140. VA Regulations and Requirements for the Protection of Human Participants: Overview

Updated August 8, 2022

The University IRB serves as the IRB of Record for the VA Sierra Nevada Health Care System (VASNHCS). The provision of services by the University IRB to the Sierra Nevada Veterans Affairs Health Care System (VASNHCS) is established through a Memorandum of Understanding that outlines the responsibilities of the VASNHCS and the University. The University IRB is designated as the Reviewing IRB for the VASNHCS pursuant to these entities’ respective FWAs. The VASNHCS has its own assurance: FWA00002329.

No aspects of the University IRB Flexibility Policy apply to Department of Veterans Affairs (VA) research. Protocols reviewed by the University IRB on behalf of the VASNHCS receive the same IRB review, both initial and continuing, as those conducted at the University. In addition to the University IRB, VA researchers may use the VA Central IRB, the IRB of another VA facility, or the IRB of another federal agency as specified in VHA Directive 1200.05(1), item 5(8)(a). The VA permits use of a commercial IRB as an IRB of Record only if it has been specifically designated by ORD as a commercial IRB that may serve as an IRB for cooperative research.

The IRB does and shall continue to meet all Department of Veterans Affairs requirements for an affiliate human studies subcommittee of the VASNHCS Research and Development Committee (hereafter referred to as “RDC”). Review of an VASNHCS Research protocol by the RDC is in addition to, and not in lieu of, IRB review and approval. IRB agrees to apply and adhere to all applicable VA Regulations, including 38 CFR Part 16 and VHA Directive 1200.05(1).

The VASNHCS is responsible for obtaining the requisite agreements, approvals, and assurances; and notifying the Office of Research Oversight (ORO). Once VASNHCS completes the requirements for one of their researchers to use another IRB of Record, VA researchers follow University IRB policy 4, The Role of Non-University of Nevada, Reno (External) IRBs, Single IRB and Independent Investigator Agreements. Classified research involving human participants cannot be approved by a VA facility, IRB, or Research and Development Committee; or performed at VA facilities.

University and affiliate investigators conducting research at a VA facility, or conducting research involving veterans should have the resources required to conduct research in a way that will protect the rights and welfare of participants and ensure the integrity of the research. These resources might include personnel, time, and access to a study population. Investigators should not commence a research study without adequate resources to protect participants and should stop a research study if resources become unavailable. Also, Investigators must comply with additional VA regulatory requirements for research including:

• the 2018 Common Rule (or the Pre-2018 Common Rule, if applicable) as adopted by the VA (Applicable Regulations: )38 CFR 16).
• VHA Directives and Handbooks, including but not limited to VHA Directive 1200.05(1) Requirements for the Protection of Human Subjects in Research (March 3, 2020), VHA Handbook 1058.01 Research Compliance Reporting Requirements (June 15, 2015), VHA Directive 1200.01 Research and Development Committee (January 24, 2019), and VHA Directive 1058.03 Assurance of Protection for Human Subjects in Research (September 17, 2020);
• ORD policies, handbooks, directives and guidance documents; and
• VASNHCS (or other VA) standard operating procedures.

The University complies 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 or the University’s IRB. Research Integrity and the IRB communicate through the VA Research Office and when warranted, directly with the Associate Chief of Staff for Research (ACOS/R). The VA Research Office is responsible for assessing the adequacy of resources for each human research project submitted for IRB review.

The University IRB will rely on the VASNHCS to make any necessary reports to governmental regulatory authorities. These reports will be made by the VASNHCS Institutional Official (the VASNHCS Director), through the Research Compliance Office. Specifically:

• Substantive Memorandum of Understanding (MOU) changes must be reported to ORO Central Office within five business days.
• Reports to ORO in writing within two business days after being notified of any research-related citation or determination of non-compliance by any state or federal agency; or any situation that has generated media attention or Congressional interest.
• Provides a copy of any ORO compliance reports regarding the research program to the associate chief of staff for research, Research and Development Committee, any relevant research review committee(s), and the research compliance officer in a timely fashion.
• Prepares reports documenting any determinations regarding VASNHCS Research to all necessary regulatory authorities (such as OHRP, FDA or other governmental agencies) with copies being sent to the VASNHCS Research Office, the Chair of the RDC, the VA Office of Research and Development and to the Regional VA Office of Research Oversight.

When applicable, the VASNHCS will work directly with research monitors to confirm their duties, authorities, and responsibilities.

When applicable, the VASNHCS hospital will render services to VA approved research projects if no veterans are available for the project.

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:

• The following employees of the VASNHCS Research Office may not serve as voting members of the facility’s 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.

