Ethics Review Committee approval and informed consent: an analysis of biomedical publications originating from Sri Lanka
© Sumathipala et al; licensee BioMed Central Ltd. 2008
Received: 27 September 2007
Accepted: 11 February 2008
Published: 11 February 2008
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.
Guidelines on ethical conduct of research have focused attention on protecting research participants [1–3]. Approval from an ethical review committee (ERC) [1, 2, 4] and ensuring informed consent from the participants are the cornerstones of ethical human subject research [3, 5, 6]. Consent is considered 'informed' when given by a person who understands the purpose and the nature of research, what is required from the participant and what may be the potential benefits and risks resulting from the study [2, 7]. In order to ensure acceptable ethical standards in externally sponsored research, protocols should undergo ethical review in both the host and the sponsoring country [1, 2]. However, research carried out in the developing world which does not comply with accepted ethical standards is a concern for academics, funding agencies, journal editors and governments .
Proof of ERC approval and consent of participants can be sought by direct and indirect methods. Inquiring from the relevant ERC or obtaining a copy of the approval is a direct method. Inquiring from the researcher or scrutinising published research for documentation is an indirect method. For informed consent, witnessing the informed consent process is the direct method whereas inquiring from the researcher, research participant, ERC or establishing evidence from documentation in published research are indirect methods.
To our knowledge there are no studies reported from South Asia examining evidence of adherence to these two requirements in published research. However, studies in South Asia have examined the issue of consent from the point of view of participants and researchers. A study carried out in Bangladesh examined participants' understanding of a community-based study of iron supplementation . Although consent had been obtained after detailed explanation of the study, many participants did not understand that they were free to decline to participate, that they could choose to leave the study, and about half believed that participation was part of routine health care . In another questionnaire survey among researchers in the developing world, the majority (62%) stated that they had obtained written informed consent . Several studies have also looked into informed consent practices relevant to patient care and clinical ethics from the perspectives of physicians and patients [10–12].
Although Sri Lanka is a developing country with a population of 19 million, it has strengths in health and education  and the tradition of biomedicine, both western and eastern, is firmly established. There is archeological evidence of hospitals dating back to the 9th century AD in the ancient kingdom of Anuradhapura . The civil medical department was established by the British in 1858 and the Colombo Medical School, which opened in 1870, is the second oldest in south Asia . The Ceylon Medical Journal (CMJ) is the oldest surviving English language medical journal in Australasia, first published as the Journal of the Ceylon Branch of the British Medical Journal in 1887 .
Sri Lanka has a long history of scientific research. Aldo Castellani, under British rule, established the Medical Research Institute (MRI) in 1901 . Influential international research collaborations have been reported [15–21] and leading funding agencies, including the Wellcome Trust (UK), National Institute of Health (USA) and the World Bank have funded research in Sri Lanka. A considerable amount of anthropological and sociological research has also been conducted .
In spite of the volume of research, bioethics is at an early stage of development in Sri Lanka . There are no formal training courses for clinical researchers except for some limited teaching in the six medical faculties from which the majority of research emanates . Institute for Research and Development has conducted a basic course in 2003 and a basic and advanced course in 2007.
In this study we draw attention to the issue of informed consent and ERC approval for human subject research in contemporary Sri Lanka. The International Committee of Medical Journal Editors (ICMJE) guidelines of 1981 required researchers to indicate that the research had IRB review  and, in 1991, the ICMJE added that when "informed consent has been obtained by authors, this should be clearly stated in the article". This study aimed to determine the extent to which ERC approval and informed consent procedures were documented in three independent sources of publications arising from human subject research carried out in Sri Lanka.
The protocol was revised in accordance with the recommendations of reviewers of the funding body. Consensus generation meetings to fine tune the protocol were conducted with the participation of the authors and those who were trained during the ethics course and qualitative workshops conducted by the Institute for Research and Development .
1. All published MD and MSc theses from 1985 to 2005 available at the Postgraduate Institute of Medicine (PGIM) library affiliated to the University of Colombo were scrutinized. PGIM is the only institute in Sri Lanka that awards post graduate medical degrees. Details of ERC approval, information leaflets and consent forms used in the research conducted to obtain the postgraduate degrees were recorded. The theses available at the PGIM were initially scrutinized by two authors (ML and MA) to ensure a comprehensive coverage. Later another two authors (SH and CS) checked the list against the bibliography of theses published by the PGIM. Then theses were perused by the two authors (ML and MA) based on pre-agreed checklists to identify and record
• any information relating to ethical approval in the methodology or elsewhere in the published work.
• If yes,
(a) Whether the ERC which granted ethical approval was named and
(b) Whether any evidence was provided; e.g.: copy of the ethical approval letter
• Information on the type of consent obtained (written/oral) and methods used in obtaining consent
• Whether a copy of the information leaflet given to the participant was attached
• Whether a copy of the consent form was attached to the thesis.
