VHA Office of Research and Development

VA ORD ? AO/ACOS Guide ver. 3.0 June 2022, replaces May 2020

VHA Office of Research and Development

Manual for Administrative Officers and Associate Chiefs of Staff

Version 3.0

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VA ORD ? AO/ACOS Guide ver. 3.0 June 2022, replaces May 2020

TABLE OF CONTENTS

FOREWORD ................................................................................................................................................... 8 INTRODUCTION............................................................................................................................................. 9

FINDING HELP ..................................................................................................................................... 10 ORD RESEARCH ? Office of Research & Development................................................................................ 11

An Overview of the Organization and Structure of ORD .................................................................... 11 Actively Manage Portfolios and Priority Areas of Research ............................................................... 13 Who's Who in Central Office .................................................................................................................. 14 Who's at Your Facility ............................................................................................................................. 14 Field Research Advisory Committee ....................................................................................................... 15 National Research Advisory Council ....................................................................................................... 15 Key Contacts ORD-Wide.......................................................................................................................... 16 VA Regions and VISN Area ...................................................................................................................... 17 Field Research Programs............................................................................................................................. 18 THE ADMINISTRATIVE OFFICER................................................................................................................... 19 THE ASSOCIATE CHIEF OF STAFF, RESEARCH & DEVELOPMENT................................................................. 20 ACRONYMS ................................................................................................................................................. 21 SECTION 1 ? Basic Information ................................................................................................................... 25 What is Research?................................................................................................................................... 25 Why Does the VA have a Research Program? ........................................................................................ 25 VA and VHA Handbooks and Directives .................................................................................................. 27 SECTION 2 ? Getting a Research Project Approved at the "X" VA.............................................................. 28 How to Determine If a Project Meets the Definition of VA Research .................................................... 28 Who Can Be a VA Investigator? .............................................................................................................. 28 The Process to Become a VA Investigator .............................................................................................. 28 Principal Investigator Orientation........................................................................................................... 28 1. To initiate a project, contact the Research Office ...................................................................... 29 2. What subcommittee approvals are needed for the proposed project?..................................... 30 3. R&D Approval.............................................................................................................................. 32 4. Required Training to Perform Research at the VA...................................................................... 32 SECTION 3 ? Finance Background ............................................................................................................... 33 Types of Money....................................................................................................................................... 34 Veterans Equitable Resource Allocation (VERA) Funds ...................................................................... 34 Award Funds ....................................................................................................................................... 36 Financial Systems .................................................................................................................................... 36 VistA .................................................................................................................................................... 36

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RDIS ..................................................................................................................................................... 36 FMS ..................................................................................................................................................... 37 Available Resources ................................................................................................................................ 39 WinRMS............................................................................................................................................... 39 RAFT ? Research Analysis and Forecasting Tool ................................................................................. 39 Income .................................................................................................................................................... 41 Expense ................................................................................................................................................... 42 Contracts ? What are they and how are they funded? ...................................................................... 42 General Post Funds ................................................................................................................................. 44 Managing Research Funding................................................................................................................... 45 VA Nonprofit Corporation....................................................................................................................... 45 SECTION 4 ? Human Resources (HR)........................................................................................................... 47 Appointment Types:................................................................................................................................ 47 Appointment Authorities ? Title 38 vs Title 5 ......................................................................................... 48 Appointment Authorities ........................................................................................................................ 48 Competitive Status.............................................................................................................................. 48 Noncompetitive and Excepted Appointments.................................................................................... 49 Schedule B........................................................................................................................................... 51 Schedule A Appointments ................................................................................................................... 51 Title 38 and Title 38 Hybrids................................................................................................................ 51 Veterans' Appointments ..................................................................................................................... 52 Use of Schedule B Vs. Title 38 Medical Support Authority ................................................................. 53 VA Recruitment Process in Brief ......................................................................................................... 53 Without Compensation Employees ........................................................................................................ 54 Intergovernmental Agency Personnel Agreements................................................................................ 55 Regulatory Authorities ........................................................................................................................ 55 Which organizations can participate in the IPA program? ................................................................. 55 Which individuals can come to the VA on an IPA? ............................................................................. 56 Term Limits of IPAs ............................................................................................................................. 56 Setting Up an IPA ................................................................................................................................ 56 Joint Personnel Agreements (JPA) .......................................................................................................... 58 Factors to Consider When Hiring VA Employees in Research Service .................................................... 58 Request for Personnel Action ................................................................................................................. 58 Recruitment ............................................................................................................................................ 59 Disciplinary Actions and Union Interaction ............................................................................................ 59 On-the-Job Injury .................................................................................................................................... 60 Performance Appraisals .......................................................................................................................... 60

