1. Research Ethics in
the MoLE m-
Learning Program
Jacob Hodges Geoff Stead
Q&P, LTD Tribal Group
CiTi HRPP Certificate: 1958669 Technology Development
This work is related to a Department of the Navy (DoN) Grant (N62909-11-01-7025) and two DoN Contracts (N68181-11-P-9000 and N68171-12-P-9000) which were awarded by the Office
of Naval Research Global (ONRG) and funded by the Coalition Warfare Program. The views expressed herein are solely those of the authors and do not represent or reflect the views of 1
any government agency or organization that participated in the project or mentioned herein.

2. INTRODUCTION
• MoLE was a two-year project focused an m-Learning
Proof of Concept (PoC)
• Provided training/reach-back capability to 22 nations
• Conducted a proof of concept focused on providing a
sustained capability once the project has finished
• Leveraged the global cellular network infrastructure,
mobile technologies and emerging mobile devices
This work is related to a Department of the Navy (DoN) Grant (N62909-11-01-7025) and two DoN Contracts (N68181-11-P-9000 and N68171-12-P-9000) which were awarded by the Office
of Naval Research Global (ONRG) and funded by the Coalition Warfare Program. The views expressed herein are solely those of the authors and do not represent or reflect the views of 2
any government agency or organization that participated in the project or mentioned herein.

3. Further info at www.mole-project.net
This work is related to a Department of the Navy (DoN) Grant (N62909-11-01-7025) and two DoN Contracts (N68181-11-P-9000 and N68171-12-P-9000) which were awarded by the Office
of Naval Research Global (ONRG) and funded by the Coalition Warfare Program. The views expressed herein are solely those of the authors and do not represent or reflect the views of
any government agency or organization that participated in the project or mentioned herein.

4. Proof of Concept Trial
22 Nations. 600 potential volunteers. Many languages. Wide range
of expectations. Use of own devices. Public app stores. No direct
connection between Management team and Volunteers
This work is related to a Department of the Navy (DoN) Grant (N62909-11-01-7025) and two DoN Contracts (N68181-11-P-9000 and N68171-12-P-9000) which were awarded by the Office
of Naval Research Global (ONRG) and funded by the Coalition Warfare Program. The views expressed herein are solely those of the authors and do not represent or reflect the views of 4
any government agency or organization that participated in the project or mentioned herein.

5. INSTRUCTIONS
• US Directives related to „Protection of Human Subjects and
Adherence to Ethical Standards in DoD-Supported Research”
• 32 CFR 219
• DoD Directive 5400.11
• DoD Directive 3216.2
• DoD Instruction 3210.7
• SECNAVINST 3900.39D
• UK MoD Ethics JSP 536
• EU Directives related to „Protection of Human Subjects and
Adherence to Ethical Standards in DoD-Supported Research”
• Ethical Review in Seventh Framework Programme (FP7)
• EU Directive 95/46/EC
• Guidance for Informed Consent
This work is related to a Department of the Navy (DoN) Grant (N62909-11-01-7025) and two DoN Contracts (N68181-11-P-9000 and N68171-12-P-9000) which were awarded by the Office
of Naval Research Global (ONRG) and funded by the Coalition Warfare Program. The views expressed herein are solely those of the authors and do not represent or reflect the views of 5
any government agency or organization that participated in the project or mentioned herein.

6. 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 RDT&D must also
meet the requirements of other countries when the research is
conducted outside the US
This work is related to a Department of the Navy (DoN) Grant (N62909-11-01-7025) and two DoN Contracts (N68181-11-P-9000 and N68171-12-P-9000) which were awarded by the Office
of Naval Research Global (ONRG) and funded by the Coalition Warfare Program. The views expressed herein are solely those of the authors and do not represent or reflect the views of 6
any government agency or organization that participated in the project or mentioned herein.

7. PROTECTION OF HUMAN SUBJECTS
32 CFR 219 (Sec 219.101):
Unless otherwise required by department or agency heads,
research activities in which the only involvement of human
subjects will be in one or more of the following categories
are exempt from this policy:
(1) Research conducted in established or commonly
accepted educational settings, involving normal educational
practices, such as (i) research on regular and special
educational instructional strategies, or (ii) research on the
effectiveness of or the comparison among instructional
techniques, curricula, or classroom management methods
This work is related to a Department of the Navy (DoN) Grant (N62909-11-01-7025) and two DoN Contracts (N68181-11-P-9000 and N68171-12-P-9000) which were awarded by the Office
of Naval Research Global (ONRG) and funded by the Coalition Warfare Program. The views expressed herein are solely those of the authors and do not represent or reflect the views of 7
any government agency or organization that participated in the project or mentioned herein.

