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:

Dr. Nikku Yadav – In-Charge, Department of Clinical Research, HIMS, SRHU
Dr. Bindu Dey – Former Secretary, TDB & Retd. Advisor, DBT Govt. of India; Director, Research, SRHU
Dr. D.C. Dhasmana – Professor, Department of Pharmacology
Dr. Ruchi Juyal – Professor, Department of Community Medicine
Prof. Yogendra Singh – Chief Librarian, SRHU
Dr. Amjad Hussain – Director, HCIE
Dr. Pradeep Varshney – Director, IQAC
Dr. Suman Bal – Professor & Head, Pharmacology, SGRR University
Mr. Abhinav Bahuguna – Lecturer, Department of Biostatistics
Dr. Ashok Kumar Srivastava – Professor & Head, Department of Community Medicine, SRHU
Dr. Manisha Sharma – Assistant Professor, Department of Clinical Research, SRHU
Mrs. Akanksha Uniyal – Lecturer, Department of Biostatistics, SRHU
Mrs. Garima Kapoor – Assistant Manager, C-PACE, SRHU
Ms. Charu Paliwal – Consultant, Quality Assurance, Bharat Biotech Pvt. Ltd.
Mr. Ashish Gupta – C-PACE, SRHU
Mrs. Ekta Rao – Assistant Professor, HSMS, SRHU
Advocate Piyush Dhyani – Assistant Registrar (Legal)
Prof. Asha Chandola-Saklani – Professor, Department of Community Medicine, SRHU
Dr. Somalata Jha – Assistant Professor, HSYS, SRHU
Dr. Neelam Bisht, Incahrge Ayurveda Centre SRHU
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.