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Incentive Awards..................................................................................................................................... 61 Quality Step Increase (QSI) ..................................................................................................................... 61 Managing Office Schedules and Leave ................................................................................................... 62 Liaison with HR........................................................................................................................................ 62

Tips on Working with Human Resources: ........................................................................................... 63 Sabbaticals - Local ................................................................................................................................... 63 SECTION 5 ? Applying for VA-funding eRA and Merit Review .................................................................. 64 Eligibility .................................................................................................................................................. 66 Calendar .................................................................................................................................................. 67 Submission Process ................................................................................................................................. 67 System for Award Management ............................................................................................................. 67 Pre-Review .............................................................................................................................................. 68 Award ...................................................................................................................................................... 68 Post Award .............................................................................................................................................. 68 ShEEP (Shared Equipment Evaluation Program) and LAMb (Laboratory Animal Major Equipment) Program................................................................................................................................................... 69 Protected Time for Research and Relationship to VERA ........................................................................ 69

Growing a Program ? Career Development Award ............................................................................ 74 Career Scientist ................................................................................................................................... 75 Starting a New Program ...................................................................................................................... 76 SECTION 6 ? Travel...................................................................................................................................... 78 SECTION 7 ? Working with Supply Chain Management ............................................................................. 83 Equipment Inventories............................................................................................................................ 83 SECTION 8 ? Credentialing for Research Staff Engaged In Human Subjects Research Projects at the XVAMC ........................................................................................................................................................ 85 Types of Personnel Engaged in Human Subjects Research .................................................................... 85 Responsibilities ....................................................................................................................................... 85 Research Scope of Practice or Scope of Work ........................................................................................ 85 Who Needs Clinical Privileging through VetPro?.................................................................................... 86 VetPro ................................................................................................................................................. 86 Registered Nurses ............................................................................................................................... 86 Human Studies Orientation ................................................................................................................ 86 How to determine if someone is engaged (or not engaged) in human subjects research................. 87 You are Not Engaged in human research if ........................................................................................ 87 SECTION 9 ? VA Training Requirements ..................................................................................................... 88 All Research Personnel Engaged in Human Subjects Research .............................................................. 88 Personnel Engaged in Animal Research.................................................................................................. 88 Personnel Engaged in Laboratory Research ........................................................................................... 88

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Training Required of all Working in VA Research ................................................................................... 88 SECTION 10 ? General Administrative Management.................................................................................. 89

