ICMR-WHO Consultation on “National Ethical Guidelines for Biomedical and Health Research involving Human Participants, 2016-2017”- A Report
ICMR Bioethics Unit NCDIR, Bangalore ICMR-WHO Consultation Meeting
“National Ethical Guidelines for Biomedical and Health Research involving Human Participants”
National Centre for Disease Informatics and Research (NCDIR), ICMR Bangalore ICMR-WHO Consultation Meeting 2017
ICMR-WHO Consultation Meeting 2017
Contents
1. Foreword 3 2. Message from Director 5 3. Acknowledgement 7 4. Abbreviations 9 5. Executive Summary 11-12 6. Regional Consultation 13-31 a. Proceedings of the consultation Meeting 14-16 b. Panel Discussion 17-31 7. National Consultation 32-53 a. Proceedings of the consultation Meeting 33-35 b. Panel Discussion 36-53 8. Meeting Agenda Regional & National 54-55 9. List of Participants (Regional & National) 56-61 10. List of Scientific/Administrative Staff 62
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Foreword
Regional and National consultation meetings were organised by ICMR in collaboration with WHO Country Office to gather inputs and comments from various stakeholders before finalising the draft “Ethical guidelines for biomedical and health research involving human participants”. The core group and subcommittee members developed the zero draft and Guidelines. ICMR brought out the first guidelines in 1980 and subsequently revised in 2000 and updated in 2006. These are looked upon by stakeholders all over the country, e.g. researchers including UG and PG students, faculty members, Institutional ethics committees and regulators as gold standard. Since the last 10 years so many developments and new concerns have evolved over the ethical dilemmas faced by the scientific and ethical committees, that it had become necessary to revisit the 2006 guidelines and develop a state of art guidelines including all contemporary issues. The new draft developed in this regard has many new sections added up and many changes incorporated in the existing sections and finally was posted for Public consultation. The response was very encouraging. In addition to appreciation huge amount of comments were received from not only biomedical researchers, but from NGOs, international agencies, industry related organisations etc. ICMR guidelines are looked upon by many developing countries as a guidance document. The comments received during these consultation meetings will offer definite inputs to improve and finalise the guidelines which will be feasible, implementable and acceptable to all stakeholders involved in clinical research. The support given to the drafting committee by ICMR and WHO to complete the work within the stipulated time needs appreciation.
Date Dr Vasantha Muthuswamy Coimbatore Chairperson, Advisory Committee
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Message from Director
I am pleased to present the consolidated report of the ICMR–WHO Consultation Meetings. It gives an insight to the proceedings of the Regional Consultation meeting held on 4th of October 2016 at National Center for Disease Informatics and Research (NCDIR), Bengaluru and National Consultation meeting held on 14th of December, 2016 at ICMR Headquarters, New Delhi. I would like to offer my sincere thanks to Dr Soumya Swaminathan, Secretary DHR and DG ICMR, Dr. Henk Bekedam, WHO representative, India and Dr. Madhur Gupta, Technical Officer, WHO Country Office for India, all the advisory group members, subcommittee members and many others for both scientific as well as administrative support towards the workshops for finalization of the draft ethical guidelines. Ethics is about views and opinions and it is necessary to find the appropriate path to consider conceptualized factors and societal perspectives to refine the draft guidelines. Experts from different disciplines like physicians, social scientists, legal experts, industry, civil society, etc. as well as senior scientists of national and international stature participated in the consultation meetings. The Bioethics discipline has been transferred from the ICMR Hqtrs, New Delhi to NCDIR, Bangalore and an ICMR Bioethics Unit has been set up at NCDIR. These two consultations were one of the first initiatives and the Unit carried out successfully in collaboration and partnership. This enthusiasm will facilitate further work in the area of Bioethics as is needed by the country.
Bangalore Dr Prashant Mathur 24.3.2017 Director, NCDIR
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Acknowledgement
ICMR is revising the Ethical Guidelines for biomedical and health research and taking several initiatives to make the process participatory so as to invite and receive feedback from variety of stakeholders involved in biomedical and health research. I am thankful to WHO-Country Office for India for agreeing to collaborate with ICMR for holding two consultation meetings in October, 2016 at Bengaluru and December, 2016 at New Delhi. A very large number of experts from various backgrounds and expertise participated in both the consultation meetings and provided very valuable feedback that was useful in the process of updation of Ethical Guidelines. I thank all who actively contributed to this exercise and shared their opinions. I take this opportunity to thank Dr. Soumya Swaminathan, DG ICMR, for her interest, encouragement and immense support. My special thanks to all the members of the advisory group, Dr Vasantha Muthuswamy for chairing the sessions and Dr S D Seth, Co-Chair, Dr N K Arora, Dr Nandini K Kumar, Dr Urmila Thatte, Dr Vijay Kumar for their intellectual inputs and critical reviews. I also express my gratitude to Dr. Henk Bekedam, WHO representative, India and Dr. Madhur Gupta, Technical Officer, WHO Country Office for India for the technical collaboration with ICMR in organizing the consultation meetings. I thank scientific and administrative staff at NCDIR Bangalore for their involvement and support. Dr Rajib, Dr Kalyani and Ms Shabeen have worked day and night to make the two events a success. I hope that the inputs received during these consultation meetings will immensely benefit us in the process of finalization of the draft ethical guidelines.
Bangalore Dr Roli Mathur 24.3.2017 Scientist E & Head ICMR Bioethics Unit
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Abbreviations
CDSCO Central Drugs Standard Control Organization CECHR Central Ethics Committee on Human Research COI Conflict of Interest CTRI Clinical Trials Registry of India DCGI Drugs Controller General of India EC Ethics Committee GCP Good Clinical Practice GOI Government of India HMSC Health Ministry Screening Committee IC Informed Consent ICD Informed Consent Document ICF Informed Consent Form ICMR Indian Council of Medical Research LAR Legally Acceptable/ Authorized Representative MoU Memorandum of Understanding NCDIR National Centre for Disease Informatics and Research PIS Patient Information Sheet/ Document ROHC Regional Occupational Health Centre SAE Serious Adverse Event SOP Standard Operating Procedure WHO World Health Organization
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Executive Summary participants from different areas, including social scientist, legal experts, representatives from the pharma industry, academic In India, Indian Council of Medical institution in public and private, Non Research (ICMR) has been on the forefront Governmental Organisations etc. and many to set the standards for defining the ethical others from across the country as well as in requirement for biomedical and health house scientists and staff of NCDIR, research. The ICMR ethical guidelines have Bangalore. The consultation received a very provided the right direction to the good feedback from participants. researchers for conducting biomedical and health research in the country. With a warm welcome Dr. Prashant Mathur, Director, NCDIR, Bangalore, briefly After a series of meetings and deliberations, introduced the objectives of the consultation the draft of the National Ethical Guidelines meeting for the National Ethical Guidelines for Biomedical and Health Research for Biomedical and Health Research involving Human Participants has been involving Human Participants. Dr. Vasantha finalized by ICMR. The draft guideline was Muthuswamy, Chairperson, advisory group made ready for public consultation and committee, gave a brief account of the posted on ICMR website to invite comments process of revision of ICMR ethical from all interested stakeholders. guidelines from 1980 to 2016. Dr. Madhur
Gupta, Technical Officer, WHO Country In order to improve the consultation process Office for India said that WHO has been and receive feedback from experts, ICMR in privileged to be closely working with ICMR collaboration with the World Health from many years in supporting the agenda Organization-Country Office for India had of ethics and the current draft guidelines jointly organized the Regional and National have extensively referred to the emerging consultation meetings on 4th October, 2016 ethical issues in the biomedical and health at National Centre for Disease Informatics research incorporating all major evidences. and Research (NCDIR), Bangalore and on Video message of Dr. Soumya 14th December, 2016 at ICMR Swaminathan, Secretary, DHR & DG Headquarters, New Delhi. Both the ICMR, was played for the audience. Dr. meetings were very useful in obtaining Roli Mathur, Scientist E and Head, ICMR valuable feedback about revised guidelines Bioethics Unit, NCDIR, Bangalore, thanked from experts. the guests for gracing the occasion and
introduced the process of consultation Regional Consultation: meeting through panel discussions for all the sections of the draft guidelines. The consultation meeting was aimed at inviting comments and feedbacks from To facilitate the focussed discussions on various stakeholders from all parts of the various ethical issues, the 14 sections of the country including East, West, South and draft guidelines were divided in 6 panels. North regarding the draft ethical guidelines. All the panelists, moderators, dignitaries and This meeting was attended by 94 senior experts participated in the discussion
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and suggested some recommendations/ and Dr. Vijay Kumar discussed on the changes for the draft ethical guidelines. various sections and the changes made During the panel discussion, feedbacks from under each section. Dr. Henk Bekedam, various stakeholders were collected for WHO Representative, Country Office for further incorporation and discussion in the India said that WHO has been privileged to next advisory group meeting to finalize the be closely working with ICMR and draft National Ethical Guidelines for discussed the importance of ethics in India Biomedical and Health Research involving and the major role played by the advisory Human Participants. group from the zero draft to the revised ethical guidelines. He also discussed about National Consultation: the online courses for ethics which needs to be implemented from ICMR. Dr. Soumya Swaminathan, Secretary, DHR & DG National Consultation Meeting was held on ICMR, welcomed the guests and thanked th 14 December, 2016 at ICMR them for sparing their valuable time. She Headquarters, New Delhi. The meeting was congratulated all the advisory group aimed at finalizing the draft with the members for their efforts and also thanked approval from DG, ICMR, CECHR WHO for their support to organize the members and other invited experts. Meeting consultation meetings for finalizing the draft was attended by 68 expert participants from guidelines. She discussed the efforts of various parts of the country. The invited ICMR and DHR in improving the quality of experts discussed the major ethical research and informed about the initiative to challenges and significant role of ICMR introduce the online course on ethics. Dr. Ethical Guidelines in Biomedical Research Roli Mathur thanked the invited guests for involving Human Participants. gracing the occasion.
With the warm welcome to all the To facilitate the focussed discussions on participants, Dr. Roli Mathur, Scientist E & various ethical issues, the 13 sections of the Head, ICMR Bioethics Unit, NCDIR, draft guidelines were divided in 6 panels. Bangalore, discussed the journey of the draft All the dignitaries and senior experts ethical guidelines from the zero draft to participated in the panel discussion and revised draft ethical guidelines. Dr. S. D. suggested some recommendations/ changes Seth, Co-Chairperson, advisory group for the revision of ethical guidelines. During committee gave a brief account of the the panel discussions, feedbacks from revision of ICMR ethical guidelines. The various stakeholders was received and advisory group members - Dr. N. K. Arora, recorded for incorporation in the revised Dr. Nandini K Kumar, Dr. Urmila Thatte draft of guidelines.
