Assessment of the ethical review process in Sudan

The ethical review process is an important component of contemporary health research worldwide. Sudan started an ethical review process rather late in comparison with other countries. In this study, we evaluate the structure and functions of existing ethics review committees. We also explore the knowledge and attitudes of Sudanese researchers toward the ethical review process and their experience with existing ethics review committees. There are four ethics review committees in the country; these committees have no institutional regulations to govern their functions. Furthermore, Sudan also lacks national guidelines. Ethical reviews are carried out primarily for studies seeking international funding and are almost always governed by the funding agencies' requirements. Nearly half of respondents (46.3%) knew about the existence of research ethics committees in Sudan. Researchers reported a variety of experiences with the ethical review process; most of them were unable to define 'ethics committee'.     

Ethics and biomedical research

Ethics in biomedical research took off from the 1947 Nuremberg Code to its own right in the wake of the Declaration of Helsinki in 1964. Since then, (inter)national regulations and guidelines providing a framework for clinical studies and protection for study participants have been drafted and implemented, while ethics committees and drug evaluation agencies have sprung up throughout the world. These two developments were crucial in bringing about the protection of rights and safety of the participants and harmonization of the conduct of biomedical research. Ethics committees and drug evaluation agencies deliver ethical and scientific assessments on the quality and safety of the projects submitted to them and issue respectively approvals and authorizations to carry out clinical trials, while ensuring that they comply with regulatory requirements, ethical principles, and scientific guidelines. The advent of biomedical ethics, together with the responsible commitment of clinical investigators and of the pharmaceutical industry, has guaranteed respect for the patient, for whom and with whom research is conducted. Just as importantly, it has also ensured that patients reap the benefit of what is the primary objective of biomedical research: greater life expectancy, well-being, and quality of life.     

How district health authorities organise cervical screening.

OBJECTIVES--To examine how district health authorities organised cervical screening with respect to Department of Health guidelines and to determine their assessment of the problems encountered. DESIGN--Postal questionnaire sent to all 190 district health authorities in England in 1989. PARTICIPANTS--190 District health authorities in England. MAIN OUTCOME MEASURES--Population coverage of screening, quality of smear testing, and follow up of abdominal test results in comparison with national guidelines for district cervical screening services, and problems encountered by districts. RESULTS--Replies were received from 178 (94%) of districts, in 143 of which the person named as responsible for cervical screening contributed. All districts implemented a computer managed scheme, 150 by the target date of 31 March 1988, but not all of these conformed with the guidelines. At the time of the survey only just over half called women in the target age group of 20-64 and only 70% expected to meet the target date of 13 March 1993 for completing the call. Considerable variation was evident among the schemes with regard to how they dealt with issues related to population coverage, quality of testing, and follow up of abnormal results. The problems most commonly identified by the districts (n = 174) were laboratory workload (107, 61%), computer software (104, 60%), availability of resources (78, 45%), non-attendance (77, 44%), rate of opportunistic screening (62, 36%), and investigation and treatment (60, 34%). CONCLUSIONS--Current practice in running cervical screening schemes needs to be examined to determine the extent to which it contributes to the goal of reducing mortality from cervical cancer.     

Research Ethics: Beyond the Guidelines

There is international recognition of the need for sustainable research ethics committees to provide ethical review of human subjects research in developing countries, but many developing countries do not have such committees (often called 'IRBs'). Theoretical and practical uncertainties encountered by an IRB on the Caribbean island of Grenada offer insight into ethical review of research in developing countries. Theoretical uncertainties include questions about whether means of ensuring confidentiality and obtaining informed consent will be effective in local settings, and whether deviations from Western norms are justifiable. International guidelines are helpful in addressing these concerns, but are subject to interpretation. Guidelines are less helpful in practical areas like selecting members or chairs. They do not address what sort of procedures and paperwork will work in a developing country, or IRBs' relationships to governments that have no mandate for them. Experiences presented here show that IRBs in developing countries can sustainably adhere to international standards. Sustainability requires knowledge, personal commitment, and an official mandate to uphold international standards. Capacity building must therefore focus on educational programs to make developing country leaders knowledgeable about the value of international guidelines to their nations. Such knowledge is needed before people will become motivated to promote, implement, and uphold the guidelines. People in developing countries must help design bridges to help their nations put international standards into practice. The structure of such bridges may, of necessity, vary in different settings.     

