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1.  Trauma, post-traumatic stress disorder and psychiatric disorders in a middle-income setting: prevalence and comorbidity 
The British Journal of Psychiatry  2014;205(5):383-389.
Background
Most studies of post-traumatic stress disorder (PTSD) in low- and middle-income countries (LMICs) have focused on ‘high-risk’ populations defined by exposure to trauma.
Aims
To estimate the prevalence of post-traumatic stress disorder (PTSD) in a LMIC, the conditional probability of PTSD given a traumatic event and the strength of associations between traumatic events and other psychiatric disorders.
Method
Our sample contained a mix of 3995 twins and 2019 non-twins. We asked participants about nine different traumatic exposures, including the category ‘other’, but excluding sexual trauma.
Results
Traumatic events were reported by 36.3% of participants and lifetime PTSD was present in 2.0%. Prevalence of non-PTSD lifetime diagnosis was 19.1%. Of people who had experienced three or more traumatic events, 13.3% had lifetime PTSD and 40.4% had a non-PTSD psychiatric diagnosis.
Conclusions
Despite high rates of exposure to trauma, this population had lower rates of PTSD than high-income populations, although the prevalence might have been slightly affected by the exclusion of sexual trauma. There are high rates of non-PTSD diagnoses associated with trauma exposure that could be considered in interventions for trauma-exposed populations. Our findings suggest that there is no unique relationship between traumatic experiences and the specific symptomatology of PTSD.
doi:10.1192/bjp.bp.113.141796
PMCID: PMC4217028  PMID: 25257062
2.  An investigation into the role of alcohol in self-harm in rural Sri Lanka: a protocol for a multimethod, qualitative study 
BMJ Open  2014;4(10):e005860.
Introduction
Sri Lanka has one of the highest suicide and self-harm rates in the world and although alcohol has been found to be a risk factor for self-harm in Sri Lanka, we know little about the connection between the two. This paper comprises a protocol for a qualitative study investigating alcohol's role in self-harm in rural Sri Lanka at three levels: the individual, community and policy level. The analysis will bring new understanding of the link between alcohol and self-harm in Sri Lanka, drawing on structural, cultural and social concepts. It will equip researchers, health systems and policy makers with vital information for developing strategies to address alcohol-related problems as they relate to self-harm.
Methods and analysis
To capture the complexity of the link between alcohol and self-harm in the Anuradhapura district in the North Central Province in Sri Lanka, qualitative methods will be utilised. Specifically, the data will consist of serial narrative life-story interviews with up to 20 individuals who have non-fatally self-harmed and where alcohol directly or indirectly was involved in the incidence as well as with their significant others; observations in communities and families; six focus group discussions with community members; and key-informant interviews with 15–25 stakeholders who have a stake in alcohol distribution, marketing, policies, prevention and treatment as they relate to self-harm.
Ethics and dissemination
The study has received ethical approval from the Ethical Review Committee of the Faculty of Medicine and Allied Sciences, Rajarata University of Sri Lanka. A sensitive data collection technique will be used and ethical issues will be considered throughout the study.
Results
The results will be disseminated in scientific peer-reviewed articles in collaboration with Sri Lankan and other international research partners.
doi:10.1136/bmjopen-2014-005860
PMCID: PMC4187453  PMID: 25293385
QUALITATIVE RESEARCH
3.  Viper bites complicate chronic agrochemical nephropathy in rural Sri Lanka 
Snakebite is a common occupational health hazard among Sri Lankan agricultural workers, particularly in the North Central Province. Viperine snakes, mainly Russell’s viper envenomation, frequently lead to acute renal failure. During the last two decades, an agrochemical nephropathy, a chronic tubulointerstitial disease has rapidly spread over this area leading to high morbidity and mortality. Most of the epidemiological characteristics of these two conditions overlap, increasing the chances of co-occurrence. Herein, we describe four representative cases of viperine snakebites leading to variable clinical presentations, in patients with chronic agrochemical nephropathy, including two patients presented with acute and delayed anuria. These cases suggest the possibility of unusual manifestations of snakebite in patients with Sri Lankan agrochemical nephropathy, of which the clinicians should be aware. It could be postulated that the existing scenario in the Central America could also lead to similar clinical presentations.
doi:10.1186/1678-9199-20-33
PMCID: PMC4136642  PMID: 25136354
Snakebite; Chronic kidney disease; Agricultural nephropathy; Epidemiology; Anuria
4.  Importance of Arsenic and pesticides in epidemic chronic kidney disease in Sri Lanka 
BMC Nephrology  2014;15:124.