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ICMR –WHO Regional Consultation
On
“National Ethical Guidelines for Biomedical and Health Research involving Human Participants”
At
National Centre for Disease Informatics and Research
4th October, 2016, Bangalore
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Proceedings of the Regional Consultation Meeting
Welcome and Opening Remarks
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Welcome and Opening Remarks
Remarks by Director, NCDIR thanked all the members of advisory group and subcommittees. She discussed about Dr. Prashant Mathur, Director, NCDIR the comments and appreciation received (ICMR), Bangalore welcomed all the from all quarters, not only from biomedical guests to the ICMR–WHO Regional researchers, but also from NGOs, Govt Consultation on “National Ethical institutions, international agencies like Guidelines for Biomedical and Health NIH, OHRP and many others. ICMR Research involving Human Participants”. guidelines are looked upon by many He emphasized the need for revision of developing countries and the revised “Ethical Guidelines for Biomedical documents would be useful for researchers Research involving Human Participants” in as well as for EC members. the current scenario. He thanked WHO Country Office India for their collaboration Remarks by Technical Officer, and jointly organizing this meeting. He WHO India mentioned that ethics is about views and opinions and it is necessary to find Dr. Madhur Gupta, WHO representative, appropriate path to consider conceptualized thanked Dr. Vasantha Muthuswamy for factors and societal perspectives which chairing the process and showing light to have been considered while refining the the journey of revision of ICMR ethical draft guidelines. He thanked the experts guidelines. She informed that the ICMR from different quarters of life like social guidelines are looked upon by researchers scientists, legal experts, those from pharma from all over the country, e.g. industries and many other very senior undergraduates, MD students, faculty experts for their valuable feedback. He said members, institutional ethics committees that their feedback would be enriching to and regulators as a gold standard. She the process of revision of ethical expressed happiness since WHO and ICMR guidelines. have closely worked together from many years to support the agenda of ethics. Remarks by Chairperson, Advisory Group Dr. Vijay Kumar, Head, Division of BMS, ICMR Headquarters, on behalf of Dr. Dr. Vasantha Muthuswamy, Chairperson, Soumya Swaminathan, Secretary, DHR & advisory group, shared the procedure DG ICMR, welcomed participants to adopted for revision of ethical guidelines. ICMR–WHO regional consultation and She informed how the core group and thanked for sparing valuable time for this subcommittee members drafted the zero important activity of finalization of draft, revised it many times and finalized National Ethical Guidelines for Biomedical the draft national ethical guidelines. She Research involving Human Participants. He said that these guidelines were posted 15 | P a g e
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on the ICMR website and have received and urged the participants to actively various comments and suggestions which discuss and give their comments. She are being incorporated. He also added up thanked all the participants for sparing their that today‟s deliberation will lead to further time and attending the regional consultation improvement and ultimately protecting meeting. rights, safety and well-being of human participants and also shared the video Dr. Roli Mathur, Scientist E and Head, message of DG, ICMR. ICMR Bioethics Unit, NCDIR, Bangalore, thanked the guests for gracing the occasion Video message of Dr. Soumya and for sharing their views and suggestions. Swaminathan, Secretary, DHR & DG She thanked DG ICMR, for encouragement ICMR, was played for the audience. She and to the advisory group for providing highlighted that as responsible citizens it is direction and the forty six subcommittee important to see that any research carried members for their intellectual inputs in out in our country is governed by and preparing the draft. She expressed her follows the ethical guidelines. It is gratitude to Dr. Henk Bekedam, WHO important to create awareness both for the representative, India and Dr. Madhur Gupta researchers as well as the research WHO representative, Country Office India participants. She said that it is important to for the technical collaboration with ICMR. incorporate the suggestions and comments She gave special thanks to the Division of in order to strengthen the draft and build Basic Medical Science, ICMR consensus among all the stakeholders. She Headquarters, New Delhi. She also thanked suggested the need of a dialogue process in all the staffs of NCDIR and ROHC for their the country for evolving new technologies keen help.
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Panel Discussion I
General Ethical Issues, Informed Consent Process, Vulnerability
Chairperson: Dr. K K Talwar, Moderator: Dr. Joseph Thomas
Panelist: Dr. Olinda Timms, Dr. Pratima Murthy, Dr. Meenakshi Bhat, Dr. Tarun Bhatnagar
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10-11.00 AM - Panel Discussion I: General Ethical Issues Informed Consent Process, Vulnerability
Chairperson: Dr. K. K. Talwar, Moderator: Dr. Joseph Thomas
Panelist: Dr. Olinda Timms, Dr. Pratima Murthy, Dr. Meenakshi Bhat and Dr. Tarun Bhatnagar
Dr. Joseph Thomas, Professor of NIMHANS, Bangalore, said that presently Urology, Kasturba Medical College, there is no uniform system of training for Manipal, gave a brief overview for the researchers and EC members and panel discussion and thanked for being therefore, the guidelines should indicate provided with an opportunity to share the how the EC members should undergo a views and comments on the various training. She raised her concerns regarding sections of the draft guidelines. He pointed breach of confidentiality when there are out the concerns related to student‟s risks to individuals. She felt that there was research as well as investigator initiated need for more clarity regarding the research and the role of institution. He scientific and ethical review of research suggested the need to find ways for the proposals. She suggested the use of term arrangement of corpus funds, payment of „persons with mental illnesses in place of compensation, insurance coverage and for „mentally ill‟ and „spouse‟ in place of finding funds to adequately run student‟s „wife or husband or widows‟. Dr. research. He also suggested that the Meenakshi Bhat, Faculty, Centre for procedure to witness informed consent for Human Genetics, Bangalore, pointed out research involving vulnerable participants the issues related to reconsent and could be explained in detail in the revealing identity in the publication and to guidelines. Dr. Olinda Timms, Adjunct what extent identity can be revealed. She faculty, St. John‟s Research Institute, suggested that type of harms can also be Bangalore, raised the issue about payment legal and social. She also suggested that a of compensation. She said that the decision proportion of budget or funding received about compensation should firmly be kept by the Institution should be allocated to under the purview of the EC. The phases provide cover for insurance or payment of of clinical trials and types of adverse compensation. Dr. Tarun Bhatnagar, events or injury should be clearly defined Scientist D, National Institute of in the guidelines. She also pointed out the Epidemiology (ICMR), Chennai, need to have an appropriate mechanism for highlighted that according to CDSCO, payment of insurance. She expressed audio visual recording of the process of concerns regarding the inclusion of oral consent is mainly applicable for economically disadvantaged, those with clinical trials in vulnerable population; limited access to health care and adequate therefore, the use of AV recording for oral provisions for their protection. Dr. consent for research should be further Pratima Murthy, Professor of Psychiatry, clarified in the guidelines. He suggested 18 | P a g e
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the need to elaborate and include the suggested that research grants could help examples for explaining the test of build a corpus and institutions should try understanding. He also suggested that to seek an insurance cover for all the templates for patient information sheet, research being conducted at the Institution. checking for conflict of interest, etc. can The issue of qualifications for chairperson be provided. Dr. K. K. Talwar, of EC was discussed in detailed and it was Department of Cardiology, Max suggested that she/he should have training Healthcare Pvt. Ltd., New Delhi, discussed and experience of being a member of EC the difficulties in the creation of corpus though she/he may be from any funds when medical institutions have very background including medical/ non limited funds for research. It was medical or legal.
General Suggestions & Recommendations:
The issue regarding principal In addition to the physical harms investigator in academic research of participation in research, there by students needs to be clarified in can also be legal and social harm the guidelines. and these can be described in the The responsibility of the guidelines. institution and the policy of compensation in case of injury The need and process for during research in academic continuing review or reporting for institutions should be explained in SAEs for clinical trial or academic detail. studies should be clearly It was suggested that it is ideal for mentioned. an institution to have a separate The guidelines should outline the scientific committee besides the various provisions for appealing ethics committee, however, the against the EC decision or ECs has every right to question suggestion by the investigator. the scientific validity even if the The details of the appellate scientific committee has approved authority need to be clarified and the study if it concerns the rights, given in more detail for follow-up welfare and safety of research at various institutions. participants.
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Panel Discussion II
Ethical Review Procedures
Chairperson: Dr. Alok Srivastava, Moderator: Dr. Vijay Prakash Mathur
Panelists: Dr. George Thomas, Dr Madhur Gupta, Dr. Bishnu Ram Das, Dr. S.V. Joga Rao
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11 AM-12.00 Noon - Panel Discussion II: Ethical Review Procedures
Chairperson: Dr. Alok Srivastava, Moderator: Dr. Vijay Prakash Mathur
Panelists: Dr. George Thomas, Dr. Madhur Gupta, Dr. Bishnu Ram Das and Dr. S.V. Joga Rao
Dr. V. P. Mathur, Additional Professor, required supports have not been provided to Pedodontics and Preventive Dentistry, them. She suggested that templates for Centre for Dental Education and Research, SOPs and terms of reference should also be All India Institute of Medical Sciences, included in the guidelines. She also New Delhi, suggested that the templates for suggested that guidelines for biosimilars SOPs can also be developed by ICMR as should be expanded and added as an these would help researchers. Scope of the annexure to the guidelines. Dr. B. R. Das, guidelines should be separately explained Associate Professor, Dept. of Community for clinical trials and for academic studies. Medicine, Jorhat Medical College, Jorhat, Some guidance or SOPs should also be Assam, appreciated the revised guidelines. provided regarding membership which He raised concerns about ensuring clarifies that all the members of EC should confidentiality of the data since it is not be changed at the same time. About 30- accessible to EC secretariat staff. He 50% of members may be changed to ensure pointed out that sometimes researchers do continuation and proper functioning of not submit all the required documents to ethics committees. Dr. George Thomas, the ECs which delays ethical review and Chief Orthopaedic Surgeon, St. Isabel's therefore, the use of checklist should be Hospital, Chennai, said that the encouraged. He also stressed on the need independent or for profit ECs exists and for capacity building of the ECs and these are not a very feasible model since researchers. Dr. S. V. Joga Rao, these encourage EC shopping. Instead Additional Professor, National Law School bigger medical institutions should have of India University, Bangalore, discussed provision to review research proposals the need to focus and strengthen the role of from smaller set ups. He suggested possible legal expert or lay person in EC meeting as collaboration between ICMR and MCI for they are the public voice. He stated that establishing medical research unit in all sometimes researchers do not co-operate medical colleges across the country. Dr. for continuous review or for being Madhur Gupta, Technical Officer- monitoring by the ECs and therefore, Pharmaceuticals, WHO Country Office for guidelines should clearly describe the India, stressed about the need for building processes in detail. Dr. Alok Srivastava, capacity and providing infrastructure to EC Professor, Department of Haematology, in the type B and C cities, since so far Christian Medical College, Vellore,
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discussed the role of ECs in detail and science and ethics both while reviewing suggested that ECs should discuss about research proposals.
