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 Physician Act

4 Laws re-form in May 2009 The 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.

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.

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.

GCP in Taiwan 1996 GCP announced as a guideline 1998, 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.

Results of GCP Inspection in Deficiencies Found in GCP Inspection Item inspectedNo. of deficiency 2000/01/02/03 1.Authorization and Management 4/ 0/ 3/ 0 2.Clinical Trial Protocol 5/ 8/ 4/ 6 3.Informed Consent 8/ 7/ 24/ 24 4.IRB 22/16/16/7 5.Verify source data with case report form 77/62/103/88 6.Drug Accountability and Management 30/30/68/71 7.Record Archiving 27/29/20/20 8.Computer System and Data Management 24/23/16/19 Total 181/182/254/244 No. of Trials inspected 31/31/37/47

Major Guideline (31) Operational Guidelines for clinical trial Committees of medical institute. Human Research Ethics Policy Guidelines. July 17, Points Guidelines for recruitment of clinical trial subject Date: June 6, 2007 Guidelines for relationship between medical doctor and industry. Sep 8, 1996

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.

Examination result workshops Took failed passed PI , , , ,694 IRB member , ,161

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.

APEC Basic Workshop on GCP clinical research inspection May 27-30, 2008, Bangkok, Thailand

APEC Advanced Workshop on GCP clinical research inspection March 2-6, 2009, Bangkok, Thailand

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.

SIDCER Public sectors WHO/TDR, Fogarty, ICMR Private Sectors - IFPMA WIRB - WIRB NGO – GCPA - PATH - PATH - MFES - MFES FOCUS FECCIS FLACEIS PABIN National Chapters National Chapters National Chapters National Chapters FERCAP National Chapters

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

Surveying & Evaluating Ethical Review Practice  Aim: to facilitate and support procedures for assisting the development of QUALITY and TRANSPARENCY in ethical review

SIDCER/FERCAP EC recognition program Since Fulfill of 5 standards Duration : 3 years

Number of FERCAP/SIDCER Recognized Ethical Committee 2005: : : :16 Total: 39 Taiwan(15) Korea(9) Thailand (8) China (3) Philippines (2)

Five Taiwan IRBs recognized in 2008

GCP Journal May 2008 SIDCER/FERCAP EC survey

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.

Certification of IRB Professionals (CIP) Certification in Ethics in Research Proficiency (CERP) Investigator IRB board member Staff

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