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      Ethics in Community-Based Research with Vulnerable Children: Perspectives from Rwanda

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          Abstract

          A “risk of harm” protocol to identify youth in need of immediate emergency assistance in a study on mental health and HIV in Rwanda among 680 youth ages 10–17 is described. Cases are presented that describe the experience in using this protocol to ensure safety of participants, with ethical and logistical challenges considered. Among the population of the study, 3.2% were deemed “risk of harm.” The most prevalent presenting problem was non-fatal suicidal behavior (91% of risk of harm cases), with 36% having a history of a reported previous attempt. Challenges included: acute food insecurity/significant poverty; lack of support/adequate supervision from family members; family violence; alcohol abuse; and HIV-related stigma. Development of a “risk of harm” protocol and collaboration between study staff, community leadership, health authorities, and health workers are critical to ensuring participants’ safety in research among vulnerable populations.

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          Most cited references8

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          What makes clinical research in developing countries ethical? The benchmarks of ethical research.

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            Bridging the implementation gap between knowledge and action for health.

            There is widespread evidence of failure to implement health interventions that have been demonstrated to be cost-effective by high-quality research; this failure affects both high-income and low-income countries. Low-income countries face additional challenges to using research evidence including: the weakness of their health systems, the lack of professional regulation and a lack of access to evidence. There is a need to strengthen institutions and mechanisms that can more systematically promote interactions between researchers, policy-makers and other stakeholders who can influence the uptake of research findings. The concept of public engagement with health research requires a public that is both informed and active. Even when systematic reviews are available further work is needed to translate their findings into guidelines or messages that are understandable to patients and health professionals. Many of the commonly used approaches for keeping health professionals' knowledge up-to-date appear to have small or inconsistent effects. The evidence-base is more extensive for interventions directed towards professionals, such as education, reminders or feedback, than for those directed at organizations or patients. The effect of interventions varies according to the setting and the behaviour that is targeted. Case studies in low-income settings suggest that some strategies can result in increased coverage of evidence-based interventions, but there is a lack of evidence from systematic reviews of rigorous research. Given the potential for near-term improvements in health, finding more effective ways of promoting the uptake of evidence-based interventions should be a priority for researchers, practitioners and policy-makers.
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              Screening for depressive disorder in children and adolescents: validating the Center for Epidemiologic Studies Depression Scale for Children.

              The utility of the Center for Epidemiologic Studies Depression Scale for Children (CES-DC), a modified version of the Center for Epidemiologic Studies Depression Scale, was explored in a sample of children, adolescents, and young adults at high or low risk for depression according to their parents' diagnosis. Proband parents were participants in the Yale Family Study of Major Depression who had children between the ages of 6 and 23 years. Diagnostic and self-report information on offspring was collected over two waves, spaced 2 years apart, from 1982 to 1986. Support was obtained for the reliability and validity of the CES-DC as a measure of depressive symptoms, especially for girls and for children and adolescents aged 12-18 years. Children with major depressive disorder or dysthymia, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Third Edition (DSM-III), had elevated scores in comparison with all other respondents. The CES-DC lacked diagnostic specificity; children with a range of current DSM-III diagnoses had elevated scores on the measure. A cutoff point of 15 and above for screening children and adolescents for current major depressive disorder or dysthymia may be optimal. Depressed respondents scoring below this cutoff point (false negatives) showed better social adjustment than true positives; nondepressed respondents scoring above this cutoff point (false positives) showed worse adjustment than true negatives. Factor analysis was used to construct an abbreviated, four-item version of the scale. The abbreviated scale was shown to be useful as a screen.
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                Author and article information

                Contributors
                Role: Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, CA USA )
                1932-6203
                28 June 2016
                2016
                : 11
                : 6
                : e0157042
                Affiliations
                [1 ]Harvard T.H. Chan School of Public Health, Department of Global Health and Population, Boston, Massachusetts, United States of America
                [2 ]Harvard Medical School, Department of Global Health and Social Medicine, Boston, Massachusetts, United States of America
                [3 ]Partners In Health-Rwanda/ Inshuti Mu Buzima (PIH-IMB), Kigali, Rwanda
                [4 ]Ministry of Health, Government of Rwanda, Kigali, Rwanda
                [5 ]Boston Children’s Hospital, Boston, Massachusetts, United States of America
                [6 ]Partners In Health, Boston, Massachusetts, United States of America
                [7 ]Dartmouth College, Hanover, New Hampshire, United States of America
                [8 ]University of Global Health Equity, Kigali, Rwanda
                [9 ]Rwanda Biomedical Center, Kigali, Rwanda
                University of Kwazulu-Natal, SOUTH AFRICA
                Author notes

                Competing Interests: The authors have declared that no competing interests exist.

                Conceived and designed the experiments: TSB MCSF. Performed the experiments: AS FK CM CK JB. Analyzed the data: LN. Contributed reagents/materials/analysis tools: CK AS FK CM JB. Wrote the paper: TSB MCSF AS FK CM JB CK LN WB GR SS YK AB.

                Article
                PONE-D-16-01319
                10.1371/journal.pone.0157042
                4924793
                27351337
                d55f6ff3-ce41-4ad6-8048-e92e6cdde546
                © 2016 Betancourt et al

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                : 12 January 2016
                : 24 May 2016
                Page count
                Figures: 0, Tables: 1, Pages: 10
                Funding
                Funded by: funder-id http://dx.doi.org/10.13039/100007301, Harvard University Center for AIDS Research;
                Award ID: HU CFAR NIH/NIAID fund 2P30AI060354-07
                Award Recipient :
                Funded by: Peter C. Alderman Foundation
                Award Recipient :
                Funded by: Harvard Center on the Developing Child
                Award Recipient :
                Funded by: Julie Henry Faculty Development Fund
                Award Recipient :
                Funded by: FXB Center for Health and Human Rights
                Award Recipient :
                Funded by: funder-id http://dx.doi.org/10.13039/100000025, National Institute of Mental Health;
                Award ID: K01MH077246
                Award Recipient :
                Funded by: funder-id http://dx.doi.org/10.13039/100000025, National Institute of Mental Health;
                Award ID: R34MH084679
                Award Recipient :
                Funded by: funder-id http://dx.doi.org/10.13039/100000025, National Institute of Mental Health;
                Award ID: T32MH093310
                Award Recipient :
                The study was funded by the Harvard University Center for AIDS Research ( http://cfar.globalhealth.harvard.edu/; HU CFAR NIH/NIAID fund 2P30AI060354-07) with additional support to the overall research program in Rwanda from the Peter C. Alderman Foundation ( http://www.petercaldermanfoundation.org/), the Harvard Center on the Developing Child ( http://developingchild.harvard.edu/), the Julie Henry Faculty Development Fund, and the FXB Center for Health and Human Rights ( http://fxb.harvard.edu/). This publication was additionally supported by grants K01MH077246-05, R34MH084679-02, and T32MH093310 from the National Institute of Mental Health ( https://www.nimh.nih.gov/index.shtml). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
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                Unfortunately, sharing the data publicly would go beyond the scope of informed consent that was agreed to by participants. However, the de-identified minimal data used to reach the conclusions and replicate the analyses described in this paper are available upon written request to, and after review and approval by, the Harvard LMA IRB. Contact information for the Institutional Review Board below: Leslie Howes, MPH, CIP (phone: 617-432-2153; email: lhowes@ 123456hsph.harvard.edu ).

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