide, enshrined in regulatory guidelines and institutional protocols. Yet challenges persist in ensuring its comprehensive understanding and implementation across diverse cultural and socio- economic contexts. The foundation of ethical clinical research lies in informed consent, which represents the intricate equilibrium between scientific progress and the safeguarding of human rights. It emphasizes the present state of informed consent, elucidates its crucial role in research ethics, and investigates the intricate relationship between medical advancement and patient autonomy. Clinical trial agreements, particularly their legalistic nature, impact participants’ ability to provide informed consent. It seeks to identify areas where agreements hinder understanding and propose potential reforms. A comprehensive review of clinical trial agreements, with a focus on informed consent procedures, identifies areas for improvement and pave the way for more ethical and equitable research practices. Standardized, accessible, and culturally sensitive consent forms; enhanced participant education and involvement; increased transparency and accountability of researchers and sponsors. The researcher aims to analyse the current state of informed consent in clinical trial agreements, identifying key challenges, and proposing potential reforms will contribute to a more ethical and equitable clinical research landscape.
Keywords: Clinical trial agreements, ethical conduct, informed consent, participant rights, participant welfare, transparency.
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