General observations & recommendations:
The ECs should review both ethical Not more than 50% of EC members and scientific aspects of research. should be replaced within a short Documents related to EC span of time (3 to 6 months). functioning should be prepared; New members of EC should attend templates, drafts, TOR‟s, specific initial meetings as guest observers SOP‟s for receiving/ review/ for orientation before they become replying and conduct of EC voting members of EC. meetings, sample forms, COI EC should specify the duration of declaration forms, confidentiality approval for study. It may grant agreements for EC members and approval for full duration of the secretarial staff. study, subject to timely submission Role and functions of independent of annual reports. In case of non ECs needs to be elaborated. submission of progress report, the The required and desirable EC should revoke its approval. qualification of each EC member Experts can join the meeting via can be given in one table and desired video/tele conferences for opinion. roles/ duties of each member may be Archiving and record keeping can be elaborated upon. carried out in electronic format.
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Panel Discussion III
Epidemiological, Public Health, Socio-Behavioral Sciences, Humanitarian Emergencies/ Disasters Research
Chairperson: Dr. NK Arora, Moderator: Dr. Mala Ramanathan Panelist: Dr. M. K. Sudarshan, Mr H. L. Gundu Rao, Dr Dorothy Lall and Dr Ragini Kulkarni
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12-1:00PM - Panel Discussion III: Epidemiological, Public Health, Socio-Behavioral Sciences, Humanitarian Emergencies/ Disasters Research
Chairperson: Dr. NK Arora, Moderator: Dr. Mala Ramanathan
Panelist: Dr. M. K. Sudarshan, Mr H. L. Gundu Rao, Dr. Dorothy Lall and Dr. Ragini Kulkarni
Dr. Mala Ramanathan, Professor, social science methods for research needs AMCHSS, Sree Chitra Tirunal Institute for to be elaborated in the guidelines. She also Medical Sciences and Technology suggested that plan for dissemination of (SCTIMST), Thiruvananthapuram, pointed results should be included beforehand. out the importance of identifying the ethical There should be full review for studies issues in public health research and involving mild deception. Examples for quantitative research so that such research Etic and Emic issues should be explained in is responsive to the health needs of our detail. Dr. H. L. Gundu Rao, Legal expert, population. Dr. M. K. Sudarshan, Bangalore, focused on interpersonal Professor and Head, Rajiv Gandhi Institute relationship and suggested linkages of Public Health, Rajiv Gandhi University between community, service provider and of Health Sciences, Bangalore, suggested researcher. Dr. N. K. Arora, Executive that the templates for the review of socio- Director, The INCLEN Trust International, behavioral research studies should be New Delhi, discussed the importance of included in the guidelines. Dr. Dorothy ethics committees review even at the Lall, Institute of Public Health, Bangalore, surveillance site and also discussed about highlighted that studies which fall in the ethical aspects of implementation research. interface of public health research and use
General observation and recommendations:-
The need for community advisory communities. board and its role may be stressed The safety of research team is upon in the guidelines. important in public health research The role of head of community to be and should be built in to the research emphasized along with the role of design. social activist and other community New drug intervention in cohort representatives. studies can be addressed in more The return of results or benefit detail in the guidelines. sharing to the community should be an essential component of Public Health research which involves 24 | P a g e
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Panel Discussion IV
Clinical trials of drugs and other interventions and New Technologies
Chairperson: Dr. G K Rath, Moderator: Dr. Santanu Tripathi
Panelist: Dr. Sanish Davis, Dr. P. Jambulingam, Dr. Mudgal Kothekar, Dr. P. Satish Chandra
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2-3.00 PM: Panel Discussion IV - Clinical trials of drugs and other interventions and New Technologies
Chairperson: Dr. G K Rath, Moderator: Dr. Santanu Tripathi
Panelist: Dr. Sanish Davis, Dr. P. Jambulingam, Dr. Mudgal Kothekar, Dr. P. Satish Chandra
Dr. Santanu Tripathi, Professor and Head Puducherry, raised the issue of providing Clinical and Experimental Pharmacology, an insurance cover for community based Calcutta School of Tropical Medicine, clinical trials and other unrelated illnesses. Kolkata, stated that therapeutic He discussed regarding the payment of misconception can be elaborated upon in compensation and suggested that clear the guidelines. He suggested that the guidance for ECs should be given in the qualification of the study team in the guidelines. Dr. P. Satish Chandra, Senior specialized area on which the trial is Professor, Department of Neurology, planned should be elucidated. PI‟s NIMHANS, Bangalore, discussed the qualification for the acceptance of study issues related to multicentric clinical trials, should also be addressed. Dr. Sanish major and minor protocol deviation, Davis, Country Head, Covance India reporting of death, SAE, removal of Pharmaceutical Services Pvt. Ltd., Mumbai internal device and sham surgery etc. He informed that ICMR Guidelines are suggested that surgical clinical trials should considered as quasi judicial. He discussed also be registered. The differences between about the validity of study duration and the regulatory and non regulatory clinical timelines for SAE reporting. Post trial trials were also discussed. Dr. G. K. Rath, access should be addressed before initiation Professor and Head, Department of of study. Dr. Mudgal Kothekar, Medical Radiation Oncology and Chief, Institute Director, Biocon, Bangalore, emphasized Rotary Cancer Hospital, All India Institute the issues of post trial access, SAE of Medical Sciences, New Delhi, reporting, standard of care, oncology appreciated ICMR‟s initiatives for clinical trials and publication ethics in addressing the emerging ethical challenges detail. Dr. P. Jambulingam, Scientist G & posed by the recent development in Director, Vector Control Research Centre, biomedical and health research.
General observation and recommendations
Therapeutic misconception in member of the research team should potential participants must be have qualification in the subject area avoided and the guidelines should in which the trial is planned. give more details on this. Issues related to SAE reporting and It was suggested that at least one its timeline should be clearly
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outlined. Publication of site specific data Site specific protocol modifications needs to be addressed in more detail and post trial access should be in multicentric clinical trials. elaborated upon in the guidelines. It was suggested that the procedure Clinical trials involving surgical interventions and those using of EC approval for multicentric radiology can also be included as clinical trials may be clarified. separate sections.
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Panel Discussion V
Human Genetics Testing and Research, Biological materials, Biobanking and Datasets
Chairperson: Dr. H Sharat Chandra, Moderator: Dr. Manjulika Vaz Panelist: Dr. Janet Parameshwar, Dr. Raghu Padinjat, Dr Jayarama S Kadandale
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3-4.00 PM: Panel Discussion V - Human Genetics Testing and Research, Biological materials, Biobanking and Datasets
Chairperson: Dr. H Sharat Chandra, Moderator: Dr. Manjulika Vaz
Panelist: Dr. Janet Parameshwar, Dr. Raghu Padinjat, Dr. Jayarama S Kadandale
Dr. Manjulika Vaz, Lecturer, Health and to deal with the ethical issues related to the Humanities Division, St. John‟s Research new technology such as CRISPR. There Institute, Bangalore, said that distinction should be distinction between research between genetic services and research carried out using human samples freshly should be further clarified. Dr. Jayaram derived from patients and human derived Kadandale, Head, Clinical & Molecular established cell lines (immortalized cell Cytogenetics, Centre for Human Genetics, lines from ATCC (American Type Culture Bangalore, highlighted the precautions to Collection)). Prof. H. Sharat Chandra, be taken for non invasive prenatal testing Honorary Director, Centre for Human and reporting by in-house testing centers. Genetics, Bangalore, discussed the Dr. Janet Parameshwar, Social Welfare concerns related to confidentiality/ privacy Officer, Kidwai Memorial Institute of of the genetic data and the difficulty to Oncology, Bangalore, said that maintain complete confidentiality of confidentiality should be maintained and information. He also pointed out that any claims for benefits of research also be genetic services and research cannot be examined and monitored. Dr. Raghu separated from one another. He suggested Padinjat, Associate Professor, National that training, accreditation facilities and Centre for Biological Sciences, Bangalore, review of certified labs are important. said that greater attention must be given Biological Sciences, Bangalore, said that greater attention must be given about how
General observation and recommendations:-
While reviewing genetic research Detailed guidelines for genetic testing, protocols or monitoring such studies, a in terms of quality control, manpower competent person in human genetics training, interpretation of results and could be invited to attend the EC counseling are required. meeting as a nonvoting expert. Governance committee of biobanks to ICMR can set up regional advisory have a representation of community cells in the country to guide ECs and members, lay members and other institutions. stakeholders.
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Panel Discussion VI
International Collaboration, Responsible Conduct of Research
Chairperson: Dr. R C Mahajan, Moderator: Dr. Siddhartha Laskar
Panelist: Dr. Pradeep Menon, Dr R.R. Gangakhedkar, Dr. G D Ravindran
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4-4:30 PM: Panel Discussion VI – International Collaboration, Responsible Conduct of Research
Chairperson: Dr. R C Mahajan, Moderator: Dr. Siddhartha Laskar
Panelist: Dr Pradeep Menon, Dr R.R. Gangakhedkar, Dr. G D Ravindran
Dr. R. C. Mahajan, Emeritus Professor, related to ghost authorship and sharing of Department of Parasitology, Postgraduate cloud data. Dr. R. R. Gangakhedkar, Institute of Medical Education & Research, Scientist F & Director-in-charge, National Chandigarh, emphasized that Indian AIDS Research Institute, Pune, emphasized partners should understand that they are the oversampling of vulnerable equal partners for international populations, e.g., anti-retroviral therapy. He collaboration research and collection of was also of the opinion that there should be samples and storing. Responsible Conduct clarity in the types of collaboration and of Research (RCR) should be clearly part online data sharing. Dr. G. D. Ravindran, and parcel of every research study. Dr. Professor and Head, General Medicine, St. Siddhartha Laskar, Professor, Dept. of John‟s Medical College, Bangalore, stated Radiation Oncology, Tata Memorial the need to have a separate section on Hospital, Mumbai, discussed about electronic data. He said that standard of streamlining the HMSC submission and care should be given to the research clearance process. Dr. Pradeep Menon, participants. He also pointed out the Scientist E, National Institute for Research difficulties in the coordination between in Tuberculosis, Chennai, raised the issues various ECs of all the study sites.
