- Contact the Committee

October 25, 2002 

The Honorable Stephen E. Buyer

Chairman, Subcommittee on Oversight and Investigations

Committee on Veterans’ Affairs

House of Representatives 

The Honorable Julia M. Carson

Ranking Member, Subcommittee on Oversight and Investigations

Committee on Veterans’ Affairs

House of Representatives

The enclosed information responds to your follow-up questions concerning our testimony before the Subcommittee on September 19, 2002, on the Department of Veterans Affairs’ (VA) use of nonprofit research corporations.  The first question asked for our views on a proposal to allow VA to transfer appropriated funds to nonprofit corporations through contracts.  The second question asked for the status of VA’s actions in response to recommendations in our September 2000 report, VA Research: Protections for Human Subjects Need to Be Strengthened, GAO/HEHS-00-155. 

If you have any questions or would like to discuss this information, please contact me at (202) 512-7101 or Michael T. Blair, Jr., Assistant Director, at (404) 679-1944.  

Sincerely yours, 

Cynthia A. Bascetta

Director, Health Care—Veterans’

Health and Benefits Issues 

Enclosure

This enclosure details your questions and our responses, which supplement information in our testimony before your Subcommittee, VA Health Care:  Nonprofit Corporations Enhance VA Research, but Would Benefit from Increased Oversight (GAO-02-1103T, Sept. 19, 2002). 

Transfer of Appropriated Funds to

Nonprofit Research Corporations 

1.         Please provide the Subcommittee with your views on a proposal to grant VA the ability to contract for services with nonprofit research corporations.  In your opinion, how would this change the relationship between the corporations and VA? 

We see no apparent advantage to VA from a proposal that would allow the direct transfer of VA appropriated funds to nonprofit corporations through contracts, since VA already has the ability to obtain services from nonprofit corporations.  Further, the proposal would require VA headquarters to oversee the transfers to ensure the appropriate use of these funds—an added burden since VA headquarters does not currently oversee and monitor corporations’ financial activities.  Also, extensive funding transfers might cause nonprofit corporations to become dependent on VA funding.   

VA and nonprofit corporations currently have options for sharing resources among projects funded with VA appropriations and those funded externally.  For example, nonprofit corporations can now purchase equipment and share their use among multiple research projects.  These shared services or “recharge centers” allow numerous researchers, including those funded by VA appropriations, to use the equipment and pay a portion of associated operation and maintenance cost.  Under current procedures, VA pays its portion of operation and maintenance cost directly to the vendor. 

Further, the proposal might also apply to the use of nonprofit corporation employees to assist in research funded with VA appropriations.  However, VA—in addition to the ability to temporarily hire employees—already has the flexibility to enter into agreements to reimburse nonprofit corporations for the salaries of their employees who work on VA-funded research projects.  Through these agreements nonprofit corporation employees who have been employed for at least 90 days, such as research technicians, can temporarily work on VA-funded research projects.  Contracting for the services of nonprofit personnel under the proposal could be very similar, but might also include a fee to cover the nonprofit’s administrative expenses. 

We also note potential problems with the relationship that would exist under the proposal.  For example, allowing the transfer of these funds to nonprofit research corporations could create opportunities for inappropriate use of appropriated funds.  Because of this possibility, the proposal would increase the need for high-level oversight of local nonprofit activities, which, as we discussed in our September 19, 2002, testimony, is not being done.  Moreover, if the proposal were implemented so that VA funding became a major component of nonprofit corporations’ revenue, they could become increasingly dependent on already limited VA research appropriations, redefining their mission of serving as a flexible funding mechanism to facilitate VA research and education.  Further, VA officials object to the proposal since it may cause nonprofit corporations to operate more like contractors whose goal is to sell services, capture indirect or overhead costs, and maximize revenue from VA appropriations. 

VA Actions in Response to GAO Recommendations

on Human Subject Protections 

2.         Have all the GAO recommendations made in 2000 to strengthen Human Research Protections been completed by VA?  If not, please provide a status report. 

