hsp progress in taiwan 2009
DESCRIPTION
HSP progress in Taiwan 2009. Benjamin I. Kuo, MD, DrPH, CIP Secretariat, Joint Institutional Review Board. Laws and regulations applied to researches in Taiwan. General Law Regulations Guideline. General Law. Civil Law Criminal Law Personal Data Protection Law Medical Care Act - PowerPoint PPT PresentationTRANSCRIPT
![Page 1: HSP progress in Taiwan 2009](https://reader035.vdocument.in/reader035/viewer/2022070502/56814b36550346895db83f98/html5/thumbnails/1.jpg)
HSP progress in Taiwan 2009
Benjamin I. Kuo, MD, DrPH, CIPSecretariat, Joint Institutional Review Board
![Page 2: HSP progress in Taiwan 2009](https://reader035.vdocument.in/reader035/viewer/2022070502/56814b36550346895db83f98/html5/thumbnails/2.jpg)
Laws and regulations applied to researches in Taiwan
• General Law• Regulations• Guideline
![Page 3: HSP progress in Taiwan 2009](https://reader035.vdocument.in/reader035/viewer/2022070502/56814b36550346895db83f98/html5/thumbnails/3.jpg)
General Law• Civil Law• Criminal Law• Personal Data Protection Law• Medical Care Act• Physician Act
![Page 4: HSP progress in Taiwan 2009](https://reader035.vdocument.in/reader035/viewer/2022070502/56814b36550346895db83f98/html5/thumbnails/4.jpg)
4
Laws re-form in May 2009The Medical Care Act (1986, 2004, May 2009)
Art. 8: Definition of “Clinical Trial”: Any experimental study on human for trials of new techniques, drugs or medical devices and Bioavailability /Bioequivalent studies. Art. 78: Teaching hospital must propose the clinical trial protocol to the Review Board of DOH for approval after being reviewed and approved by IRB. Each gender need to present no less than one third in the meeting.
![Page 5: HSP progress in Taiwan 2009](https://reader035.vdocument.in/reader035/viewer/2022070502/56814b36550346895db83f98/html5/thumbnails/5.jpg)
Art. 79: Requirements of an Informed Consent. • Item required in informed consent:
–Purpose and method–Expected risk and adverse events–Expected result–Alternatives of treatment–The right to withdrawal .–Compensation or insurance.–Confidentiality–Resue of sample or data collected in this study.
![Page 6: HSP progress in Taiwan 2009](https://reader035.vdocument.in/reader035/viewer/2022070502/56814b36550346895db83f98/html5/thumbnails/6.jpg)
行政命令 Regulations
• The Enforcement rules of the Medical Care Act Jun 20,2006
• Guideline for Good Clinical Practice (1996,2001, Jan 7, 2005)
Regulations expected to have major change soon.
![Page 7: HSP progress in Taiwan 2009](https://reader035.vdocument.in/reader035/viewer/2022070502/56814b36550346895db83f98/html5/thumbnails/7.jpg)
GCP in Taiwan1996 GCP announced as a guideline1998, GCP Inspection Workshop in Taiwan (by FDA )2000, GCP inspection for all trials for registration
purpose.2005, Adopt ICH-GCP to replace old version and set as
Regulations.
![Page 8: HSP progress in Taiwan 2009](https://reader035.vdocument.in/reader035/viewer/2022070502/56814b36550346895db83f98/html5/thumbnails/8.jpg)
Results of GCP Inspection in 2000-03Deficiencies Found in GCP Inspection
Item inspected No. of deficiency 2000/01/02/03 1. Authorization and Management 4/ 0/ 3/ 02. Clinical Trial Protocol 5/ 8/ 4/ 63. Informed Consent 8/ 7/ 24/ 244. IRB 22/16/16/75. Verify source data with case report form 77/62/103/886. Drug Accountability and Management 30/30/68/717. Record Archiving 27/29/20/208. Computer System and Data Management 24/23/16/19 Total 181/182/254/244
No. of Trials inspected 31/31/37/47
![Page 9: HSP progress in Taiwan 2009](https://reader035.vdocument.in/reader035/viewer/2022070502/56814b36550346895db83f98/html5/thumbnails/9.jpg)
Major Guideline (31)• Operational Guidelines for clinical trial
Committees of medical institute. • Human Research Ethics Policy Guidelines.
July 17, 2007 - 8 Points• Guidelines for recruitment of clinical trial
subject Date: June 6, 2007• Guidelines for relationship between medical
doctor and industry. Sep 8, 1996
![Page 10: HSP progress in Taiwan 2009](https://reader035.vdocument.in/reader035/viewer/2022070502/56814b36550346895db83f98/html5/thumbnails/10.jpg)
Domestic qualification exam for IRB members and investigators
• Supported by DOH but not compulsory.• Examination given after one day workshop.• Re-taken without limitation.• National Science Council consider to support
similar program in universities IRB.
![Page 11: HSP progress in Taiwan 2009](https://reader035.vdocument.in/reader035/viewer/2022070502/56814b36550346895db83f98/html5/thumbnails/11.jpg)
Examination result 2007-200838 workshops
Took failed passedPI2007 2,807 179 2,6282008 2,737 43 2,694IRB member2007 636 55 581 2008 1,188 27 1,161
![Page 12: HSP progress in Taiwan 2009](https://reader035.vdocument.in/reader035/viewer/2022070502/56814b36550346895db83f98/html5/thumbnails/12.jpg)
FERCAP GCP Training for Regulatory Authorities Apr. 8-9, 2008, Taipei, Taiwan
• Attendees from Mongolia, Philippine, India, Malaysia, Thailand, Indonesia.
