VA Research: Health Sciences IRBs Policy for IRB Review of Human Subjects Research that Falls Under VA Purview
Summary: The UW Health Sciences IRBs, through a Memorandum of Understanding (MOU), serve as the IRBs of record for William S. Middleton Memorial Veterans Hospital (Madison VA) 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 VA 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.
Adopted by: HS IRBs Policy Committee
Adoption date: August 7, 2015
I. Application of VA Regulations, Madison VA Policies, and UW Policies Governing Human Subjects Research
1. Study teams engaged in Madison VA human subjects research 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) Handbooks, related memoranda and other guidance documents.
2. The UW IRBs apply the Common Rule regulations at 38 CFR 16 to all Madison VA human subjects research in addition to other applicable federal regulations governing human subjects research, such as FDA and 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 VA purview and thus require VA R&D review and approval and the application of relevant VA regulations and requirements:
- The study is conducted by researchers with VA appointments while on official VA duty including those with WOC (without compensation) status
- The study involves subjects who are veterans associated with the Madison VA Hospital or its satellites (i.e., if they are patients of, or otherwise receive treatment from, VA clinics or physicians) who were
- Recruited to the research as VA patients, or
- Were recruited through the Madison VA or
- If the research involves accessing Madison VA hospital patient records or otherwise uses data from Madison VA records or those of its satellites.
- The research is VA-funded
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 VA does not conduct planned emergency research or classified research involving human subjects.
2. Research that involves provision of in vitro fertilization services cannot be conducted by VA investigators while on official duty, at VA facilities, or at VA-approved off-site facilities.
3. Research in which the focus is either a fetus, or human fetal tissue, in-utero or ex-utero (or uses human fetal tissue), cannot be conducted by VA investigators while on official duty, at VA facilities, or at VA-approved off-site facilities.
3.1 Use of stem cells is governed by the policy set by NIH for recipients of NIH research funding.
4. VA investigators cannot conduct interventions in research that enroll neonates while on official duty, at VA facilities, or at VA-approved off-site facilities.
4.1 Prospective observational and retrospective record review studies that involve neonates or neonatal outcomes are permitted.
5. Research involving prisoners cannot be conducted by VA investigators while on official VA duty, at VA facilities, or at VA-approved off-site facilities unless a waiver has been granted by the Chief Research and Development Officer (CRADO).
5.1 If such a waiver is granted, the research must comply with 45 CFR 46.301 - 46.306.
6. 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.
6.1 The Madison VA Director must approve participation of the Madison VA in any proposed research that includes children.
6.2 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.
7. All international research must also be approved explicitly in a document signed by the Madison VA Director, except for Cooperative Studies Program activities which must be approved by the CRADO.
7.1 The UW Health Sciences IRBs follow the definitions of international research outlined in VHA Handbook 1200.05.
IV. Madison VA Officials and Human Subjects Research
1. Even if a UW Health Sciences IRBs approves a study, Madison VA officials, including the VA hospital director, R&D Committee, or Office of Research Development (ORD) can disapprove.
2. Madison VA 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 VA R&D Committee and the Madison VA hospital director have the authority to suspend or terminate approval of Madison VA research.
V. Integration of IRB and R&D Reviews and Oversight
1. Non-exempt VA human subjects research
1.1 The UW Health Sciences IRBs ensure that Madison VA R&D 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&D approval for the study is obtained. Final consent documents are not released by the IRB until final VA R&D approval has been granted and the conditions of VA R&D approval have been met.
2. Exempt VA human subjects research
2.1 The UW Health Sciences IRB reviewer ensures that Madison VA R&D 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&D approval has been granted.
2.3 The VA R&D 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 R&D Committee
1. Generally, the UW Health Sciences IRBs notify the Madison VA R&D Committee 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 VA R&D via its Chair 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 to the study team and VA R&D Committee.
VII. Integration of IRB and Madison VA Privacy Officer (PO) and Information Security Officer (ISO) Reviews
1. The Madison VA PO and ISO 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 ISO 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 VA, 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. IRB records for studies that fall under VA purview are disposed in accordance with VHA Records Control Schedule (RCS) 10-1.
3. The UW Health Sciences IRBs provide the RCO and Madison VA R&D Committee 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 met.
1.2 That all criteria have been met in cases where the IRB waives informed consent.
1.3 That all criteria have been met in cases where the IRB waives elements of or alters informed consent.
1.4 That all criteria have been met 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 Research Compliance Officer (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 VA (or Involving Other Non-VA Sites)
1. Generally, whenever a human subjects research study will be conducted at both the Madison VA 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.
1.1 The VA-only protocol and/or IRB application must describe the data to be disclosed to the UW or other external entities, the entity(ies) to which the data are to be disclosed, and how the data are to be transmitted. This includes data from individual subjects as well as other data developed during the research such as the analytic data and the aggregate data.
