VA research is research that is conducted by VA investigators (serving on compensated, WOC, or Intergovernmental Personnel Agreement appointments) while on VA time. If you wish to enroll patients or staff at the VA, or use VA personnel, facilities, or medical records, you must secure prior approval of the BVAHCS Research & Development Committee (R&DC).

VHA Directive 1200.05 (new revision published January 8, 2021) is the national policy that describes the requirements for the protection of human subjects in VA research. Please review this policy if you are interested in engaging VA in your research project.

Special considerations may be found in the following sections:

• 5g—VA Investigators' Responsibilities
• 15 – Collaborative Research
• 17 – General Requirements for Informed Consent (refer to VA Informed Consent Checklist)
• 18 – Documentation of Informed Consent
• 19 – Research Involving Pregnant Women, Human Fetuses, and Neonates as Subjects (refer to ORD Memo: Restriction on Use of Fetal Tissue for all VHA Research Studies, dated August 28, 2019)
• 20 – Research Involving Prisoners (restricted by the VA)
• 23 – HIPAA Authorization

Also refer to ORPP&E’s Policy and Guidance FAQs.

Per VHA Program Guide 1200.21, activities—including some involving collection of PHI/PII—do not constitute research if they are not designed to produce information that expands the knowledge base of a scientific discipline (or other scholarly field). This includes projects focused on quality improvement, program administration, and/or program evaluation that are not designed to answer a research question nor includes a hypothesis designed to contribute to generalizable scientific knowledge.  Use the Research vs. Operations Decision Tool and Research or QA Chart to determine if the project meets the definition of research. 

Quality improvement projects do not require IRB approval, however, you must submit a Research vs. Non-Research Determination Form in IRBNet (www.gov.irbnet.org) for review and determination. The Research vs. Non-Research Determination Form can be found in IRBNet under Forms and Templates.

Please also consult with Education Service, Chief of Quality Management Service and your service chief for any additional approvals that may be needed to proceed with your project.

If you only wish to inform VA patients about a non-VA study by posting/distributing recruitment materials on the premises of a VA facility, R&DC approval is not required to conduct the Research; however, R&DC approval is required for posting of advertisement.

Complete the Request to Advertise Non-VA Research Activity in a VA Facility Form, which can be found in IRBNet under Forms and Templates. Submit the completed form in IRBNet for review and approval.

Request to Post Advertisement of Non-VA Research Activities

The Birmingham VA allows posting of advertisements for non-VA research at our facility when the following provisions are met:

1. The non-VA research is relevant to Veterans and the mission of VA. The research must not impede current VA research activities.
2. The non-VA research is from an approved VA academic affiliate.
3. There is documentation of the academic affiliate’s IRB approval of the study and advertisement.
4. The non-VA research advertisements are posted for no more than 6 months at a time and are only allowed to be posted on Birmingham VA approved bulletin boards.

Steps for Submission, Review and Approval:

1. Register an IRBNet Account (www.gov.irbnet.org) and affiliate with the Birmingham VA Health Care System.
2. Create a New Project.
3. Download the “Request for Advertisement of Non-VA Research Activities Form.” The form can be found under Forms and Templates in the Research and Development (R&DC) library.
4. Upload the Request for Advertisement of Non-VA Research Activities Form, IRB Approval Letter, IRB Approved Protocol, and Proposed Recruitment Material.
5. Sign and Submit the Package.
6. After review (R&DC review dates can be found here), you will receive a decision letter.
7. Submit the decision letter to BIR - Medical Media Request - Power Apps and complete a Medical Media Request to Print Posters.

If BAVAHCS and any other Federal or Federally-funded institutions are engaged in a non-exempt research study which has been approved or transitioned to follow the 2018 Requirements of the Common Rule, the cooperative research provisions may apply. Per these provisions, the use of a single IRB (sIRB) or ORD-approved sIRB exception is required.

When collaborating with other sites, take into consideration the single IRB requirement early in the grant writing stage, before submitting the project for IRB approval. If one or more other VA sites are engaged in your research study, first consider using VA Central IRB as your IRB of record. Contact vacentralirb@va.gov or visit the VA Central IRB website for more information.

If using a commercial IRB, refer to Commercial IRB submission guidance. 

