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  1. Study participants incentives, compensation and reimbursement in resource-constrained settings.Takafira Mduluza, Nicholas Midzi, Donold Duruza & Paul Ndebele - 2013 - BMC Medical Ethics 14 (S1):1-11.
    Controversies still exists within the research fraternity on the form and level of incentives, compensation and reimbursement to study participants in resource-constrained settings. While most research activities contribute significantly to advancement of mankind, little has been considered in rewarding directly the research participants from resource-constrained areas. A study was conducted in Zimbabwe to investigate views and expectations of various stakeholders on study participation incentives, compensation and reimbursement issues. Data was collected using various methods including a survey of about 1,008 parents/guardians (...)
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  • Achieving online consent to participation in large-scale gene-environment studies: a tangible destination.F. Wood, J. Kowalczuk, G. Elwyn, C. Mitchell & J. Gallacher - 2011 - Journal of Medical Ethics 37 (8):487-492.
    Background Population based genetics studies are dependent on large numbers of individuals in the pursuit of small effect sizes. Recruiting and consenting a large number of participants is both costly and time consuming. We explored whether an online consent process for large-scale genetics studies is acceptable for prospective participants using an example online genetics study. Methods We conducted semi-structured interviews with 42 members of the public stratified by age group, gender and newspaper readership (a measure of social status). Respondents were (...)
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  • Measuring inconsistency in research ethics committee review.Samantha Trace & Simon Erik Kolstoe - 2017 - BMC Medical Ethics 18 (1):1-10.
    Background The review of human participant research by Research Ethics Committees or Institutional Review Boards is a complex multi-faceted process that cannot be reduced to an algorithm. However, this does not give RECs/ IRBs permission to be inconsistent in their specific requirements to researchers or in their final opinions. In England the Health Research Authority coordinates 67 committees, and has adopted a consistency improvement plan including a process called “Shared Ethical Debate” where multiple committees review the same project. Committee reviews (...)
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  • Measuring inconsistency in research ethics committee review.Samantha Trace & Simon Erik Kolstoe - 2017 - BMC Medical Ethics 18 (1):65.
    The review of human participant research by Research Ethics Committees or Institutional Review Boards is a complex multi-faceted process that cannot be reduced to an algorithm. However, this does not give RECs/ IRBs permission to be inconsistent in their specific requirements to researchers or in their final opinions. In England the Health Research Authority coordinates 67 committees, and has adopted a consistency improvement plan including a process called “Shared Ethical Debate” where multiple committees review the same project. Committee reviews are (...)
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  • Perspectives of IRB chairs on the informed consent process.Eugene I. Kane & Joseph J. Gallo - 2017 - AJOB Empirical Bioethics 8 (2):137-143.
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  • Research ethics at the empirical side.C. D. Herrera - 1999 - Theoretical Medicine and Bioethics 20 (2):191-200.
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  • Informed consent instead of assent is appropriate in children from the age of twelve: Policy implications of new findings on children’s competence to consent to clinical research.Irma M. Hein, Martine C. De Vries, Pieter W. Troost, Gerben Meynen, Johannes B. Van Goudoever & Ramón J. L. Lindauer - 2015 - BMC Medical Ethics 16 (1):1-7.
    BackgroundFor many decades, the debate on children’s competence to give informed consent in medical settings concentrated on ethical and legal aspects, with little empirical underpinnings. Recently, data from empirical research became available to advance the discussion. It was shown that children’s competence to consent to clinical research could be accurately assessed by the modified MacArthur Competence Assessment Tool for Clinical Research. Age limits for children to be deemed competent to decide on research participation have been studied: generally children of 11.2 (...)
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  • Digital tools in the informed consent process: a systematic review.Francesco Gesualdo, Margherita Daverio, Laura Palazzani, Dimitris Dimitriou, Javier Diez-Domingo, Jaime Fons-Martinez, Sally Jackson, Pascal Vignally, Caterina Rizzo & Alberto Eugenio Tozzi - 2021 - BMC Medical Ethics 22 (1):1-10.
    Background Providing understandable information to patients is necessary to achieve the aims of the Informed Consent process: respecting and promoting patients’ autonomy and protecting patients from harm. In recent decades, new, primarily digital technologies have been used to apply and test innovative formats of Informed Consent. We conducted a systematic review to explore the impact of using digital tools for Informed Consent in both clinical research and in clinical practice. Understanding, satisfaction and participation were compared for digital tools versus the (...)
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