Research Service - VA Northeast Ohio Healthcare System

Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

A “systematic investigation” is an activity that involves a prospective study plan which incorporates data collection, either quantitative or qualitative, and data analysis to answer a study question. Investigations designed to develop or contribute to generalizable knowledge are those designed to draw general conclusions (i.e., knowledge gained from a study may be applied to populations outside of the specific study population), inform policy, or generalize findings.

If you are unsure if your project is research submit your project into VAEDA  VA Electronic Determination Aide (VAEDA) 

The VAEDA tool will guide you through an assessment process and, based on your answers, provide a preliminary determination regarding your activity. The outcome may indicate that your planned project is not research in accordance with 38 CFR 16. Alternatively, VAEDA might recognize your project as research but not meeting the definition of human subjects research. The preliminary determination could also be that your project aligns with the regulatory definition of human subjects research but qualifies for an exemption from additional requirements of 38 CFR 16, including IRB review. Alternatively, it may indicate that your project requires either a limited IRB review or a full IRB review. The VAEDA tool streamlines your assessment process by providing a swift and precise evaluation of your project. Whether it confirms not research status, recognizes your project as research without meeting human subjects criteria, or outlines exemptions and review needs, VAEDA ensures clarity for your regulatory journey.

• If you receive a VAEDA determination that your project is not research, a review will be conducted by Quality Management to validate the VAEDA determination and provide next steps for initiating your project. 
• Once you receive the initial approval through VAEDA, you will need to move it forward through the My Determinations page of the VAEDA Tool, on the right you will see a submit button for final determination and approval. 
• Non-research projects are under the oversight of Quality Management and do not require any review or oversight from the Research Service.  
• If you receive a VAEDA determination that the project IS Research you will need to submit applicable documents into VAIRRS/IRBnet for review and approval before starting the project.

The research/non-research evaluation form is only required when there is uncertainty about whether a proposed project constitutes research. If you are certain that your project does NOT constitute research, but need written attestation that the project is not research for the purposes of publication, do not submit the evaluation form for review. Instead, complete the Documentation of Non-Research Activities for Publications Outside the VA form and email to Christina.Bennett2@va.gov.

The majority of required study forms are available for download within VAIRRS/IRBNet from the Forms and Templates page. Certain forms must be submitted directly to the Research Office, outside of VAIRRS; see below.

Forms That Must Be Submitted OUTSIDE the VAIRRS System:

1. Conflict of Interest Statements
2. New Investigator Packets
3. Radiation Safety Forms

• All investigators (PI, co-investigators, etc.) must submit a Research Financial Conflict of Interest Statement (OGE Form 450 Alt VA) for each study in which they are listed as an investigator.
• This form must be must be completed and submitted electronically via IRBNet, and all decisions will be issued electronically via IRBNet. 

Instructions and guidance for the My COI process can be found in the  IRBNet Forms and Templates library (VANEOHS Research Administration, Cleveland, OH – Documents for Researchers) and below for reference.

How To: COI Step 1 - Creating Your COI Disclosure

How To: COI Step 2 - Submitting COI Disclosures

​New Investigator Packets

• Principal Investigators must have VA paid appointments and cannot be interns, residents, or fellows.
• If you have not previously served as Principal Investigator on a study at VANEOHS, you will need to complete a New Investigator Packet and submit to the Research Office prior to submitting your study package. Email this packet to VHACLEVAIRRS@va.gov – DO NOT upload into VAIRRS.

New Investigator Packet (for all first time VA PIs)

Radiation Safety Form

Research studies involving radiation typically require approval from the Radiation Safety Committee (RSC). Required RSC forms can be downloaded below. Please contact the Radiation Safety Officer when you are preparing your study to begin the process. If required, RSC approval must be obtained prior to IRB approval of the study.

Research Roadmap

AU-PI Application

AU-PI Amendment

Human Research Involving Ionizing Radiation Application

For questions regarding Radiation Safety:

Radiation Safety Officer

If you will be taking sensitive or patient health related data offsite, you will need the following forms:

• Request to Store/Transport Sensitive Data
  • This is requested through EPAS. Select Cleveland VAMC Store/Transport Sensitive Data Request. You must be logged on to the VA Network to access this website.
• Data Use Agreement

For questions regarding New Studies:

R&D Committee Administrator

For questions regarding VA funding applications:

Administrative Officer (216) 791-3800 x64657

You can access VAIRRS from virtually any computer by visiting gov.irbnet.org. VAIRRS does not require a connection to the VA network. 

