VA Research: Policy for IRB Review of Human Subjects Research that Falls Under VA Purview

Summary: The University of Wisconsin-Madison Health Sciences IRBs, through a Memorandum of Understanding (MOU), serve as the IRBs of record for William S. Middleton Memorial Veterans Hospital (Madison VAH) human subjects research studies which are not otherwise reviewed by a central IRB of the VA or other federal agency. This policy documents requirements for research conducted under the purview of the Madison VAH that add to or differ from those outlined in the UW-Madison Human Research Protection Program (HRPP) policies for the review of human subjects research.


I. Application of VA Regulations, Madison VAH Policies, and UW Policies Governing Human Subjects Research

1. Study teams engaged in Madison VAH human subjects research overseen by a UW IRB must follow, in addition to other applicable federal regulations, and UW-Madison policies for the protection of human subjects, all applicable policies found in Veterans Health Administration (VHA) and Department of Veterans Affairs (VA) Directives, Handbooks, related memoranda and other guidance documents.

2. The UW IRBs apply the Common Rule regulations at 38 CFR 16 to all Madison VAH human subjects research in addition to other applicable federal regulations governing human subjects research, such as US Food and Drug Administration (FDA) and Department of Defense (DOD) regulations, and VA regulations and requirements.

II. Definition of VA Research

1. If any of the following apply, a study will likely qualify as human subjects research falling under Madison VAH purview and thus require VA Research and Development Committee (R&DC) review and approval and the application of relevant VA regulations and requirements:

2. The determination as to whether a particular research study falls under VA R&D purview will be made by the Madison VA R&D Committee. Having a protocol reviewed and approved by the R&D Committee is the final defining factor determining VA status of that study (i.e., if the R&D Committee has reviewed and approved a study, that research must therefore be considered VA research unless and until that study is closed at or withdrawn from the VA).

III. Restrictions on VA Research

1. In accordance with VHA policies, the Madison VAH does not conduct planned emergency research or classified research involving human subjects.

2. Research involving the creation of a human embryo or embryos solely for research purposes or research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR 46.208(a)(2) and Section 498B of the Public Health Service Act (42 U.S.C. 289g(b)) cannot be conducted by VA Investigators, at VA facilities, or at VA- approved off-site facilities.

3. VA investigators cannot conduct interventions in research that enroll neonates while on official duty, at VA facilities, or at VA-approved off-site facilities.

4. Research involving children (including data, samples, or images derived from children even if these are de-identified) can only be approved for conduct as a VA study if its relevance to VA has been demonstrated and the research does not present greater than minimal risk.

4.1 The Madison VAH Director must approve participation of the Madison VAH in any proposed research that includes children.

4.2 The IRB must have the appropriate expertise to evaluate any VA research involving children and must comply with 45 CFR 46.401 - 46.404 and 46.408.

5. The Madison VA does not conduct international research.

IV. Madison VAH Officials and Human Subjects Research

1. Even if a UW Health Sciences IRBs approves a study, Madison VAH officials, including the R&DC and Madison VAH Director, or Office of Research Development (ORD) can disapprove the research.

2. Madison VAH officials may not approve human subjects research if it has not been approved by the IRB nor can they overrule an IRB’s determination to disapprove a study or require modifications to secure IRB approval.

3. In addition to the UW Health Sciences IRBs, the Madison VAH R&DC and the Madison VAH Director have the authority to suspend or terminate approval of Madison VAH research.

V. Integration of IRB and R&DC Reviews and Oversight

1. Non-exempt VA human subjects research

1.1 The UW Health Sciences IRBs ensure that Madison VAH R&DC endorsement is in place prior to formally reviewing the submission in the case of all initial reviews and convened IRB review of changes of protocols (aka amendments).

1.2 If a new study is approved under expedited procedures or by the convened IRB or a change of protocol is approved by the convened IRB, an administrative hold is placed on the submission to ensure final VA R&DC approval for the study is obtained. Final consent documents are not released by the IRB until final VA R&DC approval has been granted and the conditions of VA R&DC approval have been met.

2. Exempt VA human subjects research

2.1 The UW Health Sciences IRB reviewer ensures that Madison VAH R&DC endorsement is in place prior to formalizing a determination of exemption.

2.2 The notification of exemption includes a statement that the research cannot commence until final VA R&DC approval has been granted.

2.3 The VA R&DC is responsible for any further VA-required monitoring of exempted research.

3. Not human subjects research certifications

3.1 When the Health Sciences IRBs Office certifies that a project under VA purview does not meet the definition of research or research involving human subjects, they also notify the individuals who submitted the project to inform the VA Research Office prior to initiating the project.