The University IRB will consider best practices, as follows:

• At least one VA voting member of the IRB must be in attendance when VA research is discussed at a convened meeting.
• 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 facility director, administrative staff, chief of staff, other senior administrators such as associate or assistant directors, or chief nurse, may observe meetings but not serve as voting or non-voting members for research initiated or conducted at the local VA.
• The VA research compliance officer may attend meetings of the IRB when requested by the IRB or as specified by local procedure.
• There is not a maximum number of terms for IRB members.

The VASNHCS Research Office will notify Research Integrity of training deficiencies or conflicts of interest for VA IRB representatives. These members will neither be assigned to review projects nor vote until Research Integrity 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, Research Integrity 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.

VASNHCS Facility Director

VA Facility Director with regards to the VASNHCS HRPP, not otherwise stated in these Policies and Procedures, is responsible for:

• Serving as the Institutional Official (IO) for the VASNHCS medical facility. This responsibility cannot be delegated.
• Delegating authority in writing for respective roles and responsibilities for the HRPP to provide organizational structure and ensure leadership for oversight activities for all human research conducted at or by the facility.
• Overseeing the facility’s research program. The IO is responsible for the creation and implementation of an HRPP for research involving human participants.
• Ensuring that the institution’s HRPP functions effectively and that the institution provides the resources and support necessary to comply with all requirements applicable to research involving human participants.
• Appointing and ensuring that VA IRB members are appropriately knowledgeable in accordance with ethical standards and all applicable regulations.
• Appointing the privacy officer and information security officer as non-voting members or consultants of the IRB or research and development committee.
• Overseeing the R&D Committee, IRB, and other applicable subcommittees of the R&D Committee, facility research office, and all VA investigators and VA research staff who conduct human research at that facility.
• Ensuring independence of the IRB.
• Serving as the official representative of the institution to external agencies and oversight bodies, and providing all written communication with external departments, agencies, and oversight bodies.
• Ensuring appropriate documentation of required actions and responsibilities pertaining to review, approval, conduct and oversight of human research conducted at the VASNHCS.
• Ensuring all human research is reviewed and approved by an IRB and will be subject to oversight by the IRB.
• Appointing research compliance officer to conduct annual research consent document audits and triennial regulatory audits, and to assist in the VA facility’s assessments of regulatory compliance.
• Providing a copy of any ORO compliance reports regarding the research program to the associate chief of staff for research, Research and Development Committee, any relevant research review committee(s), and the research compliance officer in a timely fashion.

When the facility engages the services of another entity’s IRB as its IRB of Record, the IO is responsible for:

• Establishing and signing a Memorandum of Understanding (MOU) or Authorizing Agreement with other VA facilities or external organization(s) providing IRB services (see VHA Handbook 1058.03 and MOU Checklist).
• Ensuring that external IRBs of Record used by the VA facility hold current IRB registrations with FDA/OHRP and provide updates to membership as required by VHA Handbook 1058.03.

VA Research Compliance Officer and the IRB

VASNHCS facility director is responsible for ensuring appropriate auditing of local human research studies to assess compliance with all applicable local, VA, and other federal requirements including, but not limited to, Office of Research Oversight requirements. A research compliance officer is an individual whose primary responsibility is auditing and reviewing research projects relative to requirements for the protection of human participants. The VA facility’s lead research compliance officer must report directly to the facility director. The activities of the research compliance officer may not be determined or managed by the Research Service, research investigators, or any other research personnel.

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. The IRB may observe, or have a third party observe research activities, including the informed consent process. 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 Research Integrity Director by calling 775.327.2367 or the VA Medical Center Director by calling 775.789.6630.

The Research Integrity 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 and VA requirements 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 in the ethical principles on which human research is to be conducted before they may participate in human research in accordance with requirements specified by ORD. Researchers planning to conduct research at the VASNHCS are advised to contact the Research Program at 775.326.2789 for training requirements.

Research Integrity 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 Research Integrity 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 the University IRB, 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:

• Stop all research activities including, but not limited to, enrollment of new participants, analysis of individually identifiable data, and research interventions or interactions with currently enrolled participants, except where stopping such interventions or interactions could be harmful to participants.
• 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. Decision should be based on an over-riding safety concern or ethical issue involved such that it is in the best interests of individual participants to continue participating.

Requirements for VA Research

The University IRB considers the relevance of the research to Veterans and the mission of the VA. 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 impact clinical care, and the name and contact information of the researcher conducting the study. For studies that do not involve a medical intervention, no annotation may be made in the medical record.

