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A one-day meeting on Ethical Guidance for Investigator-Initiated Clinical Trials (IICTs) was conducted on 25 October 2024 at the ICMR Bioethics Unit, Bengaluru. The session was chaired by Dr. Neena Valecha, former director, ICMR-NIMR and the meeting was attended by 16 experts who actively engaged in meaningful and insightful discussions aimed at addressing key issues and unclear areas of IICTs Discussions primarily focused on several key topics, including the definition of IICT, the development of a risk assessment table, monitoring processes, compensation and insurance considerations, budgeting and the establishment of mechanisms for corpus funds at institutions. Additionally, there was a line-by-line review of the draft Ethical Guidance document for IICT.

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The ICMR Bioethics Unit, Bengaluru conducted a half-day online ethics training targeting the network of scientists, research staff and ethics committee members at MSSRF on 19 October 2024 and 23 November 2024. The key topics for discussion included the ICMR National Ethical Guidelines 2017, the NAITIK Portal registration for Ethics Committees, roles and responsibilities of ECs, research integrity, publication ethics, Latest updates, ICMR Initiatives, Good Clinical Practices, informed consent and community engagement. ICMR scientists, Dr. Aparna Mukherjee, Head, Clinical Trials Unit and Albina Arjuman Nair, Executive Editor, IJMR, served as faculty for the workshop. Additionally, Ms. Sarojini Nadimpally, Social scientist at SAMA also served as a faculty for the training program. The workshop successfully engaged 30 participants, who gained valuable insights through these expert-led discussions.

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Research in Integrative Medicine (RIM) bridges the gap between traditional, patient-centred Ayush practices (Ayurveda, Yoga & Naturopathy, Unani, Siddha, Sowa Rigpa, Homeopathy) and evidencebased approaches of modern medicine. This holds promise for a more holistic and effective patient care strategy. However, merging diverse systems necessitates a strong ethical foundation. Researchers in modern medicine institutions are increasingly embracing this field. Scientific robustness and ethical standards must be upheld throughout the research process, prioritizing participant safety, data security and informed consent, among others. Hence, a critical need exists for a robust ethical framework to guide Research in Integrative Medicine.

In recognition of these ethical considerations, the ICMR Bioethics Unit convened an Expert Group Meeting on "Integrative Medicine Research: Ethical Aspects" on July 19th, 2024, at its New Delhi headquarters. Co-chaired by Dr. Gautam Sharma (Centre for Integrative Medicine and Research, AIIMS Delhi) and Dr. Subarna Roy (ICMR-National Institute of Traditional Medicine, Belagavi), the meeting brought together over twenty experts from diverse fields, including Ayush and modern medicine. Focused on strengthening ethical frameworks, the discussions yielded valuable insights on the draft document and charted a path forward. This collaborative effort underscores the ICMR's commitment to ensuring the highest ethical and scientific standards for Research in Integrative Medicine.

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The ICMR Bioethics Unit organized a one-day brainstorming meeting to deliberate on the ethical concerns and other challenges regarding the conduct of Academic Clinical Trials in India. In 2019, the NDCT rules introduced new regulations for clinical trials, distinguishing academic trials as investigations exploring new indications of approved drugs for academic or research purposes only. Despite their potential, academic clinical trials face challenges such as financial constraints, ethical concerns etc. The meeting addressed these challenges and suggested the way forward for the development of a guidance for the evolving landscape of academic trials in India. After the meeting, the chairperson and other experts marked World Environment Day by planting a sapling, reinforcing our commitment to environmental consciousness.

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“Indo US Workshop- Clinical Research Ethics and Challenging Newer Areas” was organized by the ICMR Bioethics Unit and the Department of Bioethics, NIH, USA with the aim to update clinical researchers on emerging challenges in clinical research ethics. This 3 day workshop was conducted on 7-9 August 2023 at ICMR Bioethics Unit, Nirmal Bhawan, Bengaluru. Along with national and international faculties, 12 early career scholars attended participated in the program. The workshop provided hands-on training to the Early Career Scholars and gave opportunity for the update knowledge in research ethics and engage in one-to-one interaction with US faculties.

