Background: Authors are required to describe in their manuscripts ethical approval from an appropriate committee and how consent was obtained from participants when research involves human participants.Objective: To assess the reporting of these protections for several study designs in general medical journals.Design: A consecutive series of research papers published in the Annals of Internal Medicine, BMJ, JAMA, Lancet and The New England Journal of Medicine between February and May 2003 were reviewed for the reporting of ethical approval and patient consent. (...) Ethical approval, name of approving committee, type of consent, data source and whether the study used data collected as part of a study reported elsewhere were recorded. Differences in failure to report approval and consent by study design, journal and vulnerable study population were evaluated using multivariable logistic regression.Results: Ethical approval and consent were not mentioned in 31% and 47% of manuscripts, respectively. 88 papers failed to report both approval and consent. Failure to mention ethical approval or consent was significantly more likely in all study designs than in randomised controlled trials . Failure to mention approval was most common in the BMJ and was significantly more likely than in The New England Journal of Medicine. Failure to mention consent was most common in the BMJ and was significantly more likely than in all other journals. No significant differences in approval or consent were found when comparing studies of vulnerable and non-vulnerable participants.Conclusion: The reporting of ethical approval and consent in RCTs has improved, but journals are less good at reporting this information for other study designs. Journals should publish this information for all research on human participants. (shrink)

Research ethics is increasingly formally regulated, but little is known about how ethical considerations are reported in dissertations. The aim of this literature study was to describe the status and trends of ethical considerations in Swedish doctoral dissertations written by registered nurses. A total of 77 dissertations from 1987, 1997, and 2007 met the inclusion criteria and were analyzed by descriptive statistics. Ethical considerations were mostly overlooked in 1987, but almost ubiquitous by 2007. All dissertations in 2007, except one, had (...) a section on ethical considerations; however, these were short, lacking in references, and short on content. The most common topic was informed consent and approval from research ethics review boards, followed by confidentiality and ethical aspects of methodological issues. Our results imply that the quantity and quality of ethical considerations must be improved in order to assure ethical soundness for participants, patients, researchers, and society. (shrink)

Background: The high disease burden of Africa, the emergence of new diseases and efforts to address the 10/90 gap have led to an unprecedented increase in health research activities in Africa. Consequently, there is an increase in the volume and complexity of protocols that ethics review committees in Africa have to review. Methods: With a grant from the Bill and Melinda Gates Foundation, the African Malaria Network Trust (AMANET) undertook a survey of 31 ethics review committees (ERCs) across sub-Saharan Africa (...) as an initial step to a comprehensive capacity-strengthening programme. The number of members per committee ranged from 3 to 21, with an average of 11. Members of 10 institutional committees were all from the institution where the committees were based, raising prima facie questions as to whether independence and objectivity could be guaranteed in the review work of such committees. Results: The majority of the committees (92%) cited scientific design of clinical trials as the area needing the most attention in terms of training, followed by determination of risks and benefits and monitoring of research. The survey showed that 38% of the ERC members did not receive any form of training. In the light of the increasing complexity and numbers of health research studies being conducted in Africa, this deficit requires immediate attention. Outcome: The survey identified areas of weakness in the operations of ERCs in Africa. Consequently, AMANET is addressing the identified needs and weaknesses through a 4-year capacity-building project. (shrink)

Background Conducting ethically sound research is a fundamental principle of scientific inquiry. Recent research has indicated that ethical concerns are insufficiently dealt with in dissertations. Purpose To examine which research ethical topics were addressed and how these were presented in terms of complexity of reasoning in Swedish nurses' dissertations. Methods Analyses of ethical content and complexity of ethical reasoning were performed on 64 Swedish nurses' PhD dissertations dated 2007. Results A total of seven ethical topics were identified: ethical approval (94% (...) of the dissertations), information and informed consent (86%), confidentiality (67%), ethical aspects of methods (61%), use of ethical principles and regulations (39%), rationale for the study (20%) and fair participant selection (14%). Four of those of topics were most frequently addressed: the majority of dissertations (72%) included 3–5 issues. While many ethical concerns, by their nature, involve systematic concepts or metasystematic principles, ethical reasoning scored predominantly at lesser levels of complexity: abstract (6% of the dissertations), formal (84%) and systematic (10%). Conclusions Research ethics are inadequately covered in most dissertations by nurses in Sweden. Important ethical concerns are missing, and the complexity of reasoning on ethical principles, motives and implications is insufficient. This is partly due to traditions and norms that discount ethical concerns but is probably also a reflection of the ability of PhD students and supervisors to handle complexity in general. It is suggested that the importance of ethical considerations should be emphasised in graduate and post-graduate studies and that individuals with capacity to deal with systematic and metasystematic concepts are recruited to senior research positions. (shrink)

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)

