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Explore the importance of research protocols, ethical considerations, and human research protection in international projects. Understand diverse protocol guiding principles, ethical directives, and the testing and evaluation process. Implement a comprehensive strategy for data collection, analysis, and human subject protection.
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Multichannel Learning System:Research Protocol Strategy London, November 14, 2013 Dr. Andrea Lösch
Introduction • Why Research Protocol? • Provision of general information about the project (rationale & background information, study goals & objectives, methodology, expected outcomes, references etc.) • Presentation of how to deal with potential ethical and legal issues involved in human research (safety considerations, data management, data analysis, quality assurance, ethical issues, informed consent etc.) • Major problem in international research projects: Diversity of Human Research Protocol Guiding Principals in the MLS project • US Directives • Canada Tri-Council Policy Ethical conduct for Research involving Humans • EU Directives, UK Ministry of Defence Ethics • India Military Requirements • Serbia Military Requirements
Research Protocol Requirements |1 • Informed Consent Form (most important): • Informed consent form informs subjects about their rights (e.g. provision and processing of private information, withdrawing from the study, use of data etc.) • Standards for collecting and processing electronic information • How to implement Human Research Protection: • Identification of country specific, international requirements • Definition of HRP tools (e.g. informed consent forms, implementation of requirements towards processing personal data etc.) • Testing and Evaluation process: • Focus: Measures of effectiveness (utility, usefulness, self-efficacy, accessibility) • Three teams: Data collection, Data Analysis, Human Research Protection • Data collection and analysis: • data collection methods included questionnaire (demographic information, multiple choice, open text responses) as well as unobtrusive measures (tracking people’s pathways)
Rsearch Protocol Requirements |2 • Focus of analysis: • Utility: What is the effectiveness or practicality of using mobile technologies for training? • Usefulness: What is the benefit or availability of using mobile devices in training? • Self-efficacy: Do persons who have used the mobile device believe they are capable to perform a desired outcome? • Accessibility: What is the degree to which a mobile training application is available in austere environments to as many role players as possible? • Different steps of testing and evaluation process: • Demographic online questionnaire • Open ended questions embedded within the application (How useful are mobile devices for training? How useful are digital reference materials? Etc.)
Ensuring Protection of Human Subjects in MLS Project • Definition of country-specific requirements for protection of human subjects (e.g. personal data protection regulation, existing practices and procedures, etc.). Deadline: mid. 2014 • Definition of overall T&E strategy (metrics, methods for data collection, data processing and analysis etc.). Deadline: end of 2014 • Consolidation of country-specific requirements for protection of human subjects. Deadline: 3rd quarter of 2014 • Definition of MLS research protocol strategy (result: technical and procedural specifications). Deadline: end 2014 • Implementation of research protocol strategy within actual T&E activities of the project. During 2015.
Timeline 1, 3 2 2 4 5
MLS Research Protocol Strategy Thank you very much for your attention
Human Research Protection in the EU • Information on European Research Ethics (ERE) and Requirements: www.ethicsweb.eu • Collection of international rules and guidelines: http://www.ethicsweb.eu/ere/regler.shtml • Central guidance documents for European research: http://ec.europa.eu/research/participants/portal/page/fp7_documentation;efp7_SESSION_ID=GHFKSTKGmmbHGwkYPn2pJdTkLbnzyGbHb0ZvzyYF62cG5j0vdxQh!1078437264 • Template for Ethical Issues Report/Checklist: http://ec.europa.eu/research/participants/portal/page/fp7_documentation;efp7_SESSION_ID=GHFKSTKGmmbHGwkYPn2pJdTkLbnzyGbHb0ZvzyYF62cG5j0vdxQh!1078437264