2. A Medline search was carried out with MeSH major and minor heading using 'Sri Lanka' as the search term to find all published research originating from Sri Lanka, between 1st January 1999 and 1st September 2004. We downloaded full text papers published in open access journals and those available in Athens, an access management system of academic articles. If the full text papers were not available we downloaded the abstracts. We could not obtain the full text paper copies of those abstracts as the printed journals were not available in Sri Lanka. These publications were initially scrutinized by two authors (ML and MA). Later AS, SS, CS re-scrutinized the papers to select and agree on human subject research publications. Then AS and SS independently scrutinised the papers to identify
• any information related to ERC approval in the published work
• documentation on the type of consent obtained (written/oral)
3. For CMJ we analyzed the full text papers available as hard copies for the period 1999–2005. This was due to two reasons; it is the only Sri Lankan journal available in the PubMed as abstracts and we had access to hard copies. CMJ publications were initially scrutinized by two authors (ML and MA). Later CS and SH re-scrutinized the papers to select human subject research publications and to identify whether ERC approval and consent was documented.
Survey of research theses
Documentation of ERC approval and consent in different fields of study
Documentation of ERC approval (%)
Documentation of obtaining consent (%)
MD Community Dentistry
MD Community Medicine
MD Family Medicine
MD Gyn & Obs
MSc Community Medicine
MSc Community Dentistry
Documentation of ERC approval and consent in theses; five yearly trends
Theses by 5 year period
Documentation of ERC Approval
Documentation of obtaining consent
Year of submission
Approval letter attached (%)
Documented or not relevant (%)
1980 – 1985
1986 – 1990
1991 – 1995
1996 – 2000
2001 – 2005
The manner how consent is described when it was documented; 5 yearly trends
1980 – 1985
1986 – 1990
1991 – 1995
1996 – 2000
2001 – 2005
However, only three (1%) information leaflets and 23 (7.5%) consent forms were available from 291 theses.
Survey of published research in peer reviewed journals
Medline search results
The Medline search carried out for the study identified 367 publications (excluding CMJ publications), originating from Sri Lanka during the period from 1st January 1999 to 1st September 2004. Of these 250 concerned human subject research. We were able to download 111 full text papers and the remaining 139 were available only as abstracts. Of the available 111 publications on human subject research, we included only original research papers and excluded 32; letters, editorials, and data arising outside Sri Lanka from Sri Lankan authors. Of remaining 79 papers only 30 (38%) full text publications had documented ERC approval and 31(39%) informed consent.
We attempted to find out how many of these papers had authors of Sri Lankan origin but it was not feasible from the information available in the papers.
CMJ search results
Ceylon Medical Journal survey; ERC approval and consent
Year of submission
ERC approval documented (%)
Documentation of Obtaining consent (%)
Not Relevant (%)
Two (15.4%) of the 13 papers published in CMJ in 1999, had documented obtaining ERC approval. By 2005 this had increased to 9 (52.9%). In 1999, five (38.5%) of the original articles published in CMJ had documented obtaining consent from the participants. In 2005, this had risen to 12 (70.6%) with eight (44%) specifying 'informed consent'.
The survey results of three sources of research publications in Sri Lanka, theses, international journals and CMJ, all show an increasing trend in documenting ERC approval and participant consent.
Although from 1986 to 1990 only 12.4% had obtained ERC approval, this increased to 49.4%, during 2001 to 2005. More specifically, reporting about ERC approval increased from 12.5% in 1989, to 75% in 2005. Documentation of consent increased from 30% to 79.8% during the same period. It also emerged that candidates for higher qualifications (MD as opposed to MSc) documented ERC approval at a higher rate in their research projects and publications.
There is no reference to ERC approval or consent in PGIM examination rules and regulations. However each board of study is responsible for ensuring these standards. Board of study in community medicine has made it a requirement that candidates obtain ERC approval (personal communication from the chairman) since 1991. Regulations and guidelines of the board of study in family medicine state that research protocols should include details of approval of the project by a relevant ERC. We were unable to find information about requirements for ERC approval in other disciplines. Instructions to authors in CMJ  state that ethical committee approval should be mentioned in the text in 'intervention studies' with a photocopy of the approval letter attached to all submissions.
Only 38% of full text papers from 1999 to 2004 in international journals had documented ERC approval. This is a cause for concern. In CMJ, ERC approval for the same period was 32.5%. During the same period 39% of papers in international journals and 30.1% in CMJ had documented informed consent.
However, absence of documentation of ERC approval cannot be taken as absence of obtaining approval, as some may have not reported it. Further research should include direct inquiries to authors and journal editors on ERC approval for published research.
