VA Ann Arbor Research Service Guidance Documents & Resources - VA Ann Arbor Healthcare System Research Services
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VA Ann Arbor Healthcare System Research Services

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VA Ann Arbor Research Service Guidance Documents & Resources

 

To better serve the VA Ann Arbor research community, we have begun and will be continuously working on guidance documents for all things related to starting & executing research studies at the VA Ann Arbor Medical Center and the associated outpatient clinics. As such, this page will be an ongoing work in progress. If the information you need is not available on this website, please send a request to Christopher Robinson.





Grants


VA Research Funding

VA research funding differs from that provided by other federal research agencies. VA research focuses only on the needs of Veterans and funding is only awarded to VA employees with at least a 5/8 appointment. VA researchers often have joint appointments and collaborate with affiliate academic institutions. In the case of the Ann Arbor VA Healthcare System (AAVAHCS) the institution is the University of Michigan. If you are interested in applying for VA research funding, this page includes links to forms, guidance and contacts to assist you.

Our Grant Specialist locally is:

Michele B. Weston
734-845-3766
Michele.Weston@va.gov

 

Veterans Affairs Funding Opportunities and Just-in-Time (JIT)

RDC Project “Approval to Submit” is required for VA funded opportunities. The Research Department recommends that Project Application are submitted well in advance of program submission deadlines. eRA Commons is used by our station to access Application Submission System & Interface for Submission Tracking (ASSIST). Once awarded Samuel McVean and Michele Weston will assist the Investigator in the Just-in-Time “JIT” award documents and correspondence to central office.


Funding Programs & Submission Calendars:

  • Rehabilitation Research and Development (RR&D)
    • Letter of Intent – May (Summer) / November (Winter)
      • Parent Merit / Career Development Awards – June (Summer) / December (Winter)
    • Letter of Intent – February (Spring) / August (Fall)
      • Small Projects in Rehabilitation Research (SPiRE) March (Spring) / September (Fall)
  • Biomedical Laboratory Research & Development (BLRD)
    • Letter of Intent for CDA and Specials – November (Spring) / May (Fall)
      • Parent Merit / Career Development Awards / Special – March (Spring) / September (Fall)
  • Clinical Science Research and Development (CSRD)
    • Letter of Intent for CDA / Clinical Trials / Specials – November (Spring) / May (Fall)
      • Parent Merit / Career Development Awards/ Clinical Trials / Special – March (Spring) / September (Fall)
  • Health Services Research and Development (HSR&D)
    • Letter of Intent (LOI) may be required depending on the RFA - POC Fatima Makki, Fatima.Makki@va.gov


Frequently Required Information for Grant Submissions

 

Applicant Agency

Organization VA Ann Arbor Healthcare System Veterans Education and Research Association of Michigan (VERAM)
Department Research & Development ---------
Address 2215 Fuller Road, Ann Arbor, MI 48105-2303 Same
County Washtenaw Same
EIN 38-3149486 38-3060217
DUNS 0963184800000 142195713
Congressional District MI-012 Same
Authorized Representative William Weitzel, M.D. Birgit Roller, Executive Director
Contact Samuel McVean, RSC Coordinator Birgit Roller, Executive Director
Phone 734-845-5602 734-222-7125
Fax 734-845-3241 Same

Links to Useful Resources

 Content for the "resources" section of grant applications
 Federalwide Assurance (search FWA00000348)
 Grant Submission Forms
Grants.Gov (Outside Access)
Grant Proposal Guidance and Templates
Request for Applications (RFA’s) and Program Announcements
Submission Calendar for All R&D Services


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Starting a New Research Project


Determine if Your Project is a Research Project

Does your Project Require Research & Development Review?
Decision Tree for determing if your project is QI vs. Research


New Research Project Regulatory Requirements

All R&D (project), IRB (protcol) and Safety (if applicable) applications must be completed in AAROW (See AAROW "Help" Section for more guidance documents). IACUC is still paper-based but we hope to transition to AAROW in the future. In the meantime, contact Carolyn.Slusher@va.gov if you need assistance navigating IACUC-related submissions.