2. Release of VA data, images, or specimens to UW collaborators, or to other sites outside the Madison VA Hospital, must be described in the consent and HIPAA authorization forms.
3. 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 VA).
4. 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 ensure that at least two VA-compensated (minimum 1/8th full-time employee equivalent) staff from the Madison VA facility serve as voting members on each IRB of record.
1.1 At least one VA voting member of the IRB must be in attendance when Madison VA research is discussed at a convened meeting.
2. VA members of the UW Health Sciences IRBs are appointed by the Madison VA Hospital Director in accordance with Madison VA policies and procedures.
3. For the purposes of VA 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 VA cannot serve as IRB members:
4.1 Research office staff including, but not limited to, the Associate Chief of Staff for Research and Development (ACOS/R&D) and the Administrative Officer (AO/R&D)
4.2 VA Hospital Director
4.3 Other Madison VA senior administrators such as Associate or Assistant Directors or Chief of Staff
4.4 Administrative staff for any Madison VA senior administrators
4.5 Chief of Staff (COS)
5. The Madison VA Research Compliance Officer (RCO) acts as a consultant to the UW Health Sciences IRBs, but does not serve as a voting or non-voting member of the IRB.
6. The Madison VA PO and ISO serve as consultants to the UW Health Sciences IRBs and may attend IRB meetings in that capacity.
XIII. Criteria for IRB Approval
1. In addition to the criteria for IRB approval 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 to 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 VA R&D for this determination and does not approve human subjects research that is not endorsed by the Madison VA R&D.
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 VA’s research COI policies and review processes to help ensure that potential COIs that are financial in nature are addressed.
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 elements of consent:
- Any payments the subject is to receive for participating in the study;
- Any disclosure of any real or apparent conflict of interest by investigators where the research will be performed; and
- A statement that VA will provide treatment for research related injury in accordance with applicable federal regulations.
2. When appropriate, the consent form includes 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 copayments 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. Waiver and/or Alteration of Informed Consent
1. In addition to the instances outlined in the Common Rule in which the IRB can waive or alter informed consent the VA regulations allow for the following additional instances:
1.1 Informed consent can be waived or altered if the IRB finds and documents that the research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine:
1.1.1 Public benefit or service programs; procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs; and
1.1.2 The research could not practicably be carried out without the waiver or alteration.
XVI. 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.
XVII. Consent Documents
1. The date of a UW Health Sciences IRB approval is documented on consent documents.
2. Unless the IRB has waived informed consent or the requirement to obtain informed consent, the informed consent document must be signed and dated by:
2.1 The subject or the subject's Legally Authorized Representative (LAR); and
2.2 The person obtaining the informed consent.
2.2.1 The IRB may waive the requirement for the signature of the person obtaining consent (even where the signature of the subject or the LAR continues to be required) where there is no physical contact with the subject (e.g., where the only contact with the subject is by telephone or mail).
2.3 Consent may be obtained electronically so long as:
- The informed consent process meets all requirements in the VHA Handbook 1200.05 and VA requirements; and:
- Authentication controls on electronic consent provide reasonable assurance that such consent is rendered by the proper individual; and
- The subject dates the consent as is typical or the software provides the current date when signed.
XVIII. HIPAA Privacy Rule
1. As part of their review of 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 VA.
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.
3. The UW Health Sciences IRBs ensure that VA HIPAA authorization forms are separate from consent forms and that VA form 10-0493 is used as HIPAA form.
4. 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 ISO:
4.1 The IRB making the waiver determination
4.2 Date of IRB approval of waiver of HIPAA authorization;
4.3 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.
5. Activities that occur after an application to conduct human subjects research is submitted to the IRB, 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.
6. If a study team proposes to disclose PHI outside the Madison VA and also requests a waiver of HIPAA authorization and signed consent, the Madison VA 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.
XIX. 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.
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. Non-veterans may be recruited for 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 entered into VA research.
5. Non-veterans may not be entered into VA studies simply because a non-veteran population is easily accessible to the investigator.
XX. Research Involving Pregnant Women
1. Women who are known to be pregnant and/or their fetuses may be involved in research if all of the requirements of 45 CFR 46.204 are met 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 The Madison VA Hospital Director certifies that the Madison VA has sufficient expertise in women’s health to conduct the proposed research.
XXI. 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:
- No greater than minimal risk to the subject; or
- Presents a greater probability of direct benefit to the subject than harm to the subject; or
- Presents greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject’s disorder or condition that is of vital importance for the understanding or amelioration of the subject’s disorder or condition.
1.1 In addition to satisfying the conditions above, the IRB must determine that:
- The research a) cannot be performed solely with persons who possess decision-making capacity and b) the focus of the research is the disorder leading to the subjects’ lack of decision-making capacity, whether or not the lack of decision-making itself is being evaluated (e.g., an individual who lacks decision-making capacity as the result of a stroke can participate in a study of cardiovascular effects of a stroke); or
- The subject of the research is not directly related to the subjects’ lack of decision-making capacity but the investigator has presented a compelling argument for including such subjects (e.g., transmission of methicillin-resistant staphylococcus aureus infections in a nursing home where both individuals with and without decision-making capacity are affected).