VI. Notifications of the Madison VAH

1. Generally, the UW Health Sciences IRBs notify the Madison VAH R&DC through ARROW of its determinations, including approvals or disapprovals of research activities or of modifications required to secure IRB approval of a research activity.

1.1 In the case of suspensions or terminations of research, a finding of serious and/or continuing noncompliance, or a determination that an unanticipated problem involving risks to subjects or others has occurred, the UW Health Sciences IRBs notify the Madison VAH Director, Associate Chief of Staff/Research &Development (ACOS/R&DC), and Research Compliance Officer (RCO) through email rather than through ARROW.

2. For research approved under expedited procedures, the decision and the expedited review eligibility category are recorded in ARROW and thus available through the mechanism to the study team and VA R&DC.

VII. Integration of IRB and Madison VAH Privacy Officer (PO) and Information Systems Security Officer (ISSO) Reviews

1. The Madison VAH PO and ISSO do not serve on the UW Health Sciences IRBs but act in an advisory capacity to the IRBs.

2. The UW Health Sciences IRBs require study teams to provide a summary report from the VA PO and ISSO prior to formal IRB review, including expedited or convened IRB review, and consider the information within the report as part of their assessment of research studies.

VIII. Access to IRB Records

1. UW Health Sciences IRBs records are accessible for inspection and copying by authorized representatives of Madison VAH (including the RCO), Office of Research Oversight (ORO), Office for Human Research Protections (OHRP), FDA, and other authorized entities at reasonable times and in a reasonable manner.

2. In addition to the IRB records described in the UW Maintenance of IRB Records policy, the UW Health Sciences IRBs also include correspondence between the IRB and the R&DC.

3. IRB records for studies that fall under VA purview are retained and disposed of in accordance with the National Archives and Records Administration (NARA) approved records schedules found in VHA Records Control Schedule (RCS) 10-1.

3.1 The retention date for studies cancelled without participant enrollment is calculated from the date that the study is closed with or withdrawn by the IRB.

4. The UW Health Sciences IRBs provide the RCO and Madison VAH R&DC access to unredacted IRB minutes through ARROW.

IX. IRB Minutes

1. The following is documented either in IRB minutes or the IRB file:

1.1 If a non-exempt study is approved, that all of the criteria for approval of human subjects research have been satisfied.

1.2 That all criteria have been satisfied in cases where the IRB waives informed consent.

1.3 That all criteria have been satisfied in cases where the IRB waives elements of or alters informed consent.

1.4 That all criteria have been satisfied in cases where the IRB waives documentation of informed consent.

1.5 The level of risk the study presents to subjects.

X. IRB Rosters

1. UW Health Sciences IRBs rosters are updated and these revisions communicated to the Madison VA RCO for reporting to ORO and other VA offices when required.

2. The rosters list IRB members identified by name, earned degrees, representative capacity, indications of experience (such as board certifications, licenses, etc.,) sufficient to describe each member's primary anticipated contributions to IRB deliberations, and any employment or other relationship between each member and the institution.

XI. Collaborative Research Between the UW and Madison VAH (or Involving Other Non-VA Sites)

1. Generally, whenever the Madison VHA participates in a collaborative human subjects research study )i.e. one that will be conducted at both the Madison VAH and at the UW or other non-VA sites), separate IRB applications are required, one solely for the VA component of the study, and one for the non-VA component.

2. The VA-only protocol (or protocol addendum) and/or IRB application must describe the data to be disclosed to collaborators, the entity(ies) to which the data are to be disclosed, how the data are to be transmitted, and how the transmitted data will be stored, retained, destroyed, and/or further disclosed and to whom. This includes data from individual subjects as well as other data developed during the research such as the analytic data and the aggregate data.

3. Release of VA data, images, or specimens to UW collaborators, or to other sites outside the Madison VAH, must be described in the consent and HIPAA authorization forms.

4. The VA protocol or IRB application and VA consent form must be clear regarding what procedures are performed at the VA versus the UW (and any other sites outside the Madison VAH).

5. The VA consent and HIPAA documents must describe the Protected Health Information (PHI) to be collected and/or used by the VA research team, PHI to be disclosed to the UW and other institutions external to the VA, and the purposes for which the PHI may be used.

XII. IRB Membership

1. The UW Health Sciences IRBs include representatives with the Madison VAH appointments to include perspectives of individuals who have experience working with or treating veterans.