Submissions that are received, committee-ready, when the agenda is finalized will be on the agenda for that meeting.  We do our best to accommodate timely review; the agenda closes 7-10 business days before the committee meets and we may not be able to accommodate submissions that arrive less than 10 days before meeting, or are not committee-ready at that time.

Order of Committee Review and Meeting Schedule

Committee Day of month
R&D 1st Wed
IRB 2nd Thur
IACUC 2nd Fri
Safety 3rd Thur

Information Security/ Privacy Review

Pre-review & after IRB Final Approval

R&D Committee

Final Review & Approval

 ACOS Initiation Letter

Issued by email after final RDC Approval


***DO NOT BEGIN RESEARCH UNTIL AFTER RECEIVING ACOS INTITIATION LETTER.****
The Research and Development will issue the RDC approval and the ACOS approval memoranda’s once all required subcommittee protocols and reviews are completed. There are two types: (1) Full Board final review and (2) Designated Member final review. Decision will be made regarding which type will be needed at the initial review conducted at the RDC Meeting.


Other Significant Things to be AWARE of
:

  • Conflict of Interest: Project Conflicts of Interest are required for all submission for all Principal Investigator and Co- Principal Investigator at the time of Project submission. Annual Research conflict of Interest Statements are required yearly by all investigators.
  • Project Forms in AAROW: (1) Project Staff Change, (2) RDC Project Closure, (3) RDC Project Amendment (Major Protocol changes and PI changes), and (4) RDC Continuing Review (12 month intervals with reminders via AAROW).
  • Project Correspondence: Project correspondence is generated under the individual projects to the Principal Investigators and the Research Support Staff. Note: AAROW email correspondence will come from vaannarbor@imedris.net


RDC Guidance Documents

Funding Source Codes
Scope of Practice Guidance
Checklist for publishing VA research

Links to Useful Resources

ORD Policies and Guidance Documents 
 ORD VHA Directive, Handbooks, and Program Guides -- 1200 series
 VHA Office of Research & Development Intranet
 Office of Research Protections, Policy, and Education Webinars


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Human Subjects Research


IRB Guidance Documents

Does my project require IRB review?
IRB Exemption Categories for Revised Common Rule
Scanning VA Consent Forms into CPRS: when is it required?
Scanning Consent Forms, Instructions
Requirements for Reporting Study Monitor Visits to IRB
Local IRB Requirements for Central IRB Studies


Other Significant Things to be AWARE of:

  • If using Non-Veterans as Research Subjects, you will need approval from the R&D Committee.
  • Approved VA Research needs to benefit Veterans.
  • Information should be consistent between the R&D Application, IRB Application, and the Protocol. (Number of participants being recruited, etc.…)
  • Use of Email as a means of communication with Research Subjects is strictly PROHIBITED!
  • Training should be current and noted in your submission documents as well as your Regulatory Binder.
  • Revisions should always include NEW revision dates so that the IRB staff as well as outside auditors can keep track of current updates to your protocol/documents.
  • Always submit a “Tracked Changes” version of your documents when requesting a modification, as well as clean versions for easy review.
  • And finally, please make sure that the IRB Application ONLY reflects those activities that are occurring under the purview of the VA.
Best practice for obtaining consent:
  • It is very important to use the most recent IRB-approved informed consent version when obtaining consent from a study participant.
  • Use a Consent Checklist for each consent obtained.
  • Retain the original copy and provide a copy of the original to the study participant.
  • If required by IRB, enter a Research Enrollment Note and attach a scanned copy of the consent to the note.
  • Secure original consent forms in a locked filing cabinet within a locked office.


Research Compliance

The Research Compliance Office will perform annual consent audits and triennial binder audits.