In a recent study published by the National Project team on chronic kidney diseases of unknown origin in Sri Lanka, we believe there to be flaws in the design, analysis, and conclusions, which should be discussed further. The authors wanted to emphasis Cadmium as the major risk factor for chronic kidney disease of unknown etiology in Sri Lanka while undermining the importance of Arsenic and nephrotoxic pesticides. To arrive at predetermined conclusions the authors appear have changed and misinterpreted their own results. The enormous pressure applied by the agrochemical industry on this issue may be a factor. Herein, we discuss these issues in greater detail.
doi:10.1186/1471-2369-15-124
PMCID: PMC4119246  PMID: 25069452
5.  Understanding the investigators: a qualitative study investigating the barriers and enablers to the implementation of local investigator-initiated clinical trials in Ethiopia 
BMJ Open  2013;3(11):e003616.
Objectives
Clinical trials provide ‘gold standard’ evidence for policy, but insufficient locally relevant trials are conducted in low-income and middle-income countries. Local investigator-initiated trials could generate highly relevant data for national governments, but information is lacking on how to facilitate them. We aimed to identify barriers and enablers to investigator-initiated trials in Ethiopia to inform and direct capacity strengthening initiatives.
Design
Exploratory, qualitative study comprising of in-depth interviews (n=7) and focus group discussions (n=3).
Setting
Fieldwork took place in Ethiopia during March 2011.
Participants
Local health researchers with previous experiences of clinical trials or stakeholders with an interest in trials were recruited through snowball sampling (n=20).
Outcome measures
Detailed discussion notes were analysed using thematic coding analysis and key themes were identified.
Results
All participants perceived investigator-initiated trials as important for generating local evidence. System and organisational barriers included: limited funding allocation, weak regulatory and administrative systems, few learning opportunities, limited human and material capacity and poor incentives for conducting research. Operational hurdles were symptomatic of these barriers. Lack of awareness, confidence and motivation to undertake trials were important individual barriers. Training, knowledge sharing and experience exchange were key enablers to trial conduct and collaboration was unanimously regarded as important for improving capacity.
Conclusions
Barriers to trial conduct were found at individual, operational, organisational and system levels. These findings indicate that to increase locally led trial conduct in Ethiopia, system wide changes are needed to create a more receptive and enabling research environment. Crucially, the creation of research networks between potential trial groups could provide much needed practical collaborative support through sharing of financial and project management burdens, knowledge and resources. These findings could have important implications for capacity-strengthening initiatives but further research is needed before the results can be generalised more widely.
doi:10.1136/bmjopen-2013-003616
PMCID: PMC3845054  PMID: 24285629
Clinical Trial; Capacity Strengthening; Developing Country; Research Personnel; Research Organisation and Administration; TROPICAL MEDICINE
6.  Impact of exposure to conflict, tsunami and mental disorders on school absenteeism: findings from a national sample of Sri Lankan children aged 12–17 years 
BMC Public Health  2013;13:560.
Background
Armed conflicts and natural disasters are common. Millions of people, including children are killed, injured, disabled and displaced as a result. The effects of conflict and natural disaster on mental health, especially of children are well established but effects on education have received less attention. This study investigated associations between conflict and/or tsunami exposure in Sri Lanka and their associations with absenteeism in a national sample of school children.
