Challenges to Quality. Aphornpirom Ketupanya,M.D.

Transcription

1 Challenges to Quality Review in Thailand Aphornpirom Ketupanya,M.D. FERCIT Chair

2 The beginning of a history of EC in Thailand Headline news Doctors of Chiang Mai Hospital strived for money using human guinea pig in a research study In 1975, the medical students and staff protested against a research project using algae as protein supplements in human subjects. 2

3 Line of History First Era 1975 The Human Experimentation Committee (HEC) in Faculty of Medicine Chiang Mai University. NRCT set a Guideline with 12 rules for Biomedical Research Involving Human Subjects 1976 The Ethical review committee were appointed in Ministry of Public Health The Ethical review committee of Mahidol University were appointed because of CDC or FWA US. grant The Ethical review committee were appointed in Faculty of Medicine Chulalongkorn University The Ethical review committee were appointed in Faculty of Medicine Khon Kaen University The Ethical review committee were appointed in Royal Thai Army Medical Department.

4 Line of History NEW ERA 2000 Forum for Ethical Review Committees in Thailand (FERCIT) was established by the EC from 9 Medical Schools 2003 WHO & Institutions sponsored 6 months for WIRB training course on research ethics 2004 SIDCER-FERCAP settled the Quality Assurance Systems for EC The Ethical review committee of RTA, MD was presented to certificate of SIDCER- FERCAP Recognition 11 ECs have received certificate of SIDCER- FERCAP Recognition

5 No Institute Year of Year of approval renewal 1 Royal Thai Army Medical Department Faculty of Medicine Chulalongkorn University Department tof Development of Thai Traditional and Alternative Medicine Ministry of Public Health 4 Joint Research Ethics Committees Faculty of Medicine Chiang Mai University Research Institute for Health Sciences, Human Experimentation Committee, Chiang Mai University 7 Khon Kaen University Faculty of Environment and Resource Studies, Chulalongkorn l University it Faculty of Tropical Medicine, Mahidol University Faculty of Medicine, Siriraj, Mahidol University Faculty of Medicine, Thammasat University

6 No specific Laws for conducting researches No control /code of regulatory authorities Local ECs Cooperation of ECs Establishment Era (Capacity building) Capacity Building Era Working under the international ethical guidelines 6

7 Ethics Committee in Thailand Total number 69 Medical school 7 (10.2%) Government Hospital 41 (59.4%) Private Hospital 1 (1.4%) Institution/ University it 20 (29.0%) Results from a questionnaire survey in 2009

8 Problems: EC members Insufficiency of expertise 34/69 (49.3%) Inactive/inconsistent participation of EC members 23/69 (33.3%) No EC member training 30/68 (44.1%) Results from a questionnaire survey in 2009

9 Problems: Review & Procedures No SOP 36/66 (54.6%) No Expedited d review 35/64 (54.7%) No Continuing review 28/67(41.8%) No Management conflict of interest 10/69 (14.5%) Results from a questionnaire survey in 2009

10 Problems: EC Office No EC office space 47/69 (68.1%) Insufficiency i of resources to operate EC 19/69 (27.5%) Results from a questionnaire survey in 2009

11 Problems: Institutional Policy Not completely independence 5/69 (7.2%) Little or no support by the institute 13/69 (18.8%) Lacking recognition of importance of EC functions 15/69 (21.7%) Results from a questionnaire survey in 2009

12 Problems of EC in Thailand Review Procedures Institutional Policy EC not compliance to ICH GCP No continuing review Not actively participate Conflict of Interest No SOP No expertise EC members No policy for training No GCP compliance No admin. staff Inappropriate Inadequate composition support No space allocation Office No QA

13 Building Capacity of EC in Thaliand FERCIT Committee 13

14 Cooperation of ECs Building Capacity of ECs Published National guideline of ethics in research involved human subjects (2002, 2007) Organizing g workshops for training members of ECs education Research ethics GCP training SOP writing 14