General observation and recommendations:-
Guidance on constituting technical Appropriate policy is required for authorization committees, governance international transfer of data or committees for biobanks and drafting of samples, pooling of resources and Material Transfer Agreement (MTA), technology transfer. Data Transfer Agreement (DTA), etc. is required.
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ICMR –WHO National Consultation
On
“National Ethical Guidelines for Biomedical and Health Research involving Human Participants”
At
Indian Council of Medical Research
14th December, 2016, New Delhi
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Proceedings of the National Consultation Meeting
Welcome and Opening Remarks
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Welcome and Opening Remarks
Dr. Roli Mathur, Scientist-E and Head, Remarks by Co- Chairperson, ICMR Bioethics Unit, NCDIR, Bangalore, Advisory Group welcomed all the invited guests. She said that the National Consultation meeting is organized in collaboration with WHO Dr. S. D. Seth, Co- Chairperson, advisory country office India, to reach out to the group committee gave a brief account of larger panel of national experts and to seek the revision of ICMR Ethical Guidelines their comments on the revised ethical from 1980 to 2016. ICMR brought out the guidelines and to get final approval before 'Policy Statement on Ethical Considerations the document goes for printing. ICMR involved in Research on Human Subjects' ethical guidelines hope to provide an in 1980 under the chairmanship of Justice answer to deal with the emerging ethical H R Khanna, these guidelines were revised challenges and to be a reference point for in 2000 as the 'Ethical guidelines for biomedical and health research in India. Biomedical Research on Human Subjects' She stated that it is an important day when under the chairmanship of Justice MNR we are closing the process of consultation Venkatachaliah. In view of the new of revised ethical guidelines which was developments in the field of science and initiated in early August, 2016. She technology another revision was carried out welcomed members of CECHR, all the as Ethical Guidelines for Biomedical chairs and representative of various Research on Human Participants in 2006. government departments, ministries, He said that 12 subcommittees were formed agencies and councils as well as members with experts and meetings were held to of international organizations, directors and finalize the zero drafts of the sections for faculties of institutions, non government the revised guidelines. Zero drafts were organization, hospitals and associations etc. further edited and finalized by advisory She also said that the revised guidelines has group members in several meetings received positive feedback and this throughout the year. He said that after document once released will set standards finalizing the draft guidelines, it was posted not only in India but across the globe. A on the ICMR website for public very large number of persons have consultation and comments were invited contributed to the development of the from various stakeholders. The draft guidelines; to which ICMR is thankful. She guidelines were also sent to various informed that when the document was organizations like DBT, DST, and AYUSH posted on the ICMR website for public for critical comments. A large number of comments, almost 1,324 comments were comments have been received from received from individuals, institutions and approximately 63 individuals as well as agencies. The five sections of earlier 2006 organizations, valuable comments from guidelines have been extended to 13 national and international agencies like different sections. NIH and OHRP has also been received.
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Following the suggestions received, the setting up the ethical standard for research draft guidelines have been further revised. in India. He also informed everyone about the plan to develop online courses for Remarks by Advisory Group ethics committees jointly by ICMR and WHO. The Advisory group members Dr. Nandini K Kumar, Dr. N. K. Arora, Dr. Remarks by DG ICMR Urmila Thatte and Dr. Vijay Kumar discussed on the various sections which Dr. Soumya Swaminathan, Secretary, were taken care and the various changes DHR & DG ICMR, welcomed the guests made in each section under their and thanked them for sharing their valuable supervision. The new guidelines contains time. She congratulated all the advisory 13 sections with separate sections on; group members for their efforts and also Informed Consent Process, Vulnerability, thanked WHO for their support to organize Social and Behavioral Sciences Research the consultation meetings for finalizing the for Health, Biological materials, draft guidelines. She discussed some of the Biobanking and Datasets, International important sections of the revised draft Collaboration, Research during guidelines and highlighted the new Humanitarian Emergencies and Disasters additions to the guidelines that have been and Responsible Conduct of Research. The incorporated. She discussed the importance advisory group members thanked all the of online course on ethics and suggested to stakeholders for critically reviewing the pursue it at the earliest. draft guidelines and suggesting the necessary changes. They also thanked DG, Vote of Thanks by Dr. Roli ICMR for providing the opportunity for revising the ICMR Ethical Guidelines as Mathur advisory group members. Dr. Roli Mathur thanked the invited Remarks by Country guests for gracing the occasion, DG ICMR, Representative, WHO India Dr. Henk Bekedam, Dr. Madhur Gupta, all the advisory group members, subcommittee Dr. Henk Bekedam, WHO Representative, members and many others, both scientific Country Office for India said that it has as well as administrative support towards been a privilege to have closely worked the finalization of the draft ethical with ICMR for supporting the agenda of guidelines. ethics. The draft ethical guidelines have addressed the emerging issues and discussed the importance and need for
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Panel Discussion I General Ethical Issues, Informed Consent Process, Vulnerability
Chairperson: Dr. Gagandeep Kang
Panelist: Dr. Amar Jesani, Dr. V. G. Somani, Dr. Nalin Mehta
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10-11.00AM - Panel Discussion I - General Ethical Issues, Informed Consent Process & Vulnerability
Chairperson: Dr. Gagandeep Kang
Panelists: Dr. Amar Jesani, Dr. V. G. Somani and Dr. Nalin Mehta
Dr. Gagandeep Kang, Executive Director, should be clearly defined in the guidelines. Translational Health Science and This guideline may provide information as Technology Institute (THSTI), Faridabad, to who obtains the informed consent and discussed the differences in the process of where it is taken. Role of gatekeepers informed consent at different research set should be clearly defined especially when ups. She explained how conduct of research vulnerable populations are involved. Dr. V differs at hospital or at the community level G Somani, Joint Drugs Controller, and what should be the process of obtaining Ministry of Health and Family Welfare, the informed consent while protecting Government of India, New Delhi, vulnerable population at these set ups. She emphasized the need to simplify the also discussed about the need for teaching language used in the guidelines so that it ethics to researchers and providing training can be easily read by the patients and to ECs. She pointed out need to protect the common people. He discussed about the vulnerable populations and suggested ways role of treating physician as PI and when of conducting the studies that involve informed consent is obtained by the treating inclusion of pregnant women or other tribal physician. He said that the mechanism of groups in research. Dr. Amar Jesani, compensation should be smooth and details Editor, Indian Journal of Medical Ethics, needs to be provided in the protocol. Dr. Mumbai, discussed about the issues related Nalin Mehta, Professor, Dept. of to benefit-risk analysis, privacy– Physiology, AIIMS, New Dehli, discussed confidentiality, selection of participants and about post trial access to the patient, the monitoring of research. He suggested that magnitude of probable risk and definition priorities should be given to these issues in of minimal risk. He suggested that the post the guidelines. Role of audio and visuals trial access to the patient should be built in aids at the time of data collection (privacy to the study. and confidentiality of participants), undue inducement, payment for participation, etc.
General Suggestions & Recommendations:
ECs should carefully review justify the exclusion or inclusion of proposals that involve research on vulnerable populations in the vulnerable populations. protocol. Investigators should adequately There should be ways to ensure
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safety of vulnerable population Clear distinction should be made groups and protection of their between vulnerable and specific confidential information. populations to be involved in Details regarding payment of research in the guidelines. compensation for research related injury should be provided in the informed consent form.
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Panel Discussion II
Ethical Review Procedures
Chairperson: Dr. Kusum Verma Panelists: Dr. Madhur Gupta, Dr. Sita Naik, Dr. Prabha Desikan, Ms. Annam Visala
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11 AM - 12.00 Noon-Panel Discussion II - Ethical Review Procedures
Chairperson: Dr. Kusum Verma
Panelists: Dr. Madhur Gupta, Dr. Sita Naik and Dr. Prabha Desikan
Dr. Kusum Verma, Senior Consultant, highlighted that innovation and existing Department of Pathology, Sir Ganga Ram therapeutic options have become an issue, Hospital, New Delhi, stated that in the as lot of drugs coming of today are revised guidelines, this section has been variations of existing molecules which done quite well compared to earlier have limited amount of implemental document. She suggested that addendums benefit over the existing molecules. She to guidelines should be brought out every also spoke on the importance of training, six months or in an interval of one year as periodic certification and retraining on per need, members of EC should be trained ethics. Dr. Prabha Desikan, Director-in- and; training programs must be introduced Charge, Professor and Head, for EC members and researchers. Dr. Microbiology, Bhopal Memorial Hospital Madhur Gupta, Technical Officer- & Research Centre, Bhopal, stated that Pharmaceuticals, WHO Country Office for the roles of each member have been India described the online course for ethics defined quite well in this draft guideline. committee members which is being She also spoke on the importance of developed by National Institute of expedited review procedure and the need Epidemiology (ICMR). She spoke about to implement training programmes in payment of compensation and its research institutes. Ms. Annam Visala, importance in case of research related Deputy Drugs Controller, Ministry of injury. She suggested that the word „may‟ Health and Family Welfare, Government can be changed to „should/shall‟ in the of India, New Delhi, highlighted that the sentence “Ethics Committees „may‟ benefits and risk, compensation, roles and suggest appropriate compensation” as the responsibilities of chairman of EC and ethics committees are empowered to take expedited review procedure has more decision on compensation. Dr. Sita Naik, clarity as compared to the previous Advisor, Apollo Hospitals Educational & document. She suggested putting a sub Research Foundation, Apollo Indraprastha topic on role of expert in the committee, Hospital, New Delhi, spoke on benefits conflict of interest that they might bring in, and risk analysis. She discussed about the funding for the ethics committee and following parameters - assessment of institution responsibilities for providing benefits and risk to the patients; innovation infrastructures, funding and independence and existing therapeutic options and unmet to the ethics committees to function as medical health of the people. She independent organizations.
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General Suggestions & Recommendations:
It was suggested that addendums Institution‟s responsibilities for can be brought out to the revised providing infrastructures, funding ethical guidelines by ICMR every and independence to the ethics six months or in an interval of one committees to function as year as per need. independent organizations should Training programs must be be clearly defined as this would introduced for all members of EC. help improve EC functioning. Specific role of experts in the committee should be discussed in the guidelines.