For more information about cooperative research provisions requirements, refer to the ORPP&E website or email the Birmingham VA Research Office at Latanya.Higginbottom@va.gov.

VA employment or WOC status required

All personnel engaged in research at the VA, including volunteers, must be paid by the VA or have completed a federal background check and have Worker Without Compensation (WOC) status.

The VA PI (or designee) must complete a Scope of Practice for each team member listing designated research duties. If users require access to the VA’s electronic medical record (CPRS) as part of their research duties, this must be indicated in the scope and the user must be listed in key study personnel on the IRB Study Application. It is the PI’s responsibility to ensure the new personnel are listed on the IRB Study Application either in real time or that the request to add new personnel is combined with the next future IRB submission. 

Mandatory VA-specific training for research staff

IRB approvals may be delayed if key study personnel listed in the Study Application are not up to date on the following VA research training at the time of submission:

• CITI (VA Human Subjects Protection)—CITI account must be affiliated with VA Birmingham, AL-521. This training must be renewed every three years. Review the VA ORD website and CITI FAQs for more information.
• VA Privacy & HIPAA and VA Privacy & Information Security and Rules of Behavior must be updated annually via the VA TMS website. All researchers accessing identifiable VA data must complete these trainings. For assistance with TMS accounts or training requirements, contact Latanya.Higginbottom@va.gov.  

Trainings are specific to the VA. UAB training may not be substituted.

Additional training (not required)

VA Office of Research Protections, Policy, and Education (ORPP&E) webinar archive may be accessed here. It is highly recommended that VA research personnel review the topics listed and listen to any webinars that may pertain to your VA research activities.

OHRP provides Human Research Protection Training that includes foundational knowledge on protecting human subjects in research funded by the U.S. Department of Health and Human Services (HHS). The training is developed for the broad research community including IRBs, investigators and key personnel, and anyone interested in the Common Rule. Access is free.

The VA distinguishes between projects and protocols.  A project is a cohesive body of work, usually tied to one major funding source, and is reviewed for safety before any research may begin.

Projects may contain one or more Protocols (i.e., IRB, SRS, IACUC).  

IRB protocol approval and VA R&D Committee project approval are required for human subjects’ research. Protocol approval is not required for projects that are not considered human subjects research (e.g., QA/QI projects).

Protocol Approval

Log into IRBNet and submit the appropriate submission packet (Initial Review, Exempt Review) with a complete description of study procedures on the study application.

Attach all required VA forms to your IRB submission:

• VA Form 10-250 Privacy Checklist - complete Page 1 only
• Enterprise Research Data Security Plan (ERDSP)—This link is only accessible behind the VA firewall. The VA PI or designee must sign.
• Research Protocol Safety Survey (RPSS)— The VA PI must sign.

Failure to attach the above required documents may result in delays in review and approval.

Attach the following study documents, if applicable. 

Consent Documents section: 

• VA consent form(s) 
• Information sheet
• Verbal consent script

Other Study Documents section

• VA HIPAA (VA Form 10-0493)
• Non-consent phone scripts
• Request for Non-Veteran Approval form, if enrolling non-Veteran subjects in research that involves VA outpatient or VA hospital treatment
• Single IRB exception approval letter: only required for non-exempt studies if there are collaborating engaged VA sites and/or other collaborating engaged sites which are Federal entities or Federally funded
• VA Form 10-9012, if applicable
• Proactive calling approval letter issued by ORD
• Any other related materials

Review the following for information that must be included in the IRB Study Application. Failure to include this information may result in delays in approval.

Inclusion/Exclusion Criteria

If enrolling non-Veterans in VA research, include explicit justification. Refer to Non-Veteran Research Subjects section.

Qualifications of Key Study Personnel

• If the UAB PI is not affiliated with VA, indicate who will serve as the VA PI.
• Clearly distinguish VA personnel only.
• Identify personnel who will interact with VA subjects and/or have access to identifiable VA data (not required if the study is conducted at VA only).
• Identify authorized study drug prescribers, if applicable.

Study Procedures

• Describe all study procedures to be conducted at VA. If any procedures are not being done at VA or any study populations are not included at the VA, do not include them.
• Include all remote study procedures, if applicable.