Methods
A cross-sectional survey was conducted in 2006–7 among 1,505 randomly selected school children aged 12–17 years attending government schools in 17 districts. The hypotheses were that absenteeism would be more common in children previously affected by conflict or the 2004 tsunami and that at least part of this effect would be accounted for by mental disorders. Survey information included socio-demographic, conflict and tsunami exposure, mental health status (Strengths and Difficulties Questionnaire) and information on absenteeism (defined as 20% or greater non-attendance over one year).
Results
The total sample of consisted of 1,505 students aged 12–17 years with a mean age of 13.7 years. 120 children reported at least one conflict exposure and 65 reported at least one tsunami exposure while only 15 reported exposure to both conflict and tsunami. Prevalence of emotional disorder caseness was 2.7%, conduct disorder caseness 5.8%, hyperactivity disorder caseness 0.6%, and 8.5% were identified as having any psychiatric disorder. Absenteeism was present in 26.8%. Overall, previous exposure to tsunami (OR 2.29 95% CI 1.36-3.84) was significantly associated with absenteeism whereas exposure to conflict was not (OR 1.32 95% CI 0.88-1.97), although some specific conflict-related exposures were significant risk factors. Mental disorder was strongly associated with absenteeism but did not account for its association with tsunami or conflict exposure.
Conclusions
Exposure to traumatic events may have a detrimental effect on subsequent school attendance. This may give rise to perpetuating socioeconomic inequality and needs further research to inform policy and intervention.
doi:10.1186/1471-2458-13-560
PMCID: PMC3698150  PMID: 23758997
7.  Prolonged Internal Displacement and Common Mental Disorders in Sri Lanka: The COMRAID Study 
PLoS ONE  2013;8(5):e64742.
Background
Evidence is lacking on the mental health issues of internally displaced persons, particularly where displacement is prolonged. The COMRAID study was carried out in year 2011 as a comprehensive evaluation of Muslims in North-Western Sri Lanka who had been displaced since 1990 due to conflict, to investigate the prevalence and correlates of common mental disorders.
Methods
A cross-sectional survey was carried out among a randomly selected sample of internally displaced people who had migrated within last 20 years or were born in displacement. The total sample consisted of 450 adults aged 18–65 years selected from 141 settlements. Common mental disorders (CMDs) and post-traumatic stress disorder (PTSD) prevalences were measured using the Patient Health Questionnaire and CIDI sub-scale respectively.
Results
The prevalence of any CMD was 18.8%, and prevalence for subtypes was as follows: somatoform disorder 14.0%, anxiety disorder 1.3%, major depression 5.1%, other depressive syndromes 7.3%. PTSD prevalence was 2.4%. The following factors were significantly associated with CMDs: unemployment (odds ratio 2.8, 95% confidence interval 1.6–4.9), widowed or divorced status (4.9, 2.3–10.1) and food insecurity (1.7, 1.0–2.9).
Conclusions
This is the first study investigating the mental health impact of prolonged forced displacement in post-conflict Sri Lanka. Findings add new insight in to mental health issues faced by internally displaced persons in Sri Lanka and globally, highlighting the need to explore broader mental health issues of vulnerable populations affected by forced displacement.
doi:10.1371/journal.pone.0064742
PMCID: PMC3661540  PMID: 23717656
8.  Acute Myocardial Infarction following a possible direct intravenous bite of Russell’s viper (Daboia russelli) 
BMC Research Notes  2012;5:500.
Background
Russell’s viper (Daboia russelli) bites lead to high morbidity and mortality in South Asia. Although variety of clinical manifestations is reported in viper bite victims, myocardial ischemic events are rare.
Case presentation
We report a unique case of inferior wall ST elevation myocardial infarction due to a Russell’s viper bite over a vein with possible direct intravenous envenoming, in a young male with no past history or family history suggestive of ischemic cardiac disease, from Sri Lanka. In addition, the possible mechanisms of myocardial ischemia in snake bite victims are also briefly discussed.
Conclusion
Importance of the awareness of physicians on the rare, yet fatal manifestations of snake envenoming is highlighted.
doi:10.1186/1756-0500-5-500
PMCID: PMC3490800  PMID: 22971617
Myocardial infarction; Russell’s viper; Intravenous; Sri Lanka
9.  Clinical Trials Have Gone Global: Is This a Good Thing? 
PLoS Medicine  2012;9(6):e1001228.