The process for an Informed Consent Audit (ICA) is to: 1) respond to the RCO audit notice, 2) submit all Consents, HIPAA Authorization Forms, and Consent Checklists obtained since project approval or since previous ICA (copies of original forms preferred), 3) submit a Scope of Practice (SOP) form for any person obtaining & signing consent, and 4) submit a list of all consent versions approved by IRB with their dates of approval.

The process for a Regulatory Binder Audit (RBA) is to: 1) respond to RCO audit notice, 2) ensure binder is complete and up-to-date, 3) submit paper or electronic Regulatory Binder.

Study-Specific Regulatory Binders should be assembled and maintained in a manner that produces a single-source repository of all required documentation. We understand that assembling, organizing and maintaining your required binder will require considerable time and effort. To help you prepare for these comprehensive audits, we are providing the attached set of documents to assist you in meeting this VA Office of Research Oversight requirement. You will be notified in advance of your audit date with as much lead time as possible but it is recommended that you begin the preparation of your binder as soon as possible. Feel free to contact the Research Compliance Officer, Scott Sample, with questions.

Human Studies Research Regulatory Binder [12/23/14]
(New Instructions+Section Headings - Clarification on eBinders, Master List of Subjects (No Longer Required), and Obtaining Informed Consent PRIOR to First Research activity!)
Informed Consent CheckList [11/26/19]
(Recommended by RCO for each consented subject)
(Now includes check-box for HIPAA Authorization Form]


Clinical Research Project Management

Project Managers and Clinical Research Coordinators intersted in gaining access to more tips, tricks, templates, etc. for clinical research projects, contact Christopher Robinson to request access to the network folder listed below.

T:\COS (11)\11r\Clinical Research Center (CRC)\Clinical Research Resources

Entering & Signing Research Enrollment Notes in CPRS
Adverse Event and Protocol Deviation log for Continuing Review
Note-to-File Template for Protocol Deviations
Instructions for Utilizing VA Ann Arbor Pathology Services - Phlebotomy
Quarterly Report of Pathology Services Usage for Payment by Research Service



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Animal Research

Every initial protocol submission in AAROW includes a Research Safety Hazard Assessment Survey.  If the protocol uses any of the following, AAROW brings them to Laboratory Safety Hazard Assessment Form which is reviewed by the Research Subcommittee on Research Safety. Safety Amendments & Continuing Review can be completed in AAROW from the Protocol Manager. Please contact Carolyn Slusher, the Safety Coordinator, with questions.

IACUC Guidance Documents

Instructions for ACORP Version 4
ULAM Purchasing Guidelines



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Purchasing and Contracting

All purchases made with VA research funds must be made through the Research Office or CCMR. This includes but is not limited to general supplies, computers and IT supplies, equipment, contracts and animals. The Research Service Business Office and CCMR's administrative staff assist studies in many other ways as well. The table below includes the services available and appropriate contact person.

Please note: If you are new to the world of VA purchasing and contracting, it is helpful to contact the Business Office staff as soon as possible in the process.

Services Research Office Contact CCMR Contact
Grant budget development assistance and consultation Elizabeth Koester, Christine Basmajian Fatima Makki
Purchase of goods and services Jessica Bryant Beverly Hall, Michael Robertson
Subcontracts/subawards Jessica Bryant Kimberly Beers, Mike Palmer, Tabitha Metreger, Michael Robertson 
Travel Jessica Bryant Laura Poma
Subject payment Jessica Bryant Beverly Hall
IPAs Jessica Bryant

Theresa Spencer

Here are some forms used in the purchasing and contracting process. Do not attempt to complete these yourself unless you have had substantial experience doing this in the past. Otherwise, please contact the staff member listed above for guidance.