All users must be registered to access VAIRRS. New users can create an account by clicking on the “Register Now to get started!” link located on the login page. Be sure to select VA Northeast Ohio Healthcare System as your organization when registering. 

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• ALL Principal Investigators, Co-Investigators, study coordinators/primary contact personnel and study staff MUST create and activate a VAIRRS account. 
• For detailed guidance on how to create a new VAIRRS account, please refer to the New User Registration Training Energizer in the Resources section below. 

The VANEOHS Research Office is pleased to announce the adoption of the VA Innovation and Research Review System (VAIRRS). VAIRRS is the VA's enterprise version of IRBNet, a web-based software used by administrators, committee members, and researchers for electronic protocol submission/management and review and oversight of research. VAIRRS is currently in a phased implementation at all VA medical centers with research programs.

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All submissions to the IRB, IACUC, SRS and RDC (e.g., new protocols, amendments, continuing reviews, closures) must be submitted electronically via VAIRRS. E-mail and hard copy submissions will not be accepted. Investigators can self-register for a VAIRRS account and submit protocols at gov.irbnet.org 

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Study forms and templates are located in VAIRRS. You can download blank copies from the VAIRRS Forms & Templates page. Certain forms that are submitted outside of VAIRRS are available on the LINK page.

Please see the Frequently Asked Questions for information about how VAIRRS will be used at VA.

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Accessing VAIRRS

You can access VAIRRS from virtually any computer by visiting gov.irbnet.org. VAIRRS does not require a connection to the VA network. 

All users must be registered to access VAIRRS. New users can create an account by clicking on the “Register Now to get started!” link located on the login page. Be sure to select VA Northeast Ohio Healthcare System as your organization when registering. 

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• ALL Principal Investigators, Co-Investigators, study coordinators/primary contact personnel and study staff MUST create and activate a VAIRRS account. 
• For detailed guidance on how to create a new VAIRRS account, please refer to the New User Registration Training Energizer in the Resources section below. 
   

Resources

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New Registration & User Profile

• Training Energizer: New User Registration (create account, manage affiliations, maintain training records)

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For Researchers/Study Coordinators

• Training Energizer: Researcher 1 (create, share and submit a project; access review decisions & board documents)
• Training Energizer: Researcher 2 (post-submission topics; create a new package for modifications, renewals, etc.)
• Training Energizer: WIRB Submission (only for studies using Western IRB)
• IRBNet Notes: Managing Training & Credentials
• IRBNet Notes: Pasting into RTE
• IRBNet Notes: Multisite (only applies to specific multi-site projects; contact Research Office first)
• IRBNet Notes: Messages & Alerts
• IRBNet Notes: Link to CITI Account

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For Reviewers/Board Members

• Training Energizer: Reviewers/Board Members
• Training Energizer: PO/ISSO Review

Good news! CITI training is now integrated with IRBNet, so users can link their IRBNet profiles to their CITI profiles. Once the link is established, the system will automatically import and accept the CITI training that you have completed at your location on a nightly basis. 

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The linking process only takes a few minutes to complete, and it is described in this document: IRBNet Notes - Link to CITI Account. Please complete this at your earliest convenience. All staff listed on a project will need to have linked their CITI profile in IRBNet before any new submissions can be approved for that project.

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NOTE: If you’ve previously completed CITI training, DO NOT set up a new CITI account. Link your existing account so your training records transfer to IRBNet.

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If you have questions, reach out to VHACLEVAIRRS@va.gov.

Creating and Sharing a New Project

For detailed guidance on how to submit a new project in VAIRRS, please refer to the Researcher Energizer 1 which provides step-by-step instructions on how to create, submit and manage your project. Training Energizers can be found in the “Resources” section above.

Signatures Required in VAIRRS

Packages must be electronically signed by the Principal Investigator before they are submitted. The “Designee” signature mode is not accepted. Signatures cannot be deleted once applied; they are part of the permanent audit record.

