Guidelines & Reports


The Belmont report (1979) 

Clinical Safety Data Management : Definitions & Standards for Expedited Reporting : ICH Harmonised Tripartite Guideline (1995)

Guidelines for good clinical practice (GCP) for trials on pharmaceutical products (1995)

ICH guidelines (2005)

International Ethical Guidelines for Epidemiological Studies – CIOMS (2009)

Standards and Operational Guidance for Ethics review of Health related research with Human participants- WHO (2011)

Declaration of Helsinki (2013)

EFGCP Guidelines on Medical Research for and with Older People in Europe – (2013)

International Ethical Guidelines for Health-related Research Involving Humans – CIOMS (2016)


Guidelines for Ethics Review of Research Proposals Involving Animals in Sri Lanka – FERCSL – 2009

National Guidelines for the Establishment and Functioning of Ethical Review Committees in Health Care Institutions in Sri Lanka