Research Protocol Teleconference
30 January 2014
Roll Call

Julie Howell SSC Pacific (RP Lead)

Janie Glover NETSAFA (Project Manager)

Dr. Mark Ahles DISAM (Deputy Project Manager)

Tink L’Ecuyer LMITT

Jacob Hodges LMITT

Introduction

/ Julie Howell

Discussion:

-  This teleconference was a follow-up action item from the 10 January 2014 Management Team Meeting intended to provide information to the Project Manager and Deputy Project Manager of the Research Protocol (RP) strategy.

-  Julie Howell kicked-off the teleconference by stating the approach for both the Security Cooperation Offices (SCO) Interim Evaluation and Concept Evaluation (CE) focused on streamlining the RP process in order to reduce workload and cost.

-  The RP approach developed ensures the rights to privacy, confidentiality, and voluntariness for each volunteer are adhered.

Research Protocol (RP) Process

/ Jacob Hodges

Discussion:

-  Jacob Hodges discussed the flowchart process that was provided as a read-ahead prior to the teleconference. Specific areas of discussion included:

·  Letter of Support for MLS Project – This letter will serve as the foundation for obtaining approval from DoN Commanding Officers, USAF Department Heads/ Division Officers, and the Commandant/Deputy Commandant Military Academic Institutions participating in the MLS Project (i.e., Security Cooperation Offices (SCO) Interim Evaluation and Concept Evaluation). A Letter of Support has already been drafted and provided to Julie Howell for review.

·  SCO Interim Evaluation Volunteers – Based on review of the recent report that provided a snapshot of Academic Institutions involved in the International Training Program, it showed that 1071 international students that participated in the study. If the same RP process is to be followed for both the SCO Interim Evaluation and CE, (1) Jacob Hodges will need to have the email address of the volunteers so that they will receive an email that invites them to participate in the CE, and (2) a process is needed that identifies who will be responsible for sending the names of volunteers to Jacob Hodges.

·  SCO Interim Evaluation Process – Depending on when the SCO Interim Evaluation is conducted (i.e., during the out-brief or check-in process), each volunteer will need to have an email address provided to Jacob Hodges so that a ‘Welcome’ email can be sent to the volunteer outlining the process as well as provide other key information (i.e., PIN, copy of the MLS Informed Consent, etc.).

·  SSC Pacific IRB Approval Request – Once Letters of Approval for participation in the MLS Project has been received, Jacob Hodges will prepare the RP Request Package for Julie Howell. Once this package has been received, it will undergo a Scientific Review as well as an External Review (i.e., a Senior Scientist at SSC Pacific that is not tied to the project or the SSC Pacific IRB).

·  MLS Research Protocol Approval Approach – The initial request for conducting the SCO Interim Evaluation will include Letters of Approvals for those in the US. Once this protocol has been approved, the approved package will be modified to reflect the CE – the inclusion of international partners. Once the RP Management Team receives the International Letters of Approval, an Expedited Review (ER) will be requested.

·  Research Protocol Reports – Once the MLS Project has concluded, a final report is required in accordance with SSC Pacific Research Protocol Requirements. Upon completion of the SCO Interim Evaluation, a draft report will be prepared for review by the Management Team to ensure it accurately reflects the process utilized as well as the results of the interim evaluation. It will be combined with the report from the CE to ensure a comprehensive research protocol report is provided.

Discussion Topics

/ Janie Glover/ Dr. Mark Ahles

Discussion:

-  Janie Glover wanted to know if the Letter of Support for participation in the Security Cooperation Offices (SCO) Interim Evaluation could be signed by the Defense Security Cooperation Agency (DSCA) since DSCA endorsed the MLS Project, or if it should to be signed by each individual academic institution.

·  Jacob Hodges agreed that it would be easier to obtain a letter from DSCA versus each of the individual academic institution; however, in supporting the Testing & Evaluation (TE) process, we need to get an idea regarding how many volunteers will be asked to contacted vs. how may are expected to actually participate so that the data collection provides is statistically valid.

-  Janie Glover and Mark Ahles confirmed that each international student attending courses in the US has an email address; not a government email address but one that they can be contacted.

·  Jacob Hodges added that this process needs to be identified so that each potential volunteer is contacted. [If participation in the SCO Interim Evaluation is not conducted in via email, it would mean someone will be responsible for administering the Informed Consents in person, informing the volunteers of their respective Personal Identification Number (PIN) and forwarding the signed Informed Consent Documents to an appropriate MLS RP Team member.]

Action items: / POC: / Deadline:
Determine (1) if it is appropriate for DSCA to sign an overarching Letter of Support for the Academic Institutions participating in the SCO or (2) if individual Academic Institution Letters are more appropriate. / Janie Glover/ Dr. Mark Ahles / 28 Feb 2014
Identify the most effective approach for conducting the SCO Interim Evaluation (i.e., who to contact, during out-brief or check-in). / Tink L’Ecuyer/ Jacob Hodges / 1 Mar 2014
Identify the “country” participants that will participate in the SCO Interim Evaluation / Janie Glover/ Dr. Mark Ahles / 10 Mar 2014
Identify the Academic Institutions that will participate in the SCO Interim Evaluation / Dr. Mark Ahles / 14 Mar 2014
Identify informational requirements for conducting the SCO Interim Evaluation / Jacob Hodges / 14 Mar 2014
Develop the process for obtaining SCO Interim Evaluation Volunteer e-mail contact information / Jacob Hodges / 30 Mar 2014
Submit the MLS SCO Interim Evaluation Research Protocol Request Package to Julie Howell / Jacob Hodges / 21 Apr 2014
Prepare the [Draft] SCO Interim Evaluation Research Protocol Report / Jacob Hodges / 15 Aug 2014
Prepare the [Draft] CE Research Protocol Report / Jacob Hodges / 1 Jun 2015
Submit comprehensive MLS Research Protocol Report to SSC Pacific / Jacob Hodges / 30 Jun 2015

Research Protocol Conference Call Minutes – 30 January 2014Page 1