Ethics committees. Research ethics: beyond the guidelines

There is international recognition of the need for sustainable research ethics committees to provide ethical review of human subjects research in developing countries, but many developing countries do not have such committees (often called 'IRBs'). Theoretical and practical uncertainties encountered by an IRB on the Caribbean island of Grenada offer insight into ethical review of research in developing countries. Theoretical uncertainties include questions about whether means of ensuring confidentiality and obtaining informed consent will be effective in local settings, and whether deviations from Western norms are justifiable. International guidelines are helpful in addressing these concerns, but are subject to interpretation. Guidelines are less helpful in practical areas like selecting members or chairs. They do not address what sort of procedures and paperwork will work in a developing country, or IRBs' relationships to governments that have no mandate for them. Experiences presented here show that IRBs in developing countries can sustainably adhere to international standards. Sustainability requires knowledge, personal commitment, and an official mandate to uphold international standards. Capacity building must therefore focus on educational programs to make developing country leaders knowledgeable about the value of international guidelines to their nations. Such knowledge is needed before people will become motivated to promote, implement, and uphold their guidelines. People in developing countries must help design bridges to help their nations put international standards into practice. The structure of such bridges may, of necessity, very in different settings.     

Animal Research Ethics in Africa: Is Tanzania Making Progress?

The significance of animals in research cannot be over‐emphasized. The use of animals for research and training in research centres, hospitals and schools is progressively increasing. Advances in biotechnology to improve animal productivity require animal research. Drugs being developed and new interventions or therapies being invented for cure and palliation of all sorts of animal diseases and conditions need to be tested in animals for their safety and efficacy at some stages of their development. Drugs and interventions for human use pass through a similar development process and must be tested pre‐clinically in laboratory animals before clinical trials in humans can be conducted. Therefore, animals are important players in research processes which directly and indirectly benefit animals and humans. However, questions remain as to whether these uses of animals consider the best interests of animals themselves. Various research and training institutions in Tanzania have established some guidelines on animal use, including establishing animal ethics committees. However, most institutions have not established oversight committees. In institutions where there may be guidelines and policies, there are no responsible committees or units to directly oversee if and how these guidelines and policies are enforced; thus, implementation becomes difficult or impossible. This paper endeavours to raise some issues associated with the responsible use of animals in research and training in Tanzania and highlights suggestions for improvement of deficiencies that exist in order to bridge the gap between what ought to be practised and what is practised.     

CAPACITY BUILDING OF ETHICS REVIEW COMMITTEES ACROSS AFRICA BASED ON THE RESULTS OF A COMPREHENSIVE NEEDS ASSESSMENT SURVEY

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.     

Translating research findings into practice - the implementation of kangaroo mother care in Ghana