As part of a cluster of articles leading up to the 2012 World Health Report and critically reflecting on the theme of “no health without research,” Trudie Lang and Sisira Siribaddana discuss the value and challenges of doing clinical trials in developing countries.
doi:10.1371/journal.pmed.1001228
PMCID: PMC3373653  PMID: 22719228
10.  Genetic and environmental contributions to the overlap between psychological, fatigue and somatic symptoms: a twin study in Sri Lanka 
Background
Somatic symptoms often co-occur with psychological symptoms but this overlap is poorly understood. Some aspects of this overlap differ in the South Asian context, but it is not clear whether this is a reporting effect or an underlying difference in experienced illness.
Methods
Home interviews were administered to 4,024 twins randomly selected from a population-based twin register in the Colombo district of Sri Lanka (the CoTASS study). These included assessments of psychological, somatic and fatigue symptoms. The data were analysed using factor analytic and quantitative genetic approaches.
Results
Confirmatory factor analysis showed that the symptoms from the three scales represented three separate dimensions, rather than all tapping into a single dimension. However, familial correlations among the data were most consistent with a common pathway model. This implies that a portion of the underlying vulnerability is common across psychological, fatigue and somatic symptoms. There were sex differences in the aetiology of this model, with shared environmental and genetic influences playing different roles in men and women.
Conclusions
There is a complex aetiological relationship between psychological, fatigue and somatic symptoms. This is similar in Sri Lanka to Western countries, but there may be a greater influence from the family environment, suggesting that care needs to be taken when generalising research findings between countries. People who complain of certain fatigue or somatic symptoms may well also have psychologicial symptoms, or may have genetic or environmental vulnerabilities to such problems.
doi:10.1375/twin.14.1.53
PMCID: PMC3066854  PMID: 21314256
genetic; twin; Sri Lanka; somatic; fatigue
11.  Aetiology of fatigue in Sri Lanka and its overlap with depression† 
The British Journal of Psychiatry  2010;197(2):106-113.
Background
Fatigue is a common symptom in Western high-income countries but is often medically unexplained and little is known about its presentation in other populations.
Aims
To explore the epidemiology and aetiology of fatigue in Sri Lanka, and of its overlap with depression.
Method
A total of 4024 randomly selected twins from a population-based register in Sri Lanka (Colombo district) completed home interviews including the Chalder Fatigue Questionnaire.
Results
The prevalence of fatigue was similar to that in other countries, although prolonged fatigue may be less common. There was substantial comorbidity with a screen for lifetime depression. Non-shared environmental factors made the largest contributions, although genetic/family factors also contributed. The aetiology appeared consistent across the spectrum of severity.
Conclusions
The aetiology of fatigue is broadly similar in Sri Lanka and Western high-income countries. Abnormal experiences of fatigue appear to be the extreme form of more common fatigue, rather than representing independent entities with different genetic or environmental risk factors.
doi:10.1192/bjp.bp.109.069674
PMCID: PMC2913272  PMID: 20679262
12.  Epidemiology and symptomatology of depression in Sri Lanka: A cross-sectional population-based survey in Colombo District 
Journal of Affective Disorders  2010;123(1-3):188-196.
Background
It is important to understand the nature of depression in non-Western and lower-income countries, but little such research exists. This study aimed to examine the characteristic features of depression in Sri Lanka, and to identify environmental risk factors.
Methods
Depression diagnoses, symptoms and impairment were measured using the Composite International Diagnostic Interview, in a population-based sample of 6014 twins and non-twins in the Colombo region of Sri Lanka (the CoTASS sample). Socio-demographic factors and environments were assessed via questionnaires.
Results
Lifetime-ever depression was reported in 6.6% of participants, rising to 11.2% if the functional impairment criterion was excluded. The symptom profile of depression and its socio-demographic associations were very comparable to those in Western and more economically developed countries, whether functional impairment was included in the definition or not. Standard of living was independently associated with depression, especially among men at the more deprived end of the distribution. Specific associations were found with both financial wellbeing and material characteristics of the home environment.
