17th FERCAP INTERNATIONAL CONFERENCE & 5TH FERCI NATIONAL CONFERENCE

Strengthening International research collaboration through Good Ethical Practice

Date: 19 -22 November 2017

Venue
All India institute of Medical Sciences (AIIMS), New Delhi, India


Schedule of Activities

13:00 – 17:00, 19 November 2017 

  • Pre-Conference Workshops (India Habitat Centre, Lodhi Road, New Delhi):
  • Parallel Sessions
    • Roles and Responsibilities of IEC Chair/ Vice Chair
    • Workshop for Member Secretary/ Secretariat (Use of Create software and Good Documentation Practices)
    • Workshop for Non-technical Members (lawyer, lay person, social scientist)

18:00 – 21:00, 19 November 2017 – Willow Hall, India Habitat Centre

  • FERCAP Steering Committee Meeting: 

08:30 – 17:00, 20 – 21 November 2017 – AIIMS, Ansari Nagar, New Delhi

  • Main Conference

17:30-18:30, 20 November 2017

  • FERCI GB Meetin

18:30 – 21:30, 20 November 2017

  • Cultural Programme and Welcome Dinner

09:00 – 12:30, 22 November 2017

  • SIDCER Recognition Ceremony & GB meeting: 

GCP workshop for Researchers 2017

Date: 1st & 2nd November 2017

time: 8.30am

Venue: Lionel Memorial Auditorium, Sri Lanka Medical Association, No 6, Wijerama Mawatha, Colombo


Programme

Day 1: 1 st November 2017


Introduction

President SLMA


Introduction to GCP

Principles

What is GCP?

Need for GCP?

Prof Priyadarshani Galappaththy

Professor in Pharmacology

FM, Colombo

https://drive.google.com/file/d/0B7l5JzDnfa5TclFqcHY1ZVc2X0U/view?usp=sharing&resourcekey=0-1vO31jMFed17A8zUNbLG-w


Drug development process

Dr Channa Ranasinha

Senior Lecturer in Pharmacology,

FM, Kelaniya

https://drive.google.com/file/d/0B7l5JzDnfa5TQnFsLUNCTWZsTVU/view?usp=sharing&resourcekey=0-rZlXZ6ktW-VthBsIcl4lBQ


Investigational products

Prof Shalini Sri Ranganathan

Professor in Pharmacology

FM, Colombo


Clinical Trial protocol and IB

Dr Nirmala Wijekoone

Senior Lecturer in Pharmacology, FMS, USJ


Role and Responsibilities of PI

Dr Noel Somasundaram

Consultant Endocrinologist

https://drive.google.com/file/d/0B7l5JzDnfa5TTnp1dTVGRnE5RVU/view?usp=sharing&resourcekey=0-bBjKjL537RbbHqoJ-MGiLQ


Regulatory requirements for clinical trials and legal frame work

Mr Arjuna Pathmaperuma

Regulatory Pharmacist

NMDRA/ SCOCT

https://drive.google.com/file/d/0B7l5JzDnfa5TN29fNzdfbmVSWmc/view?usp=sharing&resourcekey=0-UapEOb8kFwatc5S5gPZvIg


Role of the sponsor & CRO

Prof Vajira Dissanayake

Professor of Anatomy, FM, Colombo

Board member, FERCAP


Day 2 – 2 nd November 2017


Participant safety and adverse effects

Prof Shalini Sri Ranganathan

Professor in Pharmacology

FM, Colombo


Documentation & record keeping

Prof G R Constantine

Professor in Clinical Medicine, FM, Colombo


Research ethics in Clinical Trials

Prof Chandanie Wanigatunge

Chairperson, FERCSL

Chairperson, ERC SLMA

https://drive.google.com/file/d/0B7l5JzDnfa5TY19jc2h5SjBYcW8/view?usp=sharing&resourcekey=0-eqCOxtToqL449v5VBh2WqQ


Ethics review committee – function with special ref to GCP and Clinical Trials

Dr Panduka Karunanayake

Senior Lecturer in Clinical Medicine, FM, Colombo

Secretary ERC, FM Colombo


Research misconduct and COI

Dr Malik Fernando

ERC, SLMA

https://drive.google.com/file/d/0B7l5JzDnfa5TY1RuYXE1aUI0aEk/view?usp=sharing&resourcekey=0-lykIo2dd9LQpjQk0wHSHWQ


