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    Results:

    Subject Term: "Biomedical research"

    3 publications with a total of 13 open recommendations
    Director: Beryl H. Davis
    Phone: (202) 512-2623

    11 open recommendations
    Recommendation: To improve the design of internal controls over the indirect cost rate-setting process, the Director of CAS should develop a standardized checklist and document procedures in its internal guidance instructing negotiators to use the checklist during negotiation.

    Agency: Department of Health and Human Services: Division of Cost Allocation
    Status: Open

    Comments: HHS concurred with this recommendation. In response, HHS stated that its Cost Allocation Services (CAS) will update and complete standardized checklists and that staff will be instructed to use these checklists by December 31, 2016. We are currently reviewing support received from HHS to determine if we can close the recommendation.
    Recommendation: To improve the design of internal controls over the indirect cost rate-setting process, the Director of CAS should develop detailed internal guidance for the completion and documentation of supervisory review of the indirect cost rate negotiation process to provide reasonable assurance that key control activities have been performed by the negotiators.

    Agency: Department of Health and Human Services: Division of Cost Allocation
    Status: Open

    Comments: HHS concurred with this recommendation. In response, HHS stated that by December 31, 2016, its Cost Allocation Services (CAS) will establish a document outlining standardized review procedures for supervisory review of workpapers and rate agreements. We are currently reviewing support received from HHS to determine if we can close the recommendation.
    Recommendation: To improve the design of internal controls over the indirect cost rate-setting process, the Director of CAS should develop internal guidance for negotiating indirect cost rates with all types of research organizations, including hospitals, as well as universities using the simplified method.

    Agency: Department of Health and Human Services: Division of Cost Allocation
    Status: Open

    Comments: HHS concurred with this recommendation. In response, HHS stated that its Cost Allocation Services (CAS) will update internal guidance for negotiating indirect cost rates with universities using the simplified method by December 31, 2016. This guidance will include an example under the two types of direct cost bases, a salary and wage base and a modified total direct cost base. CAS will develop internal guidance for negotiating with hospitals as soon as possible. We are currently reviewing support received from HHS to determine if we can close the recommendation.
    Recommendation: As NIH-DFAS begins formalizing its internal guidance, the Director of NIH-DFAS should update internal guidance to include key characteristics, such as policy number, purpose of the policy, effective date, and approving official, that are normally included in formal policy and procedures.

    Agency: Department of Health and Human Services: Public Health Service: National Institutes of Health: Office of Management: Office of Acquisition and Logistics Management: Office of Acquisition Management and Policy: Division of Financial Advisory Services
    Status: Open

    Comments: HHS concurred with this recommendation. In response, HHS stated that by December 31, 2016, National Institute of Health's Division of Financial Advisory Services (DFAS) will update internal guidance to include key characteristics that are normally included in formal policy and procedures. NIH-DFAS has finalized three of the five polices, which are effective as of July 1, 2017. The remaining two policies will be finalized by August 31st, 2017. We will continue to monitor the status of this recommendation.
    Recommendation: As NIH-DFAS begins formalizing its internal guidance, the Director of NIH-DFAS should develop detailed procedures for the completion and documentation of supervisory review of the indirect cost rate negotiation process to provide reasonable assurance that key control activities have been performed by the negotiator.

    Agency: Department of Health and Human Services: Public Health Service: National Institutes of Health: Office of Management: Office of Acquisition and Logistics Management: Office of Acquisition Management and Policy: Division of Financial Advisory Services
    Status: Open

    Comments: HHS concurred with this recommendation. In response, HHS stated that the National Institute of Health's Division of Financial Advisory Services (DFAS), will develop detailed procedures for the completion and documentation of supervisory review of the indirect cost rate negotiations process. NIH-DFAS has developed draft internal guidance to address the supervisory review of the indirect cost negotiation process. NIH-DFAS plans to finalize these procedures by August 31, 2017. We will continue to monitor the status of this recommendation.
    Recommendation: As NIH-DFAS begins formalizing its internal guidance, the Director of NIH-DFAS should establish a mechanism for tracking key milestones in the indirect cost rate-setting process, such as when indirect cost rate proposals are due.

