140. VA Regulations and Requirements for the Protection of Human Subjects: Overview
Updated Oct. 4, 2019
The University IRB serves as the IRB of Record for the VA Sierra Nevada Health Care System (VASNHCS). The VASNHCS has its own assurance: FWA00002304. No aspects of the University IRB Flexibility Policy apply to VA research.
In addition to the University IRB, VA researchers may use the VHA Central IRB, the IRB of another VA facility, or the IRB of another federal agency as specified in VHA Handbook 1200.05, item 5.d. The VASNHCS is responsible for obtaining the requisite agreements, approvals, and assurances; and notifying ORO. Once VASNHCS completes the requirements for one of their researchers to use another IRB of Record, VA researchers submit for acknowledgement from the University IRB as described in the IRB policy for using an external IRB. NOTE:
- Classified research involving human participants cannot be approved by a VA facility, IRB, or Research and Development Committee; or performed at VA facilities.
- A patient receiving a test article in an emergency use that is regulated by FDA is not considered to be involved in research and is not a research participant.
University and affiliate investigators conducting research at a VA facility, or conducting research involving veterans must comply with additional VA regulatory requirements for research including
- the Common Rule as adopted by the VA ( 38 CFR 16);
- VHA Handbooks, including but not limited to 1058.01 Research Compliance Reporting Requirements and 1200.05 Requirements for the Protection of Human Subjects in Research;
- ORD policies, handbooks, and guidance documents; and
- VASNHCS (or other VA) standard operating procedures.
The University and VASNHCS comply with regulatory requirements for accreditation of their HRPPs. Due to the division of responsibilities between the two institutions, accreditation requirements specific to the roles/responsibilities of the VASNHCS Medical Center Director are not under the purview of Research Integrity (RI) or the University’s IRB. RI and the IRB communicate through the VA Research Office and when warranted, directly with the Associate Chief of Staff for Research (ACOS/R). NOTE: The VA Research Office is responsible for assessing the adequacy of resources for each human research project submitted for IRB review. NOTE: The following VA policy sections address protections in addition to DHHS and FDA requirements, other agency regulations, and state laws.
VA Requirements for IRB Composition and VA Representation
The University’s IRB reviews VA research. Member composition of the IRB meets or exceeds the DHHS regulatory requirements for IRB membership ( 45CFR46.107) and complies with the following additional requirements for review of VA research:
- VASNHCS IRB representatives are compensated by the VA at least at a 1/8th full-time employee equivalent; and are neither WOCs nor those with IPA appointments.
- VASNHCS IRB representatives may be scientific or nonscientific members.
- VASNHCS IRB representatives serve as full-voting members of the IRB and may review non-VA research matters coming before the IRB.
- The following employees of the VASNHCS Research Office may not serve as voting members of the IRB: the ACOS for R&D, the AO for R&D, and IRB administrative staff.
- VASNHCS IRB members must comply with VASNHCS requirements for training, and for disclosing and updating potential financial and nonfinancial conflicts of interest.
NOTE: The VASNHCS Research Office will notify RI of training deficiencies or conflicts of interest for VA IRB representatives. These members will neither be assigned to review projects nor vote until RI is notified training requirements are fulfilled and will recuse themselves from review of research for which a significant conflict of interest exists.
- Following changes in IRB membership, RI will update the OHRP rosters and provide copies to the VASNHCS Research Office. The VASNHCS Research Office is responsible for forwarding the rosters to ORO.
Clarification of VA Affiliation and IRB Membership
- Veterans whose only relationship with the VA facility is receiving care at a VA facility or receiving benefits from the Veterans Benefits Administration are not considered to be affiliated for the purpose of being an IRB member.
- Individuals who perform occasional volunteer activities without compensation (WOC) are not considered affiliated.
- Individuals who hold a WOC appointment for volunteer activities other than IRB service are considered to be affiliated.
- Individuals who have retired from the VA and are receiving VA retirement benefits are considered affiliated.
- A non-affiliated voting IRB member must be given a VA WOC appointment if the non-affiliated voting member is performing the duties and responsibilities of an IRB voting member as a VA representative.
VA Research Compliance Officer and the IRB
The University IRB recognizes the following possible roles for the VA Research Compliance Officer (VARCO):
- The VARCO may not serve as a voting or nonvoting member of the IRB.
- The VARCO may serve as a nonvoting consultant, upon request by the IRB.
- The VARCO may attend IRB meetings upon the request of the IRB as long as possible role-related conflicts are managed.