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Panel Discussion III
Public Health Research, Socio-Behavioral Sciences, Humanitarian Emergencies/ Disasters Research
Chairperson: Dr. Sanjay Mehendale Panelist: Dr. Amita Singh, Dr. Ravi Verma, Dr. Sanghamitra Pati
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12-1.00 PM-Panel Discussion III - Public Health Research, Socio-Behavioral Sciences, Humanitarian Emergencies/ Disasters Research
Chairperson: Dr. Sanjay Mehendale Panelists: Dr. Amita Singh, Dr. Ravi Verma and Dr. Sanghmitra Pati
Dr. Sanjay Mehendale, Additional DG, Governance, Jawaharlal Nehru University, ICMR, New Delhi, raised the issue New Delhi, said that ethics is inseparable regarding the use of newer technology such from social sciences. She spoke on the as imaging and hand held devices etc. impact and differences between social which may bring out ethical issues related sciences and natural sciences. She also to breach of confidentiality and therefore, pointed out the ethical issues related to the need appropriate guidance. In public health questionnaire based research on research research, some emphasis is required on participants after humanitarian emergencies screening of populations. He spoke about and disasters. Dr. Ravi Verma, Regional concerns related to biobanking; tissue Director, Asia Regional Office, banking especially in community settings International Center for Research on where they have different sets of moral and Women's (ICRW), New Delhi, spoke on ethical concerns. He also discussed the the specificity in newer areas of social basic difference between public health science research. He spoke on the various programs and research and both should be areas of social and behavioral research such clearly defined in the introduction. He as violence against women, child sex abuse discussed on sensitivities related to social research and child marriage to be addressed science research, socio-behaviour research, in the ethical guidelines and how the risk disaster and public heath emergencies and assessment should be done to deal with said that the focus of public health these issues. Dr. Sanghamitra Pati, functionaries are directly related to Director, Regional Medical Research providing relief. Methodology and Centre, Bhubaneswar, spoke on the overlap concerns related to collection of between the clinical, public health, social information through surveillance, specific and behavioral research. She said that reference to control of outbreaks, or equitability is one of the principles of listening to people with some specific set of ethical research. She also spoke on the complaints, sensitive information, etc. is involvement of physically and mentally important. Dr. Amita Singh, Professor, challenged people in research. Centre for the Study of Law and
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General Suggestions & Recommendations:
Various areas of social and behavioral The guidelines should discuss ways of research such as violence against dealing with sensitive information. women, child sex abuse research and Guidelines for social science research child marriage to be taken as an issue are important and should be discussed in the ethical guidelines. in detail. The differences and requirements for public health programs and public health research should be clarified.
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Panel Discussion IV
Clinical trials of drugs and other interventions
Chairperson: Dr. Y. K. Gupta
Panelist: Dr. V. G. Somani, Dr. Arun Bhatt, Dr. Upendra Kaul
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2-3.00 PM-Panel Discussion IV - Clinical trials of drugs and other interventions
Chairperson: Dr. Y. K. Gupta Panelist: Dr. V G Somani, Dr. Arun Bhatt and Dr Upendra Kaul
Dr. Y K Gupta, Professor and Head, Research, Mumbai, discussed about the Department of Pharmacology, AIIMS, qualifications and research experience of New Delhi, raised the need to have clear PI in the conduct of clinical trials. He definitions for clinical trials, regulatory/ suggested that vulnerable populations and non-regulatory and academic/ non- their safety in trials should also be academic clinical trials. He also discussed considered. Dr. Upendra Kaul, Executive about the role of ECs in the assessment Director and Dean-Cardiology, Fortis and documentation of causality of research Escort Heart Institute, New Delhi, related injuries or harm. He highlighted the discussed about whether compensation importance of looking at the qualifications should be given to the injury occurred due of investigators discussing whether to trial or during the trial. Therefore, the postgraduate students can be an mechanism of causality assessment should investigator or not. It was felt that there is be in place to calculate the quantum of a need to assess the competence of compensation for research related injury. investigator. He highlighted the difficulties Dr. V. G. Somani, Joint Drugs Controller, in assessment or documentation and Ministry of Health and Family Welfare, reporting of SAE/ AE. Since the Government of India, New Delhi, compensation is decided by the ECs there discussed the issue of payment of is need for proper training for EC compensation in case of injury during members. He also discussed regarding the research. He highlighted the need for mechanism of handling patients outside harmonization of ICMR guidelines with the hospital for SAE. Dr. Arun Bhatt, the regulations. Representative, Indian Society for Clinical
General Suggestions & Recommendations:
It was suggested that there is a Structured training of EC members need to synchronize the regulatory including the procedure for the requirements in accordance to the calculation of amount of ethical guidelines for clinical trials. compensation and assessment of The ethical guidelines set standards causality for SAE is required. and the regulations should consider There is a need for continuing these while planning amendments review by ECs for high risk trials in the regulations. and should be included in the guidelines. 46 | P a g e
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Panel Discussion V
Human Genetics Testing and Research, Biological materials, Biobanking and Datasets
Chairperson: Dr. N. K. Mehra Panelist: Dr. Poonam Salotra, Mr. Prasanna Kumar B Shirol, Dr. Ratna Puri
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4.00 PM- Panel Discussion V - Human Genetics Testing and Research, Biological materials, Biobanking and Datasets
Chairperson: Dr. N. K. Mehra
Panelist: Dr. Poonam Salotra, Mr. Prasanna Kumar B Shirol and Dr. Ratna Puri
Dr. N. K. Mehra, Dr. C. G. Pandit and only hospital camera should be National Chair ICMR and Former Dean & allowed. She discussed that the ethical Head, Department of Transplant issues related to carrier testing and new Immunology & Immunogenetics, AIIMS, born screening are covered in the New Delhi, appreciated the contents of the guidelines. She raised the issue regarding genetics section in the guidelines and said secondary use of archived sample and that it has covered almost every issues suggested that archived samples should be related to genetic testing and research. He partially or fully anonymised for rare suggested that the guidelines should be disease research. Dr. Poonam Salotra, crisp and extensive details or repetitions Scientist G & Director-in-charge, National should be avoided. He highlighted the Institute of Pathology, New Delhi, ethical issues related to genetic testing and discussed about the data ownership and genetic research which are of concern authorization for archived samples. She across the country. He also spoke on the raised the issues related to issues related to innovative testing for commercialization of biobanking, datasets prenatal diagnosis and adoption under and quality assurance for biobanking. Mr. genetic testing. Dr. Ratna Puri, Senior Prasanna Kumar B Shirol, President- Consultant, Institute of Medical Genetics & Pompe Foundation, Bangalore, highlighted Genomics, Sir Ganga Ram Hospital, New the issues related to small scale research set Delhi, highlighted the practical issues for up and research for rare genetic disorders. obtaining fresh consent from patients for He discussed about the need for an publication of photographs. She suggested insurance coverage for genetic and long that all the relevant information regarding term disorders, the issues related to genetic publication should be provided to patient testing, gene editing and designer babies. while obtaining consent, e.g. taking a The issues of community consent, group photograph for genetic research. She also consent and reconsent were also discussed suggested that for protecting patient‟s in detail. privacy and confidentiality, mobile camera should not be used for taking photographs
General Suggestions & Recommendations:
It was suggested that consent should testing. be obtained even for routine genetic Genetic research and testing are 48 | P a g e
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often overlapping and therefore, Reconsent for use of research need due care. participant‟s data for publication and Data ownership and authorization teaching purpose should be clearly for archived samples should be mentioned in the guidelines. clearly mentioned.
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Panel Discussion VI
International Collaboration, Responsible Conduct of Research
Chairperson: Dr. Indira Nath
Panelist: Dr. T. S. Rao, Dr. Anant Bhan, Dr. Nithya Gogtay
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4-4.30 PM -Panel Discussion VI - International collaboration and Responsible Conduct of Research
Chairperson: Dr. Indira Nath
Panelist: Dr. T S Rao, Dr. Anant Bhan and Dr. Nithya Gogtay
Dr. Indira Nath, former Emeritus collaborators. He pointed out that there is Professor, Raja Raman Fellow, National a need to make the HMSC process more Institute of Pathology, New Delhi, efficient. He was of the opinion that congratulated ICMR for bringing out the responsible conduct of research is about wonderful document. She pointed out how responsible investigator. He raised the these guidelines will help the Indian issue of protection of whistle blowers. He investigators for international suggested that the time frame of data collaboration. She also pointed out the sharing needs to be mentioned as well as importance of capacity building to increase the issues pertaining to parachute research. awareness. Dr. T S Rao, former Senior Dr. Nithya Gogtay, Additional Professor Advisor, Department of Biotechnology, of Clinical Pharmacology, Seth GS also complemented ICMR for preparing Medical College & King Edward the very comprehensive document. He Memorial Hospital, Mumbai, suggested emphasized the issue regarding technology including the definitions of international transfer and IPR for sharing data. He also collaboration and responsible conduct of suggested that a paragraph on the role of research at the beginning of the respective sponsor in the international collaboration sections. The importance of international section should be added. He suggested that collaboration and issue of different views references regarding biosafety and of ECs within the country in multicentric biodiversity can also be included. He said trials needs to be mentioned. She stressed that the IPR and data sharing issues should that the research cell or research secretariat be clearly defined along with the role of should have standard operating procedures ECs and funding agencies. Dr. Anant (SOPs) to address all the major Bhan, Senior Manager, International components, e.g. values, policies, AIDS Vaccine Initiative (IAVI), India planning, conduct, etc. Mentor should Regional Office, New Delhi, specified that devote sufficient time towards their India is a major partner in an international mentees and improve quality of output collaboration where countries with poor from research. SOPs for the protection of resource than India are involved. whistleblower are important and should be Therefore, the guidelines should reflect the included. responsibility to protect other partners or General Suggestions & Recommendations:
It was suggested that the title of the section international collaboration
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may be changed to collaborative differentiated clearly. research. The roles and responsibilities of funder and sponsor should be
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Concluding Remarks:
Dr. P. N. Tandon, Chairperson, Central has made all efforts to engage with public Ethics Committee on Human Research as well as experts and stakeholders in (CECHR), discussed the journey of ICMR order to bring in transparency and to have guidelines from 2006, and the preparation opinion from all. She said that the inputs of the Draft of Ethics bill in the year 2013- given will strengthen the document 2014 and its subsequent submission to the further. Government for considerations of conversion to legislation. He informed the Dr. Madhur Gupta, Technical Officer- importance of the guidelines for research Pharmaceuticals, WHO Country Office in India keeping in view of the social, for India, stated that it was a fruitful day cultural, economic and religious aspects of with a lot of discussions over the various our country. He also emphasized on the sections of the guidelines and a huge need for capacity building in the field of number of inputs have been received from ethics in the country. various stakeholders.