Recruitment

• Distinguish which recruitment methods will occur at the VA.
• If there are multiple subject populations (e.g., Veterans and non-Veterans), distinguish how each group will be recruited.
• Proactive calling (sometimes referred to as “cold calling”) may be permitted in certain circumstances. Click here to request ORD approval for proactive calling. 
• The use of email or other unsecure electronic means to communicate with research subjects is prohibited.

Confidentiality

1. Include the Required VA records retention language: VA research records will be retained and disposed in accordance with the VHA Records Control Schedule (RCS 10-1). 
2. Describe:

• How VA data/specimens will be stored (e.g., de-identified, coded or identifiable). If biospecimens are collected and/or stored at Birmingham VA, specify whether the specimens will be labeled with identifiable, coded or de-identified information.
• Where data will be stored (e.g., VA server), and
• Who will have access to the data.

3. If the study involves collection or use of sensitive VA data (specifically drug abuse, alcoholism/alcohol abuse, HIV, or sickle cell anemia), include 38 USC 7332 language.
4. Specify whether non-VA personnel will have access to identifiable VA information.
5. If you plan to transmit VA data outside the VA, describe how the data will be transferred (e.g., encrypted email) AND whether VA data will be combined with non-VA data. This information must also be included on the VA consent and VA HIPAA forms.

Note that the complete record (original or copy) of all data obtained in VA research must be retained at VA.

VA consent forms are the consent document used to obtain informed consent from participants in VA-approved research, including but not limited to research conducted at VA, using VA employees and time, funded by VA, etc.

All VA consent forms and verbal consent scripts must contain:

• The required elements of consent as described in VHA Directive 1200.05
• VA treatment and compensation for research-related injury wording, if applicable.
• All 2018 Common Rule required language.

When drafting your consent form(s), refer to VA Informed Consent Template.

NOTE: You may include the Person Obtaining Consent signature block on VA consent forms if desired, however this is no longer a VA requirement.

Greater than minimal risk studies

The following language regarding VA treatment and compensation for research-related injury must be included verbatim in VA consent forms for greater than minimal risk studies:

If you are experiencing a medical emergency, please call 9-1-1. If you incur an injury or illness as a result of being in this study, the Department of Veterans Affairs (VA) will ensure that treatment is made available at a VA medical facility or non-VA facility, as appropriate. If you were following study instructions, the costs of such treatment will be covered by the VA or the study sponsor (if applicable). If you were NOT following study instructions, the costs of such treatment may be covered by the VA or the study sponsor (if applicable) or may be billed to you or your insurer just like any other medical costs, depending on a number of factors. The VA and a study sponsor do not normally provide any other form of compensation for injury or illness. For further information about this, call the study team at the number(s) provided.

DocuSign may be used to obtain signatures on VA forms (VA consent, VA HIPAA Authorization Form and other VA forms requiring subject signature).  ORD has purchased a supply of envelopes to be used in research studies requiring documentation of informed consent. All requests are considered but studies requiring the creation of <100 envelopes (100 subjects) will need to provide justification. Inpatient studies are generally not appropriate for DocuSign and study teams should consider the use of iMedConsentTM for inpatient studies. 

Requesting Use of VA DocuSign

For more information, visit instructions for requesting the use of VA DocuSign. 

If approved to use VA DocuSign

• Review DocuSign Post-Approval Instructions (only accessible behind VA firewall).
• Submit a Modification Form for your study in IRBNet.
• Attach a PDF copy of the approval correspondence from ORD.
• Attach 1) email script and 2) consent phone script as needed.

NOTE: Do not list VA DocuSign in the Disclosure section of the VA HIPAA form.

After IRB approval is granted, questions should be directed to VHACOORDRegulatory@va.gov.

Enterprise Research Data Security Plan (ERDSP)

This form must be completed and attached to all initial submissions and to any modifications that affect the study’s data and security plan.

ORD has mandated that Information Security Officers use the ERDSP (accessible only behind the VA firewall) to facilitate protocol reviews.  Once you select the Purpose of Submission, the form will branch out with questions and will continue to branch based on your responses.  Refer to ERDSP Guide and FAQs for further information.

If you plan to share VA research data (electronic and/or hard copy) with another VA or non-VA entity/institution, refer to the VA Data Transfer Methods Table for VA-approved methods for secure data transfer. 

