History of Research Ethics Review in Sri Lanka

Dr. Vajira H. W. Dissanayake MBBS (Colombo), PhD (Nottingham)Joint Secretary, Ethical Review Committee

Faculty of Medicine, University of Colombo, Sri Lanka

National Ethics CommitteesNational Ethics Committees

Institution CommitteeName, Year Established

Main Activities/Outputs

Sri Lanka Medical Association (SLMA)http://www.slma.lk

Ethics Committee, 1992 Information available on the website.

Sri Lanka Association for the Advancement of Science (SLAAS)http://www.nsf.ac.lk/slaas

Ethics Committee, 1996 Information available on the website.

Ministry of Healthhttp://www.health.gov.lk

National Health Research Council (NHRC)Functioning under the Education, Research and Training Division,2000

One of the functions of the NHRC is to promote research ethics.

National Science and Technology Commission (NASTEC)http://www.nastec.lk

Study Group IX, 2000 to 2003 Publication of “New genetics and assisted reproductive technologies in Sri Lanka – A draft national policy on biomedical ethics.”

National Science Foundation of Sri Lanka (NSF)http://www.nsf.ac.lk

National Bioethics Committee (NBC), 2002

Information available on the website.

Sri Lanka Medical Council (SLMC)http://www.slmedc.lk

Assisted Reproductive Technologies Guidelines Committee, 2004

Publication of a “Provisional code of practice for associated reproductive technologies.”

Institution CommitteeName, Year Established

Main Activities/Outputs

Sri Lanka Medical Association (SLMA)http://www.slma.lk

Ethics Committee, 1992 Information available on the website.

Sri Lanka Association for the Advancement of Science (SLAAS)http://www.nsf.ac.lk/slaas

Ethics Committee, 1996 Information available on the website.

Ministry of Healthhttp://www.health.gov.lk

National Health Research Council (NHRC)Functioning under the Education, Research and Training Division,2000

One of the functions of the NHRC is to promote research ethics.

National Science and Technology Commission (NASTEC)http://www.nastec.lk

Study Group IX, 2000 to 2003 Publication of “New genetics and assisted reproductive technologies in Sri Lanka – A draft national policy on biomedical ethics.”

National Science Foundation of Sri Lanka (NSF)http://www.nsf.ac.lk

National Bioethics Committee (NBC), 2002

Information available on the website.

Sri Lanka Medical Council (SLMC)http://www.slmedc.lk

Assisted Reproductive Technologies Guidelines Committee, 2004

Publication of a “Provisional code of practice for associated reproductive technologies.”

Institutional Ethics Committees

10

1

3

1

Institution YearEstablished

Faculty of Medicine, University of Colombo, Colombo. 1981

Faculty of Medicine, University of Peradeniya, Peradeniya early 1980s*

Faculty of Medicine, University of Ruhuna, Galle. 1984

Faculty of Medicine, University of Jaffna, Jaffna 1985

Postgraduate Medical Centre, Kandy 1992

Faculty of Medical Sciences, University of Sri Jayewardenepura, Nugegoda.

1994

Faculty of Medicine, University of Kelaniya, Ragama 1995

Faculty of Dental Sciences, University of Peradeniya, Peradeniya. 1995

Sri Lanka Medical Association 1999

Medical Research Institute, Colombo 2000

Lady Ridgeway Hospital for Children, Colombo 2002

Sri Lanka College of Paediatricians 2002

Sri Jayewardenepura General Hospital, Nugegoda 2003

National Hospital of Sri Lanka, Colombo 2004

Colombo South Teaching Hospital, Kalubowila 2004

Bioethics Education

Estd. 1870

Bioethics Legislation/Guidelines

Bioethics Activities

Networking and Future Directions

1. Waters Edge Meeting in August 2005

2. National Conference in November 2006

3. Publication of Uniform Guidelines for Research Ethics Review in Sri LankaJuly 2007

1. Waters Edge Meeting in August 2005

2. National Conference on in November 2006

3. Publication of Uniform Guidelines for Research Ethics Review in Sri LankaJuly 2007

4. Launch of the website of the Forum of Ethics Review Committees in Sri LankaSeptember 2007

http://www.fercsl.net

1. Waters Edge Meeting in August 2005

2. National Conference on in November 2006

3. Publication of Uniform Guidelines for Research Ethics Review in Sri LankaJuly 2007

4. Launch of the website of the Forum of Ethics Review Committees in Sri LankaSeptember 2007

5. Certificate course in Research Ethics ReviewApril 2008

1.1.Collaborative PartnershipCollaborative Partnership

2.2.Social ValueSocial Value

3.3.Scientific ValidityScientific Validity

4.4.Fair Subject SelectionFair Subject Selection

5.5.Favourable Risk/Benefit RatioFavourable Risk/Benefit Ratio

6.6.Independent ReviewIndependent Review

7.7.Informed ConsentInformed Consent

8.8.Respect for Research Respect for Research

ParticipantsParticipants

1.1.Collaborative PartnershipCollaborative Partnership

2.2.Social ValueSocial Value

3.3.Scientific ValidityScientific Validity

4.4.Fair Subject SelectionFair Subject Selection

5.5.Favourable Risk/Benefit RatioFavourable Risk/Benefit Ratio

6.6.Independent ReviewIndependent Review

7.7.Informed ConsentInformed Consent

8.8.Respect for Research Respect for Research

ParticipantsParticipants

Requirements for Evaluating Ethics of Research

JAMA. 2000;283:2701-2711

The Journal of Infectious Diseases 2004;189:930–7

1.1.Collaborative PartnershipCollaborative Partnership

2.2.Social ValueSocial Value

3.3.Scientific ValidityScientific Validity

4.4.Fair Subject SelectionFair Subject Selection

5.5.Favourable Risk/Benefit RatioFavourable Risk/Benefit Ratio

6.6.Independent ReviewIndependent Review

7.7.Informed ConsentInformed Consent

8.8.Respect for Research Respect for Research

ParticipantsParticipants

1.1.Collaborative PartnershipCollaborative Partnership

2.2.Social ValueSocial Value

3.3.Scientific ValidityScientific Validity

4.4.Fair Subject SelectionFair Subject Selection

5.5.Favourable Risk/Benefit RatioFavourable Risk/Benefit Ratio

6.6.Independent ReviewIndependent Review

7.7.Informed ConsentInformed Consent

8.8.Respect for Research Respect for Research

ParticipantsParticipants

Requirements for Evaluating Ethics of Research