HSP progress in Taiwan 2009

Benjamin I. Kuo, MD, DrPH, CIPSecretariat, 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 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.

Results of GCP Inspection in 2000-03

Deficiencies 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

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

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 2007-200838 workshops

Took failed passed

PI

2007 2,807 179 2,628

2008 2,737 43 2,694

IRB member

2007 636 55 581

2008 1,188 27 1,161

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.

SIDCERSIDCER

Public Public sectorssectorsWHO/TDR,

Fogarty, ICMR

Private SectorsPrivate Sectors- IFPMA- IFPMA- WIRBWIRB

NGO – GCPANGO – GCPA - PATH- PATH - MFES- MFES

FOCUSFOCUS

FECCISFECCIS

FLACEISFLACEISPABINPABIN

National Chapters

National Chapters National

Chapters

National Chapters

FERCAPFERCAPNational Chapters

www.fercap-sidcer.org

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 2005. Fulfill of 5 standards Duration : 3 years

Number of FERCAP/SIDCER Recognized Ethical Committee

• 2005: 3

• 2006: 7

• 2007: 13

• 2008:16

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

Thanks for your attention!

Taiwan FormosaTaiwan Formosa