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Using the “Sign this Package” feature in VAIRRS:

1. Enter your Username and Password at gov.irbnet.org
2. Enter the IRBNet ID in the search field and click on the study title to open the project
3. Review the necessary study details and documents
4. From the left-hand menu click “Sign this Package”
5. Use the dropdown list to select the appropriate role and click “Sign” Note: if you have previously signed this package, the system will ask you if you wish to sign it again. If you need to re-sign the package for any reason, click “OK”
6. Enter your username and password to validate your identity and click “Continue”
7. Your electronic signature has been applied to the contents of this package. IRBNet will send a notification to all users who have full access to this project.
8. After the package has been signed by the PI, you must submit the package to the Research Administration.

For additional guidance on how to sign a new project or submit your package in VAIRRS, please refer to the Researcher Energizer 1 which provides step-by-step instructions on this process. Training Energizers can be found under the “Resources”  section above. 

Signing Individual Study Forms Before Uploading Into VAIRRS

Some forms that you will submit as part of your package have a signature field on the form itself, typically requiring PI signature. If an electronic signature box, simply click the box and you will be prompted to enter your VA PIV credentials. Otherwise, follow the instructions below to stamp any document with an official VA signature.

Instructions for adding digital signature to a document using Adobe:

1. When you are ready to sign the document, if it is not already a PDF, save as a PDF.  
2. Open the PDF.
3. If using Adobe Reader: In the right panel, click the wrench for “More Tools.” Click the icon that says “Certificates.”
   If using Adobe Acrobat DC (full program): In the righthand menu, click the search bar (Search tools) and search for “Digitally Sign”
4. At the top of the page, click “Digitally Sign” and follow the prompts to add your signature and save the document. NOTE: Your PIV card must be in the computer to add your digital signature to the document.
    

Responding to a Request for Corrections/Revisions

For detailed guidance on how to respond to corrections/revisions in VAIRRS, please refer to the Researcher Energizer 2 which provides step-by-step instructions on this process. Training Energizers can be found in the “Resources” section above.

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Submitting a Continuing Review, Modification, or Other Submission for an Existing Project

If you need to submit a continuing review, modification, or other submission (e.g., adverse event, DSMB report, closure, etc.) for an existing project, you need to create a new package within the existing project. DO NOT create a new project. For detailed guidance on how to create a new package in VAIRRS, please refer to the Researcher Energizer 2 which provides step-by-step instructions on this process. Training Energizers can be found in the “Resources” section above.

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Accessing Review Decisions & Board Documents in VAIRRS

When a board issues an official determination or approved (stamped) document, it is published in the Board Documents section of VAIRRS. It is important that researchers read all correspondence and use only stamped, approved documents where applicable to ensure compliance. 

To access these documents, log into VAIRRS, click the project title, and click “Reviews.” The Reviews section is organized by Committees. Submissions are listed by package number under the Committee that conducted the review. Locate the package number of the submission and scroll to the Board Documents section. Click the paper icon at the right of the screen to download, view, and save a document.

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General Questions

If you have additional questions after reviewing the relevant Training Energizers and FAQ document, contact VHACLEVAIRRS@va.gov 

Research Credentialing is the formal, systematic process of verifying, screening and evaluating qualifications and other credentials that include education, licensure, relevant training and experience and current competence.

ALL Staff listed on a VA-approved research protocol must complete credentialing.

Research Credentialing Requirements are as follows:

• Signed & dated copy of CV/resume
• Scope of Practice

Please refer to your Scope of Practice for appropriate Research Credentialing training.

Completed credentialing paperwork can be returned in person to Christina Raymond in the research office, Room K-115.

For additional information, contact:
Management Assistant (216) 791-3800 x64660

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To view Scope of Practice and CITI training records currently on file with the Research Office, please visit the Research Study Staff Documents SharePoint site.

Log into TMS https://www.tms.va.gov/SecureAuth35/

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1. Click on Create New User

• VA TMS Self Enrollment
  • Select: Veterans Health Administration
  • Select: WOC for WOCs and IPAs, or Volunteer for Volunteers
• My Account Information:
  • Complete entire page to create account
• My Job Information page:
  • VA City: Cleveland
  • VA State: Ohio
  • VA Location Code: CLE
  • VA Point of Contact First Name: Christina
  • VA Point of Contact Last Name: Raymond
  • VA Point of Contact email address: Christina.Raymond2@va.gov
  • Point of Contact Phone Number:
  • HIPAA Training (course #10203) Required: check box if working on VA Human Studies