    Agency: Department of Health and Human Services: Public Health Service: National Institutes of Health: Office of Management: Office of Acquisition and Logistics Management: Office of Acquisition Management and Policy: Division of Financial Advisory Services
    Status: Open

    Comments: HHS concurred with this recommendations. In response, HHS stated that National Institute of Health's Division of Financial Advisory Services (DFAS) will establish a mechanism for tracking key milestones in the indirect cost rate-setting process. NIH-DFAS has initiatives underway that include moving from paper to electronic submissions of indirect cost proposals and developing a replacement to its Commercial Rate Agreement Distribution Services website. DFAS is looking into the feasibility of incorporating key milestones into these two major initiatives. NIH-DFAS is currently working with a contractor to develop a web based system that will establish a tracking system to account for when indirect cost proposal are due from organizations. The original initiative to enable the electronic submission of indirect cost proposals was modified to incorporate this new requirement. NIH-DFAS anticipates the planned date for implementation of this system to be October 1, 2017. We will continue to monitor the status of this recommendation.
    Recommendation: To improve the design of internal controls over the indirect cost rate-setting process, the Director of ONR should implement the May 2014 policy requiring an annual review of guidance so that internal guidance is updated when changes are made to applicable regulations and procedures to reasonably assure that the guidance reflects current requirements.

    Agency: Department of Defense: Department of the Navy: Office of Naval Research
    Status: Open

    Comments: DOD concurred with this recommendation. In response, DOD stated that the Office of Naval Research (ONR) will comply with its requirement for an annual review of its internal policy on negotiating indirect costs. As of June 15, 2017, no updated information has been provided by the Department of Defense. We will continue to monitor the status of this recommendation.
    Recommendation: To improve the design of internal controls over the indirect cost rate-setting process, the Director of ONR should include in its internal guidance acceptable Defense Contract Audit Agency (DCAA) audit completion time frames and identify supplemental procedures to be performed by negotiators if DCAA cannot perform its audits timely or if DCAA issues a qualified opinion or rescinds one of its previously issued audit opinions, to reasonably assure that the indirect cost rate proposal has been adequately reviewed and the negotiated rate complies with applicable regulations.

    Agency: Department of Defense: Department of the Navy: Office of Naval Research
    Status: Open

    Comments: DOD concurred with this recommendation. In response, DOD stated that the Office of Naval Research's (ONR) internal guidance will be updated to provide more realistic audit report due dates and will include general procedures to be performed by negotiators in the case of untimely audits, qualified opinions, or rescinded opinions. As of June 15, 2017, no updated information has been provided by the Department of Defense. We will continue to monitor the status of this recommendation.
    Recommendation: To improve the design of internal controls over the indirect cost rate-setting process, the Director of ONR should develop detailed procedures for the completion and documentation of supervisory review of the indirect cost rate negotiation process to provide reasonable assurance that required certifications and assurances are obtained and follow-up with the research organization is documented.

    Agency: Department of Defense: Department of the Navy: Office of Naval Research
    Status: Open

    Comments: DOD partially concurred with this recommendation. DOD did not agree that the Office of Naval Research (ONR) lacks procedures to ensure supervisors confirm that negotiators adequately performed and documented key controls. DOD noted that both the primary and secondary supervisors are required to review and approve the Business Clearance Memorandum, which records steps performed by the negotiator. While we agree that the Business Clearance Memorandum documents steps performed by the negotiator, these steps are documented at a high level and do not include detailed procedures for supervisors to follow to reasonably assure that the negotiator has performed and documented all key control activities, such as obtaining all required certifications and assurances. DOD agreed in its response that ONR's Business Clearance Memorandum can be improved and stated that ONR will update it to require the negotiator to cross-reference the review steps to the proposal to facilitate the supervisor's review process. However, it is not clear whether the planned Business Clearance Memorandum revisions will include providing detailed procedures for supervisory review as we recommended. As of June 15, 2017, no updated information has been provided by the Department of Defense. We will continue to monitor the status of this recommendation.
    Recommendation: To improve the design of internal controls over the indirect cost rate-setting process, the Director of ONR should finalize and issue internal guidance for negotiating indirect cost rates with universities and nonprofit organizations, including establishing a time frame for issuance of the internal guidance, to help ensure that the procedures are implemented in a timely manner.

