Major changes to the final VA standards explained
Changes were prompted by VA comments
IRBs that have reviewed the preliminary Veterans Affairs (VA) Human Research Protection Accreditation Program standards, created by the National Committee for Quality Assurance (NCQA) in Washington, DC, should keep in mind that several changes were made in the final version, partly in response to comments made by VA employees.
"There are three major changes from what was put out in March," says Sandra Sanford, RN, MSN, CCRC, CIP, director of human research protection accreditation programs for NCQA in Washington, DC. Also, there are two issues that received comments but did not result in big changes to the final standards. Those issues were about research involving children or prisoners. VAs typically do not engage in that type of research, Sanford notes. "There is potential for someone to do prisoner research if a subject is enrolled and then later becomes a prisoner," she adds. "But the VA does have a policy of not doing research on children because veterans are not children, although Congress did instruct the VA to conduct a study that has to do with the effects of Agent Orange in children of veterans."
Nonetheless, these areas were not among the major changes that were made to the final standards. The three changed areas are as follows:
1. Research and development (R&D) committees: The final standard refers to an institution’s R&D committee and states that the R&D committee will conform to VA policy regarding human subjects research, with the following responsibilities:
• The R&D committee is responsible for the scientific quality and appropriateness of all research involving human subjects.
• The R&D committee re-evaluates, at least annually, the scientific quality of all research studies involving human subjects to assure protection of human subjects.
• The R&D committee membership, supplemented as needed by advisors or consultants, possesses the expertise required to perform the scientific review.
• The R&D committee cannot alter an adverse report or recommendation, such as disapproval for ethical or legal reasons made by the subcommittee on human studies.
To be scored 100%, the R&D committee must meet all four factors. Otherwise the committee receives 0% in scoring.
Initially the R&D committee requirements were not included in the standards, Sanford notes. "That came from public comments," she explains. "The VAs have a unique reporting system; unlike other IRBs they may report to different individuals or departments, but are freestanding committees, and the VA felt it was important the standards represent their unique structure." Everything in the standards about the R&D committee is drawn from VA policy, Sanford adds.
2. Pharmacy: The final standards include a specific requirement for pharmacy services, including a distinct policy on the control and dispensing of investigational products. This change was also in response to VA comments about existing policies on pharmacies, Sanford says. The requirement is INR6, which reads, "The institution ensures that the use of investigational products in research with human subjects is consistent with VA and federal regulations." The requirement further instructs the institution’s pharmacy service to have policies and procedures for handling investigational drugs that address five factors: receipt, storage, security, dispensing, and disposition of unused stock.
Scoring is graduated with 100% given when all five factors are addressed in the policies and procedures; 75% when four factors are addressed; 50% when three factors are addressed, and 0% when less than three factors are addressed. Pharmacy service must maintain an investigational drug log, which includes the name of the drug, manufacturer or other source, date of receipt of the drug, quantity received, expiration date, control number, date the protocol is approved, and name of authorized practitioner signing the prescription. There are five other elements to the requirement, and the last one is that the results of pharmacy service evaluations are reported to the R&D committee or other institutional official with responsibility for oversight of the research pharmacy.
3. Continuing review: The third major change from the preliminary standards involves a clarification of the distinctions between two types of continuing review that IRBs conduct, Sanford says. "One type is the continuing reviews that occur at pre-established time frames set by IRBs," she adds. "When they review a project they say it needs to be reviewed in X’ period of time, a minimum of one year, and the other is a review that goes on during the life of a research study."
Requirement IRB7 states, "The IRB uses required and relevant information to conduct continuing review of research at specified intervals and requires changes as appropriate." The first element of this requirement states that the IRB has policies and procedures for the conduct of continuing review that include consideration of the following: changes to the research; adverse event reports; safety reports, including IND, IDE, and MedWatch; protocol violations and/or deviations, and investigator noncompliance, including noncompliance with IRB requirements for frequency of periodic continuing review.
Policies and procedures must address all five factors to receive a 100% score or receive a 0% score. Comments about the standards’ first version expressed concern about how continuing reviews are handled during the life of a trial and as amendments are made, so the final version makes these distinctions clearer, Sanford says. "It appeared that when people read our first version, they thought we had not addressed that ongoing research issue," Sanford says. "We thought we had addressed it and that we had written it clearly, but obviously we had not; so we made some clarifications in that."
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