Informed consent

Dr Manouri Gamage

Senior Lecturer, FMS, USJ

Ethics Workshop for Researchers

Date: 22nd June 2017

Start time: 8.30 am

Venue: FGS, University of Moratuwa


Programme


Research Ethics: Fundamentals & Guidelines

Prof. Chandanie Wanigatunge, 

Professor of Pharmacology, FMS USJ. Chairperson, FERCSL

https://drive.google.com/file/d/1s49oQNSdMGcUQIJLFQtsVQ7BKy6CE9Yz/view?usp=sharing


Ethics of Qualitative Research 

Dr.Shamini Prathapan, 

Senior Lecturer in Community Medicine, FMS USJ

https://drive.google.com/file/d/14FPNVDHxj79nhctdZ-0CZ9cEcSdxRSLO/view?usp=sharing


Ethics in Clinical Trials

Prof. Chandanie Wanigatunge, 

Professor of Pharmacology, FMS USJ. Chairperson, FERCSL

https://drive.google.com/file/d/1QwbgtM2S-yXSO0JvinpK-_Q1r36g1z_6/view?usp=sharing

Ethics Resources and Guidelines – June 2014

https://drive.google.com/file/d/1xoifQM4IrRTJkv_MzITkZVawiTW8_6nz/view?usp=sharing


Ethics in Social Science Research 

Prof Amala de Silva, 

Professor in Economics, University of Colombo

https://drive.google.com/file/d/1WYW0Agq10AUKo7kZNPGHYiieDcO0f6N-/view?usp=sharing


Animals in Research

Mayuri Thammitiyagodage. BVSc, MPhil

Veterinary Surgeon

Member Ethics Committee, MRI

Member Ethics Committee, SLMA.

https://drive.google.com/file/d/1msqr7W1bFAzjW0W2kG5IB5eXFs76pB_P/view?usp=sharing


Human Research Ethics in Engineering and Spatial Planning

https://drive.google.com/file/d/1spw3_HYFzUAVW5I2bDoNE4Y2Ga07Q3Lr/view?usp=sharing


Ethics in Legal Research

Dinesha Samararatne

Dept of Public & International Law,

Faculty of Law, University of Colombo

https://drive.google.com/file/d/1_s9sbIPgB-_yJH0gf9LcTSy7TDni3mDE/view?usp=sharing


Research Ethics Involving the Military

Lt. Col. (Dr.) A. Balasuriya

Dean, Faculty of Allied Health Sciences, KDU

Member, KDU ERC & FERCSL

https://drive.google.com/file/d/1jpGwckDghsIIla91kPgzbS61OGsSrxjx/view?usp=sharing

Ethical issues in Paediatric Health Research

Date: 19th June 2017

Start time: 8.30 am

Venue: Lionel Memorial Auditorium, SLMA


Programme

Opening remarks

Prof. C. Wijeyaratne, President, SLMA


Outline

Professor Shalini Sri Ranganathan

Member, ERC/SLMA and Clinical Trial Subcommittee/ Faculty of Medicine, Colombo, Section Editor/ Ceylon Medical Journal


Do we need research in children and are they vulnerable?

Dr.B.J.C.Perera

Specialist Consultant Paediatrician and Honorary Senior Fellow (PGIM),

Joint Editor, Sri Lanka Journal of Child Health

https://drive.google.com/file/d/1Tno94yEppag6AfpTam_KPr3Wrw9nfBcq/view?usp=sharing


Ethical issues in experimental studies in children

Professor Shalini Sri Ranganathan

Member, ERC/SLMA and Clinical Trial Subcommittee/ Faculty of Medicine, Colombo,

Section Editor/ Ceylon Medical Journal

https://drive.google.com/file/d/1JGcpFV4k6_pZd-TA9RawqJL_2Wiu0XGK/view?usp=sharing


Ensuring autonomy: Assent, dissent and consent in paediatric researches

Professor Chandanie Wanigatunge

Chairperson, FERCSL,

Chairperson, SLMA ERC

https://drive.google.com/file/d/1oRSYvTOY8nhocbJV3hGDqlnl0Zf_wYma/view?usp=sharing


Risk Vs. Benefit assessment in studies involving children

Dr. Jithangi Wanigasinghe

Senior Lecturer and Consultant Paediatric Neurologist

https://drive.google.com/file/d/1k7tcKVlOmSgjlwfiG1kNFuapxuPJWEJd/view?usp=sharing


Ethical issues in observational studies in children

Dr Gitanjali Sathiadas

Senior Lecturer In Paediatrics and Consultant Paediatrician

https://drive.google.com/file/d/19UHGMDiodVXFHubb0sBs8T4BzVk0Tpvz/view?usp=sharing


