Ethics Review Committee approval and informed consent: an analysis of biomedical publications originating from Sri Lanka

Athula Sumathipala¹^,2 , Sisira Siribaddana² , Suwin Hewege² , Manura Lekamwattage² , Manjula Athukorale² , Chesmal Siriwardhana² , Joanna Murray¹ and Martin Prince¹

¹Kings College; Institute of Psychiatry, Health Services and Population Research Department, De Crespigny Park, London SE5 8AF, UK

²Institutes of Research and Development, 762/4B Pannipitiya Rd, Battaramulla 10120, Sri Lanka

author email corresponding author email

BMC Medical Ethics 2008, 9:3doi:10.1186/1472-6939-9-3


Published:	11 February 2008

Abstract

Background

International guidelines on research have focused on protecting research participants. Ethical Research Committee (ERC) approval and informed consent are the cornerstones. Externally sponsored research requires approval through ethical review in both the host and the sponsoring country. This study aimed to determine to what extent ERC approval and informed consent procedures are documented in locally and internationally published human subject research carried out in Sri Lanka.

Methods

We obtained ERC approval in Sri Lanka and the United Kingdom. Theses from 1985 to 2005 available at the Postgraduate Institute of Medicine (PGIM) library affiliated to the University of Colombo were scrutinised using checklists agreed in consultation with senior research collaborators. A Medline search was carried out with MeSH major and minor heading 'Sri Lanka' as the search term for international publications originating in Sri Lanka during 1999 to 2004. All research publications from CMJ during 1999 to 2005 were also scrutinized.

Results

Of 291 theses, 34% documented ERC approvals and 61% documented obtaining consent. From the international journal survey, 250 publications originated from Sri Lanka of which only 79 full text original research publications could be accessed electronically. Of these 38% documented ERC approval and 39% documented obtaining consent. In the Ceylon Medical Journal 36% documented ERC approval and 37% documented obtaining consent.

Conclusion

Only one third of the publications scrutinized recorded ERC approval and procurement of informed consent. However, there is a positive trend in documenting these ethical requirements in local postgraduate research and in the local medical journal.