The University IRB accepts audits by the VARCO to fulfill auditing requirements. The VARCO completes audits according to the required timeframe. The IRB should counsel the VARCO if it determines that more frequent audits are warranted upon considering factors such as the involvement of vulnerable populations or increased participant risk. Audit reports are submitted to the IRB through IRBNet as follows:
- Outside audit reports are submitted by the VARCO as subsequent packages for existing projects in IRBNet.
- The package must be identified with the Submission Type Other Reportable Event.
- Reports of apparent continuing or serious noncompliance must be identified as such and submitted within five days of discovery.
Independence of the University IRB
Officials of VASNHCS may not approve research that has not been approved by a University IRB. Research that has been approved by the IRB may be subject to further appropriate review and approval or disapproval by officials of the VASHNCS. IRB-approved research activities may be disapproved by the Institutional Official, R&D Committee, or ORD. Any attempt to influence the independence of the IRB in the oversight of human research, including attempts to influence IRB members or staff may be reported to the RI Director by calling 775.327.2367 or the VA Medical Center Director by calling 775.789.6630.
The RI Director, or other appropriate University official, shall report undue influence of IRB members or staff by anyone affiliated with VASNHCS to the VA Medical Center Director by calling 775.789.6630. VASNHCS policy will be followed in responding to attempts to unduly influence the IRB.
IRB Meeting Minutes and Research Records
The University IRB provides the VASNHCS Research Office with a copy of the final (redacted) IRB minutes in a timely manner. The content of the minutes complies with requirements in the Common Rule.
Note: Required records, including the researcher’s research records, must be retained for a minimum of six years. Researchers Records include:
- Codes or keys linking participant data to identifiers.
IRB records include:
- Correspondence between the IRB and the Research and Development Committee.
- Correspondence between the IRB and researchers.
- A resume for each IRB member.
- All previous membership rosters.
- Internal serious adverse events.
- Documentation of protocol deviations.
The Research and Development Committee has access to all IRB records.
If a protocol is cancelled without participant enrollment, IRB records are maintained for at least five years after cancellation.
Training and Education Requirements for VA Researchers
Principal investigators (PIs) and others proposing to engage in VA Research must satisfy VA training requirements. Researchers planning to conduct research at the VASNHCS are advised to contact the Research Program at 775.326.2797 for training requirements.
RI staff review training records in IRBNet or contact the VASNHCS Research Office to verify training is compliant for personnel on new studies and when personnel are being added to approved studies. The IRB will not approve new research or the addition of personnel if VASNHCS education requirements have not been met.
For active studies, the VASNHCS Research Office will notify RI of training delinquencies. Upon notification from the VASHNCS Research Office, the IRB will require the PI to remove researchers with delinquent training from the protocol (and consequently to cease their activities on the study) until such time as the training has been confirmed. VASNHCS may require additional sanctions for training delinquencies.
Sanctions for PIs and research personnel for failure to comply with training requirements and delinquent training are described in VASNHCS policy. In summary, VASNHCS researchers must meet educational requirements before continuing engagement in research activities for approved studies or being added to new studies.
VASNHCS researchers involved in studies that are supported or conducted by the Department of Defense (DoD) must comply with the requirements of the DoD component for ethics training for human research (as specified in the IRB policy for DoD research). The VASNHCS Research Office addresses requests from DoD to review education policies (when applicable).
Conflicts of Interest for VA Researchers
Researchers must disclose conflicts of interest. This means disclosing to the IRB any potential, actual, or perceived conflict of interest of a financial, professional, or personal nature that may affect any aspect of the research, and complying with all applicable VA and other federal requirements regarding conflict of interest. VA investigators should follow the Standards of Ethical Conduct for Employees of the Executive Branch codified at 5 CFR Part 2635. VA facilities are not required to follow PHS requirements, even when research is funded by a PHS agency (e.g., NIH).
The VASNHCS manages researcher conflicts of interest and notifies the IRB of conflicts that may be relevant to a research project. Affiliates that serve as IRBs of record for VA facilities must use the VA financial conflict of interest form, and may not create, re-draft, or change this form.
VA Research by Students and Trainees
For VA Research, students include VA employees who are completing requirements for a degree at an academic institution. Trainees include residents and fellows. As for all research overseen by University RI, students and trainees may not be a PI. The PI must be a VA researcher with sufficient expertise in the area of the student’s/trainee’s research interest to effectively oversee the research. The PI is responsible for oversight of the student/trainee and the conduct of all aspects of the research.
