Recommendations for Executive Action

1. Status: Closed - Implemented

   Comments: MIVR project staff decided to follow conflict-of-interest procedures used by the National Institutes of Health (NIH), and has had no problems or complaints to date. This action addresses the principal GAO objection to previous procedures. Further analysis of AID agency-wide conflict-of-interest procedures is underway, as part of two other GAO reviews of AID contracting practices.

   Recommendation: To resolve outstanding MIVR project management deficiencies, the Administrator, AID, should develop descriptive guidance for the disclosure of scientific and financial interests, which would enable reviewing officials to identify and resolve real or apparent conflicts of interest in the selection of external consultants.

   Agency Affected: United States Agency for International Development

2. Status: Closed - Implemented

   Comments: AID designed a new progress report that segregates confidential/proprietary information from general information that can be circulated to other malaria researchers.

   Recommendation: To resolve outstanding MIVR project management deficiencies, the Administrator, AID, should redesign the project's semiannual progress reports to improve their usefulness as performance monitoring tools and ensure that confidential information is safeguarded, the reports receive adequate review, and the researchers receive timely feedback on their performance.

   Agency Affected: United States Agency for International Development

3. Status: Closed - Implemented

   Comments: AID has combined its scientific consultant groups for: (1) malaria vaccine research; and (2) field trials activities. It prepared a charter for the new group which has been approved by the General Services Administration and filed with appropriate agencies. Members of the old groups will be appointed to the new group shortly.

   Recommendation: To resolve outstanding MIVR project management deficiencies, the Administrator, AID, should ensure that the scientific consultants groups established for research and development and field trials activities are chartered in accordance with the Federal Advisory Committee Act.

   Agency Affected: United States Agency for International Development

4. Status: Closed - Implemented

   Comments: AID will await the completion of the IOM review before making long-term funding commitments. Interim funding decisions have reflected this commitment. New cooperative agreements have been awarded for 3, rather than 5, year periods, and tasks have been segmented sequentially to facilitate early termination of the awards of the IOM study results in a negative recommendation on the MIVR program.

   Recommendation: To resolve outstanding MIVR project management deficiencies, the Administrator, AID, should await the results of the Institute of Medicine evaluation before authorizing long-term funding commitments for malaria vaccine research activities.

   Agency Affected: United States Agency for International Development

5. Status: Closed - Implemented

   Comments: Audits of all subprojects were scheduled. Most have been completed, and the remaining are nearing completion.

   Recommendation: The Inspector General, AID, should schedule and audit those MIVR subprojects which were not audited by the Office of the Inspector General during the past year.

   Agency Affected: United States Agency for International Development: Office of the Inspector General

6. Status: Closed - Implemented

   Comments: AID has developed a plan for managing its inventory of research monkeys. It has also undertaken several studies of the suitability of various primate subspecies for malaria vaccine research. More than 600 monkeys have been transferred to other U.S. government contractor laboratories. Further deacquisitions are planned.

   Recommendation: The Administrator, AID, should develop a comprehensive management plan to be periodically reviewed by AID external scientific advisors and updated to reflect new information and scientific developments. The plan should include: (1) an assessment of the suitability of specific Aotus and Saimiri species for malaria vaccine research; (2) an assessment of future needs and a corresponding plan for acquiring suitable primate species; (3) an evaluation of the usefulness of efficacy trials in monkeys and how AID will use data from such trials in deciding to approve and support human clinical trials; and (4) plans for disposing of unsuitable and surplus monkeys.

   Agency Affected: United States Agency for International Development

7. Status: Closed - Implemented

   Comments: NIH has ensured AID that the Perrine Center meets all applicable standards for the care of laboratory animals.

   Recommendation: The Administrator, AID, should ensure that research monkeys receive appropriate care and are housed only in facilities meeting National Institutes of Health standards.

   Agency Affected: United States Agency for International Development

8. Status: Closed - Implemented

   Comments: AID tattooed all monkeys still in its inventory.

   Recommendation: The Administrator, AID, should ensure that all AID-owned monkeys are individually tattooed and included in the AID centralized inventory system.

   Agency Affected: United States Agency for International Development

9. Status: Closed - Implemented

   Comments: AID has decided not to renew its database contract with Battelle-Northwest and has decided that most of the data it has been collecting is unnecessary and current data needs can be met by its management services contractor with existing equipment.

   Recommendation: The Administrator, AID, should reexamine the MIVR project's primate databases and: (1) stop collecting unnecessary information; (2) ensure the integrity of any information collected; and (3) ensure that information is easily accessible to network researchers.

   Agency Affected: United States Agency for International Development

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