1.1 When possible, non-conflicted IRB members who serve as VA representatives will be present at convened IRB meetings during the review of human subjects research that falls under VA purview.

2. VA members of the UW Health Sciences IRBs are appointed by the Madison VAH Director in accordance with Madison VAH policies and procedures.

3. For the purposes of Madison VAH research, physicians, dentists, nurses, pharmacists, social workers, other clinicians, statisticians, and allied health professionals are considered to be scientists.

4. The following personnel at the Madison VAH cannot serve as IRB members:

4.1 Research office staff including, but not limited to, the ACOS/R&D and the Administrative Officer (AO/R&D)

4.2 Madison VAH Director

4.3 Other Madison VAH senior administrators such as Associate or Assistant Directors or Chief of Staff

4.4 Administrative staff for any Madison VAH senior administrators

5. The Madison VAH RCO acts as a consultant to the UW Health Sciences IRBs and may attend IRB meetings in that capacity, but does not serve as a voting or non-voting member of the IRB.

6. The Madison VAH PO and ISSO serve as consultants to the UW Health Sciences IRBs and may attend IRB meetings in that capacity, but do not serve as a voting or non-voting member of the IRB.

XIII. IRB Review

1. In addition to the criteria for IRB approval for non-exempt research that must be met as outlined in the University of Wisconsin-Madison Initial Review Policy, Change of Protocol Policy, and Continuing Review Policy, the VA also requires the following criteria be met:

1.1 Privacy and confidentiality provisions must take into consideration the requirements of the HIPAA Privacy Rule and other laws regarding protection and use of veterans’ and others information, including the Privacy Act of 1974, 5 U.S.C. 552a; VA Claims Confidentiality Statute, 38 U.S.C. 5701; Confidentiality of Drug Abuse, Alcoholism and Alcohol Abuse, Infection with Human Immunodeficiency Virus (HIV), and Sickle Cell Anemia Medical Records, 38 U.S.C. 7332; and Confidentiality of Healthcare Quality Assurance Review Records, 38 U.S.C. 5705.

1.2 The research must be relevant to the mission of VA and the veteran population that it serves.

1.2.1 The UW Health Sciences IRBs rely on the Madison VAH R&DC for this determination and does not approve human subjects research that is not endorsed by the Madison VAH R&DC.

1.3 If non-Veterans will be included, the protocol and related materials must justify the inclusion of non-Veterans.

1.4 Mechanisms are implemented to manage, reduce, or eliminate potential, actual, or perceived conflicts of interest (COI) related to all aspects of the research, including financial interests, clinical roles (for example, investigator-patient relationships), and other professional or personal roles.

1.4.1 The UW Health Sciences IRBs rely, in part, on the Madison VAH’s research COI policies and review processes to help ensure that potential COIs that are financial in nature are addressed.

2. The IRB reviews the storage and security procedures for test articles used in Madison VAH human subjects research, which must comply with Madison VAH policies and procedures.

3. For exempt research activities involving the study team interacting with human subjects or obtaining information by educational tests, survey or interview procedures, or behavioral interventions, the following information must be given to the prospective human subject as applicable in writing or orally:

  1. The activity is research;
  2. Participation is voluntary;
  3. Permission to participate can be withdrawn;
  4. Permission for use of data can be withdrawn for exempt research activities involving the collection and use of identifiable data; and
  5. Contact information for the Madison VAH Investigator.

3.1 If an exempt activity requires a limited IRB review, the limited IRB review must be completed prior to approval by the R&DC.

XIV. Informed Consent

1. In addition to the elements of consent required under the Common Rule and FDA regulations, the VA requires the following additional consent language for research that involves more than minimal risk: A statement that VA will provide treatment for research related injury in accordance with applicable federal regulations.

2. When appropriate, the Madison VAH consent form should include a statement that informs VA subjects that they or their insurance will not be charged for any costs related to the research.

2.1 The consent form also should indicate that some veterans are required to pay co-payments for medical care and services specifically related to their medical care provided by VA and that these co-payment requirements will continue to apply to medical care and services that are not part of the research procedures or interventions.

3. The informed consent document must include information describing any photographs, video, and/or audio recordings to be taken or obtained for research purposes, how the photographs, video, and/or audio recordings will be used for the research, and whether the photographs, video, and/or audio recordings will be disclosed outside VA.

