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IRB Responsibilities Related to Review of VA Research

Summary

This document summarizes the major differences between VA regulations governing human subjects research and the Department of Health & Human Services (DHHS) regulations as well as additional IRB review requirements imposed by VA regulations. The VA regulations generally parallel those issued by DHHS but there are some important differences. Major differences relate to tissue banking, enrollment of incompetent subjects, and restriction of the types of research that can be conducted under the auspices of the VA.

VA Regulations

The VA follows FDA regulations and the Common Rule (38 CFR 16), which is identical to the DHHS regulations (45 CFR 46), except for the subparts B-D that apply to pregnant women, fetuses, embryos, prisoners, and children. The authority and responsibilities of IRBs who review VA-regulated research are also detailed in VHA Handbook 1200.5, "Requirements for the Protection of Human Subjects Research" and 1058.03, "Assurance of Protection for Human Subjects in Research". The VA also has issued directives that outline additional requirements for the protection of human subjects.

VA Purview

The following are considered to represent VA research:

• Research involving human subjects conducted completely or partially in VA facilities, approved off-site locations, facilities, and/or by VA researchers while on official VA duty time
• Research that involves veterans associated with the VA hospital or its satellites who were recruited as veterans or were recruited through the VA
• Research that involves accessing VA hospital records also falls under VA purview

VA regulations do not permit VA investigators to enroll pregnant women, prisoners, or children in a research study or use fetuses or fetal tissue in research while on official duty or in research conducted at VA facilities. Requests for exceptions to these restrictions must be made to the VA Central Office.

VA Research & Development (R&D) Committee

All research, including human subjects research determined exempt from IRB review, quality improvement, or related development programs conducted at the VA must be reviewed and approved by the VA R&D Committee. From the perspective of the VA, the University of Nevada, Reno IRBs are subcommittees of the VA R&D committee. The VA R&D Committee is not an ethics board, but rather reviews research to:

• Determine if research fits the mission of the VA and whether it may benefit veterans
• Consider safety and ethical issues in light of the IRB's recommendations
• Conduct a scientific review of the research, including the quality of the study, study design, and the feasibility of the study
• Determine if the use of VA facilities is appropriate, the study budget is adequate, and the personnel conducting the study are appropriate

IRB Composition

VA regulations require IRBs reviewing VA research to ensure that in addition to the composition requirements outlined in the Common Rule that each committee includes:

• A licensed physician for the review of FDA-regulated products
• Two voting members with VA appointments at a certain level, one of whom must have scientific expertise

At least one VA member of the IRB is responsible for making regular reports on IRB activities to the VA Research and Development Committee.

Additional Criteria for IRB Approval

As noted in the Criteria for IRB Approval: 45 CFR 46.111 (DHHS), 21 CFR 56.111 (FDA), and 38 CFR 16.111 (VA) , the Common Rule outlines specific criteria that must be met in order for an IRB to approve a research study. In addition to these, the VA requires two more criteria to be assessed: (1) any conflict of interest must be evaluated and managed and (2) the investigator must meet particular educational requirements and certifications.

VA Consent Form Requirements

The VA requires the use of a specific consent form template for research studies under its purview (i.e., VA research consent form 10-1086). Additional requirements for VA consent forms include:

• VA-specific compensation for injury language. When a study occurs at both the VA and the University, compensation for injury language for both institutions must be included.
• Consent forms must be stamped with the IRB expiration date on each page.
• Subjects are required to initial each page of the consent form.
• A witness signature is required.
• The VA consent form also must include the VA Patient Representative .
• Consent forms for research studies involving tissue banking must contain VA-specific language.

Research Involving Tissue Banking or Re-Use of Specimens

Since November 2000, the VA does not permit researchers to bank human tissues for research purposes unless the specimens are stored in VA-sponsored or VA-approved tissue banks. Researchers seeking approval for tissue banks not housed at a VA facility must seek approval through the VA Central Office.