• Lead by Dr. Gunner from EMEA Sweden• More than 40 local attendees.
![Page 13: HSP progress in Taiwan 2009](https://reader035.vdocument.in/reader035/viewer/2022070502/56814b36550346895db83f98/html5/thumbnails/13.jpg)
APEC Basic Workshop on GCP clinical research inspection May 27-30, 2008, Bangkok, Thailand
![Page 14: HSP progress in Taiwan 2009](https://reader035.vdocument.in/reader035/viewer/2022070502/56814b36550346895db83f98/html5/thumbnails/14.jpg)
![Page 15: HSP progress in Taiwan 2009](https://reader035.vdocument.in/reader035/viewer/2022070502/56814b36550346895db83f98/html5/thumbnails/15.jpg)
APEC Advanced Workshop on GCP clinical research inspection March 2-6, 2009, Bangkok, Thailand
![Page 16: HSP progress in Taiwan 2009](https://reader035.vdocument.in/reader035/viewer/2022070502/56814b36550346895db83f98/html5/thumbnails/16.jpg)
Strategic Initiative for Developing Capacity in Ethical Review (SIDCER)
• FERCAP Forum for Ethical Review Committees in Asia and the Western Pacific
• FLACEIS Latin American Forum of Ethics Committees in Health Research
• PABIN Pan-African Bioethics Initiative
• FECCIS Forum of Ethics Committees in the Confederation of Independent States
• FOCUS Forum for ERCs/IRBs in Canada and the United States.
![Page 17: HSP progress in Taiwan 2009](https://reader035.vdocument.in/reader035/viewer/2022070502/56814b36550346895db83f98/html5/thumbnails/17.jpg)
SIDCERSIDCER
Public Public sectorssectorsWHO/TDR,
Fogarty, ICMR
Private SectorsPrivate Sectors- IFPMA- IFPMA- WIRBWIRB
NGO – GCPANGO – GCPA - PATH- PATH - MFES- MFES
FOCUSFOCUS
FECCISFECCIS
FLACEISFLACEIS PABINPABIN
National Chapters
National Chapters National
Chapters
National Chapters
FERCAPFERCAPNational Chapters
www.fercap-sidcer.org
![Page 18: HSP progress in Taiwan 2009](https://reader035.vdocument.in/reader035/viewer/2022070502/56814b36550346895db83f98/html5/thumbnails/18.jpg)
Operational Guidelines for Ethics Committees That Review Biomedical Research
The aim of these guidelines is to provide guidance for ethics committees concerning appropriate operating procedures
![Page 19: HSP progress in Taiwan 2009](https://reader035.vdocument.in/reader035/viewer/2022070502/56814b36550346895db83f98/html5/thumbnails/19.jpg)
Surveying & Evaluating Ethical Review Practice
Aim: to facilitate and support procedures for assisting the development of QUALITY and TRANSPARENCY in ethical review
![Page 20: HSP progress in Taiwan 2009](https://reader035.vdocument.in/reader035/viewer/2022070502/56814b36550346895db83f98/html5/thumbnails/20.jpg)
SIDCER/FERCAP EC recognition program
Since 2005. Fulfill of 5 standards Duration : 3 years
![Page 21: HSP progress in Taiwan 2009](https://reader035.vdocument.in/reader035/viewer/2022070502/56814b36550346895db83f98/html5/thumbnails/21.jpg)
Number of FERCAP/SIDCER Recognized Ethical Committee
• 2005: 3 • 2006: 7• 2007: 13• 2008:16Total: 39
• Taiwan(15)• Korea(9)• Thailand (8)• China (3)• Philippines (2)
![Page 22: HSP progress in Taiwan 2009](https://reader035.vdocument.in/reader035/viewer/2022070502/56814b36550346895db83f98/html5/thumbnails/22.jpg)
Five Taiwan IRBs recognized in 2008
![Page 23: HSP progress in Taiwan 2009](https://reader035.vdocument.in/reader035/viewer/2022070502/56814b36550346895db83f98/html5/thumbnails/23.jpg)
GCP Journal May 2008
SIDCER/FERCAP EC survey
![Page 24: HSP progress in Taiwan 2009](https://reader035.vdocument.in/reader035/viewer/2022070502/56814b36550346895db83f98/html5/thumbnails/24.jpg)
Network of Asian and Western Pacific Recognized Ethics Committees (NAREC)
Network among FERCAP recognized EC is needed to
enhance further human subject protection in FERCAP region.
![Page 25: HSP progress in Taiwan 2009](https://reader035.vdocument.in/reader035/viewer/2022070502/56814b36550346895db83f98/html5/thumbnails/25.jpg)
![Page 26: HSP progress in Taiwan 2009](https://reader035.vdocument.in/reader035/viewer/2022070502/56814b36550346895db83f98/html5/thumbnails/26.jpg)
Certification of IRB Professionals (CIP)
Certification in Ethics in Research Proficiency
(CERP)•Investigator•IRB board member•Staff
![Page 27: HSP progress in Taiwan 2009](https://reader035.vdocument.in/reader035/viewer/2022070502/56814b36550346895db83f98/html5/thumbnails/27.jpg)
Thanks for your attention!
Taiwan FormosaTaiwan Formosa