3.1 Informed consent to take a photograph, video and/or audio recording cannot be waived by the IRB.

3.2 The consent form does not give legal authority to disclose the photographs, video, and/or audio recordings outside VA. A HIPAA authorization is needed to make such disclosures.

XV. Use of a Short Form

1. The IRB cannot waive the requirement for a witness or witness signature when the short form consent is used.

XVI. Consent Documents

1. The date of a UW Health Sciences IRB approval is documented on consent documents.

2. Consent may be obtained electronically so long as the informed consent process meets all requirements in the VHA Directive 1200.05 and VA requirements for the use of electronic signatures.

XVII. HIPAA Privacy Rule

1. As part of their review of human subjects research, including exempt human subjects research, the UW Health Sciences IRBs are responsible for making determinations under the HIPAA Privacy Rule in regard to waivers or alterations of authorization for research uses of protected health information on behalf of the Madison VAH.

2. The UW Health Sciences IRBs review VA HIPAA authorization forms to ensure that they are consistent with the consent documents, study protocol, and other research materials.

2.1 The Madison VAH requires the written HIPAA authorization to be a standalone document using VA Form 10-0493: Authorization for Use and Release of Individually Identifiable Health Information Collected for VHA Research.

2.2 All potential disclosures to a non-VHA entity must be listed within the written authorization.

3. When a study team requests a waiver of HIPAA authorization, the UW Health Sciences IRBs records the following in the ARROW application, which is available to the study team as well as the VA PO and ISSO:

3.1 The IRB making the waiver determination

3.2 Date of IRB approval of waiver of HIPAA authorization;

3.3 Statement that the waiver of HIPAA authorization satisfies the following criteria:

  • The use or disclosure of the requested information involves no more than minimal risk to the privacy of individuals based on, at least, the presence of the following elements:
  • An adequate plan to protect the identifiers from improper use and disclosure;
  • An adequate plan to destroy the identifiers at the earliest opportunity consistent with conduct of the research, unless there is a health or research justification for retaining the identifiers or such retention is otherwise required by law.
  • Adequate written assurances that the PHI will not be reused or disclosed to any other person or entity, except as required by law, for authorized oversight of the research study, or for other research for which the use or disclosure of the requested information is permitted by the Privacy Rule;
  • The research could not practicably be conducted without the waiver;
  • The research could not practicably be conducted without access to and use of the requested information.
  • A brief description of the PHI for which the IRB has determined use or disclosure to be necessary.
  • Identification of the IRB review procedure used to approve the waiver of HIPAA authorization (either convened IRB review procedures or expedited review procedures).
  • Identification of the person recording the approval of the waiver of HIPAA authorization.

4. The VA defines preparatory to research activities as activities that are necessary for the development of a specific protocol.

4.1 PHI from data repositories or medical records may be reviewed during this process, but only aggregate data may be recorded and used in the protocol application.

4.2 Within the VA, preparatory to research does not involve the identification of potential subjects and recording of data that would be used to recruit these subjects or to link to other data.

4.3 The preparatory to research activity ends once the protocol has been submitted to the IRB and the VA R&DC for review.

4.4 Activities that occur after an application to conduct human subjects research is submitted to the IRB or VA R&DC, such as review of medical records to determine identify potential subjects, are not considered preparatory to research under VA regulations and thus require waivers of authorization.

5. If a study team proposes to disclose PHI outside the Madison VAH and also requests a waiver of HIPAA authorization and signed consent, the Madison VAH PO must ensure and document the VA’s authority to disclose the PHI to another institution in order to ensure the requirements of other applicable privacy regulations such as the Privacy Act of 1974 (5 U.S.C. 552a) are met.

XVIII. Participation of Non-Veterans in VA Research

1. 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 numbers of veteran patients suitable for the study and not simply because a non-veteran population is easily accessible to the investigator.

1.1 The UW Health Sciences IRBs require research teams to justify including non-veterans in a research study.

1.2 If a UW Health Sciences IRB finds the inclusion of non-veterans in a study to be justified, the approval for recruitment of non-veterans is documented in the meeting minutes and/or study file.

2. Other situations where non-veterans may be recruited include studies that will generally benefit veterans and their well-being but would not include veterans as subjects, such as surveys of VA providers, studies involving veterans’ family members, or studies including active duty military personnel.

3. Active duty military personnel may be entered into VA research conducted jointly by VA and DoD or within DoD facilities.

4. All VA regulations and policies related to veterans as research subjects apply to non-veterans participating in VA research.