The VA defines "banked" specimens as those collected and stored for future research purposes.

The VA requires that the reuse of specimens must be consistent with the consent under which they were collected, and the reuse must only occur through a VA-approved protocol. If a protocol requires that the specimens be analyzed or used at a non-VA institution, a written understanding between the VA investigator and the non-VA institution must specify the analysis/use as defined in the protocol. The agreement must also specify that any remaining quantities of the specimens shall be either destroyed or returned to the VA. If the remaining quantity is destroyed, that institution must certify the destruction of the specimens in writing. The remaining quantity may not be retained and/or stored by the non-VA institution.

Payment for Subjects

VA policy prohibits paying human subjects to participate in research when the research is an integral part of a patient's medical care and when it makes no special demands on the patient beyond those of usual medical care. Payment may be permitted, with approval of the IRB and the R&D Committee, in the following circumstances:

1. No direct subject benefit: 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 at the VASNHCS is to pay subjects in this situation.
2. Others being paid: In multi-institutional studies, when human subjects at a collaborating non-VA institution, such as the UW, are to be paid for the same participation in the same study.
3. Comparative situations: In other comparable situations in which, in the opinion of the IRB and R&D Committee, payment of subjects is appropriate.
4. Transportation expenses: When transportation expenses are incurred by the subject, that would not be incurred in the normal course of receiving treatment, and that are not reimbursed by any other mechanism.

In their IRB application, investigators who wish to pay research subjects must:

1. Substantiate that proposed payments are reasonable and commensurate with the expected contributions of the subject.
2. Describe the terms of the subject participation agreement and the amount of payment in the informed consent form.
3. Demonstrate that subject payments do not constitute (or appear to constitute) undue pressure, influence, or coercion on the prospective research subjects to volunteer for or continue to participate in the research study.

The IRB must review VA proposals that include subject payment to assure they conform to VA policies. This review includes consideration of the schedule of payments to avoid any coercion that might result from withholding all or most payment until the end of a long trial.

Subjects with Impaired Decision-Making Capacity, Incompetent Subjects, and Surrogate Consent

VA investigators who plan to include incompetent subjects in their research must meet additional requirements. Competence is a legal term that refers to individuals' legal and moral status that entitles them to make their own decisions, such as about health care. A court has the power to declare individuals incompetent and appoint guardians for them. In contrast, impaired decision-making capacity (also lack of capacity or decisionally impaired) is not a legal term but rather describes a situation when a person does not possess the ability to give informed consent due to medical reasons (e.g., shock, coma, sedation, onset of Alzheimer's Disease) and can be variable.

Research involving incompetent subjects who may not be able to make decisions on their own behalf can only be approved under the VA regulations when it meets all of the following conditions:

1. The investigator must demonstrate to the IRB that there is a compelling reason to include incompetent individuals or subjects. Incompetent subjects must not be included in research simply because they are readily available, but only because the proposed research cannot be conducted without their participation.
2. Incompetent people or persons with impaired decision making capacity shall not be subjects of research that imposes a risk of injury unless that research is intended to address conditions like those manifested in the subject, and the probability of benefit is greater than the probability of harm, and the likelihood of harm has been minimized.
3. The researcher must assure subject dissent is respected and that under no circumstances would subjects be forced or coerced to participate.
4. Procedures have been devised to assure that a subject's representatives are well informed regarding their roles and obligations to protect incompetent subjects. Health care agents, next-of-kin, and/or guardians must be given descriptions of both proposed research studies and the obligations of patients' representatives. They must be told that their obligation is to try to determine what the subject would do if competent, or if the subject's wishes cannot be determined, what they think is in the incompetent person's best interest.
5. Procedures for obtaining surrogate consent are consistent with Nevada State Law.

The IRB must document that research involving subjects with impaired decision-making capacity meet the above criteria. For subjects with fluctuating decision making capacity or those with decreasing capacity to consent, a re-consenting process with surrogate consent may be necessary.