Ethical Practices for Health Research in the Eastern Mediterranean Region of the World Health Organization: A Retrospective Data Analysis

BACKGROUND: Commentators have expressed concern regarding the existence of proper ethics review systems in developing countries. Our aim is to explore the extent with which investigators from countries in the Eastern Mediterranean (EM) Region consider several ethical practices in the conduct of their research. METHODOLOGY/PRINCIPAL FINDINGS: Investigators from 12 countries in the EM region submitted 143 proposals involving Public Health and Biotechnology & Genomics to a grant scheme funded by the Eastern Mediterranean Regional Office of the WHO and the Organization of Islamic Conference Standing Committee for Science and Technological Cooperation in 2006. The grant application included a 1-page questionnaire that asked investigators 1) whether ethical clearance was obtained, 2) whether they plan to obtain informed consent, and 3) whether confidentiality of human subject data would be ensured. The methodologies of the submitted researches were categorized as to whether it involved 1) human subject research (e.g., the prospective collection of biological specimens or the performance of qualitative research), 2) research that could be exempt from ongoing ethics review, and 3) research not involving human subjects. A descriptive analysis was used to analyze the investigators' responses and a chi-square analysis was used to analyze categorical variables. Of the 79 submitted proposals determined to involve "human subjects", ethical clearance was not obtained in 29%; investigators thought that informed consent was not needed in 29%; and investigators did not mention that they would ensure confidentiality of the obtained data in 8% of the studies. The magnitude of these deficiencies was similar regardless of study design type, i.e., prospective collection of biological samples and qualitative research methods. CONCLUSION/SIGNIFICANCE: These results suggest that attention to ethical safeguards is not optimal among investigators in the EM Region. Further guidelines for strengthening ethical review systems, as well as enhanced educational training in concepts of research ethics for investigators are warranted in this region

Pulmonary embolism versus pulmonary vasculitis in Hughes-Stovin syndrome: Characteristic computed tomography pulmonary angiographic findings and diagnostic and therapeutic implications. HSS International Study Group

Background and aim: Hughes-Stovin syndrome (HSS) is a rare systemic vasculitis with widespread venous/arterial thrombosis and pulmonary vasculitis. Distinguishing between pulmonary embolism (PE) and in-situ thrombosis in the early stages of HSS is challenging. The aim of the study is to compare clinical, laboratory, and computed tomography pulmonary angiography (CTPA) characteristics in patients diagnosed with PE versus those with HSS. Methods: This retrospective study included 40 HSS patients with complete CTPA studies available, previously published by the HSS study group, and 50 patients diagnosed with PE from a single center. Demographics, clinical and laboratory findings, vascular thrombotic events, were compared between both groups. The CTPA findings were reviewed, with emphasis on the distribution, adherence to the mural wall, pulmonary infarction, ground glass opacification, and intra-alveolar hemorrhage. Pulmonary artery aneurysms (PAAs) in HSS were assessed and classified. Results: The mean age of HSS patients was 35 ± 12.3 years, in PE 58.4 ± 17 (p &lt; 0.0001). Among PE 39(78 %) had co-morbidities, among HSS none. In contrast to PE, in HSS both major venous and arterial thrombotic events are seen. Various patterns of PAAs were observed in the HSS group, which were entirely absent in PE. Parenchymal hemorrhage was also more frequent in HSS compared to PE (P &lt; 0.001). Conclusion: Major vascular thrombosis with arterial aneurysms formation are characteristic of HSS. PE typically appear loosely-adherent and mobile whereas “in-situ thrombosis” seen in HSS is tightly-adherent to the mural wall. Mural wall enhancement and PAAs are distinctive pulmonary findings in HSS. The latter findings have significant therapeutic ramifications.</p

Capacity mapping of national ethics committees in the Eastern Mediterranean Region