XIX. Research Involving Pregnant Women

1. Women who are known to be pregnant and their fetuses may be involved in research if all the following requirements are met and the VA Hospital Director certifies that the VA medical facility has sufficient expertise in women’s or reproductive health to conduct the proposed research if the research includes interventional studies or invasive monitoring of pregnant women as subjects, including informed consent requirements and the following ethical and scientific criteria:

1.1 Where scientifically appropriate, preclinical studies, including studies on pregnant animals, and clinical studies, including studies on non-pregnant women, have been conducted and provide data for assessing potential risks to pregnant women and fetuses;

1.2 The risk to the fetus is caused solely by interventions or procedures that hold out the prospect of direct benefit for the woman or fetus. If there is no such prospect of benefit, then the risk to the fetus is not greater than minimal and the purpose of the research is the development of important biomedical knowledge that cannot be obtained by any other means;

1.3 Any risk is the least possible for achieving the objectives of the research; and

1.4 If the research holds out the prospect of direct benefit to the pregnant woman, the prospect of a direct benefit both to the pregnant woman and the fetus, or no prospect of benefit for the woman nor the fetus when risk to the fetus is not greater than minimal and the purpose of the research is the development of important biomedical knowledge that cannot be obtained by any other means, her consent is obtained in accord with the informed consent provisions of this directive.

1.5 Each individual providing consent is fully informed regarding the reasonably foreseeable impact of the research on the fetus or neonate.

1.6 For children who are pregnant, assent and permission are obtained in accordance with the provisions of 45 CFR Part 46, Subpart D. Research involving clinical interventions with the potential of greater than minimal risk cannot be conducted by VA for children who are pregnant.

1.7 No inducements, monetary or otherwise, will be offered to terminate a pregnancy.

1.8 Individuals engaged in the research will have no part in any decisions as to the timing, method, or procedures used to terminate a pregnancy; and

1.9 Individuals engaged in the research will have no part in determining the viability of a neonate.

XX. Research Involving Subjects Lacking Decision Making Capacity

1. For individuals who lack decision-making capacity to be enrolled in VA research, the IRB must determine that the proposed research entails:

1.1 In addition to satisfying the conditions above, the IRB must determine that:

2. As part of their consideration of research involving subjects lacking consent capacity, the UW Health Sciences IRBs review and approve the plan for surrogate consent to ensure that it is appropriate given the population and setting of the research.

2.1 When planning to enter subjects with impaired decision-making capacity, investigators must address in the IRB application how they will determine when surrogate consent (i.e., an LAR) will be required.

2.1.1 Under VA regulations an LAR is an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research.

2.1.2 An individual who is qualified as a LAR to provide informed consent on behalf of a prospective research subject may not always qualify as a personal representative for purposes of consent to use or disclose a subject’s protected health information (PHI) (i.e., signing a Health Insurance Portability and Accountability Act (HIPAA) authorization).

2.1.3 In general, the study team must perform or obtain and document a clinical assessment of decision-making capacity for any subject suspected of lacking decision-making capacity.

2.1.4 Individuals ruled incompetent by a court of law are considered to lack decision-making capacity.

2.2 If feasible, the study team must explain the proposed research to the prospective research subject even when the surrogate gives consent.

2.3 LARs must be told that their obligation is to try to determine what the subjects would do if able to make an informed decision. If the potential subjects’ wishes cannot be determined, the LARs must be told they are responsible for determining what is in the subjects’ best interest.

3. For VA research, the UW Health Sciences IRBs follow the VA regulations regarding the persons who are authorized to consent on behalf of persons who lack decision-making capacity in the following order of priority:

a) Health care agent (i.e., an individual named by the subject in a Durable Power of Attorney for Health Care);

b) Legal guardian or special guardian;

c) Next of kin: a close relative of the patient 18 years of age or older, in the following priority: spouse, child, parent, sibling, grandparent, or grandchild; or

d) Close friend.

4. Under no circumstances may a subject be forced or coerced to participate in a research study even if the LAR has provided consent.

XXI. Student and Trainee Research

1. Students or trainees cannot serve as Principal Investigators on VA human subjects research.

2. In order for a student or trainee to participate as a study team member in Madison VAH research, they must be enrolled in an institution with an educational affiliation agreement with the Madison VAH facility or be directly appointed to a VA training program that has no external institutional sponsorship (e.g. VA Advanced Fellowship).

3. If a student or trainee is involved in Madison VAH research a VA investigator sufficiently experienced in the area of the trainee’s research interest must serve as PI and is responsible for oversight of the research and the trainee/student. The PI is responsible for ensuring the trainee/student complies with all applicable local, VA, and other federal requirements including those related to research, information security, and privacy.