Roles of Ethics Review Committees and researchers in ensuring ethical health research in children

Resource persons and participants

16th FERCAP International Conference

Toward Research Ethics Harmonization in Asia
and the Western Pacific

Date: November 20-23, 2016

Venue: 
King Chulalongkorn Memorial Hospital Campus
Bhumi Siri Manglanusorn Building
1873 Ratchadamri Rd, Pathum Wan, Bangkok 10330

Conference Schedule

Nov. 20, 2016, Sunday (1300 – 1700)

  • Pre-Conference Training: Leadership Role of the Research EthicsCommittee Chair

Nov. 21-22, 2016, Monday

  • Conference Proper

Nov. 23, 2016, Tuesday

  • FERCAP Recognition Program and General Assembly

GCP Workshop for Researchers 2016

Date : 3rd & 4th November 2016

Start Time : 8.30 am

Venue : Lionel Memorial Auditorium, Sri Lanka Medical Association, No 6, Wijerama Mawatha, Colombo 7


Programme


Day 1: 3rd November 2016


Introduction

Dr Malik Fernando

FERCSL MC


Ethical Aspects in Clinical Trials

Prof. Chandanie Wanigatunge

Professor of Pharmacology, FMS USJ

Secretary, ERC SLMA

https://drive.google.com/file/d/1DA8CdgcwOOG93BZVhZUj7M0MMG2NPIHE/view?usp=sharing


Drug development process

Dr Channa Ranasinha

Senior Lecturer in Pharmacology,

FM, Kelaniya

https://drive.google.com/file/d/1T3c8GKO2uJ-eyv5pYDl0xNBoaakuZOJ2/view?usp=sharing


Introduction to GCP

Principles

What is GCP?

Need for GCP?

Prof Priyadarshani Galappaththy

Professor in Pharmacology

FM, Colombo

https://drive.google.com/file/d/11mVBNO7feFe0nWDlSusvX2eePJPFaTdu/view?usp=sharing


Investigational products

Prof Shalini Sri Ranganathan

Professor in Pharmacology

FM, Colombo

https://drive.google.com/file/d/1HM5mWScbm-paGrtoOCfq0qKRN1O0WqKe/view?usp=sharing


Role and Responsibilities of PI

Dr W S Santharaj

Consultant Cardiologist

Institute of Cardiology

https://drive.google.com/file/d/1NKVrorBiBF-T3TGwnVti5KytU0_fr1E_/view?usp=sharing


Ethics review committee – function with special ref to GCP and Clinical Trials

Dr Panduka Karunanayake

Senior Lecturer in Clinical Medicine, FM, Colombo

Secretary ERC, FM Colombo

https://drive.google.com/file/d/1WTHe1ATjib2M6de8nz_WlBCLvbje1w-k/view?usp=sharing


Clinical Trials Worldwide

Prof Vajira Dissanayake

Professor in Anatomy, FM, Colombo

Board member, FERCAP

https://drive.google.com/file/d/1oHAUWn_Lz2TDjCLLin9xmUg12Ldnd08a/view?usp=sharing


Day 2 – 4th November 2016


Clinical Trial protocol and IB

Dr Nirmala Wijekoone

Senior Lecturer in Pharmacology, FMS, USJ

https://drive.google.com/file/d/1DfG-P8OHZNCrRvLtuYeeX3KBQjJ8zD3e/view?usp=sharing


Participant safety and adverse effects

Prof Rohini Frenandopulle

Senior Professor in Pharmacology, KDU

https://drive.google.com/file/d/1NGTFs9dzM4jg08u8Yrh8lf99FAPH5NxQ/view?usp=sharing


Documentation & record keeping

Dr G R Constantine

Senior Lecturer in Clinical Medicine, FM, Colombo

https://drive.google.com/file/d/10CMfRB8vViYeAF5Vi4xuOqJ4LnCuj5Ef/view?usp=sharing


Conflict of Interest in Research

Research Integrity _ Malpractice

Dr Malik Fernando

ERC, SLMA

https://drive.google.com/file/d/1WdkLIutLEgE_LrcP29v43N_J-hce_wRV/view?usp=sharing

https://drive.google.com/file/d/1lLleNBYfNH9_igErkANW-H3coPfie1P3/view?usp=sharing


Informed consent

Dr Nilakshi Samaranayake

Senior Lecturer, FMS, Colombo

https://drive.google.com/file/d/1ULjp2OhwEuRRW1ctyuAMNz9TR5RlpSsm/view?usp=sharing