Even though the International Committee of Medical Journal Editors requires ERC approval and informed consent to be documented in the manuscripts [25, 26], our results shows that this requirement has not been strictly adhered to. Previous studies that had examined research carried out in the developed world have also shown that documentation of IRB review and IC is not consistent, even in journals that state it as a requirement [29–34]
This study relies on self reported data. Therefore, the content of the ethical review, the process of informed consent, and the level of understanding of research subjects, both of the research, the consent process, and the meaning of informed consent are not explicitly stated. This affects all three surveys. In addition the main limitation in the international journal survey is the inability to review full publications on human subject research as only the abstracts were avaialble. Given space limitations, it is reasonable to anticipate that ethical review would not always be stated in the abstract.
In all three surveys, it is possible that more researchers may have sought ERC approval than reported. Evaluation based on documentation by the researchers as opposed to actual ERC approval and consent is an inherent weakness of the study methodology.
Researchers should be requested to attach the information leaflet and consent forms to the final version of their theses, in the same way they are required to append research instruments. This will enable the examiners to assess adherence to good ethical practices and encourage new researchers to regard ethical standards as an integral part of high quality research. Similarly journal editors should implement ICMJ recommendation more robustly.
Documentation of ERC approval and consent occurs in around 35% of research publications in international journals and CMJ. Even though there is a positive trend towards documentation of ERC approval and informed consent in human subject research in Sri Lanka, the prevailing situation is not satisfactory. Increasing awareness on these two crucial safeguards; ERC approval and informed consent, will be helpful locally to promote basic ethical standards as essential components of scientific research. This may also help adherence to higher ethical standards in international collaborations.
List of abbreviations
- PGIM- Postgraduate Institute of Medicine:
ECR- ethics review committee, CMJ- The Ceylon Medical Journal, MRI- Medical Research Institute, MeSH-Medical subjects headings
The Wellcome trust UK Biomedical ethics grants (074928) for the funding for this work.
We are grateful to the three reviewers of the BMC Medical Ethics Adnan Hyder, Carol Stocking and Lisa S. S Parker for their open review and the suggestions that made the paper of a better quality.
- World Medical Association: Declaration of Helsinki. Ethical Principles for Medical Research Involving Human Subjects. [http://www.wma.net/e/policy/pdf/17c.pdf]
- Council for International organizations of Medical Sciences (CIOMS): International guidelines for ethical review of epidemiological studies. Geneva. 2002Google Scholar
- Nuffield council on Bioethics: The Ethics of Research Related to Healthcare in Developing Countries. London. 2002Google Scholar
- World Health Organisation (WHO): Operational Guidelines for Ethics Committees that Review Biomedical Research. Geneva. 2000Google Scholar
- Nuffield council on Bioethics: The Ethics of Research Related to Healthcare in Developing Countries, followup discussion paper. Lonodn. 2005Google Scholar
- Bhutta ZA: Beyond Informed Consent. Bull World Health Organ. 2004, 82: 771-776.Google Scholar
- Alderson P, Goodey C: Theories of Consent. BMJ. 1998, 317: 1313-1315.View ArticleGoogle Scholar
- Lynöe N, Hyder N: Obtaining Informed Consent in Bangladesh. N Engl J Med. 2001, 344: 460-461. 10.1056/NEJM200102083440617.View ArticleGoogle Scholar
- Hyder AA, Wali SA: Informed consent and collaborative research: perspectives from the developing world. Dev World Bioeth. 2006, 6: 33-40. 10.1111/j.1471-8847.2006.00134.x.View ArticleGoogle Scholar
- Jafarey AM, Farooqui A: Informed consent in the Pakistani milieu: the physician's perspective. J Med Ethics. 2005, 31: 93-96. 10.1136/jme.2002.002220.View ArticleGoogle Scholar
- Bhurgri H, Qidwai W: Awareness of the Process of Informed Consent among Family Practice Patients in Karachi. J Pak Med Assoc. 2004, 54: 398-Google Scholar
- Yousuf RM, Fauzi ARM, How SH, Rasool AG, Rehana K: Awareness, knowledge and attitude towards informed consent among doctors in two different cultures in Asia: a cross-sectional comparative study in Malaysia and Kashmir, India. Singapore Med J. 2007, 48: 559-565.Google Scholar