8. UK MINISTRY OF DEFENCE JSP 536
Joint Service Publication (JSP) sets our MoD Instructions for the
ethical conduct of MoD Services (both clinical and non-clinical) and
ethical treatment of human participants.
- Conduct research upon the human participant
- Conduct research to collect data on an identifiable individual’s
behaviour either directly or indirectly (such as a questionnaire or
observation)
- Identifies Required Ethical Standards for Research (General
Principles)
- Health and Safety
- Stages of Ethical Review
This work is related to a Department of the Navy (DoN) Grant (N62909-11-01-7025) and two DoN Contracts (N68181-11-P-9000 and N68171-12-P-9000) which were awarded by the Office
of Naval Research Global (ONRG) and funded by the Coalition Warfare Program. The views expressed herein are solely those of the authors and do not represent or reflect the views of 8
any government agency or organization that participated in the project or mentioned herein.

9. “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).”
This work is related to a Department of the Navy (DoN) Grant (N62909-11-01-7025) and two DoN Contracts (N68181-11-P-9000 and N68171-12-P-9000) which were awarded by the Office
of Naval Research Global (ONRG) and funded by the Coalition Warfare Program. The views expressed herein are solely those of the authors and do not represent or reflect the views of 9
any government agency or organization that participated in the project or mentioned herein.

10. BASIC RESEARCH PROTOCOL ISSUES
Basic Research Issues must include:
1. Respect for persons – autonomous human beings
2. Benefice – minimal risk and maximum benefits
3. Justice – treat people fair and design the research equitably
4. Informed Consent – proficiency in the English Language
5. Right „not to answer‟ any questions
6. Information that will be collected
7. Handling of data collected
8. Voluntary Participation and Withdrawal
9. Confidentiality
10. Consent (Acknowledgement)
This work is related to a Department of the Navy (DoN) Grant (N62909-11-01-7025) and two DoN Contracts (N68181-11-P-9000 and N68171-12-P-9000) which were awarded by the Office
of Naval Research Global (ONRG) and funded by the Coalition Warfare Program. The views expressed herein are solely those of the authors and do not represent or reflect the views of 10
any government agency or organization that participated in the project or mentioned herein.

11. Email Online
App install Activate Try it out Evaluation
announcement registration
This work is related to a Department of the Navy (DoN) Grant (N62909-11-01-7025) and two DoN Contracts (N68181-11-P-9000 and N68171-12-P-9000) which were awarded by the Office
of Naval Research Global (ONRG) and funded by the Coalition Warfare Program. The views expressed herein are solely those of the authors and do not represent or reflect the views of
any government agency or organization that participated in the project or mentioned herein.

12. Email Online
App install Activate Try it out Evaluation
announcement registration
Anonymous
demographic
data
You need to
consent to
activate your pin
This work is related to a Department of the Navy (DoN) Grant (N62909-11-01-7025) and two DoN Contracts (N68181-11-P-9000 and N68171-12-P-9000) which were awarded by the Office
of Naval Research Global (ONRG) and funded by the Coalition Warfare Program. The views expressed herein are solely those of the authors and do not represent or reflect the views of
any government agency or organization that participated in the project or mentioned herein.

13. Email Online
App install Activate Try it out Evaluation
announcement registration
Multi lingual
versions of both
demographic form,
and consent form
This work is related to a Department of the Navy (DoN) Grant (N62909-11-01-7025) and two DoN Contracts (N68181-11-P-9000 and N68171-12-P-9000) which were awarded by the Office
of Naval Research Global (ONRG) and funded by the Coalition Warfare Program. The views expressed herein are solely those of the authors and do not represent or reflect the views of
any government agency or organization that participated in the project or mentioned herein.

14. Email Online
App install Activate Try it out Evaluation
announcement registration
App publicly available from
This work is related to a Department of the Navy (DoN) Grant (N62909-11-01-7025) and two DoN Contracts (N68181-11-P-9000 and N68171-12-P-9000) all app stores. by the Office
which were awarded
of Naval Research Global (ONRG) and funded by the Coalition Warfare Program. The views expressed herein are solely those of the authors and do not represent or reflect the views of
any government agency or organization that participated in the project or mentioned herein.

15. Email Online
App install Activate Try it out Evaluation
announcement registration
Enter your unique pin
number to unlock the app.
You need to be online at this
point
This work is related to a Department of the Navy (DoN) Grant (N62909-11-01-7025) and two DoN Contracts (N68181-11-P-9000 and N68171-12-P-9000) which were awarded by the Office
of Naval Research Global (ONRG) and funded by the Coalition Warfare Program. The views expressed herein are solely those of the authors and do not represent or reflect the views of
any government agency or organization that participated in the project or mentioned herein.