XXII. Identification and Recruitment of Research Subjects

1. The IRB is required to approve the use of identifiable information to recruit subjects for VA research protocols and the approval must include an approval of a waiver of HIPAA authorization in such instances.

2. If a research repository from a previous study is used to identify subjects, there must be an IRB approved HIPAA waiver for this activity in the new IRB application.

3. Research teams cannot post recruitment documents, flyers, and advertisements for research that is not VA research within or on the premises of a VA facility.

4. Study team members can only make initial contact with potential subjects for recruitment purposes in person or by letter prior to initiating any telephone contact, unless there is written documentation that the subject is willing to be contacted by telephone about the study in question or a specific kind of research as outlined in the study.

5. Initial subject contact also must follow the most recent VA and VHA memoranda or guidance regarding this issue, which can be found on the Office of Research and Development website at www.research.va.gov.

6. Identifiable information cannot be used to re-contact individuals to obtain additional information unless approved by the IRB. The IRB will determine whether a waiver of consent and authorization is required for the study team to re-contact study participants.

XXIII. Expiration of IRB Approval

1. If approval expires for research that falls under the purview of the Madison VAH, the study team must:

1.1 Stop all research activities including, but not limited to, enrollment of new subjects, analyses of individually identifiable data, and research interventions or interactions with currently participating subjects, except where stopping such interventions or interactions could be harmful to those subjects; and

1.2 Immediately submit to the IRB Chair a list of research subjects who could be harmed by stopping specified study interventions or interactions.

1.3 The IRB Chair must determine within 2 business days whether or not such interventions or interactions may continue.

XXIV. Social Security Numbers

1. Social Security Numbers (SSNs), real or scrambled, are considered identifiers.

1.1 Scrambled SSNs are considered identifiers by the HIPAA Privacy Rule because they are unique to the individual and are derived from the SSN.

1.2 Re-identification codes from being based on an identifier such as SSN (in whole or in part), name, or other direct identifier.

2. The HS IRBs will confirm that investigators have obtained approval from the Madison VAH PO and VA R&DC to obtain real SSNs or scrambled SSNs to meet the specific aims of the research protocol.

XXV. Re-identification of De-Identified Data

1. Re-identification of de-identified data must be approved in advance by the IRB and R&DC.

2. Approval for re-identification of de-identified data may be given only if all three of the following conditions are met:

3. If the data repository’s policies state that the data repository may contain only de-identified data, then re-identification of the data may not be done by the repository staff nor can re-identified data be placed in the repository.

4. If a research data repository contains only de-identified data by policy, the individual or body responsible for administering the data repository must amend the policies and the protocol governing the research repository before placing re-identified data in the data repository. The new policies permitting storage of re-identified data in the data repository must be approved by the IRB and R&DC for the facility where the research data repository resides. Only after these approvals have been obtained may the repository contain identifiable data.

5. If the facility where the research data repository resides does not have a Federal-wide Assurance (FWA) or IRB of record, identifiable data may not be entered into the research repository.

XXVI. Data Security

1. The UW Health Sciences IRBs help ensure that the transmission and transfer of identifiable data are performed in accordance with VA security policies by confirming that the ISSO has reviewed and approved such transmission and transfer.

XXVII. Data Repositories

1. IRB review and approval are required for the creation of a VA-created or VA-controlled research data repository that constitutes human research.

2. Data from research studies may not be used for other research purposes, including re-contact of subjects for future research, unless allowed by the informed consent under which they were collected, approved by the IRB, and placed in a research data repository.

3. When research data repositories that involve human subjects are created and maintained by the Madison VAH, the IRB ensures that:

3.1 The repositories comply with the requirements of VHA Directives and Handbooks and all relevant COI policies.

3.2 The repositories have a security plan for all data maintained, which is consistent with VA requirements.

3.2.1 The ISSO is consulted for any questions or to assist in the development of this plan.

3.3 The repositories are maintained and operated in accordance with the requirements of VHA Handbook, Directives, and all other applicable policies and regulations.

4. When reviewing a Madison VAH human subjects study that involves the access and use of data held in a VA-created or VA-controlled repository, the IRB:

4.1 Ensures the use complies with the requirements of VHA Handbooks 1200.05 and 1200.12.

4.2 Obtains sufficient information from the research team to adequately assess the request including if the data to be used are reasonable and necessary to conduct the research.