Regulatory requirements for clinical trials and legal frame work

Mr Arjuna Pathmaperuma

Regulatory Pharmacist

NMDRA/ SCOCT

https://drive.google.com/file/d/1Pg1tUW2kTgugyIGnw8lxXXHcBXJMuwaO/view?usp=sharing

Commonwealth Medical Association – 24th Triennial Conference 2016 – Satellite Meeting on Research and Clinical Ethics

COMMONWEALTH MEDICAL ASSOCIATION
24TH TRIENNIAL CONFERENCE  2016

http://www.cma2016.org

Co-organised by 
Sri Lanka Medical Association, Health Informatics Society of Sri Lanka, Ministry of Health, Sri Lanka

SATELLITE MEETING ON RESEARCH AND CLINICAL ETHICS

In collaboration with the

Collaborative Institutional Training Initiative (CITI), University of Miami, USA

Forum for Ethical Review Committees in Asia and the Western Pacific (FERCAP)

Forum for Ethics Review Committees in Sri Lanka (FERCSL)

15 & 16 OCTOBER 2016


DAY 1: 15 OCTOBER 2016

10.30 am

Symposium on Accreditation and Recognition of Research Ethics Committees and International Capacity Building in Bioethics

The SIDCER Recognition Programme of the FERCAP

Dr. Christina Torres

Coordinator

Forum for Ethical Review Committees in Asia and the Western Pacific

Developing Global Human Subjects Research Protections Programs: The Role of AAHRPP

Elyse Summers JD

Chief Executive Officer

Association for the Accreditation of Human Research Protection Programmes (AAHARP)

USA

International Network of the Unesco Chair in Bioethics

Prof. Harischandra Gambhira

Head

Sri Lanka Unit, Unesco Chair in Bioethics

Sri Lanka


12.00 Noon

Lunch


1.00 pm

Symposium on Bioethics and Research Ethics Training

The CITI Programme. A Cost Effective Alternative for Research Ethics Education

Prof. Paul Braunschweiger

Senior Executive VP & Managing Director CITI Program

Biomedical Research Alliance of New York

Professor Emeritus

University of Miami

USA

The role of National Medical Associations in Bioethics and Research Ethics Education – the Sri Lankan experience

Prof. Chandani Wanigatunge

Chairperson

Forum for Ethics Review Committees in Sri Lanka (FERCSL)

Research on the terminally ill

Dr. Susan Miller

Methodist Hospital, Houston, Texas

USA


2.30 pm

Tea


3.00 pm

Symposium on Challenges in the Ethics Review Process

Our experience from the University of Miami, USA

Prof. Dushyantha T. Jayaweera

Interim Executive Dean for Research and Research Education

Professor of Medicine, Miller School of Medicine, University of Miami

USA

Our Experience from Sri Ramachandra, India

Prof. S P Thyagarajan

Former Vice-Chancellor, University of Madras
Professor of Eminence & Dean (Research), Sri Ramachandra University, Porur, Chennai

India

Our Experience from Sri Lanka

Prof. Hemantha Senanayake

Chairperson, Ethics Review Committee and Professor of Obstetrics and Gynaecology, Faculty of Medicine, University of Colombo

Sri Lanka

4.30 pm

Close


DAY 2: 16 OCTOBER 2016

8.30 am

Symposium on Ethics issues in Clinical Trials

Observations from surveys in 200 ethics review committees in the Asia Pacific Region

Prof. Christina Torres

Coordinator

Forum for Ethical Review Committees in Asia and the Western Pacific

Thailand

Research Integrity and Reproducibility

Prof. Paul Braunschweiger

Senior Executive VP & Managing Director CITI Program

Biomedical Research Alliance of New York

Professor Emeritus University of Miami

USA

Ethics issues in Clinical Trials in Complementary and Traditional Medicine

Dr. Kamal Perera

Head of Department of Ayurveda Pharmacology and Pharmaceutics, Institute of Indigenous Medicine, University of Colombo, Colombo

Sri Lanka


10.00 am

Tea


10.30 am

Symposium on Special Topics in Research Ethics – 1

Ethics of Global Health Policy and Systems Research

Prof. Adriane Gelpi

Assistant Professor, Department of Public Health Sciences
Institute of Bioethics and Health Policy
University of Miami Miller School of Medicine
USA

Challenges in International Collaborative Research between Developed and Developing Countries

Prof. Sergio Litewka

Associate Professor

International Director, CITI Program

International Director, University of Miami Institute of Bioethics

USA

Ethical Issues on Big Data Management

Prof. Adriane Gelpi

Assistant Professor, Department of Public Health Sciences
Institute of Bioethics and Health Policy
University of Miami Miller School of Medicine
USA