VA Form 10-250 (required by VHA Directive 1605.03

This form must be completed and attached to all initial submissions as well as to any modification that result in changes to: data collection/use/storage/transmission/disposition, VA informed consent, VA HIPAA Authorization form, Data Use Agreement (DUA), or when the modification impacts waiver of HIPAA Authorization.

Complete the Study Information section (Page 1 only) of the VA Form 10-250 and upload in IRBNet. Include all relevant information in the Study Application for consistency.

Unless it’s determined that Privacy Officer review is not required, the VA Privacy Officer will email a signed copy of the form to the study team documenting the final privacy review. Please visit this website for more information about VA Privacy requirements (only accessible behind VA firewall).

VA HIPAA

Authorization for Use & Release of Protected Health Information for Research Form 10-0493 This pdf works best with Internet Explorer. The VA HIPAA form must be used when written HIPAA authorization is required for a VA study. If you have questions, contact the VA Privacy Officer at VHABIRPrivacyFOIAOfficers@va.gov.

Required VA records retention language

Include the following statement verbatim in the Confidentiality section of the Study Application: VA research records will be retained and disposed in accordance with the VHA Records Control Schedule (RCS 10-1).

Refer to VHA Records Control Schedule (RCS 10-1) Section 8300.6 Research Investigator Files for VA research records maintenance. Contact the Research Office for assistance with off-site records storage.

Required 38 USC 7332 language

38 U.S.C. Section 7332 makes all VA records that contain the identity, diagnosis, prognosis or treatment of VA patients or research subjects for drug abuse, alcoholism or alcohol abuse, infection with human immunodeficiency virus (HIV/AIDS), or Sickle Cell Anemia strictly confidential. This statute applies to information regardless of whether it is recorded in a document or a Department record.

If a study collects or uses individually identifiable patient health information covered under 38 U.S.C. 7332 (DRUG, ALCOHOL, HIV AND SICKLE CELL ANEMIA INFORMATION), include the following statement verbatim in the Study Application:

This study includes collection of information covered under 38 U.S.C. 7332 (drug, alcohol, HIV and/or sickle cell information). The purpose of the data is to conduct scientific research. No personnel involved in the study will identify, directly or indirectly, any individual patient or subject in any report of such research, e.g. manuscript or publication.

For additional guidance, refer to ORPP&E’s Research Information Security & Cybersecurity Toolkit.

External disclosure of patient information for non-VA research (Form 10-5345 required)

If VA staff will obtain VA patients’ contact information from the VA medical record and provide it to UAB staff (e.g., for recruitment into a non-VA study), this is considered an external disclosure which requires the VA patient’s signed authorization. This disclosure of identifiable information must be documented using VA Form 10-5345 (Release of Information Form).

The 10-5345 must be collected by the VA employee and sent to HIMS for scanning into the patients’ medical records. Information may be pre-filled for the patient (except for the section related to authorizing disclosure of 7332-protected information), then the patient must review and sign it.  Electronic signatures are not accepted.  The 10-5345 must be filled out completely to be valid. If you plan to pre-fill the form for patients, the Privacy Officer must review the form prior to use.  Email the pre-filled form to VHABIRPrivacyFOIAOfficers@va.gov for review.

Reporting Privacy and Information Security Incidents

To report privacy incidents, email the VA Privacy Office at VHABIRPrivacyFOIAOfficers@va.gov.  

To report data security incidents, email the VA Information Security Office at oitdsoesoareabirminghamissos@va.gov.

Certificates of Confidentiality

When requesting a Certificate of Confidentiality, you may find more details about how to respond to the specific sections of the request here. Further questions should be directed to the NIH CoC Coordinator at NIH-CoC-Coordinator@mail.nih.gov

Per VA Directive 1200.01, non-Veterans may be entered into a VA-approved research study that involves VA outpatient or VA hospital treatment, but only when there are insufficient Veteran patients suitable for the study.  Non-Veteran subjects include students, fellows, clinical staff, caregivers or any other research subject who is not a Veteran. In addition to IRB approval, you must obtain R&D approval before enrolling non-Veterans (by obtaining consent, written or verbal). Complete the Request for Non-Veteran Approval Form and submit in IRBNet.