In our September 2000 report VA Research:  Protections for Human Subjects Need to Be Strengthened, we made recommendations for improving human subject protections.  VA’s actions in response to our recommendations are discussed below. 

Recommendation:  To strengthen VA's protections for human subjects, the Acting Secretary of Veterans Affairs should direct the Under Secretary for Health to take immediate steps to ensure VA medical centers, their institutional review boards (IRB)—whether operated by VA or not—and VA investigators comply with all applicable regulations for the protection of human subjects by: 

• providing research staff with current, comprehensive, and clear guidance regarding protection for the rights and welfare of human research subjects.

While VA has provided some guidance to research staff, it has not fully implemented this recommendation.  In September 2001, VA’s Office of Research Compliance and Assurance (ORCA) issued a guidebook describing standard operating procedures for IRBs and distributed a self-assessment tool for evaluating the quality of human subject protection at VA facilities.  Since the guidebook and the assessment tool are optional they might not be used.  However, VA is formalizing its policies and requirements in a handbook for protecting human subjects in research that all facilities must follow.  According to VA, the handbook will provide current, comprehensive guidance regarding the responsibilities of investigators and IRBs in protecting the rights and welfare of human research subjects.  Although a preliminary draft was issued in December 2000, VA does not expect to issue the handbook in final form until early 2003. 

• providing periodic training to investigators, IRB members, and IRB staff about research ethics and standards for protecting human subjects.

VA has implemented this recommendation.  ORCA has developed standardized educational and training activities for investigators, IRB members, and staff on protecting human subjects in research.  Further, VA requires investigators who apply for VA research funds to complete training on human subject protection.  Further, ORCA issues biweekly information letters and sponsors seminars and conferences on research ethics and standards for protecting human subjects. 

• developing a mechanism for handling adverse event reports to ensure that IRBs have the information they need to safeguard the rights and welfare of human research participants.

VA is in the process of implementing this recommendation.  In September 2001, ORCA issued guidance on IRB operating procedures to each medical center, including what information investigators should include in adverse event reports to IRBs and how IRBs should review the data and determine any necessary action.  ORCA is leading an effort to simplify VA adverse event reporting requirements and make them consistent with the requirements of other federal agencies, such as the Office for Human Research Protections and the Food and Drug Administration.  In doing so, ORCA has been coordinating with these agencies to discuss federal government-wide adverse event reporting requirements.  VA, as a result of these efforts, plans to publish a directive including the new requirements within the next year.  When this directive is complete, ORCA plans to use it as a basis to monitor local IRBs’ handling of adverse event reports. 

• expediting development of information needed to monitor local protection systems, investigators, and studies and to ensure that oversight activities are implemented.

VA has implemented this recommendation.  VA has begun several agency-wide initiatives to monitor local oversight activities.  VA contracted with the National Committee for Quality Assurance (NCQA) in April 2000 to review and accredit the human protection programs at VA medical centers every 3 years.  The NCQA accreditation process includes reviewing local research policies and standard operating procedures, IRB procedures and records, qualifications and training of IRB members and staff, and medical centers’ implementation and monitoring of informed consent procedures.  NCQA finalized its accreditation standards in August 2001 and VA medical centers have begun the accreditation process.  NCQA has surveyed 23 medical centers, 19 of which have been “Accredited with Conditions,” and 4 of which have not been accredited.  Ninety have yet to be reviewed. 

When a medical center receives a final result of “Not Accredited,” an ORCA team visits the center to determine if patients have been harmed, which could result in the suspension or restriction of the center’s research program.  In addition, ORCA conducts reviews of research programs whenever it receives a report of problems or has other reason to suspect them.  Also, at medical centers’ request ORCA reviews their research programs to help ensure that human subjects are protected. 

·        determining the funding levels needed to support human subject protection activities at medical centers and ensuring an appropriate allocation of funds to support these activities.  

VA is in the process of implementing this recommendation.  It completed a study that estimates the cost of operating IRBs at small, medium, and large research programs.  VA plans to use the study, which was completed in June 2002, to help determine funding levels for medical centers’ human subject protection activities.