Category: Training Programmes & Workshops

Basics of Research Ethics 2023

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Date: 09th November 2023

Time: 09:00 – 11:30

Venue: Virtual

Resource Persons:

Professor Chandanie Wangatunge
President, FERCSL &
Professor Of Pharmacology
Faculty of Medical Sciences, University of Sri Jayawardenepura


Dr. Mizaya Cader
Consultant Community Physician
Ministry of Health


Professor Naazima Kamardeen
Professor of Commercial Law,
University of Colombo

GCP Workshop for Researchers 2018

Date: 12th & 13th June 2018

time: 9.00am

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

Programme

Day 1: 12th June 2018

Introduction

President FERCSL

Introduction to GCP, Principles. What is GCP? Need for GCP?

Prof Priyadarshani Galappaththy

Professor in Pharmacology

FM, Colombo

https://drive.google.com/file/d/1Ro67fvNQ_OZzBcT5WtFjB6uKWqIaX6Q3/view?usp=sharing

Role and Responsibilities of PI

Prof Priyadarshani Galappaththy

Professor in Pharmacology

FM, Colombo

https://drive.google.com/file/d/1Itu-H_wOQ0bNaGOBKdbvHe3BpH7TXaE9/view?usp=sharing

Drug development process

Dr Channa Ranasinha

Senior Lecturer in Pharmacology,

FM, Kelaniya

https://drive.google.com/file/d/1VhLDG1w0aHkj6kPX-kMlUJ1St-8pzQvA/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/12yGio1fsDAvcsVdWJkPRkqIICUDkOLSI/view?usp=sharing

Clinical Trial protocol and Investigation Brochure

Prof G R Constantine

Professor in Clinical Medicine,

FM, Colombo

https://drive.google.com/file/d/1LdBZxvAA8ufQmPQlsy_dIKU-vmcSVGTy/view?usp=sharing

Participant safety and adverse effects

Prof Shalini Sri Ranganathan

Professor in Pharmacology

FM, Colombo

https://drive.google.com/file/d/1OsIYV_MRp1n9KAeX1-aPaQtf0eNvirYW/view?usp=sharing

Documentation and record keeping

Dr Noel Somasundaram

Consultant Endocrinologist

https://drive.google.com/file/d/1S4Z04qAEDVN7rSrDKNewqoFrvQzsxtwy/view?usp=sharing

Day 2 – 13th June 2018

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/1lnO5RMnjYLNl3ZMKmaXkyDI0gDzLjPns/view?usp=sharing

Informed consent

Dr Manori Gamage

Senior Lecturer, FMS, USJ

https://drive.google.com/file/d/1T_dKUE0rzTkCN8tcp-eJhXhWt0a2WDKA/view?usp=sharing

Research ethics in Clinical Trials

Prof. Chandanie Wanigatunge

Chairperson, FERCSL

Chairperson, ERC SLMA

https://drive.google.com/file/d/11u62rMNTJdK_EebAlGeKYLBc1udeJ4Jf/view?usp=sharing

Investigational products

Prof Shalini Sri Ranganathan

Professor in Pharmacology

FM, Colombo

https://drive.google.com/file/d/1jiHWmZ1f7LDUoK1RfxxsMJGNYpuQbNWg/view?usp=sharing

Role of the sponsor & Contract Research Organization (CRO)

Prof Asitha de Silva

Senior Professor of Pharmacology,

FM, University of Kelaniya

https://drive.google.com/file/d/1v0CY5c_iWKRHhpjRr5V0rlY7c0TEFR7L/view?usp=sharing

Research Misconduct and Conflict of Interest

Dr Malik Fernando

ERC, SLMA

https://drive.google.com/file/d/1c5LhATYyJf30Y3Z9NehjVho_Mbvo3w-X/view?usp=sharing

Dilemmas in Ethics

Date: 14th May 2018

Venue: Lionel Memorial Auditorium, SLMA

Time: 9 am to 12.30 pm

Programme

TimeTitleDiscussion
8.30 – 9.00 amRegistration
9.00 – 9.15 amIntroduction and instructionsProfessor Chandanie Wanigatunge
9.15 – 10.00 amGroup work
10.00 – 10.15 amTea
10.15 – 10.45 amEstablishing registriesPresented by Group 1
Discussion lead by
Dr Jayanie Weeratne
Professor Chandanie Wanigatunge
( Sri Lanka Medical Association )
10.45 – 11.00 amEthical Issues related to studies on herbal medicinePresented by Group 2
Discussion lead by
Dr.Vajira Seneviratne
Professor Renu Wickramasinghe (Faculty of Medical Sciences, USJ)
11.00 – 11.30 amAnalysis of genomic variations and population history among two major ethnic groups and Vedda population in Sri LankaPresented by Group 3
Discussion lead by
Dr. Panduka Karunanayake (Faculty of Medicine, University of Colombo)
11.30 – 12.00 pmHIV screeningPresented by Group 4
Discussion lead by
Faculty of Medicine, University of Jaffna
12.00 – 12.30 pmStudies that involve development and validation of toolsPresented by Group 5
Discussion lead by
Prof Sureka Chackrewarthy (Faculty of   Medicine, University of Kelaniya)

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

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

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