Help Resolve Any Issues That Arise..................................................................................................... 89 Committees......................................................................................................................................... 89 Customer Service ................................................................................................................................ 90 Working with Clinical Services ................................................................................................................ 91 Research Space ....................................................................................................................................... 92 Assignment and Review of Space ....................................................................................................... 92 Renovations ........................................................................................................................................ 94 Tips in Space Management ................................................................................................................. 95 General Oversight of Research Lab Areas and Other Odds and Ends .................................................... 95 Enter Work Orders to Engineering...................................................................................................... 95 Examples Engineering Work Orders: .................................................................................................. 95 Involvement in Emergency Preparedness Plan................................................................................... 95 Emergency Cascade Plan .................................................................................................................... 96 Facility Level ........................................................................................................................................ 96 New Staff............................................................................................................................................. 96 PIV Badges........................................................................................................................................... 96 Service Needs...................................................................................................................................... 96 Oversight of Construction and Upgrade Projects ............................................................................... 97 Key Requests ....................................................................................................................................... 97 Hood Certification............................................................................................................................... 97 Prescription Pads for Research MDs ................................................................................................... 97 Staff Meetings ..................................................................................................................................... 98 Researcher Communication and Meetings......................................................................................... 98 Research Week Event Planning and Coordination.............................................................................. 98 SECTION 11 ? Information Technology (IT)................................................................................................. 99 IT Allocation ? Attention to Source of Computers and Data Storage Devices........................................ 99 VHA Research and Development IT/Informatics Guidance FAQs (Updated Annually) ............................ 101 ADPAC ? Automated Data Package Application Coordinator............................................................... 101 Information System Security Officer (ISSO) .......................................................................................... 101 Privacy Officer ....................................................................................................................................... 102 SECTION 12 ? Project Management ......................................................................................................... 103 Compliance Issues................................................................................................................................. 103 Tracking Dates....................................................................................................................................... 103 Liaison for Construction and Engineering Projects ............................................................................... 103 Paperwork Reduction Act ..................................................................................................................... 103

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SECTION 13 ? Compliance......................................................................................................................... 104 ORO ....................................................................................................................................................... 104 RCO........................................................................................................................................................ 105 Corrective Action Plan........................................................................................................................... 105

SECTION 14 ? Updating Databases ........................................................................................................... 106 ePROMISe ............................................................................................................................................. 106

RDIS ? Accessed thru ePROMISe............................................................................................................... 106 VAIRRS (VA Innovation and Research Review System)............................................................................. 106 SECTION 15 ? Affiliate University.............................................................................................................. 107

Time Effort MOU Guidance................................................................................................................... 107 Background ....................................................................................................................................... 107 Issues................................................................................................................................................. 108 Plan.................................................................................................................................................... 108 Guidance for MOUs: ......................................................................................................................... 108 NIH Requirements for Time and Effort MOU.................................................................................... 109

SECTION 16 - VA Non-Profit Corporations ................................................................................................ 111 SECTION 17 ? Local Facility ....................................................................................................................... 114

Services You'll Interact With: ............................................................................................................ 114 Emergency Procedures ......................................................................................................................... 115 SECTION 18 ? Safety & Security ................................................................................................................ 116 Directives & Handbooks........................................................................................................................ 116 SRS (Subcommittee on Research Safety).............................................................................................. 116 Safety Compliance ................................................................................................................................ 116 Security ................................................................................................................................................. 116 Information System Security Officer (ISSO) .......................................................................................... 117 Police Service ........................................................................................................................................ 117 SECTION 19 ? Privacy ................................................................................................................................ 118 Directives & Handbooks........................................................................................................................ 118 SECTION 20 ? Animal Program.................................................................................................................. 119 Handbooks ............................................................................................................................................ 119 Veterinary Medical Unit........................................................................................................................ 119 Institutional Animal Care and Use Committee ..................................................................................... 119 Assurance .............................................................................................................................................. 120 Reports.................................................................................................................................................. 120 SECTION 21 ? Site Visit Coordination........................................................................................................ 121 SECTION 22 ? IBC Registration and Annual Reporting.............................................................................. 122 Institutional Biosafety Committee ........................................................................................................ 122