VASNHCS Research and Development Committee (RDC) shall review the VASNHCS Research protocol with regard to ensuring that any requirements for the protection of human participants have been met, that the study is meritorious and the scientific objectives are valid, and that the informed consent form used in the protocol conforms to VASNHCS standards. The RDC is permitted to assign scientific review and some administrative responsibilities, including compliance issues, to more appropriate subcommittees and individuals. RDC shall provide the IRB with correspondence to the PI detailing any human participant protection concerns that the RDC identifies during its review of the protocol. In the event that the RDC restricts or limits the ability of an investigator to perform research, the RDC shall notify the IRB immediately and provide the IRB with copies of any minutes or other documentation pertaining to the RDC’s review or oversight of a protocol that is subject to IRB jurisdiction.

PIs who wish to perform VASNHCS Research protocols must use the standard VASNHCS informed consent template and the VASNHCS HIPAA Authorization template or combined consent and HIPAA authorization template. The VA Privacy Officer must review the HIPAA Authorization to ensure it contains all required elements and is consistent with all privacy requirements before the PI can begin to use or collect the individual’s information based on an approved research protocol.

When research involves an investigational drug, the VA PI ensures the local Pharmacy Service or Research Service Investigational Pharmacy receives:

• Documentation of IRB and any other relevant approvals.
• A copy of VA Form 10-9012 (if applicable).
• A copy of the current approval protocol.
• A copy of the consent document for each participating participant with all appropriate signatures.
• Documentation of IRB continuing review approval.
• Copies of sponsor-related correspondence specific to the drugs as appropriate.
• Copies of all correspondence addressed to the researcher from the FDA specific to the investigational drugs as appropriate.
• Inform the chief, pharmacy service, the research pharmacy when applicable, and the IRB in writing with a study involving investigational drugs has been suspended, terminated, or closed.

PIs who wish to perform VASNHCS Research protocols must:

• Comply with all dispensing requirements.
• Comply with all documentation requirements and make relevant records accessible to the investigational drug pharmacist when requested.
• Ensure appropriate telephone contact with participants.
• Maintain oversight of recruitment. consent, and protocol procedures
• Delegate responsibility to qualified staff, commensurate with their training and qualifications.

Prohibited Research for VA

• Research in which the focus is either fetus, human fetal tissue, in-utero, or ex-utero, is not allowed.
• Interventional research involving neonates is not allowed.
• Research involving pregnant women as participants is not allowed unless the IRB determines the requirements in 45 CRR 46.204 are met, and the facility director certifies the facility has sufficient expertise in women’s health to conduct the proposed research.
• Research involving prisoners as participants is not allowed unless a waiver has been granted by the VASNHCS ACOS.

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. The PI, but also all local site researchers, must obtain written approvals from the relevant local VA facilities’ IRBs of record and all other local committees, subcommittees, and other approvals according to the respective applicable local, VA and other federal requirements. Research cannot be initiated at any given site until the local VA researcher has obtained written notification that the research can be initiated from the VASNHCS associate chief of staff for research and development.

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. Collaborative research requires a signed agreement that addresses the responsibilities of each party, including ownership of data and reuse of data for other research.

VASNHCS PIs conducting collaborative VA Research must provide the IRB with the following, as applicable:

1. contact information and FWA for the collaborating VA facilities’ IRBs of Record;
2. documentation of approval from collaborating VA facilities’ committees and subcommittees as required by the participating VA sites, the federal VA, and other federal agencies;
3. 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;
4. informed consent document reflecting VA requirements;
5. HIPAA Authorization form approved by the VASNHCS for research involving the collection of PHI; PO/ISSO 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
6. 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. Individuals working under a contract with VA cannot serve as VA investigators, but may participate in research in other ways, such as collaborators or consultants.

Requirements for International VA Research

The VASNHCS facility director must ensure all international research is approved explicitly in a document signed by the facility director, except for Cooperative Studies Program activities which must be approved by the CRADO. The PI 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.

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.
• holds 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.

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 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:

• 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 Research Integrity Director. Upon receipt, Research Integrity 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. *Research Integrity staff will verify VA Research office signoff in IRBNet package.
• Privacy Officer†, ‡(PO)
• Information System Security Officer† (ISSO)
• Institutional Biosafety Committee (IBC): The IBC also functions as the Subcommittee on Research Safety (SRS) as per VHA Directive 1200.08 Safety of Personnel and Security of Laboratories Involved in VA Research. IBC is responsible for reviewing, approving, and monitoring all VA research projects involving biological materials that may pose differing levels of safety, health, or environmental risk to animals or humans
• Other VA committees as relevant to the research

NOTE: PRS requirements for flagging medical records will be monitored by the VASNHCS Research Office.

†PO and ISSO 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 research pages of Research Integrity website.