Dr. G. N. Singh, Drugs Controller Finally, Dr. Roli Mathur thanked General of India, mentioned that this everyone for the fruitful conclusion of the document will be useful to the country and national consultation meeting. She will help to strengthen the ethics informed that all the suggestions would be committee perform their duties and taken to the Advisory Group for their thereby help the regulators. He suggested consideration before finalization of that the document should be prepared in revised ICMR Ethical Guidelines. simple language so that it is very easy to understand.
Dr. Soumya Swaminathan, DG ICMR, expressed her happiness and thanked all the experts for actively participating and giving the inputs for finalization of the Draft National Ethical Guidelines. ICMR
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Meeting Agenda Regional Consultation
ICMR –WHO Regional Consultation “National Ethical Guidelines for Biomedical and Health Research involving Human Participants, 2016” Date: 4 Oct 2016 Time: 9 AM- 5.30 PM
Venue: Conference Hall (GF), National Centre for Disease Informatics and Research, Indian Council of Medical Research, Nirmal Bhawan, Poojanhalli Road, Off NH-7, Adjacent to Trumpet Flyover of BIAL, Kannamangala Post, Bangalore- 562110
9.00 - 9.30 AM Registration 9.30 -10.00 Welcome by Director NCDIR: Dr. Prashant Mathur AM Remarks by Chairperson: Dr Vasantha Muthuswamy Opening WHO Perspective: Dr Madhur Gupta, WHO India Country Office Session Vote of Thanks: Dr. Roli Mathur
10-11.00 AM General Ethical Issues Dr. K K Talwar (Chairperson) Panel Informed Consent Process, Dr. Joseph Thomas (Moderator) Discussion I Vulnerability Dr. Olinda Timms Dr. Pratima Murthy Dr. Meenakshi Bhat Dr. Tarun Bhatnagar 11-12.00 noon Ethical Review Procedures Dr. Alok Srivastava (Chairperson) Panel Dr. Vijay Prakash Mathur (Moderator) Discussion II Dr. George Thomas Dr Madhur Gupta Prof.(Dr) Bishnu Ram Das Dr. S.V. Joga Rao
12-1.00 PM Epidemiological, Public Dr. NK Arora (Chairperson) Panel Health, Socio-Behavioral Dr. Mala Ramanathan (Moderator) Discussion III Sciences, Humanitarian Dr. M. K. Sudarshan Mr H. L. Gundu Rao Emergencies / Disasters Dr Dorothy Lall Dr Ragini Kulkarni Research 1- 2.00 PM LUNCH 2-3.00 PM Clinical trials of drugs and Dr. G K Rath (Chairperson) Panel other interventions Dr. Santanu Tripathi (Moderator) Discussion IV and New Technologies Dr. Sanish Davis Dr. P. Jambulingam Dr. Mudgal Kothekar Dr. P. Satish Chandra 3-4.00 PM Human Genetics Testing Dr. H Sharat Chandra (Chairperson) Panel and Research, Biological Dr. Manjulika Vaz (Moderator) Discussion V materials, Biobanking and Dr. Janet Parameshwar Dr. Raghu Padinjat Datasets Dr Jayarama S Kadandale 4- 4.30 PM International Collaboration, Dr. R C Mahajan (Chairperson) Panel Responsible Conduct of Dr. Siddhartha Laskar (Moderator) Discussion VI Research Dr Pradeep Menon Dr R.R. Gangakhedkar Dr. G D Ravindran 4.30 -5.00 PM Discussion and Final Recommendations
5- 5.30 PM Tea and Closure
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Meeting Agenda National Consultation
ICMR –WHO National Consultation “National Ethical Guidelines for Biomedical and Health Research involving Human Participants”
Date: 14th December, 2016 Time: 9 AM- 5.00 PM
Venue: Conference Hall (Second Floor), Indian Council of Medical Research, Ansari Nagar, New Delhi – 110029
9.00 - 9.15 AM Registration 9.15 -10.00 AM Welcome by Co - Chairperson (Advisory Group): Dr. S. D. Seth Opening Remarks by Advisory Group Members: Dr. Nandini K Kumar, Dr. N. K. Arora, Session Dr. Urmila Thatte and Dr. Vijay Kumar Remarks by WHO Representative: Dr. Henk Bekedam Remarks by DG, ICMR: Dr. Soumya Swaminathan Vote of Thanks: Dr. Roli Mathur 10-11.00 AM General Ethical Issues Informed Chairperson: Dr. Gagandeep Kang Panel Consent Process, Vulnerability Panelist 1: Dr. Amar Jesani Discussion I Panelist 2: Dr. V. G. Somani Panelist 3: Dr. Nalin Mehta 11-12.00 noon Ethical Review Procedures Chairperson: Dr. Kusum Verma Panel Panelist 1: Dr. Madhur Gupta Discussion II Panelist 2: Dr. Sita Naik Panelist 3: Dr. Prabha Desikan Panelist 4: Ms. Annam Visala 12-1.00 PM Public Health Research, Socio- Chairperson: Dr. Sanjay Mehendale Panel Behavioral Sciences, Panelist 1: Dr. Amita Singh Discussion III Humanitarian Emergencies/ Panelist 2: Dr. Ravi Verma Disasters Research Panelist 3: Dr. Sanghamitra Pati 1- 2.00 PM LUNCH 2-3.00 PM Clinical trials of drugs and Chairperson: Dr. Y. K. Gupta Panel other interventions Panelist 1: Dr. V. G. Somani Discussion IV Panelist 2: Dr. Arun Bhatt Panelist 3: Dr. Upendra Kaul 3-4.00 PM Human Genetics Testing and Chairperson: Dr. N. K. Mehra Panel Research, Biological materials, Panelist 1: Dr. Poonam Salotra Discussion V Biobanking and Datasets Panelist 2: Mr. Prasanna Kumar B Shirol Panelist 3: Dr. Ratna Puri 4- 4.30 PM International Collaboration, Chairperson: Dr. Indira Nath Panel Responsible Conduct of Panelist 1: Dr. T. S. Rao Discussion VI Research Panelist 2: Dr. Anant Bhan Panelist 3: Dr. Nithya Gogtay 4.30 - 5.00 PM Dr. Madhur Gupta (Technical Officer, WHO Country Office for India) Concluding Dr. G. N. Singh (Drugs Controller General of India) Remarks Dr. P. N. Tandon (Chairperson, Central Ethics Committee for Human Research)
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List of Participants Regional Consultation, NCDIR, Bangalore
Dr. A Nandkumar Dr. Alok Kumar Deb Dr. Alok Srivastava Consultant to Director General, Scientist E/ Deputy Director Professor ICMR, II Floor of Nirmal Bhawan, Epidemiology Division Department of Haematology ICMR Complex National Institute of Cholera and Christian Medical College Poojanhalli Road, Off NH-7, Enteric Diseases, P-33, CIT Road Vellore – 632004 Kannamangala Post, Scheme XM, Post Box No 177 Bangalore - 562 110 Beliaghata, Kolkata-700010 Dr. B Ravichandran Prof. (Dr) Bishnu Ram Das Dr. Dorothy Lall Scientist D & Officer-in-Charge Professor, & Head Member-secretary IPH Ethics Regional Occupational Health Deptt of Community Medicine, Committee Center (S), Nirmal Bhavan, ICMR Assam Medical College Institute of Public Health, Complex, Poojanahalli Road Barbari, Dibrugarh, Assam, No 250, 2nd „C‟ Cross, 2nd „C‟ Devanahalli Taluk, NH44, PIN - 786 002 Main, Girinagar 1st Phase, Kannamangala, Bangalore – 560085 Bangalore – 562110 Dr. Debjit Chakraborty Mrs. F S Roselind Dr. G D Ravindran Scientist-B Scientist-D Professor& Head NCDIR, Nirmal Bhawan - ICMR NCDIR, Nirmal Bhawan - ICMR General Medicine, St John‟s Complex (II Floor), Complex (II Floor), Medical College, Sarjapur Road, Poojanahalli Road, Kannamangala Bangalore – 560 034 Poojanahalli Road, Kannamangala Post, Bangalore – 562 110 Post, Bangalore – 562 110 Dr. G K Rath Dr. George Thomas Prof. H Sharat Chandra Professor and Head (Former Editor IJME), Chief Honorary Director Department of Radiation Oncology Orthopaedic Surgeon Centre for Human Genetics, and Chief, Institute Rotary Cancer St Isabel's Hospital, Professor Emeritus – IISc, Hospital , All India Institute of Mylapore, Chennai 600004 Bangalore, Electronics City Phase 1, Medical Sciences, Ansari Nagar, Electronic City, Bengaluru, New Delhi – 110 029 Karnataka 560100 Mr. H L Gundu Rao Dr. Janet Parameshwar Dr. Jayarama S Kadandale 612, 3rd Cross, 2nd Stage, A Block, Social Welfare Officer Head, Clinical & Molecular RHCS Layout, SrigandhadaKavlu, Kidwai Memorial Institute of Cytogenetics, Centre for Human Bengaluru 560091 Oncology, Bengaluru- 560029 Genetics, Biotech Park, Electronic City, Phase I, Bangalore 560100 Dr. Joseph Thomas Dr. K K Talwar Dr. Kalyani Thakur Professor of Urology Chairman Cardiology Department Research Associate Dept of Urology, of Cardiology NCDIR (ICMR), Nirmal Bhawan - Kasturba Medical College, Max Healthcare Pvt. Ltd. Saket, ICMR Complex (II Floor), Manipal 576 104 Press Enclave Road, Saket, New Poojanahalli Road, Kannamangala Delhi – 110 017 Post, Bangalore – 562 110 Dr. Kameshwar Prasad Dr. Kumaraswamy Prof. K Ramachandran Professor and Head Flat No 304, „B‟ Block, Former Prof of Biostatistics, Department of Neurology and Shivaranjani Apartments, 1st East AIIMS, Plot No 122, DSR – Wood Director, Clinical Epidemiology Main Road, ITI Layout, BSK III Winds (Near Wipro), Sarjapur Unit, All India Institute of Medical Stage, Bengaluru – 560 085 Road, Bengaluru – 560 035 Sciences, 704, 7th Floor, C N Centre, Ansari Nagar, New Delhi – 110029 Dr. Madhur Gupta, WHO Dr. M K Sudarshan Dr. Meesha Chaturvedi Technical Officer- Pharmaceuticals Professor and Head Scientist-C WHO Country Office for India, RK Rajiv Gandhi Institute of Public NCDIR, Nirmal Bhawan - ICMR Khanna Tennis Stadium, Safdarjung Health Rajiv Gandhi University of Complex (II Floor), Enclave, New Delhi – 110029 Health Sciences, Annex Building, Poojanahalli Road, Kannamangala 426/27, 33rd Cross, 18th Main, Post, Bangalore – 562 110 56 | P a g e
