BackgroundInternational 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.MethodsWe 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.ResultsOf 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.ConclusionOnly 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. (shrink)

BackgroundApproval 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.MethodsWe 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.ResultsTwenty-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.ConclusionThe 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. (shrink)

BackgroundIt is widely acknowledged that there is a global divide on health care and health research known as the 10/90 divide.MethodsA 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.ResultsThe 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.ConclusionsThere 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. (shrink)

BackgroundLack 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.MethodsConvenience 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.Results66 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.ConclusionsThe 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. (shrink)

Background: Establishment of Sri Lankan Twin Registry demanded development of ethical guidelines, as an effective ethical framework was not available in Sri Lanka. Design: Objectives were to find out whether the ombudsman concept exists in current informed consent practices and to investigate opinion about ombudsmen. We searched Pub Med, conducted a postal survey, and monitored Internet discussion. Results: The responses were categorized into current practices and existing models in informed consent process, reservations expressed about current practices, arguments supporting the concept, (...) concerns and issues, alternatives, and how to implement the proposal. The concept of a third person is not entirely novel. How to find a truly independent person, the financial implication, confidentiality, obligations, and liabilities of ombudsmen, also emerged. Conclusions: The concept of an ombudsman is conceptually and ethically sound and acceptable but the challenges posed by this very same solution to creating a better process of informed consent will have to be faced. (shrink)

Background Medical ethics deals with the ethical obligations of doctors to their patients, colleagues and society. The annual reports of Sri Lanka Medical Council indicate that the number of complaints against doctors has increased over the years. We aimed to assess the level of knowledge, attitude and practice regarding medical ethics among doctors in three teaching hospitals in Sri Lanka. Methods A hospital-based cross-sectional study was conducted among doctors using a pre-tested self-administered, anonymous questionnaire. Chi Squared test, and ANOVA test (...) were used to identify the significance of association between level of knowledge and selected factors. Results Most doctors had a poor level of knowledge on medical ethics, with postgraduate trainees showing significantly higher level of knowledge. The average knowledge on medical ethics among doctors was significantly different between the three hospitals. Over 95% had a favourable attitude towards gaining knowledge and advocated the need for training. The majority indicated awareness of unethical practices. 24.6% of respondents stated that they get a chaperone ‘sometimes’ during patient examination while 3.5% never do. The majority responded that they never accept gifts from pharmaceutical companies in recognition of their prescribing pattern. 12–41% of doctors participated in the study acknowledged that they ‘sometime’ engaged in unethical practices related to prescribing drugs, accepting gifts from pharmaceutical companies and when obtaining leave. Conclusion Most doctors had a poor level of knowledge of medical ethics. Postgraduate trainees had a higher level of knowledge than other doctors. The majority showed a favourable attitude towards gaining knowledge and the need of training. Regular in-service training on medical ethics for doctors would help to improve their knowledge on medical ethics, as well as attitudes and ethical conduct. (shrink)

Engagement with genomic medicine and research has increased globally during the past few decades, including rapid developments in Sri Lanka. Genomic research is carried out in Sri Lanka on a variety of scales and with different aims and perspectives. However, there are concerns about participants' understanding of genomic research, including the validity of informed consent. This article reports a qualitative study aiming to explore the understanding, knowledge, and attitudes of the Sri Lankan public towards genomic medicine and to inform the (...) development of an effective and appropriate process for informed consent in that setting. Purposive sampling was employed. Participants were recruited from a sub-group of the public in Colombo, Sri Lanka who had either consented or refused to donate genetic material for a biobank. Data were collected using face-to-face semi-structured interviews. Interview data were transcribed verbatim and translated into English. Conventional content analysis was used. The analysis developed three key themes: a) ‘Scientific literacy’ describes an apparent lack of scientific knowledge that seems to affect a participant’s ability to understand the research, b) ‘Motivation’ describes narratives about why participants chose (not) to take part in the research, despite not understanding it, and c) ‘Trust’ describes how trust served to mitigate the apparent ethical deficit created by not being fully informed. In this article, we argue that informed trust is likely an acceptable basis for consent, particularly in settings where scientific literacy might be low. However, researchers must work to be worthy of that trust and ensure that misconceptions are actively addressed. (shrink)

Millions of people undergo displacement in the world. Internally displaced people (IDP) are especially vulnerable as they are not protected by special legislation in contrast to other migrants. Research conducted among IDPs must be correspondingly sensitive in dealing with ethical issues that may arise. Muslim IDPs in Puttalam district in the North-Western province of Sri Lanka were initially displaced from Northern Sri Lanka due to the conflict in 1991. In the backdrop of a study exploring the prevalence of common mental (...) disorders among the IDPs, researchers encountered various ethical challenges. These included inter-related issues of autonomy, non-maleficence, beneficence, confidentiality and informed consent, and how these were tailored in a culture-specific way to a population that has increased vulnerability. This paper analyses how these ethical issues were perceived, detected and managed by the researchers, and the role of ethics review committees in mental health research concerning IDPs. The relevance of guidelines and methodologies in the context of an atypical study population and the benefit versus risk potential of research for IDPs are also discussed. The limitations that were encountered while dealing with ethical challenges during the study are discussed. The concept of post-research ethical conduct audit is suggested to be considered as a potential step to minimize the exploitation of vulnerable populations such as IDPs in mental health research. (shrink)