VHA Notice of Privacy Practices for Non-Veterans

Some non-Veteran research participants must be provided the VHA Notice of Privacy Practices (NoPP) in accordance with VHA Handbook 1605.04.  VHA health care facilities must provide the Notice of Privacy Practices when a non-Veteran patient attends their first research visit associated with an episode of care.  Only pharmacy medication pick-up, laboratory appointments and Tuberculosis screening, are not considered episodes of care.   

In some circumstances (i.e., if a medical record is created), the non-Veteran participant must sign VA Form 10-0483 (Acknowledgment of the Notice of Privacy Practices) and the form must be scanned into the non-Veteran’s medical record.

If you must provide the NoPP or obtain the VA Form 10-0483, note this in the Study Application.

For additional guidance, click here or contact the VA Privacy Office at VHABIRPrivacyFOIAOfficers@va.gov.

VA Investigational Drug Information Report (10-9012)

The VA form 10-9012 is required for studies involving investigational drugs. An investigational drug is defined as a new chemical compound, which has not been approved by the FDA, or an approved drug that is being studied in a clinical investigation for an approved or unapproved use, dose, dosage form, administration schedule, or under an IND application.

The 10-9012 must indicate who may prescribe the research medications and include any safety information that may not be available in published references. Please ensure this form is signed by VA PI, IRB Chair, and R&DC Chair.

VA Form 10-9012 is not required if a package insert is available (for studies involving approved drugs used according to FDA-approved labeling). Identify authorized study drug prescribers in the qualifications of key study personnel section.

Research pharmacy requirements

The pharmacy charges researchers a modest fee for its services. Researchers are encouraged to discuss dispensing issues and fees with the research pharmacist (Bradley.Clements@va.gov) before the budget is finalized. Please see the Pharmacy Fee Memo for a breakdown of costs.

When the study is conducted at BVAHCS, the following additional obligations must be met by the researcher:

• The research pharmacy must be provided:
  • A copy of VA Form 10-9012 (if applicable).
  • A copy of the consent document for each participant with all appropriate signatures.
  • Copies of Sponsor-related correspondence specific to the drug(s) if applicable.
  • Copies of all correspondence addressed to the Researcher from the FDA related to the investigational drugs or devices.
• Inform the chief of pharmacy service, the research pharmacy, and the IRB in writing when a study involving investigational drugs or devices has been suspended, terminated, or closed.
• Comply with all documentation requirements and make relevant records accessible to the research pharmacist when requested.

Research Audits

Informed consent audits are completed by the VA Research Compliance Officer (RCO) annually. Regulatory audits are conducted every three years depending on IRB status of study. Contact the VA RCO, Jacob Kepins (Jacob.Kepins@va.gov), for more information.

For essential documents templates and good clinical practice documentation guidance, refer to the VA Site Monitoring, Auditing and Resource Team (SMART) website.

Research guidance and templates are also available on the ORPP&E website.

Adverse Events/Incident Reports/Unanticipated Problems

The VA requires that all adverse events/incident reports/unanticipated problems are reported within 5 business days of discovery of the event. See VHA Directive 1058.01 (revised October 22, 2020) for specific examples. Note that reporting requirements for research subject deaths are shorter than 5 business days—see 1058.01 for more information related to reporting requirements.

Please consult with the VA Research Office and review the following VA decision charts to determine if your adverse event report or protocol violation or incident needs to be reported to the IRB.

Examples of Noncompliance in VA Human Subjects Research that ORO Typically Considers to Meet the Definition of Serious or Continuing Noncompliance (March 8, 2021)

Decision Chart: Reporting Human Deaths, Unanticipated Problems and Accident, Injury, Illness or Exposure in VA Research (March 12, 2021)

Note: Some types of apparent serious or continuing noncompliance be reviewed at a convened IRB meeting for determination of whether they constitute actual serious or continuing noncompliance.

Refer to VA ORO Publications and Guidance for more information.

Additional VA Research Guidance

There are additional requirements in VHA Handbooks 1058.01, 1200.01,1605.1, and 6500. The full list of VHA Publications may be found here. 

• IRBNet
• ORD Policies and Guidance
• Office of Research Oversight (ORO) Publications and Guidance
• ORPP&E Policy and Guidance FAQs
• ORPP&E Communication Page for VHA Researchers.  Items included on this page:
  • DocuSign
  • FERSS
  • Proactive Calling
  • Qualtrics Requests