2. Select: VA TMS Self Enrollment 

• IMPORTANT: Send an email to the Management Assistant when this is complete so any additional training can be added

3. Complete required "Mandatory Training for Trainees"

4. Obtain Certificate(s) of Completion and forward to the Management Assistant

• AFTER course completion, return to Learning
• Go to My History at bottom right, click View All
• Locate the course and either
  • Hover mouse, choose Print Certificate
  • In the Action column, click on the printer icon
• Save or print certificate 

Human Subject Protection (HSP) Education

Participants in human subject research must complete the VA-required human subject protection education every 3 years at www.citiprogram.org. Before going to the CITI page, it is recommended that you review and print the following directions. Select the link that applies to you.

I am a new user, not enrolled in CASE CREC

I am currently enrolled in CASE CREC

I am already registered and I am returning to VA CITI course to update my VA training

The required courses will be populated for you.

For additional information, contact the IRB Administrator 

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Electronic Patient Records

To receive access to the Computerized Patient Record System (CRPS), you must:

1. Watch this training video, accessible from any computer: https://players.brightcove.net/2851863979001/default_default/index.html?videoId=5477475460001
2. Complete the CPRS Training Evaluation Form
3. Download the CPRS Pocket Guide and iMedConsent Pocket Guide
4. Sign the Acknowledgement Form
5. Send the Evaluation and Acknowledge forms to the Management Assistant

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For CPRS-related questions, contact the CPRS Helpline ) or email vhacleCPRS@va.gov.

All individuals working with animals in the Animal Research Facility (ARF) must complete the training listed below:

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VA CITI Training

• Register or login at: www.citiprogram.org 
• Complete registration
  • Select “VA Cleveland, OH 541” as the organization
• Complete the following courses (automatically assigned to you):
  • "Working with the IACUC"
  • "VA ARF Orientation"
  • "Occupational Health VA"
  • Any other protocol-specific or species-specific courses

Occupational Health

Complete the Laboratory Animal Allergy Screening at Personnel Health (part of new employee physical).

The Management Assistant will schedule appointments for WOC appointees.

Annually in March: Laboratory Animal Allergy Questionnaire Follow-Up (notification sent via email)

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ARF Orientation and Hands-on Training

Complete the ARF Orientation and hands-on training with ARF veterinary staff.

New Employee Safety Orientation

See below for details.

New Employee Safety Orientation:

Complete the in-person Research Safety Orientation.

To schedule training, contact the Research Safety Coordinator

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Annual Safety Training:

1. Review the Medical Research Safety Training Manual
2. Complete the Research Service Training Safety Exam
3. Send the completed exam to the Research Safety Coordinator

A written refresher training is required annually. Individuals are notified via email when this is required.

VA EMPLOYMENT

All forms must be completed as part of the application process for VA paid employees/positions within Medical Research Service. Official job offers are made only by Human Resource Management staff.

• New Employee Information Sheet (to be completed by supervisor) 
• OF-306 Declaration for Federal Employment
• Scope of Practice
• VA Form 2850a - Application for Nurses and Nurse Anesthetists (if applicable)
• VA Form 2850c - Application for Associated Health Occupations (if applicable)
• A signed & dated copy of resume/CV
• A copy of college transcripts

WITHOUT COMPENSATION (WOC) APPOINTMENT

Individuals paid by an institution other than the VA, who perform work at the VA and/or have access to VA Patient Information Systems must have a WOC Appointment. All forms must be completed prior to individual performing work at this facility. Paperwork must be received in the research office 4 weeks prior to requested start date.

ALL NEW WOCs:

STEP 1 - To initiate a WOC appointment, Supervisor to complete a New Employee Information Sheet and submit to the Management Assistant 

STEP 2 - complete the following forms and send to the Management Assistant :