ICMR-WHO Consultation Meeting 2017
4th T Block, Jayanagar, Bangalore -560 041 Dr. Mala Ramanathan Dr. Manchala Raghunath Dr. Manju Balasubramaniam Additional Professor AMCHSS, Scientist G & Head Principal DPS, Bangalore North, SCTIMST, Thiruvananthapuram - Endocrinology and Metabolism Survey No 35/1A, 695 011 Kerala Division Sathnur Village, Bagalur Post, Off National Institute of Nutrition, Bellary Road, Jalla Hobli, Hyderabad 500007 Bangalore Dr. Manjulika Vaz Dr. Meenakshi Bhat Dr. Mudgal Kothekar Lecturer Centre for Human Genetics, Biotech Medical Director Biocon Health and Humanities Division, Park, Electronic City Phase 1 Biocon Special Economic Zone, Plot St John‟s Research Institute, Bangalore 560 100 no 2&3, Phase IV-B Bommasandra, Opposite BDA Complex, Jigani Link Road, Bangalore- Koramangala, 560099 Bengaluru – 560 034 Dr. N K Arora Dr. N Medappa Dr. Nandini K Kumar Executive Director Ex Sr. DDG & Chief, Former Deputy Director General The INCLEN Trust International, Division of P&I, ICMR Senior Grade (ICMR), 2nd Floor, F-1/5, Okhla Industrial 26, Lang Ford Gardens, Adjunct Visiting Professor, KMC, Area, Phase-I, New Delhi-110020 Bangalore-560025 Manipal Dr. Nirmala Murthy Dr. Olinda Timms Dr. P Jambulingam Founder Adjunct Professor Scientist G & Director Foundation for Research on Health Division - Health and Humanities, Vector Control Research Centre, Systems St John's Research Institute, Medical Complex, Indira Nagar, G-1, Brigade Suites, 100 Feet Road St John's National Academy of Puducherry - 605006 Jayangar 2nd Block, Bangalore- Health Sciences, 560011 Bangalore - 560 034
Mrs. Priyanka Das Dr. P Satish Chandra Dr. Pradeep Aravindan Menon Scientist-C Senior Professor Scientist „E‟ NCDIR, Nirmal Bhawan - ICMR Department of Neurology National Institute for Research in Complex (II Floor), National Institute of Mental Health Tuberculosis, Poojanahalli Road, Kannamangala and Neuro Sciences (NIMHANS), No 1, Mayor Sathiyamoorthy Post, Bangalore – 562 110 Dairy circle, Hosur Road, Road, Chetpet, Chennai - 600 031 Bengaluru-560 029 Dr. Prashant Mathur Dr. Pratima Murthy Dr. Praveen Vemula Director Professor Research Investigator National Centre for Disease Department of Psychiatry Laboratory of Self-Assembled Informatics and Research, Nirmal NIMHANS, Hosur Road Biomaterials and Bhawan - ICMR Complex (II Floor), Bangalore-560029 Translational Research Poojanahalli Road, Kannamangala inStem, NCBS, GKVK Campus Post, Bangalore – 562 110 Bellary Road, Bangalore-560065 Dr. R Prabhu Prof. R C Mahajan Prof. R S Ramaswamy Scientist C SN Bose INSA Research Professor Director General, CCRS National Institute of Epidemiology and Emeritus Professor Central Council for Research in (ICMR), Second Main Road, Department of Parasitology , Siddha, Govt. Anna Hospital Tamil Nadu Housing Board, Postgraduate Institute of Medical Campus, Arumbakkam, Ayapakkam, Near Ambattur, Education & Research, Chennai - 600106, Chennai 600 077 Chandigarh – 160 012 Dr. R R Gangakhedkar Dr. Raghu Padinjat Dr. Ragini Kulkarni Scientist 'G' & Director-in-charge Associate Professor Scientist 'D' National AIDS Research Institute, National Centre for Biological Department of Operational Plot No 73, Block G, MIDC Sciences, Bellary Road, Bangalore Research, National Institute for Complex, Bhosari, Pune-411026 560065 Research in Reproductive Health (NIRRH), Jehangir Merwanji Street, Parel, Mumbai-400 012 57 | P a g e
ICMR-WHO Consultation Meeting 2017
Dr. Rajib Kishore Hazam Dr. Roli Mathur Dr. Sanish Davis Research Associate Scientist E& Head, ICMR Bioethics Country Head, India and Senior NCDIR (ICMR), Nirmal Bhawan - Unit,NCDIR, Nirmal Bhawan - Medical Director, ICMR Complex (II Floor), ICMR Complex (II Floor), Covance India Pharmaceutical Poojanahalli Road, Kannamangala Poojanahalli Road, Kannamangala Services Pvt. Ltd, Mumbai, Post, Bangalore – 562 110 Post, Bangalore – 562 110 Maharashtra – 400615
Dr. Santanu K Tripathi Dr. Sathya Prakash M Mr. Sudarshan K L Professor and Head Scientist-D Scientist-C, NCDIR, Nirmal Clinical and Experimental NCDIR, Nirmal Bhawan - ICMR Bhawan - ICMR Complex (II Floor), Pharmacology Complex (II Floor), Poojanahalli Road, Kannamangala Calcutta School of Tropical Poojanahalli Road, Kannamangala Medicine, 108, Chittaranjan Avenue, Post, Bangalore – 562 110 Post, Bangalore – 562 110 Kolkata - 700 073
Mr. Sathish Kumar K Dr. Siddhartha Laskar Dr. Sukanya R Scientist-B Professor Scientist-D NCDIR, Nirmal Bhawan - ICMR Dept of Radiation Oncology, NCDIR (ICMR), Nirmal Bhawan - Complex (II Floor), Member Secretary, Institutional ICMR Complex (II Floor), Poojanahalli Road, Kannamangala Poojanahalli Road, Kannamangala Review Board, Tata Memorial Post, Bangalore – 562 110 Post, Bangalore – 562 110 Hospital Parel, Mumbai - 400012
Dr. Sushant K Ghosh Dr. S V Joga Rao Dr. Tarun Bhatnagar Scientist 'G' &Officer-in-charge, Additional Professor, National Scientist D National Institute of Malaria Law School of India University, National Institute of Epidemiology Research, Field Unit Epidemic Nagarbhavi (ICMR), Second Main Road, Disease Hospital, Old Ma as Road, Bangalore-560072 Tamil Nadu Housing Board, Bangalore- 56003 Ayapakkam, Near Ambattur, Chennai 600 077 Dr. Urmila Thatte Dr. Vasantha Muthuswamy Dr. Vijay Kumar Prof and Head Senior Deputy Director General Scientist - G & Head Department of Clinical (Retd.) ICMR, Division of BMS, Pharmacology, President, FERCI Indian Council of Medical Seth GS Medical College and KEM A-101, Manchester Regent, Research, V. Ramalinga Swami Hospital, Avinashi Road, P.N. Palayam, Bhavan Ansari Nagar MS Building, 1st Floor, Parel, Coimbatore, Tamil Nadu – 641037 New Delhi-110029 Mumbai-400012 Dr. Vijay Prakash Mathur Mr. K Vaitheeswaran Mr. Vinay Urs K S Additional Professor Scientist-C Scientist-B Centre for Dental Education and NCDIR, Nirmal Bhawan - ICMR NCDIR, Nirmal Bhawan - ICMR Research Complex (II Floor), Complex (II Floor), AIIMS Poojanahalli Road, Kannamangala Poojanahalli Road, Kannamangala New Delhi-110029 Post, Bangalore – 562 110 Post, Bangalore – 562 110 Mr. V Raju Naik Scientist-B NCDIR, Nirmal Bhawan - ICMR Complex (II Floor), Poojanahalli Road, Kannamangala Post, Bangalore – 562 110
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ICMR-WHO Consultation Meeting 2017
List of Participants National Consultation, ICMR, New Delhi
Dr. Alka Sharma Dr. Amar Jesani Dr. Amita Singh Director, Scientist F Editor, Indian Journal of Medical Professor, Centre for the Study of Department of Biotechnology Ethics, 310 Prabhu Darshan, 31 Law and Governance, Jawaharlal 6th-8th Floor, Block 2, CGO Swatantra Sainik Nagar, Amboli, Nehru University, Aruna Asaf Ali Complex, Lodhi Road, Andheri West, Mumbai 400058 Marg, New Delhi – 110067 New Delhi - 110 003. Dr. Anant Bhan Ms. Annam Visala Dr. Bikash Medhi Senior Manager, Deputy Drugs Controller (India) Professor & Additional Medical International AIDS Vaccine Ministry of Health and Family Superintendent (AMS), Department Initiative (IAVI), Welfare, Government of India, of Pharmacology, Research Block B, India Regional Office FDA Bhavan, ITO, Kotla Road, 4th Floor, Room no 4043, 4 Factory Road, Near Safdarjung New Delhi -110002 Postgraduate Institute of Medical Hospital , Ansari Nagar West, New Education & Research, Chandigarh, Delhi – 110029 160012 Dr. C. A. K. Yesudian Lt. Gen. D. Raghunath Dr. G. N. Singh Health Systems Consultant and 247, 2nd Main Road, 7th Block, Drugs Controller General of India Trainer , C-503, Runwal Centre Jayanagar, Bangalore- 560070 Ministry of Health and Family Govandi Station Road Welfare, Government of India, Deonar, Mumbai - 400088 FDA Bhavan, ITO, New Delhi - 110002