ABSTRACT: BACKGROUND: Kangaroo mother care (KMC) is a safe and effective method of caring for low birth weight infants and is promoted for its potential to improve newborn survival. Many countries find it difficult to take KMC to scale in healthcare facilities providing newborn care. KMC Ghana was an initiative to scale up KMC in four regions in Ghana. Research findings from two outreach trials in South Africa informed the design of the initiative. Two key points of departure were to equip healthcare facilities that conduct deliveries with the necessary skills for KMC practice and to single out KMC for special attention instead of embedding it in other newborn care initiatives. This paper describes the contextualisation and practical application of previous research findings and the results of monitoring the progress of the implementation of KMC in Ghana. METHODS: A three-phase outreach intervention was adapted from previous research findings to suit the local setting. A more structured system of KMC regional steering committees was introduced to drive the process and take the initiative forward. During Phase I, health workers in regions and districts were oriented in KMC and received basic support for the management of the outreach. Phase II entailed the strengthening of the regional steering committees. Phase III comprised a more formal assessment, utilising a previously validated KMC progressmonitoring instrument. RESULTS: Twenty-six out of 38 hospitals (68 %) scored over 10 out of 30 and had reached the level of 'evidence of practice' by the end of Phase III. Seven hospitals exceeded expected performance by scoring at the level of 'evidence of routine and institutionalised practice.' The collective mean score for all participating hospitals was 12.07. Hospitals that had attained baby-friendly status or had been re-accredited in the five years before the intervention scored significantly better than the rest, with a mean score of 14.64. CONCLUSION: The KMC Ghana initiative demonstrated how research findings regarding successful outreach for the implementation of KMC could be transferred to a different context by making context-appropriate adaptations to the model.     

Seroprevalence study of Francisella tularensis among hunters in Germany

In 2005 and 2006, Francisella tularensis unexpectedly reemerged in western Germany, when several semi-free-living marmosets (Callithrix jacchus) in a research facility died from tularemia and a group of hare hunters became infected. It is believed that hunters may have an elevated risk to be exposed to zoonotic pathogens, including F. tularensis. A previous cross-sectional study of the German population (n=6883) revealed a prevalence of 0.2%. Here, we investigated 286 sera from individuals mainly hunting in districts with emerging tularemia cases (group 1) and 84 sera from a region currently not conspicuous for tularemia (group 2). Methods included standard enzyme-linked immunosorbent assay (ELISA), Western blot analysis and indirect immunofluorescence assay. We found five out of the 286 hunters (1.7%; 95% CI 0.6-4.0%) in group 1 positive with standard ELISA and Western blot, but none in the Berlin area (group 2; 95% CI 0-0.04%). Group 1 showed an elevated risk for hunters to be seropositive for F. tularensis compared with the cross-sectional study (OR=7.7; P<0.001). This indicates a higher prevalence for tularemia in hunters of a suspected endemic region of Germany.     

What Affects Authors’ and Editors’ Use of Reporting Guidelines? Findings from an Online Survey and Qualitative Interviews

Objectives

To identify and understand, through data from multiple sources, some of the factors that affect authors’ and editors’ decisions to use reporting guidelines in the publication of health research.

Design

Mixed methods study comprising an online survey and semi-structured interviews with a sample of authors (online survey: n = 56; response rate = 32%; semi-structured interviews: n = 5) and journal editors (online survey: n = 43; response rate = 27%; semi-structured interviews: n = 6) involved in publishing health and medical research. Participants were recruited from an earlier study examining the effectiveness of the TREND reporting guideline.

Results

Four types of factors interacted to affect authors’ and editors’ likelihood of reporting guideline use; individual (e.g. having multiple reasons for use of reporting guidelines); the professional culture in which people work; environmental (e.g. policies of journals); and, practical (e.g. having time to use reporting guidelines). Having multiple reasons for using reporting guidelines was a particularly salient factor in facilitating reporting guidelines use for both groups of participants.

Conclusions

Improving the completeness and consistency of reporting of research studies is critical to the integrity and synthesis of health research. The use of reporting guidelines offers one potentially efficient and effective means for achieving this, but decisions to use (or not use) reporting guidelines take many factors into account. These findings could be used to inform future studies that might, for example, test the factors that we have identified within a wider theoretical framework for understanding changes in professional practices. The use of reporting guidelines by senior professionals appears to shape the expectations of what constitutes best practice and can be assimilated into the culture of a field or discipline. Without evidence of effectiveness of reporting guidelines, and sustained, multifaceted efforts to improve reporting, little progress seems likely to be made.     