Abstract Background Ethics issues in the areas of science, technology and medicine have emerged during the last few decades. Many countries have responded by establishing ethics committees at the national level. Identification of National Ethics Committees (NECs) in the Eastern Mediterranean (EM) region and the extent of their functions and capacity would be helpful in developing capacity building programs that address the needs of these committees. Accordingly, we conducted a survey to determine the characteristics of existing NECs in the EM region. Methods We developed a questionnaire to collect information on different aspects of NECs. The questionnaire was sent to the WHO country office in each of the 22 Member States in the EM region. We used descriptive statistics to analyze the data. Results We obtained responses from 77% (17/22) of the EM countries; 88% (15/17) of the countries stated they had NECs. Of these NECs, 40% (6/15) were involved in the ethics of science and technology, 73% (11/15) in medical ethics, and 93% (14/15) in medical research ethics; 10 NECs stated they reviewed research protocols. Of the respondent NECs, 25% (4/15) met at least on a monthly basis. Regarding training, 21% of the members from all of the NECs had received formal training in ethics; 53% (8/15) of the NECs had none of their members with formal training in ethics. Regarding support, 33% (5/15) received financial support and 60% (9/15) had administrative support. Conclusion While many countries in the EM region report the existence of NECs, many meet infrequently, many have members without formal training in ethics, and many lack important financial and administrative resources. Further efforts should be directed towards capacity building programs that include ethics training and provision of important infrastructure resources for these committees.</p

In vitro anticancer activity of polysaccharide extracted from red alga Jania rubens against breast and colon cancer cell lines

Objective: To evaluate the potential role of the polysaccharides of the marine algae as an anticancer agent in vitro against colon cancer cell line (CoCa2) and breast cancer (MCF7) cell lines and to measure lactate dehydrogenase enzyme (LDH) activity as biomarker of membrane integrity of the cells. Methods: The cells of breast cancer (MCF7) and colon cancer (CoCa2) were used to evaluate the potential anticancer role of the polysaccharides of marine algae. Anti-proliferative activity against MCF7 and CoCa2 cell lines were evaluated in vitro by the 3-(4,5-dimethyl-2-thiazolyl)-2,5-diphenyl-2H-tetrazolium bromide (MTT) assay. Results: The in vitro assay of the antioxidant activity of eight marine seaweed species showed that the red seaweed Jania rubens (J. rubens) had the highest DPPH (2,2 diphenyl-1-picrylhydrazyl) free radical scavenging activity. The extracted polysaccharides with concentrations 0.1–40.0 mg/mL from J. rubens were tested for its anticancer potentiality and cytotoxic effects against the cell lines of human breast (MCF7) and colon cancer (CoCa2) cell lines by MTT assay. The inhibitory concentration at 50 (IC50) value the of J. rubens polysaccharide extract was 0.312 5 mg/mL for MCF7 and 20 mg/mL for CoCa2. LDH activity and annexin V concentration were higher in the treated MCF7 and CaCo2 cells than in the untreated ones. Quantitative polymerase chain reaction technique indicated that the polysaccharide treatments caused up-regulation of Bax, caspase 8 and P53 genes expression in CoCa2 cells, and up-regulation of caspase 3 and down-regulation of Bcl2 genes expression in MCF7 cells. Conclusions: The polysaccharides of the red marine alga J. rubens could be a potential candidate for the natural compounds as antioxidant and anticancer therapy

Attitudes towards transfers of human tissue samples across borders: An international survey of researchers and policy makers in five countries

Background: Sharing of tissue samples for research and disease surveillance purposes has become increasingly important. While it is clear that this is an area of intense, international controversy, there is an absence of data about what researchers themselves and those involved in the transfer of samples think about these issues, particularly in developing countries. Methods: A survey was carried out in a number of Asian countries and in Egypt to explore what researchers and others involved in research, storage and transfer of human tissue samples thought about some of the issues related to sharing of such samples. Results: The results demonstrated broad agreement with the positions taken by developing countries in the current debate, favoring quite severe restrictions on the use of samples by developed countries. Conclusions: It is recommended that an international agreement is developed on what conditions should be attached to any sharing of human tissue samples across borders