Limitations
The observational associations identified are cross-sectional, so do not necessarily imply causal links.
Conclusions
Aside from a lower prevalence, depression is very similar in this predominantly urban Sri Lankan sample to higher-income, Western countries, and may be under-identified due to a relatively low cultural appropriateness of the assessment of impairment. Under Sri Lanka's cultural and environmental context, certain aspects of the material environment are associated with depression among certain segments of society, perhaps because of their particular link to social status and social networks.
doi:10.1016/j.jad.2009.08.014
PMCID: PMC2946561  PMID: 19762085
Depression; Epidemiology; Sri Lanka; Environment; Risk factors
13.  Understanding of research: a Sri Lankan perspective 
BMC Medical Ethics  2010;11:7.
Background
Lack of proper understanding on the part of researchers about public understanding of research and informed consent will increase the potential for malpractice. As a part of a larger study on ethics and informed consent in Sri Lanka, this study aimed to ascertain the level of understanding of 'research' by exploring the views of the public and professionals.
Methods
Convenience sampling and snow ball technique were used for recruitment with an emphasis on balanced age and gender representation, diverse educational, socio-cultural and professional backgrounds, and previous research experience, either as researchers or participants. Content analysis of the data was carried out.
Results
66 persons (37 males, 29 females) participated. Although fundamentally a qualitative study, themes were also quantitatively analysed for informative results. Most participants thought that the word 'research' meant searching, looking, inquiring while some others thought it meant gathering information, gaining knowledge and learning.
A third of participants did not offer an alternative word for research. Others suggested the words survey, exploration, search, experiment, discovery, invention and study as being synonymous. Doctors, health professionals, health institutions, scientists, professionals, businessmen, pharmaceutical companies, students, teachers were identified as people who conduct research.
Participants indicated that crucial information on deciding to participate in research included objectives of the research, project importance and relevance, potential benefits to individuals and society, credibility & legitimacy of researchers, what is expected of participant, reason for selection, expected outcome, confidentiality and ability to withdraw at any time. A majority (89%) expressed their willingness to participate in future research.
Conclusions
The results show that with or without prior experience in research, participants in this study had a reasonable understanding of research. The findings show that a decision about taking part in research is dependent on knowledge, education and also on social networks.
The results demonstrate that the majority were supportive of health research and believe that research is beneficial to the welfare of society.
doi:10.1186/1472-6939-11-7
PMCID: PMC2874563  PMID: 20423516
14.  Environmental exposures and their genetic or environmental contribution to depression and fatigue: a twin study in Sri Lanka 
BMC Psychiatry  2010;10:13.
Background
There is very little genetically informative research identifying true environmental risks for psychiatric conditions. These may be best explored in regions with diverse environmental exposures. The current study aimed to explore similarities and differences in such risks contributing to depression and fatigue.
Methods
Home interviews assessed depression (lifetime-ever), fatigue and environmental exposures in 4,024 randomly selected twins from a population-based register in the Colombo district of Sri Lanka.
Results
Early school leaving and standard of living showed environmentally-mediated effects on depression, in men. In women, life events were associated with depression partly through genetic pathways (however, the temporal order is consistent with life events being an outcome of depression, as well as the other way around). For fatigue, there were environmentally mediated effects (through early school leaving and life events) and strong suggestions of family-environmental influences.
Conclusions
Compared to previous studies from higher-income countries, novel environmentally-mediated risk factors for depression and fatigue were identified in Sri Lanka. But as seen elsewhere, the association between life events and depression was partially genetically mediated in women. These results have implications for understanding environmental mechanisms around the world.
doi:10.1186/1471-244X-10-13
PMCID: PMC2828435  PMID: 20122265
15.  Genetic and environmental contributions to depression in Sri Lanka 
The British Journal of Psychiatry  2009;195(6):504-509.