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“The ICMR Bioethics Unit organised a one-day brainstorming meeting to deliberate upon the ethical issues around the conduct of Controlled Human Infection Studies (CHIS) in India on 24th March 2023 at Nirmal Bhawan, ICMR Complex, Kannamangala, Bengaluru. Experts deliberated on the framework and suggested the way forward for the development of the guidelines.”

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WHO has developed a draft Benchmarking Tool, aiming to assist its Member States in reviewing their current capacity for ethical oversight of health-related research. As a WHO Collaborating Centre, ICMR Bioethics Unit was approached by the WHO to pilot the Benchmarking Tool in India to understand the functionality and acceptability of the tool in an Indian setting. In this regard, ICMR Bioethics Unit Organised a Workshop titled “WHO workshop on Piloting the Tool for Benchmarking Ethics Oversight of Health-Related Research with Human Participants” on 6-7 December, 2022. The workshop generated insights that would assist in improving the tool and enhancing the country's current oversight for ethical conduct of research.
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An important objective of WHO is to support Member States in building and strengthening capacity in the oversight of health-related research with human participants. In view of this WHO has developed a tool for benchmarking research ethics oversight to assist the member nations for a robust ethics oversight system. The study was piloted in different countries around the globe to understand the adaptability of the tool in their local settings. Dr Roli Mathur, Head, ICMR Bioethics Unit, was invited as a facilitator for the workshop held in Nepal on 14-16 November 2022 and was able to provide insights of National Ethical Guidelines, and other regulatory frameworks for ethics oversight in India. The workshop was attended by national level experts from Nepal and the tool's applicability was extensively discussed during the program. The feedback generated from the workshop helped in the further improvement of the tool.

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ICMR Bioethics Unit, in collaboration with the Department of Health Research (DHR), conducted a webinar on "Biomedical & Research Ethics Update" on 18th May 2022 in hybrid mode. The program was tailored and customized for ethics committee members of ICMR network of institutions in consultation with DHR. Ms. Anu Nagar, Joint Secretary, DHR, joined the program physically at ICMR-NCDIR, Bengaluru, along with other DHR Staff. Relevant updates with respect to the ICMR National Ethical Guidelines 2017 & 2020, Roles and Responsibilities of EC members, EC registration on DHR Naitik Portal, SOPs, Communications of EC, Training of EC members, Common Review of Multicentre Research by ICMR network of institutions, etc., were discussed by speakers. More than 150 Researchers and Ethics Committee members from ICMR institutions and some Non - ICMR institutions participated in the event. The program was conducted with the specific objective of sensitizing the ethics committee members with the latest updates and DHR requirements for ethics committee registration on the National Ethics Committee Registry for Biomedical and Health Research (NECRBHR) on Naitik Portal. (https://naitik.gov.in/DHR/Homepage)

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The ICMR Reference Book was released on 7th April 2022 on the occasion of World Health Day by Prof. (Dr.) Balram Bhargava, DG ICMR & Secretary DHR at ICMR Headquarters, New Delhi. The book is expected to serve as a tool for teaching and guidance document for students, researchers and Ethics Committee members and is the first of its kind prepared to address ethics issues from an Indian perspective.

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In the context of 75th Independence Day celebration (Azadi ka Amrit Mahotsav), ICMR Bioethics Unit, ICMR-NCDIR had organised a public webinar on Ethics, Compassion, Dignity in End of Life Care & Death on 24th Aug 2021. The webinar was intended for public participants involved or interested in caregiving of patients on life sustaining treatment. Eminent speakers talked about provision of home-based care for people who are terminally ill, ethical issues that may arise while their loved ones are in the death bed requiring life support technologies, caregiver’s role in decision-making for assuring compassion and dignity to the ailing relatives, and about the ICMR’s initiatives in End of Life Care & Death. The webinar was also live streamed on YouTube. About 150 attendees benefitted by participating in this webinar.