Dr. Gangandeep Kang Dr. Geeta Jotwani Dr. Ganapathy Murugan Executive Director Scientist E , BMS Secretary and Executive Director, Translational Health Science and Division of BMS Public Health Resource Society, G Technology Institute (THSTI), Indian Council of Medical Research, 46, First Floor, Green Park Main, NCR Biotech Science Cluster V. Ramalinga Swami Bhavan Ansari New Delhi 110016 3rd Milestone, Faridabad-Gurgaon Nagar, New Delhi-110029 Expressway, PO Box#4, Faridabad, Haryana-120001 Dr. Henk Bekedam Dr. I C Verma Dr. Indira Nath Country Representative Director Former Emeritus Professor, Raja Office of the WHO Representative Institute of Medical Genetics & Raman Fellow, National Institute of to India, 537, A Wing, Nirman Genomics, Sir Ganga Ram Hospital, Pathology, Bhawan, Maulana Azad Road, New Rajinder Nagar No707, Sarvapriya Apartments, Delhi 110 011 New Delhi 110060 Sarvapriya Vihar, New Delhi-110016 B9/21, Vasant Vihar, New Delhi - 110057 Dr. Kusum Verma Dr. K.N. Chaturvedi Dr. Kalyani Thakur Senior Consultant, Advocate, Supreme Court Research Associate, Department of Pathology, Former Law Secretary National Centre for Disease Sir Ganga Ram Hospital, C-41, Pkt-7, Kendriya Vihar, Sector- Informatics and Research, Nirmal Old Rajinder Nagar, New Delhi – 82, Noida – 201306 Bhawan - ICMR Complex (II Floor), 110060 Poojanahalli Road, Kannamangala Post, Bangalore – 562 110 Dr. Madhulika Kabra Dr Madhur Gupta Dr. Mausumi Bharadwaj Professor, Technical Officer- Pharmaceuticals, Scientist F Department of Pediatrics, Genetics WHO Country Office for India, RK National Institute of Cancer Unit, Khanna Tennis Stadium, Safdarjung Prevention and Research (ICMR), I- AIIMS, New Delhi – 110029 Enclave, New Delhi – 110029 7, Sector - 39, Noida - 201301
Dr. Mukesh Kumar Dr. Monika Pahuja Dr. Nandita Chopra Director, Scientist C, NIH Representative Indo French Centre for the Division of BMS HHS Office South Asia, U.S. Promotion of Advanced Research Indian Council of Medical Research, Embassy, Shantipath, Chanakyapuri, 59 | P a g e
ICMR-WHO Consultation Meeting 2017
(IFCPAR), 5B, Ground Floor, India Ansari Nagar, V. Ramalinga Swami New Delhi-110021 Habitat Centre, Lodhi Road, New Bhavan, New Delhi-110029 Delhi – 110003 Dr. Nalin Mehta Dr. Narinder K Mehra Dr. Nithya Gogtay Professor, Dept. of Physiology, Dr. C. G. Pandit National Chair Additional Professor of Clinical AIIMS, Ansari Nagar, New Dehli – ICMR and Former Dean & Head, Pharmacology, Seth GS Medical 110029 Department of Transplant College & King Edward Memorial Immunology & Immunogenetics Hospital, Mumbai 400012 AIIMS, New Delhi – 110 029 Dr. Neena Valecha Ms. N. Sarojini Dr. Nandini K Kumar Scientist G & Director Sama- Resource Group for Women Former Deputy Director General National Institute of Malaria & Health, B-45, 2nd Floor, Main Senior Grade (ICMR), Adjunct Research,Sector-8, Dwarka, Road Shivalik, Malviya Nagar, New Visiting Professor, KMC, Manipal New Delhi-110077 Delhi-110017 Dr. N K Arora Dr. N. Srikant Dr. Nikhil Tandon Executive Director Deputy Director General Professor & Head The INCLEN Trust International, Central Council for Research in All India Institute of Medical 2nd Floor, F-1/5, Okhla Industrial Ayurvedic Sciences (CCRAS), Sciences, Ansari Nagar, New Delhi - Area, Jawahar Lal Nehru Bhartiya Chikitsa 110029 Phase-I, New Delhi-110020 Avum Homeopathy Anusandhan Bhavan, No.61-65, Institutional Area, Opp. 'D' Block, Janakpuri, New Delhi - 110058 Dr. Nita Bhandari Dr. Nitya Wadhwa Dr. Neerja Gupta Centre for Health Research and Scientist „E‟, Pediatric Biology Assistant professor in the Division Development, Society for Applied Centre, Translational Health Science of Genetics Studies (SAS) – NGO, 45, Kalu and Technology Institute, India AIIMS, Ansari Nagar Sarai, New Delhi – 110016 New Dehli – 110029 Dr. O. P. Agarwal Dr. P. N. Tandon Dr. Prashant Mathur Advisor, ICMR, Ansari Nagar, Chairperson, CECHR Director New Delhi – 110029 1, Jagriti Enclave, National Centre for Disease Flat No.27, Sakshara Apartment, Vikas Marg, Delhi-110092 Informatics and Research, Nirmal Block No. A3, Near Balaji Bhawan - ICMR Complex (II Floor), Hospital, 4th Complex, Paschim Poojanahalli Road, Kannamangala Vihar, New Delhi -110063 Post, Bangalore – 562 110 Dr. Prabha Desikan Dr. Poonam Salotra Mr. Prasanna Kumar B Shirol Director-in- Charge, Professor and Scientist G & Director-in-charge, Co founder ORDI (Organisation for Head Microbiology, Bhopal National Institute of Pathology Rare Diseases India) Memorial Hospital & Research Safdarjung Hospital Campus Founder- Inclusive In India Centre, Raisen Bypass Road, Post Box No. 4909, New Delhi- President - Pompe Foundation Near Karond Chouraha, 110029 Founder & Former President - Bhopal - 462038 (M.P.) LSDSS (Lysosomal Storage Disorder Support Society Dr. P. S. S. Sunder Rao Mrs. Priyanka Das Dr. Pooja Sharma Consultant, Biostatistics and Res. Scientist C, NCDIR Sr. Scientist, Medanta Institute of Methodology National Centre for Disease Education and Research, Medanta- 88, 4th cross Kuvempu Layout, Informatics and Research, Nirmal The Medicity, Sector – 38, Gurgaon, Gubbi cross, Kothanur, Bangalore Bhawan - ICMR Complex (II Floor), Haryana 122 001 560077 Poojanahalli Road, Kannamangala Post, Bangalore – 562 110 Dr. Ravi Verma Dr. Ratna Puri Ms. Ritu Dhillon Regional Director, Professor & Senior Consultant, Sr. Financial Advisor Asia Regional Office Institute of Medical Genetics & Indian Council of Medical Research, International Center for Research Genomics, Sir Ganga Ram Hospital, V. Ramalinga Swami Bhavan , on Women's (ICRW), New Delhi Rajinder Nagar Ansari Nagar, New Delhi New Delhi 110060
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Dr. Rajni Kaul Dr. Roli Mathur Dr. Rajib Kishore Hazam Scientist G, Scientist E & Head, ICMR Bioethics Research Associate, NCDIR Division of BMS Unit , NCDIR, Nirmal Bhawan - National Centre for Disease Indian Council of Medical ICMR Complex (II Floor) Informatics and Research, Nirmal Research, V. Ramalinga Swami Poojanahalli Road, Bhawan - ICMR Complex (II Floor), Bhavan Ansari Nagar, New Delhi- Kannamangala Post Poojanahalli Road, Kannamangala 110029 Bangalore – 562 110 Post, Bangalore – 562 110
Dr. S D Seth Dr. Sanjay Mehendale Dr. Sanghmitra Pati Former Chair in Clinical Additional DG ICMR Director Pharmacology and Advisor Clinical Indian Council of Medical Research Regional Medical Research Centre Trials Registry, ICMR; N 14/D, V. Ramalinga Swami Bhavan Chandrasekharpur, DDA Flats, Mandir Marg, Saket, Ansari Nagar, New Delhi- 110029 Bhubaneswar-751 023, Odisha New Delhi-110017 Dr. Sita Naik Dr. Soumya Swaminathan Dr. Suneeta Singh Advisor, Apollo Hospitals Secretary DHR & Director General Chief Executive Officer Educational & Research Indian Council of Medical Research Amaltas Consulting Pvt. Ltd Foundation, Apollo Indraprastha V. Ramalinga Swami Bhavan, C 20 Hauz Khas (Near Hauz Khas Hospital, Mathura Road, Ansari Nagar, New Delhi-110029 Police Station), New Delhi-110016 New Delhi Dr. T S Rao Dr. Upendra Kaul Dr. Urmila Thatte Former Senior Advisor, Executive Director and Dean- Prof and Head, Department of Department of Biotechnology, Cardiology, Fortis Escort Heart Clinical Pharmacology, Seth GS M/O Science & Technology, Institute, Okhla Road, Medical College and KEM Hospital, Government of India New Delhi - 110025 Parel, Mumbai-400012 Dr. Vijay Kumar Dr VG Somani Prof. V M Katoch Scientist - G & Head Joint Drugs Controller (India) Former Secretary, Department of Division of BMS, Ministry of Health and Family Health Research, Ministry of Health Indian Council of Medical Welfare, Government of India, & Family Welfare, Govt. of India Research, V. Ramalinga Swami FDA Bhavan, ITO, Kotla Road, New & Former Director General (ICMR); Bhavan Ansari Nagar, Delhi -110002 B-16, Govind Marg, Raja Park, New Delhi-110029 Jaipur 302004 (Rajasthan)
Dr. Vid Nukala Dr Y K Gupta Senior Advisor, Professor and Head, Department of Office of Global Affairs (OGA), Pharmacology, AIIMS, U.S. Department of Health and New Delhi – 110029 Human Services (HHS), U.S. Embassy, New Delhi – 110021
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List of Scientific/Administrative Staff
National Centre for Disease Informatics and Research, Bangalore
Mr. N M Ramesha Administrative Officer Mr. C Somasekhar Accounts Officer Mrs. K R Chandrika Technical Assistant Ms. Kaveri Mohan Kumbhar Assistant Mrs. R. Shabeen Taj Project Admin. Assistant Mrs. Latha V Lower Division Clerk Mr. Harish Siddaraju Lower Division Clerk Ms. Kamalamma Data Entry Operator (B)
Indian Council of Medical Research, New Delhi
Mr. G.S. Sandhu Administrative Officer Mrs. Rajni Khurana Section Officer Mr. Shyam Singh Section Officer Mr. Santosh K Saini Assistant Mr. Sarita Personal Assistant
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