Students conducting VA Research must attend schools with an academic affiliation agreement consistent with current VHA policy or be directly appointed to a VA training program that has no external institutional sponsorship (e.g. VA Advanced Fellowship). NOTE: A waiver may be obtained from the CRADO under special circumstances. Student eligibility to be engaged in VA Research will be confirmed by the VASNHCS Research Office with documentation submitted with new or amended research projects. If students/trainees do not complete all aspects of the research prior to leaving the VA, the PI must ensure the protocol is completed or terminated in an orderly fashion, in accordance with all applicable local, VA, and other federal requirements; and must notify the IRB of the student’s departure from the research or study termination.
Failure to Renew Study Prior to Expiration Date
If a researcher does not provide continuing review information to the IRB or the IRB has not approved a protocol by the expiration date:
Immediately submit to the IRB chair a list of research participants who could be harmed by stopping study procedures.
The IRB chair, with appropriate consultation with the chief of staff, must determine within two business days whether participants on the list may continue participating in the research interventions or interactions.
Requirements for VA Research
When reviewing VA research, the University IRB considers the relevance of the research to Veterans and the mission of the VA.
Enrolling Non-veterans in VA Research
The IRB may allow non-veterans to be enrolled in VA Research only under the following conditions:
- There are insufficient veterans available to complete the study.
- The PI presents a compelling argument to the IRB for the inclusion of non-veterans (e.g., survey of VA employees; study of active duty military; study involving veterans’ family members) and the research is relevant to the care of veterans or active duty military personnel.
Requirements for VA Multi-site Research
Multi-site research involves more than one research site and may include VA and non-VA institutions, and both collaborative research and research conducted under a CRADA with a pharmaceutical company or other non-Federal entity.
Collaborative VA Research
Collaborative VA Research involves investigators from more than one institution, including VA and non-VA institutions, but does not include research conducted under a Cooperative Research and Development Agreement (CRADA) with a pharmaceutical company or other non-Federal partners.
VASNHCS PIs conducting collaborative VA Research must provide the IRB with the following, as applicable:
- contact information and FWA for the collaborating VA facilities’ IRBs of Record;
- documentation of approval from collaborating VA facilities’ committees and subcommittees as required by the participating VA sites, the federal VA, and other federal agencies;
- IRB application that delineates the VASNHCS research activities, specifies the data that will be disclosed to collaborators or other entities, and describes the disclosure processes;
- informed consent document reflecting VA requirements;
- HIPAA Authorization form approved by the VASNHCS for research involving the collection of PHI; PO/ISO approval and confirmation that all data collected by VASNHCS researchers will be retained at the VASNHCS or transmitted in accordance with federal requirements for privacy and security; and
- written notification from the VASNHCS ACOS/R or the ACOS/R of collaborating VA sites stating the research may be initiated.
The VASNHCS Research Office is responsible for confirming the requisite signed, written agreement is in place.
IRB Requirements for Research Conducted Under a CRADA
The VASNHCS is responsible for addressing requirements for research conducted under a CRADA, obtaining the requisite written agreements, and ensuring VA researchers submit all documents for IRB review, and approval or acknowledgement as required by level of review.
Requirements for International VA Research
International VA Research, regardless of funding, includes VA-approved research that
- is conducted at international sites (i.e., not within the US, its territories, or Commonwealths);
- uses either identifiable or de-identified human biological specimens or data originating from international sites; and
- involves sending identifiable or de-identified human biological specimens or data out of the US.
International VA Research involving prisoners is not allowed.
For VA Research that includes international sites, if the study-wide PI is not a VASNHCS investigator, neither the University IRB nor the VASNHCS consider the research to be international as long as the VASHNCS is not the study sponsor, does not hold the IND, and does not manage the data collection and analyses for the other participating sites.
The University IRB requires that protections for participants in international research are equivalent to those for participants in studies conducted in the US (per DHHS requirements for International research). The researcher must conduct the research in accordance with VA requirements and all other applicable federal requirements for protecting human participants, tissue banking, use of databases, federal criminal laws, and the standards of ethical conduct for employees of the executive branch.
All international sites must hold an international federalwide assurance, and the research must be approved by the IRB or Ethics Committee of the participating sites listed on the international federalwide assurance.
Cooperative Studies Program activities must be approved by the CRADO. All other VA international research requires written approval from the VASNHCS Facility Director.
IRB Notifications for VA Researchers
Procedures for notifying VA researchers of IRB determinations mirror those for all University and affiliate researchers with the following differences:
- Human research determinations are processed outside of IRBNet.
- VA researchers Share research projects in IRBNet with the VASNHCS Research Office to allow the Office to access project documents and IRB correspondence.
