Multichannel Learning System (MLS) Research Protocol Requirements Jacob Hodges Lockheed Martin International Training Team (LMITT) 1

Research Protocol Team US Government Lead Julie Howell (SPAWAR Pacific) Kristen ‘Cuda’ Barrera (711th) MLS Project Team(1) Dr. Andrea Loesch (GIRAF PM) Jacob Hodges (LMITT) Dr. Venkat Sastry (DAUK) Dr. Andrey Girenko (DFKI) Country Representatives Remi Tremblay (Canada) Dr. Venkat Sastry (India Lead) Biljana Presnall (Serbia) Noor Sulieman (Jordan) (1) All MLS Project Team members have successfully completed the mandatory Collaborative Institute Training Initiative (CITI) Course 2

Terms of Reference│1 Research - Any systematic investigation to include a project, task, test, experiment, development, demonstration, evaluation, or similar undertaking designed to develop or contribute to generalized knowledge. This includes activities where the results are intended for publication, distribution, or where the results are to be used in future research activities [Next MLS Phases] Activities that meet this definition constitute research for purposes of this instruction whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities. [32 CFR 219.102(d)] 3

Terms of Reference │2 Human Subject - A living individual about whom an investigator conducting research obtains either data through intervention or interaction with the individual, or identifiable private information. Intervention includes both physical procedures by which data are gathered and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. Identifiable private information is any information from which the identity of the subject associated with the collected data is or may be readily ascertained by the investigator or associated with the institution. 4

Terms of Reference │3 Private Information - Private information also includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public. 5

Why Does This Apply? │1 32 CFR 219.101 Applies to all research involving human subjects conducted, supported or otherwise subject to regulation by any federal department or agency which takes appropriate administrative action to make the policy applicable to such research. Includes research conducted by federal civilian employees or military personnel, except that each department or agency head may adopt such procedural modifications as may be appropriate from an administrative standpoint. It also includes research conducted, supported, or otherwise subject to regulation by the federal government outside the United States. 6

Why Does This Apply? │2 32 CFR 219.101 Research that is conducted or supported by a federal department or agency, whether or not it is regulated as defined in Sec. 219.102(e), must comply with all sections of this policy. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. 7

Why Does This Apply? │3 32 CFR 219.101 Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects. 8

Human Research Protocol Guiding Directives/Instructions US Directives/Instructions: 32 CFR 219 DoD Directive 5400.11 DoD Directive 3216.2 DoD Instruction 3210.7 SECNAVINST 3900.39D US Air Force Instruction 40-402 UK Ministry of Defence (MoD) Ethics JSP 536 EU Directives: Ethical Review EU Directive 95/46/EC Guidance for Informed Consent Canada Tri-council Policy Ethical Conduct for Research involving Humans Serbia Approval for Conducting Research with Military Personnel 9

Privacy Of Individuals DoD Directive 5400.11 (DoD Privacy Program) The privacy of an individual is a personal and fundamental right that shall be respected and protected DoD Directive 3216.2 (Protection of Human Subjects in DoD-Supported Research) …specifies authority for protecting the rights and welfare of human beings “used as subjects of study” in DoD-supported RDT&E …identifies the requirement that US DoD-support research efforts must also meet the requirements of other countries when the research is conducted outside the US 10

“Informed Consent Is Not Just About Patients” EU Data Protection Requirements: “From a data protection and privacy issues points of view, all study participants present in a research project need to be informed about the planned research use of the collected data independently of they type of data collected If a survey is planned within a project, participant need not only to be informed of how their personal data is planned to be handled, but also provide appropriate authorization. The design of the survey must guarantee that only data specifically required for the purpose of the research project will be gathered (unless clearly stated otherwise).” 11

Canada Ethical Conduct For Research Consent must be voluntarily Consent shall be voluntarily, can be withdrawn at any time, and if a participants withdraws consent the participant can also request the withdrawal of their data Consent shall be informed Researchers shall provide to prospective participants, or authorized third parties, full disclosure of all information necessary for making an informed decision to participate in a research project. Incidental Findings Researchers have an obligation to disclose to the participant any material incidental findings discovered in the course of research. “Incidental findings” is a term that describes unanticipated discoveries made in the course of research but that are outside the scope of the research. 12

Informed Consent Process Country Team Approvals Commanding Officers / Division Approvals SSC Pacific Package Prepared & Submitted MLS Concept Evaluation Informed Consent Document Developed Dr. Andrea Lösch will present the MLS Research Protocol Strategy 13

Questions / Comments 14