Background
Susceptibility to depression results from genetic and non-familially shared environmental influences in high-income, Western countries. Environments may play a different role for populations in different contexts.
Aims
To examine heritability of depression in the first large, population-based twin study in a low-income country.
Method
Lifetime depression and a broader measure of depression susceptibility (D-probe) were assessed in 3908 adult twins in Sri Lanka (the CoTASS study).
Results
There were gender differences for the broad definition (D-probe), with a higher genetic contribution in females (61%) than males (4%). Results were similar for depression, but the prevalence was too low to estimate heritability for males.
Conclusions
Genetic influences on depression in women appear to be at least as strong in this Sri Lankan sample as in higher-income countries. Conclusions are less clear for men but suggest a larger role for environments rather than genes. The nature as well as the magnitude of environmental influences may also differ across populations.
doi:10.1192/bjp.bp.109.063529
PMCID: PMC2802529  PMID: 19949199
16.  Understanding the explanatory model of the patient on their medically unexplained symptoms and its implication on treatment development research: a Sri Lanka Study 
BMC Psychiatry  2008;8:54.
Background
Patients with medically unexplained symptoms (MUS) are often distressed, disabled and dissatisfied with the care they receive. Illness beliefs held by patients have a major influence on the decision to consult, persistence of symptoms and the degree of disability. Illness perception models consist of frameworks to organise information from multiple sources into distinct but interrelated dimensions: identity (the illness label), cause, consequences, emotional representations perceived control and timeline.
Our aim was to elicit the illness perceptions of patients with MUS in Sri Lankan primary care to modify and improve a CBT intervention.
Method
An intervention study was conducted in a hospital primary care clinic in Colombo, Sri Lanka using CBT for MUS. As a part of the baseline assessment, qualitative data was collected using; the Short Explanatory Model Interview (SEMI), from 68 patients (16–65 years) with MUS. We categorised the qualitative data in to key components of the illness perception model, to refine CBT intervention for a subsequent larger trial study.
Results
The cohort was chronically ill and 87% of the patients were ill for more than six months (range six months to 20 years) with 5 or more symptoms and 6 or more visits over preceding six months. A majority were unable to offer an explanation on identity (59%) or the cause (56%), but in the consequence domain 95% expressed significant illness worries; 37% believed their symptoms indicated moderately serious illness and 58% very serious illness. Reflecting emotional representation, 33% reported fear of death, 20% fear of paralysis, 13% fear of developing cancer and the rest unspecified incurable illness. Consequence and emotional domains were significant determinants of distress and consultations. Their repeated visits were to seek help to alleviate symptoms. Only a minority expected investigations (8.8 %) or diagnosis (8.8%). However, the doctors who had previously treated them allegedly concentrated more on identity than cause. The above information was used to develop simple techniques incorporating analogies to alter their perceptions
Conclusion
The illness perception model is useful in understanding the continued distress of patients with persistent symptoms without an underlying organic cause. Hence it can make a significant contribution when developing and evaluating culturally sensitive patient friendly interventions.
doi:10.1186/1471-244X-8-54
PMCID: PMC2474860  PMID: 18611253
17.  Colombo Twin and Singleton Study (CoTASS): A description of a population based twin study of mental disorders in Sri Lanka 
BMC Psychiatry  2008;8:49.
Background
The Sri Lankan twin registry is one of the first to be established in a developing country, and its design has ensured sampling from a wide range of environmental conditions. It thus has great potential to examine environmental and genetic influences on diverse phenotypes, including psychiatric disorders, in the context of a diversity of environmental exposures, which may not have been fully explored in previous twin studies in developed countries. This paper presents the rationale for the study, describes its context, and the methods for twin ascertainment and data collection.
Methods
A population-based twin register was established in the Colombo district of Sri Lanka using infrastructure designed to periodically update the electoral register. We invited a subsample from this register to participate in the project on common mental disorders, using random ascertainment. A separate non-twin sample was randomly selected from the geographical areas where twins were found. Home interviewers collected diagnostic information on common mental disorders, as well as environmental exposures including life events, socio-economic conditions, and the impact of the civil war and the Tsunami of 2004.
