Sumathipala Athula, Siribaddana Sisira, Hewege Suwin, Lekamwattage Manura, Athukorale Manjula, Siriwardhana Chesmal, Murray Joanna, Prince Martin
Kings College, Institute of Psychiatry, Health Services and Population Research Department, De Crespigny Park, London SE5 8AF, UK.
BMC Med Ethics. 2008 Feb 11;9:3. doi: 10.1186/1472-6939-9-3.
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.
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.
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.
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.
国际研究指南着重于保护研究参与者。伦理研究委员会（ERC）批准和知情同意是其基石。外部资助的研究需要在主办国和资助国都通过伦理审查。本研究旨在确定在斯里兰卡进行的本地和国际发表的人体研究中，ERC批准和知情同意程序的记录程度。
我们在斯里兰卡和英国获得了ERC批准。使用与资深研究合作者协商一致的清单，对科伦坡大学附属医学研究生学院（PGIM）图书馆中1985年至2005年的论文进行了审查。以“斯里兰卡”作为主题词，使用医学主题词表的主要和次要主题词在Medline上进行搜索，以查找1999年至2004年源自斯里兰卡的国际出版物。还审查了1999年至2005年期间《锡兰医学杂志》（CMJ）的所有研究出版物。
在291篇论文中，34%记录了ERC批准，61%记录了获得同意。在国际期刊调查中，有250篇出版物源自斯里兰卡，其中只有79篇全文原始研究出版物可通过电子方式获取。在这些出版物中，38%记录了ERC批准，39%记录了获得同意。在《锡兰医学杂志》中，36%记录了ERC批准，37%记录了获得同意。
在审查的出版物中，只有三分之一记录了ERC批准和获得知情同意的情况。然而，在本地研究生研究和本地医学期刊中记录这些伦理要求方面存在积极趋势。