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.
XXII. 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 VA research, they must be enrolled in an institution with an educational affiliation agreement with the Madison VA 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 VA 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.
XXIII. 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 are required for the study team to re-contact study participants.
XXIV. Expiration of IRB Approval
1. If approval expires for a study that falls under the purview of the Madison VA, 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.
XXV. 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. Real SSNs may be obtained only when required to meet the specific aims of the research protocol.
3. When a research study calls for use of scrambled SSNs, the SSNs cannot be unscrambled by research staff or other individuals without an amendment to the research protocol and approval by the VA R&D and VA PO.
XXVI. Re-identification of De-Identified Data
1. Re-identification of de-identified data must be approved in advance by the IRB and R&D Committee.
2. Approval for re-identification of de-identified data may be given only if all three of the following conditions are met:
- The research could not be conducted without re-identification of the data.
- Re-identification is necessary to validate the results of the research.
- The data being re-identified are contained in a data repository.
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&D Committee 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.
XXVII. 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 ISO has reviewed and approved such transmission and transfer.
XXVIII. Data Repositories
1. IRB review and approval are required for the creation of a 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 VA, the IRB ensures that:
3.1 The repositories comply with the requirements of VHA Handbooks 1200.05 and 1200.12 and all COI policies.
3.2 The repositories have a security plan for all data maintained, which is consistent with VA requirements.
3.2.1 The ISO 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 1200.12 and all other applicable VA and VHA policies and regulations.
4. When reviewing a Madison VA human subjects study that involves the access and use of data held in a 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.
18.104.22.168 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.
22.214.171.124 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.
126.96.36.199 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.
188.8.131.52 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.
XXIX. Apparent Serious or Continuing Noncompliance
1. The UW Health Sciences IRBs follow Handbooks 1200.05 and 1058.01 for the identification, assessment, and reporting of apparent serious or continuing noncompliance.
2. Within 5 business days of becoming aware of any apparent serious or continuing noncompliance with applicable human research protection requirements, members of the VA research community are required to ensure that the apparent noncompliance has been reported in writing to the IRB.
3. The IRB reviews any report of apparent serious or continuing noncompliance at its next convened meeting.
4. If the IRB makes a preliminary or final determination that the reported incident constitutes serious noncompliance or continuing noncompliance, the IRB Chair (or designee) reports the determination via email directly (without intermediaries) to the Madison VA Director within 5 business days after the determination with copies to the ACOS for Research, the R&D Committee Chair, and the RCO.
5. The IRB reaches determinations in regard to whether an incident(s) represented serious or continuing noncompliance within 30-45 days after receiving a report of apparent noncompliance.
6. Remedial actions involving a specific study or research team must be completed within 90-120 days after the IRB’s determination.
7. Remedial actions involving programmatic noncompliance must be completed within 120-180 days after the IRB’s determination, unless remediation requires substantial renovation, fiscal expenditure, hiring, legal negotiations, etc.
XXX. 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. Within 5 business days after a report of a serious unanticipated problem involving risks to subjects or others, or of a local unanticipated SAE, the convened IRB or a qualified IRB member-reviewer determines and documents whether or not the reported incident was serious and unanticipated and related to the research.
3. If the convened IRB or the qualified IRB member-reviewer determines that the problem or event is serious and unanticipated and related to the research, the IRB Chair or designee reports the problem or event directly (without intermediaries) to the ORO within 48 hours and to the Madison VA Hospital Director within 5 business days after the determination.
3.1 The report is be made in writing, with a simultaneous copy to the ACOS for Research, the R&D Committee Chair, and the RCO.
4. If the convened IRB or the qualified IRB member-reviewer determines that the problem or event was serious and unanticipated and related to the research, a simultaneous determination is required regarding the need for any action (e.g., suspension of activities; notification of subjects) necessary to prevent an immediate hazard to subjects in accordance with VA regulations
4.1 Determinations of the qualified IRB member-reviewer (regardless of outcome) are reported to the IRB at its next convened meeting.
5. If it were determined that the problem or event is serious and unanticipated and related to the research, the convened IRB determines and documents whether or not a protocol or informed consent modification is warranted.
6. If the convened IRB determines that a protocol or informed consent modification is warranted, the IRB also determines and document:
6.1 Whether or not previously enrolled subjects must be notified of the modification and, if so, when such notification must take place and how such notification must be documented.
XXXI. 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 VA Director within 5 business days after the termination or suspension occurs with simultaneous copies to the ACOS for Research, the R&D Committee Chair, and the RCO.
- VHA Handbook 1058.01
- VHA Handbook 1058.05
- VHA Handbook 1200.05
- VHA Handbook 1200.12