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Workshop on Good Clinical Practices, Good Laboratory Practices, and Ethics

Published on: March 26, 2025

The Department of Clinical Research at the Himalayan Institute of Medical Sciences (HIMS), Swami Rama Himalayan University, organized a workshop on Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and Ethics on 26th March 2025. Held at Sushruta LT-3, the workshop aimed to deepen the understanding of regulatory guidelines, ethical considerations, and best practices essential for clinical and laboratory research among 117 postgraduate students and faculty members.

The event began with a pretest to assess participants’ baseline knowledge of GCP, GLP, and research ethics. The sessions covered a comprehensive range of topics, starting with new drug discovery and development, presented by Dr. Nikku Yadav, which outlined the stages from preclinical testing to post-market surveillance. Prof. A.K. Srivastava explained various epidemiological study designs, distinguishing between observational and experimental studies, and highlighting their appropriate use in research.

Dr. Taruna Sharma discussed the fundamental principles of GCP, emphasizing its critical role in clinical research to ensure participant safety and study integrity. Mr. Abhinav Bahuguna introduced the basics of biostatistics, including study design, data types, and the importance of minimizing bias and error. The workshop also addressed professional ethics, where Dr. Pragya Tripathi elaborated on the medical code of conduct, underscoring patient welfare, competence, integrity, and accountability.

A key session on human research ethics was conducted by Prof. D.C. Dhasmana, focusing on the New Drugs and Clinical Trials Rules (NDCT) 2019. This included the responsibilities of sponsors, investigators, and Institutional Ethics Committees, as well as the informed consent process designed to protect research participants, especially vulnerable groups. Dr. Manisha Sharma highlighted Indian GCP and GLP guidelines, stressing ethical conduct, scientific rigor, data confidentiality, quality assurance, and regulatory compliance in clinical trials and laboratory studies.

To reinforce learning, MSc Clinical Research students performed role plays simulating study start-up activities, providing practical insights into regulatory trial procedures. The workshop concluded with an interactive post-test and feedback session, confirming enhanced participant knowledge and appreciation of the ethical and regulatory frameworks governing clinical research.

Overall, the workshop successfully fostered awareness and adherence to good practices and ethical standards necessary for quality biomedical research. It was recommended that continuous educational initiatives be implemented to further strengthen regulatory compliance and promote interdisciplinary collaboration among researchers and healthcare professionals.

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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.