Background: The Declaration of Helsinki prohibits the publication of articles that do not meet defined ethical standards for reporting of research ethics board approval and informed consent. Despite this prohibition and a call to highlight the deficiency for the reader, articles with potential ethical shortcomings continue to be published.Objective: To determine what proportion of articles in major medical journals lack statements confirming REB approval and informed consent, and whether accompanying commentary alerts readers to this deficiency.Design: Retrospective, observational study.Setting: Online review (...) of five major medical journals.Population: All clinical research articles published online between 1 January 2005 and 31 December 2006 in the BMJ, Lancet, Annals of Internal Medicine, JAMA and the New England Journal of Medicine.Measurements: Statement of REB approval and informed consent.Results: Of 1780 articles reviewed, 1133 met inclusion criteria , 36 articles lacked a statement of REB approval, 62 lacked disclosure of informed consent and 15 articles lacked both. Articles that did not state REB approval were associated with not stating informed consent . There were no editorial comments to alert readers to the lack of either REB approval or informed consent statements associated with any of the deficient articles.Conclusions: Articles that lack explicit statements of REB approval and informed consent are infrequent but continue to be published in major medical journals without editorial statements to alert the reader to this deficiency. (shrink)

The involvement of developing countries in international clinical trials is necessary for the development of appropriate medicines for local populations. However, the absence of appropriate structures for ethical review represents a barrier for certain countries. Currently there is very little information available on existing structures dedicated to ethics in western and central Africa. This article briefly describes historical milestones in the development of networks dedicated to capacity building in ethical review in these regions and outlines the major conclusions of two (...) workshops on this issue, which were held in September and October 2002 in Libreville, Gabon, and Paris, France. The workshops were the culmination of collaboration between the African Malaria Network Trust (AMANET) and the Pan African Bioethics Initiative (PABIN). They produced an update on ethics organizations with regard to mission, function, activities, members, and contact people, in eight countries within the regions discussed. As a result of the commitment of mandated delegates, a further prominent outcome followed these workshops: the creation of national structures, where none existed before, dedicated to the ethical review of clinical trials. (shrink)

Genetic research presents ethical challenges to the achievement of valid informed consent, especially in developing countries with areas of low literacy. During the last several years, a number of genetic research proposals involving Omani nationals were submitted to the Department of Research and Studies, Ministry of Health, Oman.The objective of this paper is to report on the results of an internal quality assurance initiative to determine the extent of the information being provided in genetic research informed consent forms. In order (...) to achieve this, we developed checklists to assess the inclusion of basic elements of informed consent as well as elements related to the collection and future storage of biological samples. Three of the authors independently evaluated and reached consensus on seven informed consent forms that were available for review.Of the seven consent forms, four had less than half of the basic elements of informed consent. None contained any information regarding whether genetic information relevant to health would be disclosed, whether participants may share in commercial products, the extent of confidentiality protections, and the inclusion of additional consent forms for future storage and use of tissue samples. Information regarding genetic risks and withdrawal of samples were rarely mentioned (1/7), whereas limits on future use of samples were mentioned in 3 of 7 consent forms.Ultimately, consent forms are not likely to address key issues regarding genetic research that have been recommended by research ethics guidelines. We recommend enhanced educational efforts to increase awareness, on the part of researchers, of information that should be included in consent forms. (shrink)

The central importance of reproduction in all human cultures has given rise to many methods and techniques of assisting reproduction or overcoming infertility. Such methods and techniques have achieved spectacular successes in the Western world, where processes like in vitro fertilization (IVF) constitute a remarkable breakthrough. In this paper, the author attempts to reflect critically on assisted reproduction technologies (ART) from the background and perspective of African culture, a culture within which human reproduction is given the highest priority but which (...) also exhibits a highly ambivalent attitude to modern technology-assisted methods of reproduction. The author considers the ethical crux of reproductive technologies to be linked to the issue of the moral status of the human embryo and argues that a morally significant line of demarcation cannot be drawn between embryos and other categories of humans. (shrink)

I argue for the universality of morality as against and in spite of the plurality and inevitable relativity of human cultures. Univer.

Many ethical concerns surrounding human genetics studies remain unresolved. We report here the situation in Cameroon.Objectives: To describe the profile of human genetic studies that used Cameroonian DNA samples, with specific focus on i) the research centres that were involved, ii) authorship, iii) population studied, iv) research topics and v) ethics disclosure, with the aim of raising ethical issues that emerged from these studies.Method: Bibliometric Studies; we conducted a PubMed-based systematic review of all the studies on human genetics that used (...) Cameroonian DNA samples from 1989 to 2009.Results and Discussion: Fifty articles were identified, involving predominantly research centres from Europe (64%) and America (32%). Only 7 (14%) Cameroonian institutions and 14 (28%) Cameroonian authors were associated with these publications.At least 52% of publications were devoted to population genetics (variation/migration patterns) amongst 30 Cameroonian ethnic groups. Very few studies concerned public health related genetic issues and only 5 (10%) references were found for hemoglobinopathies like sickle cell anaemia. Almost all DNA samples are ‘banked’ outside of the African continent.Capacity building, rights to the genetic information and benefits to the individuals, communities and populations who contribute to these studies are addressed.Conclusions: 1) Our data suggests the need for a wider debate towards building capacity and addressing ethical issues related to human genomic research in sub-Saharan Africa and specifically in Cameroon; 2) National ethical guidelines and regulations concerning the collection, use and storage of human DNA are urgently needed in Cameroon. (shrink)