- World Health Organization: World Health Report. Geneva. 2000Google Scholar
- Uragoda CG: History of Medicine in Sri Lanka. 1987, Colombo: Sri Lanka Medical AssociationGoogle Scholar
- Weerasooriya MV, Gunewardena NK, Itoh M, Qiu XG, Kimura E: Prevalence and intensity of Wuchereria Bancrofty anitigenaemia in Sri Lanka by Og4C3 ELISA. Using filter paper absorbed whole blood. Trans R Soc Trop Med Hyg. 2002, 96: 41-45. 10.1016/S0035-9203(02)90234-8.View ArticleGoogle Scholar
- Ahluwalia N, De Silva A, Athukorale S, Weaver V, Molls R: Ferritine concentration in dried serum spots from capillary and venous blood in children in Sri Lanka; a validation study. Am J Clin Nutr. 2002, 75: 289-94.Google Scholar
- Ariyaratnam CA, Sjostrom L, Raziek Z, Kularatne SA, Arachchi RW, Shrief MH, Theakston RD, Warrell DA: An open, randomized comparative trail of two anti venoms for the treatment of envenoming by Sri Lankan Russell viper. Trans R Soc Trop Med Hyg. 2001, 95: 74-80. 10.1016/S0035-9203(01)90339-6.View ArticleGoogle Scholar
- Mackinnon MJ, Gunewardena DM, Rajakaruna J, Weeresingha S, Mendis KN, Carter R: Quantifying genetic and non genetic contributions to Malarial infection in Sri Lankan population. Proc Nal Acad Sci USA. 2000, 97 (23): 2661-2666.View ArticleGoogle Scholar
- Eddleston M, Ariyaratnam CA, Sjostrom L, Jayalath S, Rajakanthan K, Rajapakse S, Colbert D, Meyer WP, Perera G, Atapattu S, Sheriff MR, Warrel DA: Acute yellow oleander poisoning; cardiac arrhythmias, electrolyte disturbances, and serum cardiac glycoside concentrations on presentation to hospitals. Heart. 2000, 83: 301-6. 10.1136/heart.83.3.301.View ArticleGoogle Scholar
- Premaratna R, Saparamadu A, Samarasekera DN, Warren BF, Jewell DP, de Silva HJ: Eosinophilic granulomatous vasculitis mimicking a gastric neoplasm. Histopathology. 1999, 35: 479-81. 10.1046/j.1365-2559.1999.035005479.x.View ArticleGoogle Scholar
- Sumathipala A, Hewege S, Hanwella R, Mann AH: Randomised controlled trial of cognitive behaviour therapy for repeated consultations for medically unexplained complaints: a feasibility study in Sri Lanka. Psychol Med. 2000, 30: 747-757. 10.1017/S0033291799002160.View ArticleGoogle Scholar
- Goonatilake S: Anthropologizing Sri Lanka. A Eurocentric Misadventure. 2001, Indianapolis: Indiana University PressGoogle Scholar
- Simpson B: Ethics regulation and the new reproductive technologies in Sri Lanka: perspectives of ethics committee members. Ceylon Med J. 2001, 46 (2): 54-57.Google Scholar
- Kasturiarachchi N, Lie R, Seeberg J: Health Ethics in Six SEAR countries. WHO-SEARO. 1999, 1: 76-84.Google Scholar
- International Committee of Medical Journal Editors: Uniform requirements for manuscripts submitted to biomedical journals. Ann InternMed. 1982, 96: 766-77.View ArticleGoogle Scholar
- International Committee of Medical Journal Editors: Statements from the International Committee of Medical Journal Editors. JAMA. 1991, 265: 2697-2698. 10.1001/jama.265.20.2697.View ArticleGoogle Scholar
- Institute for Research and Development: [http://www.irdsrilanka.org/joomla/]
- Editors: How to do it: check list for CMJ authors. Ceylon Med J. 2007, 52: 115-
- Drummond R, Yank V: Disclosure to the reader of institutional review board approval and informed consent. JAMA. 1997, 277: 922-923. 10.1001/jama.277.19.1552.View ArticleGoogle Scholar
- Rikkert M, ten Have H, Hoefnagels W: Informed consent in biomedical studies on aging: survey of four journals. BMJ. 1996, 313: 1117-1120.View ArticleGoogle Scholar
- Ruiz-Canela M, Martinez-Gonzalez MA, Gomez-Gracia E, Fernandez-Crehuet J: Informed consent and approval by institutional review boards in published reports on clinical trials. N Engl J Med. 1999, 340: 1114-1115. 10.1056/NEJM199904083401412.View ArticleGoogle Scholar
- Bauchner H, Sharfstein J: Failure to report ethical approval in child health research: review of published papers. BMJ. 2001, 323: 318-319. 10.1136/bmj.323.7308.318.View ArticleGoogle Scholar
- Karlawish JHT, Hougham GW, Stocking CB, Sachs GA: What is the quality of the reporting of research ethics in publications of nursing home research?. J Am Geriatr Soc. 1999, 47: 76-81.View ArticleGoogle Scholar
- Roggin KK, Chwals WJ, Tracy TF: Institutional review board approval for prospective experimental studies on infants and children. J Pediatr Surg. 2001, 36: 205-208. 10.1053/jpsu.2001.20054.View ArticleGoogle Scholar
- The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1472-6939/9/3/prepub
This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.