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A half day online training program was organized on 30th June 2021 by ICMR-National Institute of Implementation Research on Non-Communicable Diseases (ICMR-NIIRNCD), Jodhpur, (Raj.) in association with ICMR Bioethics Unit, National Centre for Disease Informatics and Research (ICMR- NCDIR), Bengaluru. Eminent speakers shared their knowledge and perspectives on ethical conduct of research across various sessions with special emphasis on topics such as Roles and Responsibilities of Ethics Committee Members, ICMR National Ethical Guidelines, Registration of ECs, New Drugs and Clinical Trial Rules 2019, Vulnerability and Consent. Around 100 delegates (Ethics Committee members, Faculty, Scientists, Researchers, etc.) from various institutions in and around Rajasthan participated and benefitted from the training.

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An online training program was organized on 16th March 2021 by ICMR Bioethics Unit, National Centre for Disease Informatics and Research (NCDIR), Bengaluru which is also a WHO Collaborating Centre for Strengthening Ethics in Biomedical and Health Research to train the Ethics Committees members in their roles & responsibilities. Participants were from across the country as well as from several neighbouring countries. An eminent panel of experts representing a multidisciplinary ethics committee shared their perspectives. The training was also live streamed on You Tube. Almost 700 participants benefitted from this training.

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A 3-hour online webinar training program was organized on 3rd Nov 2020 by ICMR Bioethics Unit, National Centre for Disease Informatics and Research (NCDIR), Bengaluru which is also a WHO Collaborating Centre for Strengthening Ethics in Biomedical and Health Research to train the members of the Ethics Committees and to bolster epidemiologic research. Participants were from across the country.

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A one-day training program was organized by ICMR Bioethics Unit for ICMR Research Integrity Officers (RIOs), scientists of ICMR institutes from across the country, clinicians, biomedical health researchers, nursing faculty, students etc. The training encompassed a wide range of topics like responsible conduct of research, research misconduct, ethics in scientific writing, ICMR National Ethical Guidelines and also ICMR Policy on Research Integrity and Publication Ethics through interactive sessions and case discussions. The profound contribution of women scientists in the field of science was also acknowledged by celebrating the theme ‘Women in Science’ on the esteemed occasion of ‘National Science day’.

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The one-and-half-day training program was attended by over 170 enthusiastic participants from various disciplines including Ethics Committee Members, faculty, students, scientists and research scholars. The training covered a wide range of topics including Responsible Conduct of Research, ICMR National Ethical Guidelines, Registration of ECs, etc. through interactive lectures and case discussions.

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ICMR Bioethics Unit, NCDIR, Bangalore and St John’s Medical College, Bangalore jointly organised “Ethics Committee training program on ICMR National Ethical Guidelines” on 20th September, 2019 at St. John’s Medical College, Bangalore. The dissemination program was attended by 45 participants.

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ICMR Bioethics Unit, NCDIR, Bangalore and St John’s Medical College, Bangalore jointly organised the Dissemination program on “ICMR National Ethical Guidelines for Biomedical and Health Research” on 19th September, 2019 at St. John’s Medical College, Bangalore. The dissemination program was attended by 162 participants.

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ICMR Bioethics Unit and Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER), Puducherry jointly organised the Workshop on Ethical Guidance for Biomedical Research and GCP Guidelines on 16th – 17th September, 2019 at JIPMER Academic Centre, Puducherry. The workshop was attended by 80 participants.

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ICMR Bioethics Unit and KIMS, Bhubaneswar jointly organized the “Training for Ethics Committee members on ICMR National Ethical Guidelines and GCP Guidelines” on 29th June 2019 at Kalinga Institute for Medical Sciences (KIMS), KIIT University, Bhubaneswar, Odisha. The training program was attended by 71 participants from 15 institutes

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ICMR Bioethics Unit and KIMS, Bhubaneswar jointly organized a “Dissemination program on ICMR National Ethical Guidelines and GCP Guidelines” on 28th June 2019 at Kalinga Institute for Medical Sciences (KIMS), KIIT University, Bhubaneswar, Odisha. The Dissemiantion program was attended by 170 participants from 23 institutes.

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Dissemination Cum Training on ICMR National Ethical Guidelines, 2017 at Gadag Institute of Medical Sciences, Gadag, Karnataka on 7th March, 2019

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Workshop on Ethical Guidance for Biomedical Research at NARI, Pune on 17-18th January, 2019

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