4.3 Reviews the source of the data and the purpose for which the data were originally collected, including whether they were collected for research purposes.

4.3.1 If the data were collected for other research projects, the IRB assesses whether the reuse is consistent with the consent under which they were collected.

4.3.2 If the data were collected for administrative or clinical reasons, the IRB assesses whether the guidelines under which they were collected allow for storage in a specific data repository and reuse for research purposes.

4.3.3 If the data are to be obtained from an administrative or clinical data repository, the IRB assesses whether the administrative policies and procedures for the data repository allow for use of the data for research purposes, and if so, whether they allow for it as identified, de-identified, or coded.

4.3.3.1 Although some data obtained from an administrative or clinical data repository may be used for a research protocol, the administrative policies for the administrative or clinical repository may not allow the data to be placed in a research data repository for reuse, and use in any other research projects would require requesting the data from the original source repository.

4.4 Assesses whether the data are identified, de-identified, or coded.

4.4.1 If the data are identified or coded, a justification for use of this type of data is required.

4.5 Assesses any requests, and justification thereof, for the use of real SSNs.

4.6 Reviews information on data storage and security including:

4.6.1 All locations where the data is to be stored, accessed, or used including servers, desktop personal computers, laptops, non-VA locations, or portable media.

4.6.1.1 The subject’s contact information including name, address, SSN, and phone number needs to be maintained in a separate file at the VA and be linked with the remainder of the subject’s data only when it is necessary to conduct the research.

4.6.2 Information on the need and mechanism for copying data from a secure VA server and transmitting or transporting data to other locations.

4.6.3 Plans for the destruction of data if they are not to be placed in a data repository after the protocol is completed and the retention period has expired.

4.6.4 Information on any plans to contact, re-contact, or recruit the patients or individuals for further information, or to recruit them for any other research project.

4.6.5 How the privacy and confidentiality of subjects associated with the data is to be maintained.

4.6.6 Information on any plans to use the current data and the data obtained from the proposed project for future research. If data is to be retained for future research, the protocol must describe the repository in which they are to be maintained, its location, and its security measures.

4.6.6.1 If the data are retained for future research, the data repository must be established and maintained in accordance with VHA Handbook 1200.12.

4.6.7 If any data are going to be released outside VA.

4.6.7.1 If data will be released outside the VA, the IRB consults with the VA PO to ensure the release it is consistent with the VHA policy, the Privacy Act, and HIPAA and also determines whether the release is adequately justified.

4.6.8 Information on the PI’s ability to finish the protocol.

4.6.9 Documentation that all research team members are to be working within their scope of practice, privileges, or functional statements.

4.7 Ensuring that if the data were collected during the conduct of a previous research protocol, the reuse in the new protocol is consistent with the original informed consent. If it is not, or the original informed consent did not address the reuse of the data, the IRB must specifically approve the proposed reuse.

4.7.1 If the informed consent states specifically that the data will not be used for other purposes, it cannot be reused. Reuse may be approved under following condition:

  • The subjects must again provide consent and a new HIPAA authorization obtained; or
  • The subject's name SSN, scrambled SSN or date of birth are not used plus all criteria are met to waive informed consent and waive HIPAA authorization; or
  • The research is exempt from IRB review, and the criteria for waiver of HIPAA authorization have been met; or
  • The data are de-identified prior to use.

4.8 Ensuring the data accessed from the data repository are required by the approved protocol and used only for the purposes defined in the approved protocol.

4.8.1 Reuse of the data may not occur without approval of a new protocol, unless the use is preparatory to research as defined above.

XVIII. Apparent Serious or Continuing Noncompliance

1. The UW Health Sciences IRBs follow VHA Directive 1200.05 and VA Handbook 1058.01 for the identification, assessment, and reporting of apparent serious or continuing noncompliance.

2. VA employees are required to report to the IRB in writing any apparent serious or continuing noncompliance within 5 business days of becoming aware of the incident.

3. The IRB chair may take interim action as needed to eliminate any apparent immediate hazards to subjects.

4. The convened IRB reviews any notification of apparent serious or continuing noncompliance within 30 business days from receipt of the report.

5. The convened IRB determines and documents whether or not serious or continuing noncompliance occurred.

5.1 If the IRB determinations serious or continuing noncompliance occurred the committee also makes a determination and documents whether remedial actions are warranted.

6. If the IRB determined that serious noncompliance or continuing noncompliance occurred, the IRB notifies the Madison VAH Director, ACOS/R&D, and RCO within 5 business days after its determination.