Complex evaluation of endemicity level of the territory affected by hemorrhagic fever with renal syndorome

A new formula for the calculation of the endemicity index of the territory affected by hemorrhagic fever with renal syndrome (HFRS) based on empiric data collected in the Volga region near Saratov in 1982-2000 is proposed. As found in this research 21% of the administrative districts of the region have a high endemicity level (with the average index for several years reaching 35 points), 8% of the districts have a medium enemicity level (20 points) and 71% of the districts--a low endemicity level (9 points). It is pointed out that under conditions of financial constraints territories with high and medium endemicity levels should be first examined for HFRS; these territories should also be given priority in prophylactic deratization in the field and human settlements.     

A guide to defining and implementing protocols for the welfare assessment of laboratory animals: eleventh report of the BVAAWF/FRAME/RSPCA/UFAW Joint Working Group on Refinement

The refinement of husbandry and procedures to reduce animal suffering and improve welfare is an essential component of humane science. Successful refinement depends upon the ability to assess animal welfare effectively, and detect any signs of pain or distress as rapidly as possible, so that any suffering can be alleviated. This document provides practical guidance on setting up and operating effective protocols for the welfare assessment of animals used in research and testing. It sets out general principles for more objective observation of animals, recognizing and assessing indicators of pain or distress and tailoring these to individual projects. Systems for recording indicators, including score sheets, are reviewed and guidance is set out on determining practical monitoring regimes that are more likely to detect any signs of suffering. This guidance is intended for all staff required to assess or monitor animal welfare, including animal technologists and care staff, veterinarians and scientists. It will also be of use to members of ethics or animal care and use committees. A longer version of this document, with further background information and extra topics including training and information sharing, is available on the Laboratory Animals website.     

Prevalence of clinical malaria and household characteristics of patients in tribal districts of Pakistan

BackgroundMalaria, disproportionately affects poor people more than any other disease of public health concern in developing countries. In resource-constrained environments, monitoring the occurrence of malaria is essential for the success of national malaria control programs. Militancy and military conflicts have been a major challenge in monitoring the incidence and controlling malaria and other emerging infectious diseases. The conflicts and instability in Afghanistan have resulted in the migration of refugees into the war-torn tribal districts of Pakistan’s Khyber Pakhtunkhwa (KPK) province and the possible introduction of many contagious epidemics. Although malaria is very common in all tribal districts, molecular, clinical and epidemiological data are scarce in these high-burden districts. Therefore, for the proper surveillance, detection, and control of malaria, obtaining and analyzing reliable data in these districts is essential.Methodology/Principal findingsAll 1,127 malaria-suspected patients were sampled within the transmission season in the tribal districts of KPK province between March 2016 to December 2018. After a detailed demographic and clinical investigation of malaria-suspected patients, the data were recorded. The data of the control group was collected simultaneously at the same site. They were considered as uncomplicated cases for statistical analyses. Blood samples were collected from malaria-suspected patients for the detection of Plasmodium species using microscopy and nested PCR (nPCR). Microscopy and nPCR examination detected 78% (n = 882) and 38% (n = 429) Plasmodium-positive patients, respectively. Among1,127 of 429nPCR detected cases with both species of malaria, the frequency of complications was as follows: anemia (n = 71; 16.5%), decompensated shock (n = 40; 9%), hyperpyrexia (n = 117; 27%), hyperparasitaemia (n = 49; 11%) hypoglycemia (n = 45; 10.5%), jaundice (n = 54; 13%), multiple convulsions (n = 37; 9%), and petechia (n = 16; 4%). We observed that 37% (n = 157 out of 429) of those patients infected by both Plasmodium species were children between the ages of 1 and 15 years old. The results revealed that Bajaur (24%), Kurram (20%), and Khyber (18%) districtshada higher proportion of P. vivax than P. falciparum cases. Most of the malaria cases were males (74%). Patients infected by both Plasmodium species tended to less commonly have received formal education and ownership of wealth indicators (e.g., fridge, TV set) was lower.Conclusions/SignificanceMalaria in tribal districts of the KPK province largely affects young males. P. vivax is a major contributor to the spread of malaria in the area, including severe malaria. We observed a high prevalence of P. vivax in the Bajaur district. Children were the susceptible population to malaria infections whereas they were the least expected to use satisfactory prevention strategies. A higher level of education, a possession of TV sets, the use of bed nets, the use of repellent fluids, and fridges were all associated with protection from malaria. An increased investment in socio-economic development, a strong health infrastructure, and malaria education are key interventions to reduce malaria in the tribal districts.     

