1. © Services GmbH Multichannel Learning System: Research Protocol Strategy London, November 14, 2013 Dr. Andrea Lösch

2. © Services GmbH Introduction 2 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

3. © Services GmbH Research Protocol Requirements |1 3 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 2) 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.) 3) 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)

4. © Services GmbH Rsearch Protocol Requirements |2 4 4) 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? 5) 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.)

5. © Services GmbH Ensuring Protection of Human Subjects in MLS Project 5 1. Definition of country-specific requirements for protection of human subjects (e.g. personal data protection regulation, existing practices and procedures, etc.). Deadline: mid. 2014 2. Definition of overall T&E strategy (metrics, methods for data collection, data processing and analysis etc.). Deadline: end of 2014 3. Consolidation of country-specific requirements for protection of human subjects. Deadline: 3 rd quarter of 2014 4. Definition of MLS research protocol strategy (result: technical and procedural specifications). Deadline: end 2014 5. Implementation of research protocol strategy within actual T&E activities of the project. During 2015.

6. © Services GmbH Timeline 1, 3 2 4 5 2

7. © Services GmbH MLS Research Protocol Strategy Thank you very much for your attention

8. © Services GmbH Human Research Protection in the EU 8 Information on European Research Ethics (ERE) and Requirements: www.ethicsweb.eu www.ethicsweb.eu Collection of international rules and guidelines: http://www.ethicsweb.eu/ere/regler.shtml http://www.ethicsweb.eu/ere/regler.shtml Central guidance documents for European research: http://ec.europa.eu/research/participants/portal/page/fp7_docume ntation;efp7_SESSION_ID=GHFKSTKGmmbHGwkYPn2pJdTkLbnzyGbH b0ZvzyYF62cG5j0vdxQh!1078437264 http://ec.europa.eu/research/participants/portal/page/fp7_docume ntation;efp7_SESSION_ID=GHFKSTKGmmbHGwkYPn2pJdTkLbnzyGbH b0ZvzyYF62cG5j0vdxQh!1078437264 Template for Ethical Issues Report/Checklist: http://ec.europa.eu/research/participants/portal/page/fp7_docume ntation;efp7_SESSION_ID=GHFKSTKGmmbHGwkYPn2pJdTkLbnzyGbH b0ZvzyYF62cG5j0vdxQh!1078437264 http://ec.europa.eu/research/participants/portal/page/fp7_docume ntation;efp7_SESSION_ID=GHFKSTKGmmbHGwkYPn2pJdTkLbnzyGbH b0ZvzyYF62cG5j0vdxQh!1078437264