• Intellectual Property Agreement
• OF-306 Declaration for Federal Employment (as the WOC, you must sign and date line 17a only. DO NOT sign line 17b)
• Patient Data Sheet for TB Test
• Request For Personal Identity Verification (PIV) Card
• Scope of Practice
• SF61 Appointment Affidavit (notarization NOT required)
• VA Form 0710 - Authorization for Release of Information
• VA Form-10-230-covid-19-vaccination-form - please complete the form and submit along with a copy of your COVID vaccination card.
• A signed & dated copy of resume/CV
• ​FOR MDs, RNs, and LICENSED PROFESSIONALS:
  • VetPro Enrollment Form​
  • Credentialing Release of Information Authorization
  • Copy of SSN card (MDs only)
  • VA Form 2850a - Application for Nurses and Nurse Anesthetists (if applicable)
  • VA Form 2850c - Application for Associated Health Occupations (if applicable)
• FOR NON-US CITIZENS:
  • I-9 Employment Eligibility Verification
  • I-94 (found here https://i94.cbp.dhs.gov/I94/#/home)
  • Current/valid passport
  • Document that allows you to work in the US, such as DS2019 or I-20/F-1, or I797A or I797B Notice of Action/Approval Notice

STEP 3 - Create VAIRRS Account and upload CV/CITI training

• Please create an account in VAIRRS/IRBNet, if you have not already, to upload your CV/Resume and/or Citiprogram training.  VA Research now uses VAIRRS/IRBNet for tracking and storing pertinent Research Citiprogram training, CV/Resumes, Research Scope of Practice and study submission documents.
• Christina Raymond will upload your Scope of Practice in VAIRRS after she receives the completed copy signed by you and your PI and she has the ACOS of Research, Dr. Peachey sign it.
• For details on creating a VAIRRS account and uploading your training, see the New User Registration training energizer on our VAIRRS/IRBNet page.

​STEP 4 - Click here for training options (TMS/Citiprogram/Safety Training).

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ALL RENEWAL WOCs:

• OF-306 Declaration for Federal Employment (as the WOC, you must sign and date line 17a only. DO NOT sign line 17b)
• Self-Certification of Continuous Service
• SF61 Appointment Affidavit
• I-9, if applicable (see above FOR NON-US CITIZENS)
• A signed & dated copy of resume/CV

INTERGOVERNMENTAL PERSONNEL AGREEMENT (IPA)

General Information

• IPAs are set up in 2-year increments for up to 4 years.
• IPAs always start on the 1st of the month.
• Employees participating in an IPA must be permanent employees of their institution for at least 90 days.
• IPAs are for 'higher level' positions, not for RA I's and/or Fellows.
• You are responsible for getting the signature of the participating institution.
• Paperwork must be received in the research office 4 weeks prior to requested start date.

STEP 1 - To initiate an IPA, Supervisor to complete a New Employee Information Sheet and submit to the Management Assistant 

STEP 2 - complete the following forms and send to the Management Assistant 

• IPA Assignment Agreement
• OF-306 Declaration for Federal Employment
• Request For Personal Identity Verification (PIV) Card
• VA Form-10-230-covid-19-vaccination-form - please complete the form and submit along with a copy of your COVID vaccination card.
• Scope of Practice
• A signed & dated copy of resume/CV

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Click here for training options.

VOLUNTEER (minors under age 18)

Paperwork must be received in the research office 4 weeks prior to requested start date.

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STEP 1 - To initiate a Volunteer appointment, PI to complete and submit to the Management Assistant :

• New Employee Information Sheet
• Provide a short job description of the duties the Volunteer will be performing

STEP 2 - complete the following forms and submit to the Management Assistant :​​

• Scope of Practice
• A signed & dated copy of resume/CV, if applicable
• Volunteer/Guardian must contact Vernell.Whipple@va.gov in the Communications & External Affairs office to process your volunteer to set up a time to complete the VA Volunteer Application. If you have trouble contacting them, please contact the Management Assistant .

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Click here for training options.

• Supports-new methods and approaches to clinical and translational research
• Improve institutional procedures
• Provide new treatments more efficiently and quickly to patients
• Assemble interdisciplinary teams

AMENITIES

Extensive Clinical Trial Review

Assess new trials to ensure we have sufficient resources, staff, and suitable population for recruitment

Match investigators with new clinical trial opportunities

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Management of Clinical Trial

Evaluation of enrollment

Overlap of study staff

Assistance with start up activities

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Clinical Research Coordinators

Highly experienced and dedicated clinical research nurses and coordinators

Cross-trained staff

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Dedicated Clinical Trial Space

For room scheduling:
Linda Colosimo*

All other concerns/questions:
CRC Director

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Click here for more information about the CRC.

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* These links use regular email and are not secure. Do not send personal or medical information unprotected over the Internet.