Researchers' Perspectives Regarding Ethical Issues of Biobank Research in the Arab Region.

Background: The recent expansion of genomic biobank research in the Arab region in the Middle East North Africa has raised complex ethical and regulatory issues. However, there is a lack of studies regarding the views of Arab researchers involved in such research. We aimed to assess the perceptions and attitudes of Arab researchers regarding these issues in biobank research. Methods: We developed a questionnaire to assess the perceptions and attitudes regarding genetic research of researchers from Egypt, Sudan, Morocco, and Jordan. The questionnaire requested demographic data, perceptions, and attitudes regarding the collection, storage, and use of biospecimens and data, the use of broad consent, data security, data sharing, and community engagement. We used multiple linear regressions to identify predictors of perceptions and attitudes. Results: We recruited 383 researchers. Researchers favored equally the use of broad and tiered consent (44.1% and 39.1%, respectively). Most respondents agreed with the importance of confidentiality protections to ensure data security (91.8%). However, lower percentages were seen regarding the importance of community engagement (64.5%), data sharing with national colleagues and international partners (60.9% and 41.1%, respectively), and biospecimen sharing with national colleagues and international partners (59.9% and 36.2%, respectively). Investigators were evenly split on whether the return of individual research results should depend on the availability or not of a medical intervention that can be offered to address the genetic anomaly (47.5% and 46.4%, respectively). Predictors of attitudes toward biospecimen research included serving on Research Ethics Committees, prior research ethics training, and affiliation with nonacademic institutions. Conclusions: We recommend further exploratory research with researchers regarding the importance of community engagement and to address their concerns about data sharing, with researchers within and outside their countries.

Perceptions, attitudes, and willingness of the public in low- and middle-income countries of the Arab region to participate in biobank research.

Population-based genomics studies have proven successful in identifying genetic variants associated with diseases. High-quality biospecimens linked with informative health data from diverse segments of the population have made such research possible. However, the success of biobank research depends on the willingness of the public to participate in this type of research. We aimed to explore the factors associated with the willingness of the public to participate in biobank research from four low- and middle-income countries in the Arab region (Egypt, Jordan, Morocco, and Sudan). We used a previously validated questionnaire to assess several constructs that included the public's perceptions, attitudes, and willingness to participate in biobank research. We recruited 967 participants. More than half did not have prior awareness of biobanks. Participants' willingness to donate biospecimens and health data was less than 10%. Our results also showed that participants harbored concerns with trust, privacy, and with data-sharing involving international researchers. Predictors of willingness to participate in biobank research included no previous involvement in research and positive attitudes toward biobanks. Finally, our study showed several differences between the four countries regarding several of the investigated constructs. We conclude there should be additional efforts to raise public awareness and enhance perceptions of the public in biobanking research to enhance trust. We further recommend qualitative research to explore the underlying factors that contribute to the public's concerns with international data sharing that would enhance global health.

Biobanks in the low- and middle-income countries of the Arab Middle East region: challenges, ethical issues, and governance arrangements-a qualitative study involving biobank managers.