Results
We identified 19,302 individuals in the creation of the population based twin register. We randomly selected a subsample, of whom 4,387 were eligible to participate and 4,024 agreed to be interviewed (including data on 1,954 complete pairs of twins and 5 sets of triplets). Those who refused consent had a similar mean age and sex ratio to those who were interviewed. We invited 2,485 singletons to participate and 2,019 were interviewed.
Conclusion
Initial exploration of the data suggests the samples are very representative of the Colombo district of Sri Lanka, so we have created a unique resource for understanding the influences on mental disorders in developing countries, and to compare to the influences found in developed countries.
doi:10.1186/1471-244X-8-49
PMCID: PMC2475532  PMID: 18588676
18.  Informed consent in Sri Lanka: A survey among ethics committee members 
BMC Medical Ethics  2008;9:10.
Background
Approval of the research proposal by an ethical review committee from both sponsoring and host countries is a generally agreed requirement in externally sponsored research.
However, capacity for ethics review is not universal. Aim of this study was to identify opinions and views of the members serving in ethical review and ethics committees in Sri Lanka on informed consent, essential components in the information leaflet and the consent form.
Methods
We obtained ethical approval from UK and Sri Lanka. A series of consensus generation meetings on the protocol were conducted. A task oriented interview guide was developed. The interview was based on open-ended questionnaire. Then the participants were given a WHO checklist on informed consent and requested to rate the items on a three point scale ranging from extremely important to not important.
Results
Twenty-nine members from ethics committees participated. Majority of participants (23), believed a copy of the information leaflet and consent form, should accompany research proposal. Opinions about the items that should be included in the information leaflets varied. Participants identified 18 criteria as requirements in the information leaflet and 19 for the consent form.
The majority, 20 (69%), believed that all research need ethical approval but identified limited human resource, time and inadequate capacity as constraints. Fifteen (52%) believed that written consent is not required for all research. Verbal consent emerged as an alternative to written consent. The majority of participants rated all components of the WHO checklist as important.
Conclusion
The number of themes generated for the consent form (N = 18) is as many as for the information leaflet (N = 19) and had several overlaps. This suggests that the consent form should be itemized to reflect the contents covered in the information leaflet. The participants' opinion on components of the information leaflets and consent forms proved to be similar with WHO checklist on informed consent.
doi:10.1186/1472-6939-9-10
PMCID: PMC2413248  PMID: 18489793
19.  Ethics Review Committee approval and informed consent: an analysis of biomedical publications originating from Sri Lanka 
BMC Medical Ethics  2008;9:3.
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.
doi:10.1186/1472-6939-9-3
PMCID: PMC2270278  PMID: 18267015
21.  Under-representation of developing countries in the research literature: ethical issues arising from a survey of five leading medical journals 
BMC Medical Ethics  2004;5:5.
Background
It is widely acknowledged that there is a global divide on health care and health research known as the 10/90 divide.
Methods
A retrospective survey of articles published in the BMJ, Lancet, NEJM, Annals of Internal Medicine & JAMA in a calendar year to examine the contribution of the developing world to medical literature. We categorized countries into four regions: UK, USA, Other Euro-American countries (OEAC) and (RoW). OEAC were European countries other than the UK but including Australia, New Zealand and Canada. RoW comprised all other countries.
Results
The average contribution of the RoW to the research literature in the five journals was 6.5%. In the two British journals 7.6% of the articles were from the RoW; in the three American journals 4.8% of articles were from RoW. The highest proportion of papers from the RoW was in the Lancet (12%). An analysis of the authorship of 151 articles from RoW showed that 104 (68.9%) involved authorship with developed countries in Europe or North America. There were 15 original papers in these journals with data from RoW but without any authors from RoW.
Conclusions
There is a marked under-representation of countries in high-impact general medical journals. The ethical implications of this inequity and ways of reducing it are discussed.
doi:10.1186/1472-6939-5-5
PMCID: PMC524359  PMID: 15461820

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