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Multichannel Learning System:

Research Protocol Strategy

London, November 14, 2013Dr. Andrea Lösch

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Introduction

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• 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

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Research Protocol Requirements |1

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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)

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Rsearch Protocol Requirements |2

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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.)

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Ensuring Protection of Human Subjects in MLS Project

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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: 3rd 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.

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Timeline

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1 2 3 4 1 2 3 4

Multichannel Learning System (MLS) Project Kick-Off All Participants

Project Management Support, POA&M, Briefings, etc LMITT

Identify Courses (US/ International) DISAM

Human Research Protection Program (HRPP) Development All

Testing & Evaluation (T&E) Plan Development T&E TEam

Identify T&E Transparent Data Collection Strategy T&E Team

MLS Management Team Teleconferences Management Team

Testing & Evaluation (T&E) Teleconferences T&E Team

Testing & Evaluation (T&E) Plan Development T&E TEam

Develop content in multiple formats DISAM

Technical In-Progress-Reviews (IPR) DISAM

T&E Questionnaire Development Working Group T&E TEam

Identify T&E Transparent Data Collection Requirements T&E Team

Research Protocl Approvals LMITT

Research Protocol Application to SPAWAR Pacific LMITT

MLS Concept Evaluatin (CE) Train-the-Trainer Meeting All

Pre-Operational Testing (Public Beta) All

Concept Evaluation (CE) Help Desk Support DISAM

Conduct Concept Evaluation (CE) All

ConductConcept Evaluation (CE) Analysis T&E Team

Prepare MLS Final Report (DRAFT) LMITT

Conduct MLS Final Project MeetingMoLE Management

Team

FY 2014 FY 2015Project Activities Performing Org

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MLS Research Protocol Strategy

Thank you very much for your attention

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Human Research Protection in the EU

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• 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