- Event reports submitted for problems that are not unanticipated will be withdrawn unless such reporting is required by the contract. The PI and VASNHCS Research Office will be notified by email when problem reports are withdrawn.
IRB Notification of CRADO Waivers and Facility Director Approvals
The VASNHCS Research Office will send waivers from the CRADO and approvals from the Facility Director to the IRB email: RIO.IRBNet@unr.edu. Upon receipt, RI staff will add the waivers or approvals as a board decision letters to the relevant project/package in IRBNet thus making these available for IRB review. Notifications will reference CRADO waivers and Facility Director approvals.
VASNHCS RDC and PRS Reviews, and ACOS/R Authorization
In addition to IRB approval, VA Research is subject to approval from the following:
- Research and Development Committee (RDC): The University IRB serves as subcommittee of the RDC.
- VASNHCS Protocol Review Subcommittee (PRS): The PRS reviews VA Research to confirm researcher qualifications to conduct the research, assess for conflicts of interest, verify the research is scientifically sound and complies with VASNHCS and VA requirements, and determine if medical records should be flagged.* NOTE: The VASNHCS Research Office will confirm PRS reviews are added to new projects and continuing review packages before submitting for exempt or IRB review. RI staff will confirm the PRS reviews are added before sending for review.
- Subcommittee on Research Safety
- Privacy Officer†, ‡(PO)
- Information Security Officer† (ISO)
- Biosafety Committee
- Other VA committees as relevant to the research
*PRS requirements for flagging medical records will be monitored by the VASNHCS Research Office.
†PO and ISO reviews take place both before and after IRB review and approval.
‡The PO (or VASNHCS Research Office) will address requirements for notifying non-Veterans in VA Research of VA privacy practices and for disclosing PHI to contacting forms. Researchers are advised to contact the VASNHCS Research Office for details about internal VA review processes. Contact information is available from the VA human subject research pages of RI website.
PO and ISO Reviews
PO and ISO Reviews, Pre-IRB Review
PO and ISO determinations that occur before IRB review are submitted for IRB review and consideration as follows:
- The PO and ISO prepare correspondence that indicates pre-IRB reviews were completed.
- The correspondence will specify whether or not deficiencies were noted, and in the latter case will list the deficiencies and options for correcting same.
- According to the process specified by the VASNHCS Research Office, PO and ISO pre-IRB review correspondence will be added to projects/packages in IRBNet for IRB review.
- IRB review will not proceed without the required correspondence from the PO and ISO.
- Following IRB review, deficiencies noted by the PO and ISO and the related requested revisions will be included in IRB review letters.
NOTE: The University IRB does not require submission of PO and ISO pre-IRB review checklists.
VA Reviews that Follow IRB Approval
PO and ISO Reviews, Post-IRB Approval
Final PO and ISO reviews occur after IRB approval. This final review will constitute follow-up with the investigator and/or the IRB to ensure the proposed research is compliant with privacy, confidentiality, and information security requirements.
If the PO or ISO identify deficiencies during the final review, the deficiencies and necessary corrections will be communicated via internal VASNHCS channels to the PI. The PI will be told the research may not commence until the deficiencies have been corrected. The PI will be instructed to submit the additional PO/ISO requested changes as a new amendment package in IRBNet. The IRB will follow standard procedures in reviewing the amendment request.
VASNHCS Documentation of VA Committee Approvals
The VASNHCS Research Office documents VA committee decisions as follows:
- An ACOS/R letter confirms approval by the RDC, PO, ISO and other relevant VA committees; and informs the PI the research may be initiated.
- The PRS Committee review form documents the PRS committee review.
Copies of the ACOS/R letter and PRS Committee review form are sent by email to RIO.IRBNet@unr.edu. RI staff add the documents as board decision letters to the relevant projects/packages in IRBNet. The IRB takes no further action.
Investigational Drug Information Record
The VA Research Office forwards the Investigational Drug Information Records (VA Form 10-9012) (signed by the PI) for signature approval by the IRB Chair. RI staff add the signed document to the project/package in IRBNet as board decision letters. IRBNet. The IRB takes no further action.
Certificates of Confidentiality for VA Research
IRB policy for Certificate of Confidentiality (CoC) applies to eligible VA research. Requirements for additional provisions for documentation of CoC in health records will be monitored by the VASNHCS Research Office.
- For studies that do not involve a medical intervention, no annotation may be made in the medical record.
- For studies involving a medical intervention, a progress note in the medical record should be made, indicating the individual has been enrolled in a research study, any details that would affect clinical care, and the name and contact information of the researcher conducting the study.