The second National conference of the Forum for Ethics Review Committees in India was held at Coimbatore from November 8 th -9 th 2013.

Transcription

1 The Forum for Ethics Review Committees in India FERCI 2 nd National Conference November 8 th -9 th 2013 Organized by PSG Institute of Medical Sciences and Research Coimbatore Theme: Bioethics and Clinical Research Regulations The second National conference of the Forum for Ethics Review Committees in India was held at Coimbatore from November 8 th -9 th The main theme of the conference was Bioethics and Clinical research Regulations aptly timed with the recent changes in the regulatory scenario in India. The Objectives were as follows To highlight the recent changes in the clinical trial regulations and its impact on the clinical trial landscape in India To address the challenges faced by the ethics committees in the current regulatory scenario To build a confined understanding among various stakeholders including the research participants regarding current clinical research regulations for promoting more efficient functioning and higher levels of protection of research participants Improve networking and communication among various Institutional Human Ethics Committees The Subthemes of the conference were Current Global Clinical Research Regulation Scenario Recent changes in the Indian Clinical Research Regulation Scenario Experience sharing - Registration& Accreditation of Ethics Committees Emerging areas in clinical research including Biobanks, Stem cell research Compensation in clinical research- Quantum and Relatedness The audience were from diverse background such as research scientists, Pharma company representatives, NGOs, Lay persons, social scientists, Principal Investigators in clinical trials, academicians, undergraduate and postgraduate students.

2 There were totally 202 registrations. Fig 1: Region wise distribution of the delegates * *There was one representation from the Pharma industry Preconference Workshop There was a Preconference workshop on Ethical Review of Protocols on the November 7 th The Pre conference workshop was well received with about 100 participants from various backgrounds. There were plenary sessions on Basic principles of Bioethics by Dr Nandini Kumar which introduced the participants to basic tenets of bioethics. The next session was on Risk-benefit analyses by Dr Swarnalakshmi who clearly explained the concepts of risk benefit that should be kept in mind while reviewing a protocol. The last plenary session was by Dr Paul Kumaran who explained about the Protocol review format and the salient aspects of protocol review. This was followed by group work when the participants were given different case

3 scenarios based on the topics a) Vulnerable population b) vaccine trial c) Pharma sponsored trial d) Research using biological samples. The participants discussed the cases in their respective groups and made a short presentation. Each case was extensively discussed. Conference Proceedings The inauguration was on November 8 th 2013 at PSGIMSR Auditorium. There were two eminent personalities who inaugurated the conference. Prof Ranjit Roy Choudhry was the chief guest of the occasion and Dr Madhav Menon was the guest of honor. Sri. L Gopalakrishnan Managing Trustee, PSG Institutions presided over the occasion. Dr S Ramalingam, Principal welcomed the gathering, Sri L Gopalakrishnan delivered the presidential address, Dr Vasantha Muthuswamy spoke about the conference and Dr Urmila Thatte spoke about FERCI. The inaugural address was by Prof Ranjit Roy Choudhry. His speech focused on the evolution of the clinical research in India and the present clinical trial scenario in India. He highlighted the important features of the Prof Ranjit Roy Choudhry committee recommendations. He emphasized on establishing a strong, fair, transparent and efficient regulatory mechanism in India. He also spoke on the need for the accreditation of the ethics committees and training of IEC members and monitoring of the functioning of ethics committees in India. Prof Ranjit Roy Choudhry delivering the inaugural address The Keynote address was given by Prof Madhav Menon. He eloquently brought out the need to follow ethical guidelines in clinical research. he also emphasized on the need for accreditation of ethics committees and establishment of a transparent and efficient system for regulation.

4 Prof Madhav Menon delivering the keynote address Excerpts from the Inauguration The session kindled more questions that formed the base for the discussions in the subsequent proceedings. The vote of thanks was proposed by Sudha Ramalingam, Organizing Secretary, FERCI Technical Sessions The technical sessions were based on the major subthemes.

