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Guest Lecture Sheds Light on Global Ethical Guidelines in Clinical Research

Published on: March 1, 2025

The Department of Clinical Research, Himalayan Institute of Medical Sciences at Swami Rama Himalayan University, hosted an insightful guest lecture on February 5, 2025, aimed at familiarizing students with critical global ethical and regulatory frameworks in clinical research. The session was conducted by Dr. Bindu Dey and held at the department’s premises with the participation of 20 M.Sc. Clinical Research students.

Dr. Dey provided a detailed introduction to major international and national guidelines that uphold the integrity, safety, and quality of clinical research and pharmaceutical development. The session began with an overview of the International Council for Harmonisation (ICH), which harmonizes technical standards globally to ensure pharmaceutical product safety, efficacy, and quality.

She further elaborated on Good Clinical Practice (GCP), a globally accepted ethical and scientific quality standard for conducting clinical trials involving human subjects. GCP ensures participant protection and the credibility of trial data. Complementing this, Dr. Dey discussed Good Laboratory Practice (GLP), which focuses on the integrity and consistency of non-clinical safety studies, and Good Manufacturing Practice (GMP), which governs the quality of production processes to ensure safe and effective pharmaceutical products.

The lecture also covered the roles of national and regional regulatory authorities such as the Central Drugs Standard Control Organization (CDSCO), the Drug Controller General of India (DCGI), and the European Union (EU) regulatory systems. Dr. Dey introduced students to the Code of Federal Regulations (CFR) from the U.S., highlighting its broad regulatory scope and relevance to clinical and pharmaceutical practices.

Throughout the session, students gained valuable insights into how these ethical guidelines and frameworks collectively safeguard public health and uphold scientific credibility in clinical and pharmaceutical research. Dr. Bindu Dey’s engaging approach and in-depth knowledge were appreciated by attendees, making the session both informative and impactful.

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International Endowed Chair Professor

Prof Rakesh Kumar

Prof Rakesh Kumar is the Founder and President of the Breast Cancer in Young Women Foundation (USA), dedicated to vaddressing the distinct issues affecting young women with breast cancer. He also serves as the International Endowed Chair Professor at the Cancer Research Institute of the Himalayan Institute of Medical Sciences. Additionally, he holds adjunct professorships at Rutgers New Jersey Medical School and Virginia Commonwealth University.

Dr Kumar earned his Ph.D. from the All India Institute of Medical Sciences in 1984 and began his research career at Memorial Sloan Kettering Cancer Center in January 1986. From 1988 to 2017, he held various academic and leadership positions —including faculty member, tenured professor, distinguished professor, endowed chair, department chair, and research leader—at esteemed institutions such as Memorial Sloan Kettering Cancer Center in New York and the University of Texas MD Anderson Cancer Center in Houston. From 2017 to 2022, he served as the National Chair for Cancer Research for the Government of India and as a distinguished professor, continuing his innovative work in breast cancer research.

With nearly 40 years of research and professional experience, Dr. Kumar has made conceptual contributions to the field of cancer research (h-index 108, citations >50,000). He has authored over 325 peer-reviewed publications, edited or co-edited nine books, and delivered 290 invited lectures worldwide. His work has been featured on the covers of 18 major cancer journals and has been highlighted in institutional research reports of the MD Anderson Cancer Center.

A passionate educator and mentor, Dr. Kumar has guided 67 trainees throughout his career. He serves on the editorial boards of multiple leading cancer journals and has served on the editorial boards of 21 top cancer journals. His global reputation is further demonstrated by his participation in about 100 peer-review panels for cancer research funding in the US and internationally over the past 28 years.

Dr. Kumar's innovative research has earned him numerous prestigious honors, including the Hinkle Society Faculty Award at Penn State University (1994), the Dalla/Fort Worth Living Legend Faculty Achievement Award in Basic Sciences (2004), the Ranbaxy Research Award (2006), and the Lifetime Achievement Award from the American Association of Indian Scientists in Cancer Research (2013), among others. Dr. Kumar's pioneering research continues to have a profound influence on the fields of oncology and breast cancer, opening up new opportunities for biomedical scientists and trainees worldwide.