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Veterans Affairs Research and the IRB
Effective December 31, 2011, the UK IRB is no longer the IRB of record for the VA. Any research that involves VA patients, facilities and / or monies must be reviewed and approved by the VA IRB. If you would like more information on conducting research at the VA, please contact Michele Jackson @233-4511, extension 4282 (17x4282) or e-mail her @ Michele.Jackson3@va.gov.
The University of Kentucky’s (UK) Medical Institutional Review Board (IRB) serves as the IRB of record for research involving recruitment of human subjects (e.g., patients, staff, volunteers) from the Veterans Affairs Medical Center (VAMC) or uses VA resources (e.g., funds, equipment, space, VA personnel). A Memorandum of Understanding (MOU) between UK and Veterans Affairs (VA) establishes guidelines for responsibilities between the two entities. In addition, standard operating procedures (SOPs) have been established to further document the coordination between the UK IRB and the VA.
The Medical IRB is charged with protection of the rights and welfare of the individuals enrolled as subjects in research. The VAMC also has a Research and Development Committee (R&DC) which reviews protocols falling under VA purview for scientific merit. Both IRB and VA R&DC approvals are required before any research procedures can be implemented at the VA. The VA’s Research and Development Committee will not consider an application without prior UK Medical IRB review and approval. See the Lexington VAMC Research Resources web page for more VA research links and VA requirements.
In order for the IRB to consider approval for a protocol falling under the VA’s purview, the following materials and details must be included in the IRB application submission.
- VA Form 10-1223 Report of Subcommittee on Human Studies - The PI should fill in the project/program title, PI name, and VAMC name at the top of this form. The IRB/ORI staff will complete the "Committee Findings" section.
- If the requirement for documentation of informed consent has not been waived, all VA research protocols must include a VA-specific consent form ("VA Research Consent Form" - aka "VA 10-1086") containing the appropriate VA verbiage.
- For investigational drug studies, use a VA Form 10-9012, Investigational Drug Information Record. (ORI staff send the form to the VA after obtaining the IRB Chair or designee’s signature.) Download 10-9012 Side 1 [PDF] ; Download 10-9012 Side 2 [WORD]
- For consent for use of picture and/or voice use a VA Form 10-3203 [PDF]. Specific consent is required to make a photograph, video recording, or audio recording of a human subject for research purposes and must be included in the research informed consent. ORO recommends (but does not require) that VA Form 10-3203 be referenced in and appended to the informed consent document for this purpose. However, VHA Handbook 1907.01, Paragraph 8(s)(3) requires use of VA Form 10-3203 when such a recording is made and documentation of the subject’s research participation is included in the subject’s VHA health record.
University Kentucky researchers who utilize VA facilities, recruit VA patients for UK studies, or who have joint appointments must complete mandatory education in any area applicable to the research being conducted. These VA requirements are in the following areas: Human Subjects, Animal Care and Use, Occupational Health and Safety, Hazardous Materials Management, Radiation Safety, Fire and Safety, and Data Security. For specific information, contact the VA Research Service Office at 281-4927.
For more VA research information and links see the Lexington VAMC Research Resources web page.
VA research is research conducted by a VA investigator on VA time or using VA resources (regardless of location), or by a VA investigator in a VA facility. The research may be funded by VA, by other sources, or be unfunded. A VA Investigator-initiated (unfunded) protocol is VA research. VA research encompasses recruitment of all subject deemed to be "VA patients". NOTE: The term "VA Research" is further discussed in Veterans Health Administration (VHA) Handbook 1200.05.
VA policy prohibits paying human subjects to participate in research when the research is integrated with a patient’s medical care and when it makes no special demands on the patient beyond those of usual medical care [VHA Handbook 1200.05, Section 12-Payments for Subjects]. Payment may be permitted, with IRB approval, in the following circumstances:
- When the study to be performed is not directly intended to enhance the diagnosis or treatment of the medical condition for which the volunteer subject is being treated, and when the standard of practice in affiliated non-VA institutions is to pay subjects in this situation.
- In multi-institutional studies, when human subjects at a collaborating non-VA institution are to be paid for the same participation in the same study at the same rate proposed.
- In other comparable situations in which, in the opinion of the IRB, payment of subjects is appropriate.
- When transportation expenses are incurred by the subject that would not be incurred in the normal course of receiving treatment and which are not reimbursed by any other mechanism.
VA subjects cannot be charged for any research-related medical care and their insurance cannot be billed. Veteran subjects will not be required to pay for care received as subjects in VA research projects except if they are in an eligibility category that requires they pay a co-pay for medical services that are not part of the study.
If specimens will be banked, genetic testing done, or a commercial product developed, VA policy must be followed [VHA Handbook 1200.05 Appendix C-The Informed Consent, (b)7]. For details see the VHA Directive 2000-043 memo. This directive requires that all human biological specimens and linked clinical data collected as part of research projects conducted by VA investigators in VA facilities or approved off-site locations will be maintained at either VA-sponsored tissue banks or VA (ORD) approved tissue banks. Sites that may not be acceptable for storage of tissue specimens include non-academic, for-profit institutions, such as pharmaceutical or biotech companies.
