DHR sponsored training program (6 Jan 2025-7 Feb 2025)

Published on: February 20, 2025

Ensuring Integrity in Healthcare: Good Clinical Practice & Medical Ethics: A five week training program (6th Jan 2025-7th Feb 2025)

Organized by:

Department of Clinical Research, Himalayan Institute of Medical Sciences, Swami Rama Himalayan University (SRHU)

Sponsored by::

Department of Health Research, Ministry of Health and Family Welfare (MoHFW), Government of India

Duration:

January 6 – February 7, 2025, 5 Week

Introduction

The Department of Clinical Research at the Himalayan Institute of Medical Sciences (HIMS), Swami Rama Himalayan University (SRHU), successfully conducted a five-week training program from January 6 to February 7, 2025. Sponsored by the Department of Health Research, Ministry of Health and Family Welfare (MoHFW), this initiative was aimed at enhancing ethical competencies among faculty and Ethics Committees in Uttarakhand.

Training Workshop on Bioethics

As part of this initiative, a two-day workshop titled “Training Workshop on Bioethics” was held on January 6–7, 2025, in collaboration with the ICMR Bioethics Unit, Bengaluru. The workshop covered essential topics related to bioethics, emphasizing ethical considerations in clinical research and the role of Ethics Committees.

Overview of the Five-Week Training Program

Following the bioethics workshop, the five-week training program continued with a structured curriculum covering various aspects of Good Clinical Practice (GCP). A total of 97 sessions were conducted by distinguished faculty members and guest speakers, ensuring comprehensive coverage of relevant topics. 31 participants actively engaged in the program, benefitting from expert knowledge and interactive discussions.

Speakers and Resource Persons

A total of 21 distinguished speakers contributed to the training program, sharing their expertise on various topics related to bioethics, clinical research, and Good Clinical Practice. The list of speakers included:

  1. Dr. Nikku Yadav – In-Charge, Department of Clinical Research, HIMS, SRHU
  2. Dr. Bindu Dey – Former Secretary, TDB & Retd. Advisor, DBT Govt. of India; Director, Research, SRHU
  3. Dr. D.C. Dhasmana – Professor, Department of Pharmacology
  4. Dr. Ruchi Juyal – Professor, Department of Community Medicine
  5. Prof. Yogendra Singh – Chief Librarian, SRHU
  6. Dr. Amjad Hussain – Director, HCIE
  7. Dr. Pradeep Varshney – Director, IQAC
  8. Dr. Suman Bal – Professor & Head, Pharmacology, SGRR University
  9. Mr. Abhinav Bahuguna – Lecturer, Department of Biostatistics
  10. Dr. Ashok Kumar Srivastava – Professor & Head, Department of Community Medicine, SRHU
  11. Dr. Manisha Sharma – Assistant Professor, Department of Clinical Research, SRHU
  12. Mrs. Akanksha Uniyal – Lecturer, Department of Biostatistics, SRHU
  13. Mrs. Garima Kapoor – Assistant Manager, C-PACE, SRHU
  14. Ms. Charu Paliwal – Consultant, Quality Assurance, Bharat Biotech Pvt. Ltd.
  15. Mr. Ashish Gupta – C-PACE, SRHU
  16. Mrs. Ekta Rao – Assistant Professor, HSMS, SRHU
  17. Advocate Piyush Dhyani – Assistant Registrar (Legal)
  18. Prof. Asha Chandola-Saklani – Professor, Department of Community Medicine, SRHU
  19. Dr. Somalata Jha – Assistant Professor, HSYS, SRHU
  20. Dr. Neelam Bisht, Incahrge Ayurveda Centre SRHU
  21. Dr. Bhavana Pal, IPR Cell, Scientific Officer SRHU

5 Week Schedule of the training program: Key Highlights

Week 1

Topic: Introduction to GCP and Ethics

Significance to Healthcare industry: An introduction to Good Clinical Practice (GCP) and ethics is essential to ensure the safety, rights, and well-being of research participants and to uphold the integrity of clinical research. It provides a framework for ethical decision-making and compliance with regulatory standards in clinical trials.

Week 2

Topic: Regulatory Compliance and Protocol Development

Regulatory compliance ensures that clinical research adheres to legal and ethical standards, safeguarding participant rights and data integrity. Protocol development is critical for structuring studies systematically, ensuring scientific validity, and aligning with regulatory and ethical guidelines.

Week 3

Topic: Conducting Clinical Trials

Conducting clinical trials is vital for evaluating the safety, efficacy, and quality of medical interventions, enabling evidence-based advancements in healthcare. It ensures that new treatments meet regulatory and ethical standards before becoming widely available to patients.

Week 4:

Topic: Ethical Issues and Professional Integrity

Addressing ethical issues and upholding professional integrity are crucial to maintaining trust, transparency, and fairness in clinical research. They ensure the protection of participant rights, the credibility of scientific findings, and adherence to moral and professional standards.

Week 5:

Topic: Hands on Training and skill-based learning

Hands-on training and skill-based learning are essential for bridging the gap between theoretical knowledge and practical application. They enhance competency, confidence, and readiness to perform tasks effectively in real-world clinical research settings.

Conclusion

The five-week training program successfully provided faculty members and Ethics Committee members in Uttarakhand with valuable knowledge and insights into bioethics and Good Clinical Practice. The diverse panel of speakers ensured a holistic learning experience, covering various critical aspects of clinical research ethics and regulatory frameworks.

The Department of Clinical Research at HIMS, SRHU, remains committed to fostering excellence in research and ethical clinical practices, with future initiatives aimed at further strengthening research ethics and governance in medical sciences.

“Group picture of students and faculty after successful completion on 5 weeks training dt 7 Feb 2025”

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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.