16. Email Online
App install Activate Try it out Evaluation
announcement registration
The Menu has six major content categories:
Mission Tools
A collection of interactive job aids to support mission preparation and
performance in the field.
Learning
The Learning section focuses on informal and formal training experiences.
Library
The Library contains a multimedia collection of indexed materials in different
media (text, eBook, video) covering topics relevant to the organization and
delivery of healthcare services in a humanitarian or relief mission.
Mission Packs
Mission packs is not yet active.
Standards
The Standards section contains materials to allow users to review international
rules of engagement and understand legal and ethical responsibilities.
Network
The Network section is an area intended to facilitate finding, documenting and
sharing information about resources on a mission.
This work is related to a Department of the Navy (DoN) Grant (N62909-11-01-7025) and two DoN Contracts (N68181-11-P-9000 and N68171-12-P-9000) which were awarded by the Office
of Naval Research Global (ONRG) and funded by the Coalition Warfare Program. The views expressed herein are solely those of the authors and do not represent or reflect the views of
any government agency or organization that participated in the project or mentioned herein.

17. Email Online
App install Activate Try it out Evaluation
announcement registration
For the evaluation process, you will
be asked to assume you are taking
part in a disaster relief scenario.
You will be required to carry out a
series of tasks within the content of
the app.
This work is related to a Department of the Navy (DoN) Grant (N62909-11-01-7025) and two DoN Contracts (N68181-11-P-9000 and N68171-12-P-9000) which were awarded by the Office
of Naval Research Global (ONRG) and funded by the Coalition Warfare Program. The views expressed herein are solely those of the authors and do not represent or reflect the views of
any government agency or organization that participated in the project or mentioned herein.

18. “IN APP” EVALUATION
Volunteers complete the evaluation “in
app”.
This allows for richer access to real time
tracking data, as well as consistent data
collection across the 22 trial nations
Evaluation is multi-lingual
Transparent data collection
This work is related to a Department of the Navy (DoN) Grant (N62909-11-01-7025) and two DoN Contracts (N68181-11-P-9000 and N68171-12-P-9000) which were awarded by the Office
of Naval Research Global (ONRG) and funded by the Coalition Warfare Program. The views expressed herein are solely those of the authors and do not represent or reflect the views of
any government agency or organization that participated in the project or mentioned herein.

19. “IN APP” EVALUATION
APP: This jumps you into
EVAL: Press the Go the app to do the task. EVAL: Answer the
button to start your questions about
task. Press Evaluation to get that task to proceed
back
This work is related to a Department of the Navy (DoN) Grant (N62909-11-01-7025) and two DoN Contracts (N68181-11-P-9000 and N68171-12-P-9000) which were awarded by the Office
of Naval Research Global (ONRG) and funded by the Coalition Warfare Program. The views expressed herein are solely those of the authors and do not represent or reflect the views of
any government agency or organization that participated in the project or mentioned herein.

20. TRANSPARENT DATA COLLECTION
This work is related to a Department of the Navy (DoN) Grant (N62909-11-01-7025) and two DoN Contracts (N68181-11-P-9000 and N68171-12-P-9000) which were awarded by the Office
of Naval Research Global (ONRG) and funded by the Coalition Warfare Program. The views expressed herein are solely those of the authors and do not represent or reflect the views of
any government agency or organization that participated in the project or mentioned herein.

21. CONCLUSION
• Demonstrated project objectives and fulfilled ethical and social
responsibility practices
• Involved a complex development and testing strategy to
incorporate US, EU and International Research Ethics Guidelines
• Successful development, testing and evaluation was the
collective effort of all three working groups and international
partners
This work is related to a Department of the Navy (DoN) Grant (N62909-11-01-7025) and two DoN Contracts (N68181-11-P-9000 and N68171-12-P-9000) which were awarded by the Office
of Naval Research Global (ONRG) and funded by the Coalition Warfare Program. The views expressed herein are solely those of the authors and do not represent or reflect the views of 22
any government agency or organization that participated in the project or mentioned herein.

22. QUESTIONS & COMMENTS
This work is related to a Department of the Navy (DoN) Grant (N62909-11-01-7025) and two DoN Contracts (N68181-11-P-9000 and N68171-12-P-9000) which were awarded by the Office
of Naval Research Global (ONRG) and funded by the Coalition Warfare Program. The views expressed herein are solely those of the authors and do not represent or reflect the views of 23
any government agency or organization that participated in the project or mentioned herein.