Scientific and technological improvements are accomplished only because of much research. The increase in the number of research studies causes a rise in ethical problems. Nursing research is no exception to this. The aim of this study is to identify and analyse ethical problems in nursing studies. This research is descriptive and partly analytical. It is retrospective in the sense that 169 Master of Science and 66 doctoral theses written between 1972 and 1998 in the Department of Nursing, Institute of (...) Health Sciences, Hacettepe University, Ankara, Turkey, were examined. The following ethical rules were used as criteria: that no harm should be caused to the subject; the subject was informed about the research topic; permission was obtained from the subject; and the privacy of the subject was maintained. The evaluation was carried out by distributing the theses among background variables and by employing nonparametric tests. The research associated with the theses was not harmful to the participants in 93.2%, while 6.8% were considered to have caused harm. In 72.7% of the theses the subjects were not informed of the research; in 73.6%, the researchers did not obtain permission from the subjects; and in 8.5% their privacy was not kept. An ethical score was assigned to each thesis, which varyed between 0 and 15. The mean score was 5.02. (shrink)

Western moral philosophy is driven by the attempt to sharply distinguish persons from the rest of the cosmos, and then to identify the ways in which persons must be treated. The traditional African approach is different on both counts.

Background The Regional Committee for Africa of the World Health Organization in 2001 expressed concern that some health-related studies undertaken in the Region were not subjected to any form of ethics review. In 2003, the study reported in this paper was conducted to determine which Member country did not have a national research ethics committee with a view to guiding the WHO Regional Office in developing practical strategies for supporting those countries. Methods This is a descriptive study. The questionnaire was (...) prepared and sent by diplomatic pouch to all the 46 Member States in the WHO African Region, through the WHO country representatives, for facilitation and follow up. The data were entered in Excel spreadsheet and subsequently exported to STATA for analysis. A Chi-Squared test for independence was undertaken to test the relationship between presence/absence of Research Ethics Committee and selected individual socioeconomic and health variables. Results The main findings were as follows: the response rate was 61% ; 64% confirmed the existence of RECs; 36% of the respondent countries did not have a REC ; 85% of the countries that responded to this question indicated that ethical approval of research proposals was, in principle, required; and although 59% of the countries that had a REC expected it to meet every month, only 44% of them reported that the REC actually met on a monthly basis. In the Chi-Squared test, only the average population in the group of countries with a REC was statistically different from that of the group of countries without a REC. Conclusion In the current era of globalized biomedical research, good ethics stewardship demands that every country, irrespective of its level of economic development, should have in place a functional research ethics review system in order to protect the dignity, integrity and safety of its citizens who participate in research. (shrink)

Cameroon is a Central African country lying at latitude 6°N and longitude 12°E. The country has a surface area of circa 475,442 square kilometers, and is bordered by several other African countries: Nigeria, Chad, the Central African Republic, the Republic of Congo, Equatorial Guinea, and Gabon. With a population of nearly 20 million inhabitants, Cameroon is a very diverse country, geographically, culturally, and linguistically.

A needs assessment survey of ethics review committees (ERCs) across Africa was conducted in order to establish their major needs and areas of weaknesses in terms of ethical review capacity. The response rate was 84% (31 of 37 targeted committees), and committees surveyed were located in 18 African countries. The majority of the responding committees (61%) have been in existence between 5 and 10 years; approximately 74% of the respondents were institutional committees, with the remainder being either national (6/31) or (...) regional (2/31). In terms of the ethical review process, nine of the 31 committees that responded did not have standard operating procedures (SOPs), and seven of the 22 that did have SOPs had never revised them after their initial development (an average period of three years). Of the 31 committees, 10 operated without any ethical guidelines. Many of the committees (13/30) met once per month, and the number of proposals reviewed annually varied, ranging from five to over 100. All respondents relied on paper-based data management and archiving systems. Overall, the survey identified the major constraints on ERCs as lack of office equipment, outdated or lack of SOPs, lack of electronic data management systems, inadequate resources, lack of or insufficient expertise on the committees, and poor recognition of the importance of the role of the committees. Consequently, the authors are addressing the identified needs and weaknesses through the Bill and Melinda Gates Foundation-funded capacity building project. The impact of the intervention project will be assessed during and at the end of the four-year longitudinal project. (shrink)