6.1 If the notification of apparently serious or apparently continuing noncompliance resulted from an RCO audit, the IRB notifies the RCO within 5 business days after making its determination, regardless of outcome.

7. The IRB tracks the number of notifications of apparently serious or apparently continuing noncompliance it receives and the number resulting in IRB determinations of serious or continuing noncompliance.

XIX. Unanticipated Serious Adverse Events (SAEs) and Unanticipated Problems Involving Risks to Subjects or Others

1. The UW Health Sciences IRBs follow Handbook 1058.01 for the identification, assessment, and reporting of serious unanticipated problems and unanticipated SAEs.

2. If a VA employee becomes aware of a death of a Madison VAH research participant for a study under the purview of a UW Health Sciences IRB that is both unanticipated (i.e., new or greater than previously known in terms of nature, severity, or frequency, given the procedures described in protocol documents and the characteristics of the study population) and related to the research (i.e., reasonably regarded as caused by, or probably caused by, the research), the employee must immediately notify the IRB orally and provide written notification of the event within 5 business days.

2.1 The IRB must alert the Office for Research Oversight (ORO) by email or telephone within 2 business days after receiving oral notification with concurrent notification to the Hospital Director, the ACOS/R&D, and the VA RCO.

3. If a VA employee becomes aware of a serious adverse event or serious problem, which did not involve a subject death, that occurred on a Madison VAH research study (i.e., a serious unanticipated problem) under the purview of a UW Health Sciences IRB that is both unanticipated (i.e., new or greater than previously known in terms of nature, severity, or frequency, given the procedures described in protocol documents and the characteristics of the study population) and related to the research (i.e., reasonably regarded as caused by, or probably caused by, the research), the employee must provide written notification of the event within 5 business days to the IRB.

4. Within 5 business days after a report of any event that may be unanticipated and related to the research, including deaths, the IRB Chair or a qualified IRB member-reviewer must determine and document whether any actions are warranted to eliminate apparent immediate hazards to subjects.

5. The IRB reviews the event and the determination of the IRB Chair or qualified IRB member-reviewer at its next convened meeting and determines and documents the following:

5.1 About the event:

  1. Whether the event was serious and unanticipated and related to the research; or
  2. Whether there is insufficient information to determine whether the incident was serious and unanticipated and related; or
  3. Whether the incident was not serious and/or the incident was not unanticipated and/or the incident was not related.

5.2 About actions related to the event:

  1. Whether any protocol or informed consent modifications are warranted, and if so,
  2. Whether investigators must notify or solicit renewed/revised consent from previously enrolled subjects, and if so,
  3. When and how consent is to be documented.

6. In the case of a Madison VAH subject death, the IRB notifies the Madison VAH Director, and ACOS/R&D, and RCO of its determinations within 5 business days.

7. In the case a serious adverse event or serious problem that is not a death, the IRB notifies Madison VAH Director, and ACOS/R&D, and RCO of its determinations within 5 business days after the convened meeting if:

  1. Actions were taken to eliminate hazards to subjects, or
  2. The incident was serious and unanticipated and related to the research, or
  3. There was insufficient information to make a determination regarding the event, or
  4. Protocol or informed consent modifications were warranted.

8. The Madison VAH Director is responsible for additional reporting to ORO and any other relevant agencies (e.g., FDA, OHRP) after receiving the IRB’s notification.

XXX. Termination or Suspension of Human Subjects Research

1. Any termination or suspension of VA research by a UW Health Sciences IRB related to concerns about the safety, rights, or welfare of human research subjects, research staff, or others will be reported in writing directly (without intermediaries) to the Madison VAH Director within 5 business days after the termination or suspension occurs with simultaneous copies to the ACOS/R&DC, and the RCO.

2. The convened IRB reviews any notifications of an external entity’s suspension or termination of research at the earliest practicable opportunity, not to exceed 30 business days after notification, to determine whether it:

  1. Resulted from a local adverse event(s), local noncompliance, or other local issue(s); or
  2. Requires local action (in addition to the suspension/termination) to ensure the safety, rights, or welfare of local human research subjects, personnel, or others or the effectiveness of the local HRPP.

3. The IRB will notify the Madison VAH Director, ACOS/R&D, and RCO within 5 business days after the determination if it finds either that the suspension or termination resulted from a local adverse event(s), local noncompliance, or other local issue(s) or required local action (in addition to the suspension/termination) to ensure the safety, rights, or welfare of local human research subjects, personnel, or others, or the effectiveness of the local HRPP.

References