 Purchase Order
 FMS Vendor File Request Form
 Justification for Single Source Awards <$150,000
 Justification for Single Source Awards >$150,000



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Disposal of Temporary Research Records

Research records that have met their Records Control Schedule (RCS), by the approved NARA schedule or other contractual obligation (whichever retention schedule is longest), may be disposed of. Any temporary research records created as part of VAAAHS approved research are subject to the approved NARA schedule for disposition, and must remain VAAAAHS property even if an investigator transfers to another facility. Inventory of destroyed records is required to be maintained by a Research Service Records Liaison (RL). Temporary records may not be disposed of until the retention period in the RCS has been met.

  • Paper Records. Paper records may be destroyed using approved shred bins. Prior to destruction, the RL must complete VA Form 7468 (Request for Disposition of Records).   This form is to be completed by the Service Records Liaison (Catherine Kaczmarek/Terry Robinson/ Sheena Hatcher), signed by the Records Officer and a file copy is to be kept by both, the RL and the RO. Please contact the Research Office BEFORE the disposition of research records.
  • Compact Discs/DVDs. CD/DVD’s are collected and boxed by the Research Service RL, prior to having another contractor pick them up, taking them to their facility, shredding them, and providing us a certified copy of that destruction. A VA Form 7468 will need to be completed to prove that VA was the owner of those files. The current contractor we use to destroy CD/DVDs is: Rapid Shred, LLC. Please contact the Research Office if you have CD/DVDs that have past their retention period.
  • Electronic records Stored on VA Servers. At study completion, all investigator files should transfer to a file maintained by the research RL. The research RL utilizes a naming convention to track the study and disposition date for the files. Files stored on VA servers, when they have met their retention requirement, can be destroyed by deleting the file. It will be over-written and it will be no longer retrievable. The RL will maintain record of what was deleted and when.
  • Electronic records Stored on Non-VA servers. The mechanism for storage and deletion of VA records stored on non-VA servers must be detailed in contractual agreement. Issues such as third-party back-up servers and encryption are typical issues dealt with in these arrangements; use of VA servers wherever possible is strongly preferred.
  • Electronic Records Stored on Portable Media. Portable media used to store VA records, such as external hard-drives, or thumb-drives must be handled in accordance with current information security guidelines. The Information Security Officer must perform a sanitization of the portable media device and provide documentation of having completed the sanitization. A copy of that documentation must be provided to the Research Service RL for record-keeping.

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Investigators Leaving the Ann Arbor VA

Principal Investigator MUST Close or Transfer all Active Research Projects Protocols PRIOR to leaving the VA!
(See the document in "Miscellaneous VA & Research Information" below for PI transfer instructions.)

If the investigator leaves VA, all research records are retained by the VA facility where the research was conducted. If the grant is ongoing and the investigator leaves one VA facility to go to another VA facility, the investigator must obtain approval for a copy of relevant materials to be provided to the new VA facility's research office. The investigator is not the grantee, nor does the investigator own the data.


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Miscellaneous VA & Research Information

Reporting changes in investigator or study team members
Guide to VA Acronyms



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Ann Arbor VA Research Forms

As of June 1, 2017, most VAAAHS research oversight forms are to be completed in AAROW. The forms below are, for the time-being, still being completed using paper forms.

R&D

IRB

Animals

Safety

Data Security

Revised Scope of Practice - PDF Form (11/1/15) Serious Adverse Events Reporting (9/12/2019) A C O R P Form OOR-1 Radiation - General License DUA for Federal Entity
Cost-Share Agreement (October 2018) Form IND - Investigational Drugs in Research Safety Application Form OOR-1A Radiation - Human Use DUA for non-Federal Entity
  Device Management Form UCUCA Exemption Policy (UM Form) For projects conducted at the Ann Arbor VA  Chemical Hygiene Plan Training for VAAAHS Research Service Data Security and Confidentiality of Data in Research (ISP/PO Reviews)
    IACUC Amendment Request  Formaldehyde Training for VAAAHS Research Service  
    ULAM Animal Order Form    



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