Serious or Continuing Noncompliance. Within 5 business days of becoming aware of possible serious or continuing noncompliance with VA or other Federal requirements related to human research (e.g., VHA Handbook 1200.5; the Common Rule at 36 CFR 16; Food and Drug Administration (FDA) regulations at 21 CFR 50 and 56) or with IRB requirements or determinations, members of the VA research community must report the possible noncompliance to the ACOS for R and the IRB. NOTE: For purposes of this Handbook, “possible serious or continuing noncompliance” includes all findings of noncompliance related to human research by any VA office, any other Federal department or agency (e.g., FDA), or any other entity.
(a) If the IRB determines that the possible noncompliance is or was serious or continuing, the IRB Chairperson must report the noncompliance to the Facility Director and the R&D Committee as soon as possible, but no later than 5 business days after the IRB’s determination.
(b) In addition to the requirements in preceding subparagraphs 6a(4) and 6a(4)(a), an RCO identifying serious or continuing noncompliance, during an informed consent or regulatory audit, must report the noncompliance to the Facility Director, the ACOS for R, the R&D Committee, and the IRB as soon as possible but no later than 5 business days after becoming aware of the noncompliance.
Consent and/or Authorization by a Legally Authorized Representative for VA Research
The PI may obtain consent by a legally authorized representative only in situations where the prospective subject is incompetent or has impaired decision-making capacity, as determined and documented in the person’s medical record in a signed and dated progress note. The determination that a subject is incompetent or has an impaired decision-making capacity must be made by a legal determination or a determination by the practitioner, in consultation with the chief of service after appropriate medical evaluation that the prospective subject lacks decision-making capacity and is unlikely to regain it within a reasonable period of time.
In cases where the determination that a prospective subject lacks decision-making capacity is based on a diagnosis of mental illness, VA policy requires consultation with a psychiatrist or licensed psychologist.[For more information, see the UK ORI/IRB Informed Consent SOP, and the VHA Handbook 1200.05, Section 11 - Research Involving Human Subjects with Surrogate Consent]
VA Research Consent Form (VA 10-1086)
On October 30, 1992, the Veterans Affairs federal requirement (VHA Handbook 1200.05 Appendix C-The Informed Consent) dictated that informed consent obtained from VA patients being enrolled in research studies should be documented on a VA 10-1086 form. The VA enforces the use of the VA Research Consent form (VA 10-1086) for those studies approved to enroll VA patients in research. The consent form must conform to all VA requirements, including an appropriate VA-specific indemnification and notification clause. Use the VA 10-1086 consent template to ensure applicable VA verbiage is included.
VA Research Consent Form Template (VA 10-1086): [WORD] [Revised 9/3/08]
Please note that this is a VA initiative. Studies that do not involve the enrollment of VA patients will not be affected. If you have questions about the VA research consent form, please contact the VA at 17-4927.
VA and Health Insurance Portability and Accountability Act (HIPAA)
The UK IRB does not review HIPAA related materials for the VA. All HIPAA related forms should be included in your submission to the VA. If you have issues with any of the VA HIPAA materials, please contact the VA Research Administrative Office at (859) 281-5947.
HIPAA VA Privacy Rule Compliance Guidelines [PDF]VA HIPAA Forms
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HIPAA VA Authorization [WORD]
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HIPAA VA Waiver Request [PDF]
What is HIPAA?
The Health Insurance Portability and Accountability Act (HIPAA) is a complex regulation that affects many researchers. HIPAA is designed to protect the use and disclosure of individually identifiable health information (also defined as Protected Health Information or PHI). PHI is defined as any of the 18 HIPAA recognized identifiers (see below) in combination with health information.
HIPAA recognized identifiers:
- Names;
- All geographic subdivisions smaller than a State, including street address, city, county, precinct, zip code, and their equivalent geocodes;
- All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, date of death;
- Telephone numbers;
- Fax numbers;
- Electronic mail addresses;
- Social security numbers;
- Medical record numbers;
- Health plan beneficiary numbers;
- Account numbers;
- Certificate/license numbers;
- Vehicle identifiers and serial numbers, including license plate numbers;
- Device identifiers and serial numbers;
- Web Universal Resource Locators (URLs);
- Internet Protocol (IP) address numbers;
- Biometric identifiers, including finger and voice prints;
- Full face photographic images and any comparable images;
- Any other unique identifying number, characteristic, or code.
It is important that you understand that you could face criminal and/or civil liabilities for non-compliance.
Reporting Serious Adverse Events and Problems Involving Risks to Subjects or Others (in VA Research) [VHA Handbook 1058.01, May 21, 2010]
Veterans Affairs Definitions [VHA Handbook 1200.05, July 31, 2008]
Administrative Hold. An administrative hold is a voluntary interruption of research enrollments and/or ongoing research activities by an appropriate facility official, research investigator, or sponsor (including the VHA Office of Research and Development (ORD) when ORD is the sponsor). For the purposes of the VHA Handbook:(1) The term “administrative hold” excludes interruptions of research related to concerns regarding:
(a) The safety, rights, or welfare of human research subjects, research investigators, research staff, or others; or
(b) The safety or welfare of laboratory animals.