A multicenter study of the awareness and attitudes of Egyptian faculty towards research ethics: a pilot study

The awareness and attitudes of faculty towards research ethics committees (RECs) and research ethics practices are largely unknown. Accordingly, we conducted a cross-sectional survey study involving various faculties (Medicine, Nursing, Pharmacy, and Dentistry) from four universities in Egypt. A large majority (> 85%) held positive attitudes towards RECs, but almost a third thought that RECs would delay research. More than half had not received prior training in research or medical ethics, but more than 90% thought that this subject matter should be taught to postgraduates. A large majority recognized the need for informed consent and confidentiality protections in research, but some held attitudes regarding certain research ethics practices that were questionable. We conclude that a curriculum in research ethics should be developed for university faculty and that further qualitative studies should explore the basis of several of the attitudes regarding practices in research ethics.     

Agricultural (nonbiomedical) animal research outside the laboratory: a review of guidelines for institutional animal care and use committees

Challenges and published guidelines associated with appropriate care and use of farm animals in agricultural research conducted outside the laboratory are briefly reviewed. The Animal Welfare Act (Title 9 of the 2000 Code of Federal Regulations), which regulates the care and use of agricultural animals in biomedical research, does not include livestock and poultry used in agricultural research. Farm animal research funded (and thereby regulated) by the US Public Health Service is further discussed in the National Research Council's 1996 Guide for the Care and Use of Laboratory Animals. However, neither of these guidelines adequately addresses the unique attributes of research and teaching designed to improve production agriculture. That information is contained in the Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching (the Ag Guide), published by the Federation of Animal Science Societies in 1999. The Ag Guide provides excellent general recommendations for agricultural animal research. It serves as an invaluable resource for institutional animal care and use committees, which attempt to balance the welfare of farm animals and the needs of those working to improve animal agriculture.     

The refining influence of ethics committees on animal experimentation in Sweden

Mandatory scrutiny of projects by animal ethics committees was introduced in Sweden in 1979. The present study investigated the minutes of meetings held between 1989 and 2000 at which consideration of applications for experimental work in animals resulted in requests for modification (n = 3607). 18.1% of the applications received were approved only after modifications. The majority of the changes requested may be classified as 'Refinement'. The most common requests were for improvement of project design, euthanasia method and housing and husbandry. There was a relative increase in modifications requested by the committees related to anaesthesia, choice of licensed supervisor and the need for licenses or informed consent from animal owners during the period investigated. There was a relative decrease in modifications related to euthanasia, housing and husbandry, and general endpoint assertions. The results suggest that the work of the committees may be perceived as an ongoing process, since several of the applications for which modification was requested were projects that had been approved on a previous occasion but were now up for renewal. In order to have maximal influence on the refinement of scientific protocols it is important that the scientists in the committees are continuously updated on developments in laboratory animal science.     