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Who Must Be On the IBC .................................................................................................................. 122 The Institution shall file an annual report with NIH/OBA, which includes: ...................................... 122 SECTION 23 ? Human Research Protection Program................................................................................ 123 Office of Research Protections, Policy and Education .......................................................................... 123 FWA or Federal-Wide Assurance .......................................................................................................... 123 Belmont Report..................................................................................................................................... 123 The Common Rule................................................................................................................................. 124 Working with Boards and Committees ................................................................................................. 124 Research and Development Committee........................................................................................... 124 Institutional Review Board (IRB) ....................................................................................................... 125 Affiliate IRB........................................................................................................................................ 125 VA Central IRB ................................................................................................................................... 125 VA Central IRB Liaison ....................................................................................................................... 126 IRB of Another Federal Agency ......................................................................................................... 126 Single IRB Mandate () ................... 126 Subcommittee on Research Safety ................................................................................................... 126 Non-Research Committees Responsible for the Review of Research .................................................. 127 Pharmacy and Therapeutics Committee........................................................................................... 127 Radiation Safety Committee ............................................................................................................. 127 Key Issues to Address When Terminating Human Subject Studies at a VA Facility with a Human Research Protection Program ............................................................................................................... 128 VHA Office of Research and Development, March 25, 2016 ............................................................ 128 SECTION 24 ? SOPs.................................................................................................................................... 130 SECTION 25 ? VA Technology Transfer Program (TTP) ............................................................................. 131 Cooperative Research and Development Agreements (CRADAs) ........................................................ 131 SECTION 26 ? Records Control Schedule .................................................................................................. 133 Getting Started...................................................................................................................................... 134 Policies, Resources, and Helpful Links .................................................................................................. 136 SECTION 27 ? Financial Conflict of Interest The FCOI Form..................................................................... 138 SECTION 28 ? Publishing VA Research ...................................................................................................... 140 SECTION 29 ? Communications Working with the Public Affairs Office and ORD Communications ...... 141 SECTION 30 ? Research Misconduct Transgressions in Research............................................................ 142 Appendix A ? VHA DIRECTIVES AND HANDBOOKS and PROGRAM GUIDES............................................. 144 Appendix B? Useful Web Links ................................................................................................................. 145 Appendix C ? Research Calendar .............................................................................................................. 146 Appendix D? Other Commonly Used Forms ............................................................................................. 149

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VA ORD ? AO/ACOS Guide ver. 3.0 June 2022, replaces May 2020

FOREWORD

This third iteration of the ACOS/AO Handbook updates many sections based on the numerous changes in policy and procedures that have occurred over the past 3 years. We plan to continue updating every two years or as needed. Indeed, Research continues to be the best kept secret in the VA; however, many steps are underway to maximize communication to the field and stakeholders. Included are 9 initiatives and a reorganization that will optimize research over the next few years. VA continues to support an intramural program that blends the Clinical Care mission of the VA with its Research mission, with clinician scientists and non-clinician scientists seeking new and innovative ways to improve clinical diagnosis and therapies that will benefit its Veteran patients. The VA's Research program addresses clinical issues directly affecting Veterans, however many of the discoveries made by VA researchers are applicable to the population at large. In addition, VA research improves systems processes in care delivery, engages Veterans, and helps ensure that they receive high-quality, high-value health care. VA Research has been a key element in attracting and recruiting the best and brightest clinicians and non-clinicians to its facilities, as well as a tool to retain these extraordinary individuals. Underlying the research itself, and the investigators and staff who are directly engaged in the research, are unheralded individuals and teams who comprise Research Administration, and make it possible to execute the research mission. This starts in the Office of Research and Development, the Veterans Health Administration, and the VA Central Office, but it is carried out by the local Research Office on a day-to-day basis at the individual VA Medical Centers. The burden of responsibility in ensuring that investigators can perform their research duties ? in the most supportive of an environment possible ? lies with the Research Administrative Officer and the Associate Chief of Staff for Research and Development in the field office. Thus, this Manual is dedicated to all in Research Administration, who are the behind-the-scenes folks who facilitate the VA research enterprise.

"BECAUSE OF YOU, IT WORKS!" The AO/ACOS Training and Mentoring Group

Special thank you to Holly Birdsall, MD, Dean Yamaguchi, MD and Marisue Cody, PhD for getting the ball rolling on the initial version back in 2016. We want to also thank the Research Administration Council, the ACOSs, the AOs, the NPPO, the ROTC-D and the ORD program officials who contributed to the rewrite of this manual.

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