BACKGROUND: Biobanks have recently been established in several low- and middle-income countries (LMICs) in the Arab region of the Middle East. We aimed to explore the views of biobank managers regarding the challenges, ethical issues, and governance arrangements of their biobanks. METHODS: In-depth semi-structured qualitative interviews were conducted with a purposive sample of eight biobank managers from Egypt (6), Jordan (1), and Sudan (1). Interviews were performed either face-to-face, by phone, or via Zoom and lasted approximately 45-75 min. After verbal consent, interviews were recorded and then transcribed. The authors performed a thematic analysis of the transcripts independently and then integrated the themes via a consensus process. RESULTS: Biobank managers discussed the main challenges in establishing their biobanks. These included the staff's lack of experience and training, limited funds, deficit awareness of biobanks, obtaining funding from different sources. Only four reported they were active in distributing biospecimens and health data to researchers. Six biobanks used a broad consent model, one used tiered consent, and another allowed participants to opt-out of being recontacted. Five managers avoided partnerships with pharmaceutical companies due to concerns with unfavorable reactions from the community. Five managers did not have clear policies for returning research results to the donors. Five expressed challenges with sample and data sharing with international collaborators; all five used material transfer agreements. The biobank managers revealed variable governance arrangements and activities with community involving awareness and educational efforts rather than active engagement. Several expressed the importance of transparency with the operations of their biobanks and gaining the trust of their stakeholders. CONCLUSION: Managers of biobanks in LMICs in the Arab Middle East encounter financial, operational, and social challenges toward their sustainability efforts. Discussions with key stakeholders are warranted to manage ethical issues involving informed consent, privacy, data sharing, and the return of results. We recommend that biobank managers in the Arab Middle East form collaborative networks within the region and internationally, develop trusting governance relationships with their stakeholders, and pursue engagement activities with their communities to enhance trust.

Development and Validation of a Biobank Questionnaire Intended for the Public in the Arab Region.

Background: Assessing the public perspectives regarding donation of biospecimens to biobanks would be helpful with the establishment of biobanks in the Arab region. Objective: To develop a biobanking questionnaire in Arabic and assess its psychometric properties. Design: Multicenter cross-sectional study. Methods: We used a two-step process for questionnaire development. First, we decided on the important constructs for a questionnaire followed by development of an item pool through review of the scientific literature and published questionnaires. The questionnaire was refined through cognitive interviews and translation. An expert panel assessed content validity. The final questionnaire included five domains: perceptions; aspects important to participation in biobank research; preferences for type of biobank; attitudes toward biobanking; and willingness to participate in biobank research. Second, we distributed the questionnaire to 250 members of the public from Egypt, Jordan, Sudan, and Morocco to assess the questionnaire's psychometric properties, including reliability (internal consistency and Cronbach's alpha) and construct validity (convergent and divergent validity and exploratory factor analysis [EFA]). Results: Internal consistency yielded a range of Cronbach's alpha for the five domains from 0.62 to 0.80. EFA showed a 12-factorial solution. Kaiser-Meyer-Olkin measure of sampling adequacy was 0.907 and Bartlett's test of sphericity was significant (p < 0.005). Attitudes were positively correlated with willingness to donate (r = 0.30; p < 0.001). Conclusions: The final biobank Arabic language questionnaire showed excellent reliability and acceptable validity parameters. The newly developed Arabic questionnaire is the first psychometrically tested tool that can be used in the Arab region to assess the public perspectives on participation in biobanking research.

Salivary TNFα levels in groups of subjects with rheumatoid arthritis and chronic periodontitis.

BACKGROUND: Rheumatoid arthritis (RA) and chronic periodontitis are the most common chronic inflammatory diseases with significant pathological and clinical similarities. Numerous studies have indicated a relationship between rheumatoid arthritis and periodontal disease. The aim of this study was to compare the TNF-α levels in saliva among patients with Rheumatoid arthritis (RA) and chronic periodontitis as well as healthy subjects. METHODS: One hundred and seventy-one patients were enrolled in this cross-sectional study. Fifty-seven patients diagnosed of RA, 57 patients with chronic periodontitis and 57 healthy subjects. These patients have been examined with regard to TNF-α level from salivary samples. Their teeth were examined with regard to Plaque Index , Gingival Index, probing depth and clinical attachment level.All patients were non-smokers. RESULTS: The results revealed a significant difference in all periodontal parameters among the three groups. The chronic periodontitis group showed a significantly higher value in all clinical periodontal parameters in comparison to both the RA and healthy groups. No significant difference was found between salivary TNF-α level among the three study groups. CONCLUSIONS: Patients with chronic periodontitis had the highest periodontal indices. However there was no significant difference regarding the level of salivary TNF-α. Hence, suppression of proinflammatory cytokines might prove beneficial in suppressing periodontal diseases among RA patients.