Introduction Stored human samples and the establishment of biobanks are increasing in the world. Along with this there are the questions of ethics that arise such as the correct method of obtaining informed consent for research on stored samples and the policies involved in collaborative research using collected samples. This study is an attempt to evaluate the researchers, academics and policy makers' views on these ethical aspects. Methods This was an anonymised study involving a Sri Lankan population of researchers, ethics (...) committee members, and policy makers. A self administered questionnaire was utilised as the study instrument. The questionnaire captured four major areas of interest: demographic characteristics of respondents, their attitudes on informed consent policy, their opinion on rights of collaborating researchers, their attitudes on dealing with international differences in regulatory frameworks. Results The study included 55 responders with 40/55 agreeing that donors should receive the option of giving informed consent for future research, with 31/55 considering multiple- type consent options most appropriate. Regarding the issue of shared samples in collaborative research majority agreed that source country ethics review committee approval was necessary 53/55. Conclusion The study concludes that sample donors should be given the option of giving advance consent to unspecified future research provided that future research is approved by an ethics committee. In collaborative research, it is necessary to involve ethics committees from donor countries in the research approval process. (shrink)

PurposeThe purpose of this paper was to develop a framework of working-together relations and investigate ways to enhance working-together relations among people, organisations, communities and neighbourhoods using working-together applications. Today, people in communities, neighbourhoods and constituencies often work together in a coalition of public, private and non-profit institutions. The technology used today has enabled new forms of communications and collaboration. The rapid growth of mobile technologies and interactive, collaborative applications based on Web technologies has enabled the development of new approaches (...) to derive and share organisational and local knowledge. Not all of these applications have succeeded; after a certain time, users tend to stop using online applications that do not assist them in developing collaborative practices with their team members.Design/methodology/approachTo better understand the essential characteristics of a successful online application that effectively supports people to work together, the authors undertook an inductive analysis of related literature and existing social media application.FindingsBy combining and categorising the findings, it was possible to articulate the characteristics associated with four identified categories of working-together relations: networking, coordination, cooperation and collaboration. The study also identified essential activities that are performed in each working-together category and the factors that enable successful working-together relations: trust, risk and rewards.Research limitations/implicationsFuture studies will look into how applications could be further enhanced, so that, for example, an application that is currently classified as “coordination” could be improved and the required characteristics of “collaboration” could be met.Practical implicationsIt is expected that the framework derived will assist in the design of successful online applications to support different categories of working-together relations.Originality/valueThe main contribution of this study is a new framework that can now be used to identify how effective an existing application can be in assisting the working-together relations. (shrink)

Gastrulation is the process of early development that reorganizes cells into the three fundamental tissue types of ectoderm, mesoderm, and endoderm. It is a coordinated series of morphogenetic and molecular changes that exemplify many developmental phenomena. In this review, we explore one of the classic developmental systems, the sea urchin embryo, where investigators from different backgrounds have converged on a common interest to study the origin, morphogenesis, and developmental regulation of the endoderm. The sea urchin embryo is remarkably plastic in (...) its developmental potential, and the endoderm is especially instructive for its morphological and molecular responsiveness to inductive cell interactions. We start by examining and integrating the several models for the morphogenetic mechanisms of invagination and tissue elongation, the basic processes of endoderm morphogenesis in this embryo. We next critique the proposed mechanisms of inductive gene regulation in the endoderm that exemplifies a concept of modular transcriptional regulation. Finally, we end with an examination of the current molecular models to explain cell fate determination of the endoderm. Recent progress at the molecular level should soon allow us to explain the seminal experimental observations made in this embryo over a hundred years ago. BioEssays 21:459–471, 1999. © 1999 John Wiley & Sons, Inc. (shrink)

Purpose This study aims to explore ways to enhance competitiveness of commercial lighting industry because of the growing digitally connected stakeholder community. Positive responses from stakeholders to recurring business interactions help build trust and formation of a community; value chains being one form of such trusted community. Because of the increasing trust, the effort to search right value chain partners diminishes, business interactions become less formal and transaction costs are reduced, thus increasing the competitiveness. Design/methodology/approach In this research, a cross-sectional (...) study of commercial lighting industry domain in Australia was carried out, focusing on two states: New South Wales and Victoria. Based on the findings, an approach and a supporting platform to enhance competitiveness of commercial lighting industry were synthesized. Findings Based on the findings from the study, formation of such value chains, namely, “Entrusted Circles” and its two types of formations, fully and partial, were observed. Their further growth was hindered by high transaction costs. To reduce this transaction cost, this paper proposes a platform to create dynamic value chains, among stakeholders of commercial lighting industry, making use of growing digital connectivity leading toward agile formation of Entrusted Circles to enhance competitiveness. Research limitations/implications This study focuses on the commercial lighting industry in Australia, which is not tested in any other domain to investigate its wider applicability. However, it is conceptually applicable to be used in industries with compliance and standard procedures. Originality/value This paper shows how to identify Entrusted Circles and build, support and sustain such relationships among value chain partners to successfully conduct business transactions in a dynamic value chain. (shrink)