Ecological risk assessment of multiple hatchery programs in the upper Columbia watershed using Delphi and modeling approaches

Ecological risks of Pacific salmon (spring, summer, and fall run Chinook, coho, and sockeye salmon) and steelhead trout hatchery programs operated between 2013 and 2023 in the Upper Columbia Watershed will be assessed using Delphi and modeling approaches. Committees composed of resource managers and public utility districts identified non-target taxa of concern (i.e., taxa that are not the target of supplementation), and acceptable hatchery impacts (i.e., change in population status) to those taxa. Biologists assembled information about hatchery programs, non-target taxa, and ecological interactions and this information will be provided to expert panelists in the Delphi process to facilitate assessment of risks and also used to populate the Predation, Competition, and Disease (PCD) Risk 1 model. Delphi panelists will independently estimate the proportion of a non-target taxa population that will be affected by each individual hatchery program. Estimates from each of the two approaches will be independently averaged, a measure of dispersion calculated (e.g., standard deviation), and subsequently compared to the acceptable hatchery impact levels that were determined previously by committees of resource managers and public utility districts. Measures of dispersion will be used to estimate the scientific uncertainty associated with risk estimates. Delphi and model results will be compared to evaluate the qualities of the two approaches. Furthermore, estimates of impacts from each hatchery program will be combined together to generate an estimate of cumulative impact to each non-target taxon.     

Are research ethics committees behaving unethically? Some suggestions for improving performance and accountability.

The results of recent empirical investigations in research synthesis imply that research ethics committees are behaving unethically by endorsing new research which is unnecessary and by acquiescing in biased under-reporting of research which they have approved. The performance and accountability of research ethics committees would be improved if they required those proposing research to present systematic reviews of relevant previous research in support of their applications; to summarise the results of these reviews in the information prepared for potential participants; to register new controlled trials at inception; and to ensure that the results of these trials are made publicly available within a reasonable period of time after completion of data collection.     

Quality of Animal Experiments in Anti-Angiogenic Cancer Drug Development – A Systematic Review

Translation from preclinical animal research to clinical bedside has proven to be difficult to impossible in many fields of research (e.g. acute stroke, ALS and HIV vaccination development) with oncology showing particularly low translation rates (5% vs. 20% for cardiovascular diseases). Several investigations on published preclinical animal research have revealed that apart from plain species differences, translational problems can arise from low study quality (e.g. study design) or non-representative experimental conditions (e.g. treatment schedule).This review assessed the published experimental circumstances and quality of anti-angiogenic cancer drug development in 232 in vivo studies. The quality of study design was often insufficient; at least the information published about the experiments was not satisfactory in most cases. There was no quality improvement over time, with the exception of conflict of interest statements. This increase presumably arose mainly because journal guidelines request such statements more often recently.Visual inspection of data and a cluster analysis confirmed a trend described in literature that low study quality tends to overestimate study outcome. It was also found that experimental outcome was more favorable when a potential drug was investigated as the main focus of a study, compared to drugs that were used as comparison interventions. We assume that this effect arises from the frequent neglect of blinding investigators towards treatment arms and refer to it as hypothesis bias.In conclusion, the reporting and presumably also the experimental performance of animal studies in drug development for oncology suffer from similar shortcomings as other fields of research (such as stroke or ALS). We consider it necessary to enforce experimental quality and reporting that corresponds to the level of clinical studies. It seems that only clear journal guidelines or guidelines from licensing authorities, where failure to fulfill prevents publication or experimental license, can help to improve this situation.     

Evaluation of the cervical cytology screening programme in an inner city health district.

District health authorities have been instructed to operate a cervical cytology call and recall screening programme using the age-sex registers held by family practitioner committees. A detailed evaluation of implementation in an inner London district showed that 477 out of 687 (69%) invitation letters sent to women by the family practitioner committee were either inaccurate or inappropriate: almost half of the recorded addresses were incorrect and a further fifth of the women were not eligible for a test. Overall, 90 women had a smear, which is only 13% of the total but 43% of those found to be eligible. The findings did not differ significantly with age. The findings have major implications not only for the effectiveness of call and recall for screening for cervical cancer but also for the future development of screening for breast cancer in such areas.