12.00 noon

Lunch


01.00 pm

Symposium on Clinical Ethics

Ethics of end of life care

Dr. Susan Miller

Methodist Hospital, Houston, Texas

USA


2.30 pm

Tea


3.00 pm

Symposium on Special Topics in Research Ethics 2

International Perspectives on Research Integrity
Prof. Sergio Litewka

Associate Professor, International Director, CITI Program, International Director University of Miami Institute of Bioethics
USA

Publication Integrity

Dr. B. J.C. Perera

President

Sri Lanka Forum of Medical Editors (SLFOME)

Sri Lanka

AAHRPP accreditation and its value in our global research enterprise
Elyse Summers JD

Chief Executive Officer

Association for the Accreditation of Human Research Protection Programmes (AAHRPP)USA

4.30 pm

Close

Surveying and Evaluating Ethical Review Practices 2016


conducted by Forum for Ethical Review Committees in Asia & the Western Pacific (FERCAP)

and Forum for Ethics Review Committees in Sri Lanka (FERCSL)


Date: 5th June 2016

Time: 9:00 to 16:00

Venue: Auditorium, PGIM, University of Colombo


Programme


Research Ethics and the Ethics Review Process

Prof. Vajira H. W. Dissanayake

https://drive.google.com/file/d/1oH463qeQ1tIn2M6JhuQYKtCM6UitsTpr/view?usp=sharing


Risk-Benefit Assessment in a survey

Dr Cristina E. Torres

https://drive.google.com/file/d/1sFnLCuyoyhsoh3wmSAYnyM1FZod-Yqrf/view?usp=sharing


Ethics Review of Academic Research

Dr Cristina E. Torres

https://drive.google.com/file/d/1SJ666gKgu5SZlLUqMtUX1HYN-opb54Cp/view?usp=sharing


Assessment of Quality of Review

Prof. Chandanie Wanigatunge

https://drive.google.com/file/d/1WJclrWHnVCV6_d8uOyDuH_GYMv99GRR2/view?usp=sharing


Woking Groups Practical: Preparing for a site visit

  • Preparing the Survey Plan
  • Grouping the Surveyors and Trainees
  • Assigning responsibilities to the Survey Groups
  • Selection of persos to be interviewed
  • Selection of Protocols for review

A Workshop on Vulnerability and Research Ethics

Date : 28th March 2016

Time : 8.30 am to 12 noon

Venue : Lionel Memorial Auditorium, Sri Lanka Medical Association, No 6, Wijerama Mawatha, Colombo 7


Programme

Overview of vulnerability and Ethics

Professor Chandanie Wanigatunge

Chairperson, FERCSL

https://drive.google.com/file/d/1ZswEKtCiyyqyf0HmNuiTPXr_Y3kubkLu/view?usp=sharing


Research involving those who lack mental capacity to consent

Dr. Jayan Mendis,

Consultant Psychiatrist

NIMH

https://drive.google.com/file/d/1vRbu39EtmKTALy2l7W4C0XwtR12hwDHl/view?usp=sharing


Ethics in Research involving Children

Professor Shalini Sri Ranganathan

Professor in Pharmacology,

Faculty of Medicine

University of Colombo

https://drive.google.com/file/d/1bnpAmcHVq2ZeNjpjoThYrrnTA7abHETK/view?usp=sharing


Ethics in Research involving Women

Professor Maithree Wickramasinghe

Professor in English,

Department of English

University of Kelaniya

https://drive.google.com/file/d/1lqU4v8hYSowt57AH0E1fnFuivre_ow18/view?usp=sharing

Workshop on Evaluation of Research Proposals by ERCs 2016

Organised by

Ethical Review Committee, Faculty of Medicine, General Sir John Kotelawala Defence University

&

Forum for Ethics Review Committees in Sri Lanka


Date : 16th February 2016

Time : 8.30 am to 1.00 pm

Venue : Staff Development Centre, 5th floor, Faculty of Medicine building, KDU


Programme

Welcome Address

Prof. Rohini Fernandopulle

Chairperson, ERC, FoM, KDU


Evaluation of protocols by the ERC

Prof. Shalini Sri Ranganathan

Professor in Pharmacology,

Faculty of Medicine

University of Colombo


Evaluation of Information sheets, consent forms and assent forms

Dr. Malik Fernando

Member,

ERC, Sri Lanka Medical Association


Sociological issues in research proposal evaluation

Dr. Chandani Liyanage

Senior Lecturer,

Department of Sociology

University of Colombo