15 Cooperation of ECs Building Capacity of ECs Exchange knowledge and experience among members of ECs FERCIT newsletters FERCIT website FERCIT annual meeting FERCIT database information for members 15

16 Cooperation of ECs Building Capacity of ECs Co-ordinate with other national and international ti organizations Annual seminar for the Thailand towards Center of Excellence in Clinical trials (ThaiTECT) ( ) FERCAP/SIDCER for affiliated training, meeting and recognition 16

17 Cooperation of ECs Building Capacity of ECs Co-ordinate with stakeholder Achieving Guidance in Clinical Trial safety information 21 March

18 Cooperation of ECs Building Capacity of ECs Co-ordinate with stakeholder Guidance for adverse event report Define terminology o Local adverse events o Non-local adverse events Whom/When/How to report Report forms 18

19 What step are we going? National Laws Cooperation of ECs Capacity Building of ECs Strong Capacity ECs Research Ethics Committee National Accreditation System 19

20 Research Ethics Committee National Accreditation System of Thailand National EC Accreditation Board (IHRP, 5 organizations) Policy, Standards, Guidelines Affiliated Training & Certified Organization FERCIT, FERCAP/SIDCER Capacity Building Model Development & Training (Research ethics, GCP, SOP writing) Quality Assurance Monitoring Auditing Inspection Response to Complaint/Request NRCT Secretariat for EC Accreditation ti System EC Certification Quality assurance (Audit /monitoring) Regulators Thai FDA, US FDA, EMA NRCT Administrative Oversight Funders/Sponsors 5 organization, i Pharmaceuticals, Universities, WHO Thailand Networking Conferences, Seminar

21 Establishment & Capacity Building of EC in Thailand 21

22 10 years FERCIT EC EC EC EC EC EC 25 years 22

23 Institutional Support 10 years WIRB fellows FERCIT EC EC EC EC EC EC 25 years 23

24 Good researches Smiling participants FERCIT Good Good GCP EC EC Quality Compliance EC EC EC EC 24

25 Conclusion Developing a network of EC institutes is useful for building capacity of EC in Thailand. FERCIT and WIRB fellows plays an important role in strengthening ECs around country. A f h i i A strong support from the organization leader is a key factor for the success.

26 The Next Challenges National Research Ethics Law ( Regulatory Authorities for Research Ethics Committees) Research Ethics Committee National Accreditation System Cooperate with Thai FDA in recognition more quality ethics committee for clinical trial ( import the research medicine) 26

27 Auditing and accreditation programs Make important t contributions ti to the quality of the ethic review process Develop standardized policies and procedures, which consistent application of ethical principles p Adhering to the policies and procedures they claim to be following EC structure and process Standard operating procedures are complete Process of protocol review is adequately documented

28 Al large concern Exclusive focus on structure and process Is it capable of answering EC review actually yprotects the rights and interest of research participants and their communities

29 examples Risk and benefit was documented d by the EC for Protocol s risks and potential benefits does not mean that it has done a good job identifying or weighing these factors Consent form contains all relevant information does not mean that participants will actually understand or absorb the information, or that it will have any appreciable impact on their decision-making Auditing and accreditation programs tell us is whether EC are carrying out the specific tasks that have been assigned to them. Does not prove that and EC system work

30 Moving beyond compliance Measuring Ethical Quality Integrating Quality assurance principles into EC assessment. Relevant elements of quality must be identified with precision Identify what prospective research participants and their communities hope to get out of the ethics review process

31 Outcomes assessment of research ethics committees First, does research ethics committee review improve participants' understanding of the risks and potential benefits of studies? Second, does the process affect prospective participants' decisions about whether to participate in research? Third, does it change participants' subjective experiences in studies or their attitudes about research? Fourth, does it reduce the riskiness of research? Fifth, does it result in more research responsive to the local community's self-identified needs? Sixth, is research ethics committees' guidance to researchers actually being followed?

32 Plan for year 2012 Continue quality improvement Set the Key performance indicator (KPI) According to the outcome assessment. 32

33 Quality Compliance

34 THANK YOU 34