Precision Military Medicine: Conducting a multi-site clinical utility study of genomic and lifestyle risk factors in the United States Air Force

Susan K Delaney,Tara J Schmidlen,Ruth Brenner,Erynn S Gordon,Leo Jose,Kim E London,Joseph P Jarvis,Laura B Scheinfeldt,Kaveri D Rajula,Michael P Dempsey,Mark Bellafante,Ashley Nasuti,Michael F Christman,Norman P Gerry

doi:10.1038/s41525-016-0004-1

Abstract

Following several years enrolling disease-specific and otherwise healthy cohorts into the Coriell Personalized Medicine Collaborative, a prospective study aimed at evaluating the clinical utility of personal genomic information for common complex disease and pharmacogenomics, the Coriell Personalized Medicine Collaborative expanded to create a military cohort, specifically, the United States Air Force. Initial recruitment focused on Air Force Medical Service personnel and later expanded to include all Active Duty Air Force members and beneficiaries. Now in its 6th year, the study has produced a wide variety of insights, including optimal study design for military-sponsored genomic research, and discussion on genetic information sharing between and amongst Air Force study participants, civilian and military researchers, and the United States Department of Defense. Over the longer term, analyses will further contribute to the development of policies and processes relevant to clinical decision support and data sharing within the US military, and on-going work with the Air Force Medical Service sub-cohort will generate critical insights into how best to deploy useful genomic information in clinical care. Here we discuss challenges faced and critical success factors for military-civilian collaborations around genomic research.

Highlights

INTRODUCTIONSurgeon General Directive and launched by the Air Force Medical Service (AFMS) Innovations to gather clinical knowledge and provide recommendations for translating genome-informed medicine into precision healthcare for all Air Force (AF) healthcare beneficiaries
In 2010 the Air Force Medical Service (AFMS) Patient-CenteredPrecision Care (PC2-Z) Program was established as an Air ForceSurgeon General Directive and launched by the AFMS Innovations to gather clinical knowledge and provide recommendations for translating genome-informed medicine into precision healthcare for all Air Force (AF) healthcare beneficiaries
The Coriell Personalized MedicineCollaborative (CPMC) is an ongoing prospective study investigating the impact of personalized genetic risk reports for common complex diseases and drug metabolism on health behavior and outcomes; the CPMC’s actionable variant list is available on the study website.[1]

Summary

INTRODUCTION

Surgeon General Directive and launched by the AFMS Innovations to gather clinical knowledge and provide recommendations for translating genome-informed medicine into precision healthcare for all Air Force (AF) healthcare beneficiaries. CHARTING A NEW COURSE IN MILITARY PRECISION MEDICINE RESEARCH The CUS protocol is the first USAF research study to return genome-based risk reports to healthy participants Charting this novel course required more specific considerations of military human subject research such as presence of superiors during recruitment activities (perceived coercion), Cadet/Basic Trainee enrollment in a “Greater than Minimal Risk” (GTMR) protocol, genetic privacy protections, and national security of personnel medical and deployment data. After expressing interest to Coriell study staff potential participants view an AFRL/IRB-approved 20-min video on an iPad which describes the study and purpose, what to expect as a CUS participant, the risks and benefits of participation, what they may learn during their participation, who to contact if they need to report an adverse event, and other key details about the study This video enables a comprehensive and consistent review of the informed consent document (ICD) and enables the efficient enrollment of multiple participants at once and at staggered times.

Findings

DISCUSSION

CONCLUSION