(2) The terms “suspension” and “termination” apply to research interruptions related to concerns about safety, rights, or welfare as described at preceding subparagraphs 4a(1)(a) and 4a(1)(b).
(4) Suspension and termination do not include:
(a) Interruptions in human research resulting solely from the expiration of the IRB approval period.
(b) “Administrative holds” or other actions initiated voluntarily by an appropriate facility official, research investigator, or sponsor for reasons other than those described in preceding subparagraph 4v(3) (see subpar. 4a).
Adverse Event (AE). An AE is any untoward physical or psychological occurrence in a human subject participating in research. An AE can be any unfavorable or unintended event, including an abnormal laboratory finding, symptom, or disease associated with the research or the use of a medical investigational test article. An AE does not necessarily have to have a causal relationship with the research, or any risk associated with the research or the research intervention, or assessment (see subpar. 4u). A local AE is one occurring at a site for which the VA investigator's Institutional Review Board (IRB) of Record is responsible. NOTE: AEs are further discussed in VHA Handbook 1200.05 and VHA Handbook 1058.01.
Continuing Noncompliance. Continuing noncompliance is persistent or repeated failure, either in the past or extending into the present, to satisfy VA or other Federal research requirements.
Human Research. Human research is any research involving any of the following:
(1) One or more human subject(s).
(2) Data containing identifiable private information about one or more living individuals.
(3) One or more human biological specimen(s).
Human Subject. A human subject is a living individual about whom an investigator conducting research obtains:
(1) Data through intervention or interaction with the individual; and/or
(2) Identifiable private information. NOTE: The term “human subject” and related terms are further defined in VA regulations and policy at Title 38 Code of Federal Regulations (CFR) Part 16 and VHA Handbook 1200.05.
Problem. Problems include both risks to subjects and risks to other individuals (e.g., research personnel, subjects’ family members). Risks may reflect any type of potential harm (e.g., physical, psychological, social, economic, and breach of privacy).
Research. Research is a systematic investigation designed to develop or contribute to generalizable knowledge. NOTE: The term “research” is further defined in VA regulations at 38 CFR 16 and VHA Handbook 1200.05.
Research and Development (R&D) Committee. The R&D Committee is a committee responsible, through the Chief of Staff (COS) to the VA Facility Director, for oversight of the facility’s research program and for maintenance of high standards throughout that program. NOTE: The term “Research and Development Committee” is further defined in VHA Handbook 1200.1. All VA research must be reviewed and approved by the VA R&D Committee.
Serious Noncompliance. Serious noncompliance is the failure to adhere to the laws, regulations, or policies governing VA research that:
(1) Results in substantive harm or damage (or risk of substantive harm or damage) to the safety, rights, or welfare of human subjects, research staff, or others; or
(2) Results in substantive harm or damage (or risk of substantive harm or damage) to the safety or welfare of laboratory animals; or
(3) Substantively compromises the integrity or effectiveness of research protections, either systemically or relative to a particular protocol or project.
Serious AE (SAE) or Serious Problem. For the purposes of this Handbook:
(1) An SAE in research is an AE that results in death, a life-threatening experience, inpatient hospitalization, prolongation of hospitalization, persistent or significant disability or incapacity, congenital anomaly, or birth defect.
(2) A serious problem in research is one that results in:
(a) Substantive harm or damage (or risk of substantive harm or damage) to the safety, rights, or welfare of research subjects, research staff, or others;
(3) An AE or problem in research is also considered serious when medical, surgical, behavioral, social, or other intervention is needed to prevent preceding subparagraphs 4u(1) or 4u(2).
Suspension or Termination of Research. For purposes of the VHA Handbook:
(1) Suspension refers to a temporary interruption in the enrollment of new subjects or other ongoing research activities.
(2) Termination refers to a permanent halt in the enrollment of new subjects or other research activities.
(3) The terms “suspension” and “termination” apply to interruptions related to concerns regarding:
(a) The safety, rights, or welfare of human research subjects, research investigators, research staff, or others; or
(b) The safety or welfare of laboratory animals.
(4) Suspension and termination do not include:
(a) Interruptions in human research resulting solely from the expiration of the IRB approval period.
(b) “Administrative holds” or other actions initiated voluntarily by an appropriate facility official, research investigator, or sponsor for reasons other than those described in preceding subparagraph 4v(3).
Unanticipated or Unexpected Problem or AE. An unanticipated or unexpected problem or AE is one that is unforeseen in terms of nature, severity, or frequency of occurrence, as documented in the protocol or other materials approved by the R&D Committee, IRB, IACUC, or other relevant oversight committee. For human research, such materials may include the informed consent document, clinical investigators’ brochure, product labeling, etc.