    Agency: Department of Defense: Department of the Navy: Office of Naval Research
    Status: Open

    Comments: DOD concurred with this recommendation. In response, DOD stated that the Office of Naval Research (ONR) is currently updating its internal guidance and currently plans to issue this guidance by December 31, 2016. As of June 15, 2017, no updated information has been provided by the Department of Defense. We will continue to monitor the status of this recommendation.
    Recommendation: To improve the design of internal controls over the indirect cost rate-setting process, the Director of ONR should update ONR's existing process for tracking key milestones in the indirect cost rate-setting process to include information such as when indirect cost rate proposals are overdue and when DCAA's audit reports are due.

    Agency: Department of Defense: Department of the Navy: Office of Naval Research
    Status: Open

    Comments: DOD concurred with this recommendation. In response, DOD stated that the Office of Naval Research will update its existing processes for tracking key milestones to include information such as due dates for rate proposals and DCAA audit reports. As of June 15, 2017, no updated information has been provided by the Department of Defense. We will continue to monitor the status of this recommendation.
    Director: Kohn, Linda T
    Phone: (202) 512-7114

    1 open recommendations
    Recommendation: To help address the uncertainty NIH faces, related to the potential impact of increasing indirect costs on its funding of future research, the Director of NIH should assess the impact of growth in indirect costs on its research mission, including, as necessary, planning for how to deal with potential future increases in indirect costs that could limit the amount of funding available for total research, including the direct costs of research projects.

    Agency: Department of Health and Human Services: Public Health Service: National Institutes of Health
    Status: Open

    Comments: As of July 7, 2015, NIH provided some information indicating that it had taken action to address our recommendation by tracking the size of indirect costs as a proportion of NIH's overall budget as part of the agency's annual budget planning process and risk assessment program. However, we determined that the actions did not fully address the recommendation because they focus on the agency's overall budget and do not assess the potential ongoing impact of indirect costs for universities on its mission. As of August 2017, NIH officials have not informed us of any additional actions taken to implement this recommendation. We will update the status of this recommendation when we receive additional information.
    Director: Kohn, Linda T
    Phone: (202) 512-7114

    1 open recommendations
    Recommendation: To ensure that nonmedical DOD research organizations coordinate with the Assistant Secretary of Defense for Health Affairs early in the research process to understand medical research requirements and avoid inefficiencies that may lead to duplicative work, the Secretary of Defense should direct the Under Secretary of Defense for Acquisition, Technology and Logistics to communicate to DOD's nonmedical research organizations the importance of coordination with the Joint Program Committee for Combat Casualty Care chair on combat casualty care issues, and require this coordination early in the research process when these organizations conduct research with implications for combat casualty care.

    Agency: Department of Defense
    Status: Open

    Comments: DOD took several actions in 2014 to communicate to DOD's nonmedical research organizations the importance of coordination with the Joint Program Committee for Combat Casualty Care. Specifically, DOD chartered the Armed Services Biomedical Research Evaluation and Management Community of Interest to include both medical and non-medical researchers and to improve coordination, collaboration, and cooperation. DOD also appointed senior leaders to work in both this community of interest and in other DOD research communities of interest, to improve coordination. Furthermore, DOD conducted joint research meetings to share research data across the medical and non-medical communities. As of September 2017, DOD had not indicated a requirement for this coordination to occur early in the research process, as included in GAO's recommendation.