PO and ISSO Reviews

PO and ISSO determinations that occur before IRB review are submitted for IRB review and consideration as follows:

• The PO and ISSO prepare correspondence that indicates pre-IRB reviews were completed.
• The correspondence will specify whether 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 ISSO 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 ISSO.
• Following IRB review, deficiencies noted by the PO and ISSO and the related requested revisions will be included in IRB review letters.

NOTE: The University IRB does not require submission of PO and ISSO pre-IRB review checklists.

VA Reviews that Follow IRB Approval

Final PO and ISSO 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 ISSO 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/ISSO 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, ISSO 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. Research Integrity 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. Research Integrity 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

Generally, any federally funded research project that involves the use or collection of identifiable, sensitive information will be required to have a Certificate of Confidentiality as required by Section 2012 of the 21st Century Cures Act (42 U.S.C. 241). For purposes of this section and as defined in the 21st Century Cures Act, the term identifiable, sensitive information means information about an individual that is gathered or used during the course of research in which an individual is identified; or there is at least a very small risk, as determined by current scientific practices or statistical methods, that some combination of the information, a request for the information, and other available data sources could be used to deduce the identity of an individual. An investigator issued a certificate must protect the privacy of individuals involved in the research study and may not disclose or provide to any other person not connected with the research the name of subjects or any information, document, or biospecimen that contains identifiable, sensitive information about subjects that was created or compiled for purposes of the research.

Certificate of Confidentiality (CoC) applies to eligible VA research. When the information is used for other scientific research that is following applicable Federal regulations governing the protection of human participants in research. When VA conducts a study that is protected by a Certificate of Confidentiality, the following requirements apply:

1. For studies in which information about the subject’s participation will be included in the subject’s VHA medical record, information must be given to the prospective participants as part of the informed consent process that information regarding study participation will be included in the medical record;
2. For studies in which the IRB requires a written informed consent, the informed consent document approved by the IRB must include a statement that the study has a Certificate of Confidentiality.

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.

VA Principal Investigator Noncompliance

Noncompliance refers to not following laws or regulations that govern research involving human participants, the organization’s policies and procedures, or the requirements or determinations of the IRB or EC. Noncompliance can be relatively minor or serious. Noncompliance can also be a one-time event or a continuing problem. The determination that noncompliance is “serious” or “continuing” rests with the IRB. Within five business days of becoming aware of any apparent or possible serious or continuing noncompliance, members of the VA research community are required to ensure that the apparent noncompliance has been reported in writing to the IRB.

Research compliance officer reports of apparent serious or continuing noncompliance. Within five business days of identifying apparent serious or continuing noncompliance based on a consent document audit, regulatory audit, or press coverage (including but not limited to radio, TV, newspaper, online publications) of a negative nature regarding the Organization’s HRPP systematic audit of VA research, the VA research compliance officer must provide a written report of the apparent noncompliance directly (without intermediaries) to:

• Facility director.
• Associate chief of staff for research.
• The Research and Development Committee.
• The IRB.
• Other relevant research review committees.

An initial report of apparent serious or continuing noncompliance based on a VA research compliance officer consent document audit, VA research compliance officer regulatory audit, or other systematic research compliance officer audit is required regardless of whether disposition of the matter has been resolved at the time of the report.

Within five business days of receiving such notification, the facility director must report the apparent serious or continuing noncompliance to:

• The appropriate Office of Research Oversight research officer.
• Veterans Integrated Service Network (VISN) director.
• Office of Research Development.

Should the IRB determine that the reported incident constitutes serious noncompliance or continuing noncompliance, within five business days after the determination the IRB chair, or designee must provide a written report of the determination directly to:

• Facility director.
• Associate chief of staff for research.
• Research and Development Committee.
• The VARCO, if the apparent serious or continuing noncompliance was identified by a VARCO audit, regardless of outcome.

The facility director must report the determination to:

• The appropriate Office of Research Oversight research officer.
• The VISN director.
• Office of Research Development.
• VA Privacy Office, when the report involves unauthorized use, loss, or disclosure of individually identifiable patient information.
• VHA Information Security Officer when the report involves violations of VA information security requirements.

If it was determined that the problem or event is serious, unanticipated, and related to the research, the convened IRB must determine and document whether a protocol or consent document modification is warranted. If the convened IRB determines that a protocol or consent document modification is warranted, the IRB must also determine and document:

• Whether previously enrolled participants must be notified of the modification.
• Simultaneous determination is required regarding the need for any action (e.g., suspension of activities; notification of participants) necessary to prevent an immediate hazard to participants in accordance with VA regulations.
• Procedures for withdrawal of enrolled participants consider their rights and welfare (e.g., making arrangements for medical care outside of a research study, transfer to another researcher, and continuation in the research under independent monitoring.