5 The first session was on the Current global clinical research scenario. The speaker was Dr Roli Mathur who detailed on the role of the funding bodies in India and their contribution towards regulation of clinical research in India. The next session was on the impact of recent changes in the clinical trial regulation scenario on various stakeholders. The perspectives of the regulatory bodies was well brought out by Dr PBN Prasad, Deputy DCGI,Chennai. The Pharma industry was represented by Dr Chandrasekhar Potkar from Pfizer.Dr Urmila Thatte deliberated on the ethics committee s perspective. The investigators perspective was clearly represented by Dr K Srikanth, Pulmonologist, Coimbatore. The laypersons perspective was given by Mrs Sameena Maldar from Mumbai. The post lunch sessions deliberated on the various accreditation mechanisms for the Institution Human Ethics Committees. Dr Pratibha Pereira highlighted the processes involved with AAHRPP accreditation. Dr Siddharth Lasker from Tata Memorial Hospital explained their experience during the SIDCER reaccreditation process. Dr S Ramalingam PSGIMSR shared the steps involved in the first time accreditation with SIDCER. Dr PBN Prasad spoke on the steps involved in CDSCO registration of ethics committees. This was followed by free paper presentations. There were 5 paper presentations which were shortlisted from about 40 abstracts that were received. One best paper was selected by a panel of three judges. Dr Amol Dongre, Manakula vinayagar medical college, Pudhucherry won the best paper award for his study on Ethical issues in Qualitative Research The sessions on the first day concluded by 5.30 pm in the evening. The second day s sessions began with a virtual talk by Dr Edward Bartlett. He updated the present International scenario on clinical trial. Due to technical reasons Dr Bebe Loff could not make it to the conference for her session. The post tea session was a very thought provoking panel discussion on Compensation in clinical research Quantum and Relatedness. The panelists were Dr Nandhini Kumar, Dr Murali Neelakantan, Dr Anil Seth and Dr Rakhi Tripathi. Various issues on the recent changes in the compensation clause were discussed and there was an active participation from the audience. Dr Vasantha Muthuswamy and Mr Nandhakumar (Legal expert, IHE-PSGIMSR) were the chairpersons. The next session was poster display. More than 40 research posters were displayed and a panel of judges selected three best posters. The post lunch sessions began with a talk on ethical issues in stem cell research by Dr Seshagiri Rao from IISc Bangalore. He gave an interactive talk on the stem cell work he has been involved in and highlighted the ethical dilemmas. This was followed by a talk on Ethical issues of

6 Biobanking by Dr Sangeeta Desai of Tata memorial hospital. She updated the current scenario on Biobanking in India and emphasized on the need for updated guidelines and training in Biobank ethics. The session on Ethics is pediatric clinical trials was handled by Dr Ramesh Agarwal from AIIMS. He highlighted the new pediatric clinical research guidelines that is in process of finalization. Ethics of clinical trial with special reference to Ayurveda was discussed by Dr Somit Kumar from Arya vaidya pharmacy, Coimbatore. He brought out the unique difficulties of an Ayurvedic clinical trial very well and discussed the related issues. The last session was on the IEC Exchange forum by Dr Anant Bhan. He discussed the evolution of the IEC exchange, its scope and the present status. Prize winners Best paper Award: Dr Amol Dongre Best Poster Award: First place: Dr Vijaya D and Dr Padmaja Marathe Second Place: Dr Deena Sangeetha The conference came to an end with the valedictory ceremony. Prizes were announced for best paper and best poster and were given out by Dr S Ramalingam, Dr Vasantha Muthuswamy, Dr Urmila Thatte, Dr Nandini Kumar and Dr Sandhya Kamat.

7 Conference Program Nov 8 th, 2013 Time Topic Speakers Inauguration Sri. L Gopalakrishnan, Managing Trustee, PSG Institutions Dr. Ranjit Roy Choudhry Dr Madhav Menon Dr Vasantha Muthusamy Dr S Ramalingam Dr Urmila Thatte Tea Sub theme1:current Global Clinical Research Regulation Scenario National Scenario Sub Theme 2 : Recent changes in the Indian Clinical Research Regulation Scenario New notifications from DCGI New regulations-impact on Pharmaceutical companies New Regulations and their Implications for IECs Impact on the Investigators Impact on the community Lunch Sub Theme III-Experience sharing - Registration& Accreditation of Ethics Committees AAHRPP FERCAP CDSCO Tea Dr Roli Mathur, ICMR Dr PBN Prasad Dr Chandrasekhar Potkar Dr Urmila Thatte Dr K Srikanth Ms Sameena Maldar Dr Pratibha Pereira Manipal Dr Siddharth Lasker, Tata memorial Hospital (Reaccreditation) and Dr S.Ramalingam PSGIMSR (New Accreditation) Dr B KS Prasad

8 Free Paper Presentations ** 7.00 FERCI General Body Meeting 9 th November Sub Theme IV-Emerging areas in clinical research Emerging areas of Clinical Research-International Scenario Tea Panel Discussion Compensation in clinical research Quantum and Relatedness Dr. Edward Bartlett (virtual online talk) Dr Nandini Kumar Dr Rakhi Tripathi Mr Murali Neelakantan Dr Anil Seth Poster Presentations Lunch Subtheme IV : Emerging areas in Clinical Research Stem cell Research Biobanking Clinical Trials with Ayurvedic drugs Ethical issues in Pediatrics Clinical Research Open forum Experience Sharing - IEC Exchange Dr Seshagiri Rao Dr Sangeeta Desai Dr Somit kumar Dr Ramesh Agarwal Dr Anant Bhan Prize distribution & Valediction Dr S Ramalingam, Dr Vasantha Muthusamy,Dr Urmila Thatte