Reports & Testimonies

  • GAO’s recommendations database contains report recommendations that still need to be addressed.

    GAO’s recommendations help congressional and agency leaders prepare for appropriations and oversight activities, as well as help improve government operations. Recommendations remain open until they are designated as Closed-implemented or Closed-not implemented. You can explore open recommendations by searching or browsing.

    GAO's priority recommendations are those that we believe warrant priority attention. We sent letters to the heads of key departments and agencies, urging them to continue focusing on these issues. These recommendations are labeled as such. You can find priority recommendations by searching or browsing our open recommendations below, or through our mobile app.

  • Browse Open Recommendations

    Explore priority recommendations by subject terms or browse by federal agency

    Search Open Recommendations

    Search for a specific priority recommendation by word or phrase



  • Governing on the go?

    Our Priorities for Policy Makers app makes it easier for leaders to search our recommendations on the go.

    See the November 10th Press Release


  • Have a Question about a Recommendation?

    • For questions about a specific recommendation, contact the person or office listed with the recommendation.
    • For general information about recommendations, contact GAO's Audit Policy and Quality Assurance office at (202) 512-6100 or apqa@gao.gov.
  • « Back to Results List Sort by   

    Results:

    Subject Term: "Medical research"

    11 publications with a total of 26 open recommendations
    Director: Melissa Emrey-Arras
    Phone: (617) 788-0534

    3 open recommendations
    Recommendation: To help ensure VHA medical examiners are prepared to conduct the Gulf War general medical exam, the Secretary of Veterans Affairs should direct the Under Secretary for Health to require medical examiners to complete training, such as the 90-minute Gulf War Illness web-based course, before conducting these exams.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: VA agreed this recommendation and stated it has plans to address it. Specifically, VA said it plans to make its 90-minute web-based training course mandatory for its medical examiners who conduct Gulf War Illness exams.
    Recommendation: To provide more complete information to veterans whose Gulf War Illness claims are denied, the Secretary of Veterans Affairs should direct the Under Secretary for Benefits to update guidance to require that decision letters indicate whether Gulf War Illness medical issues were evaluated under both a presumptive and direct service connection method.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: VA agreed this recommendation and stated it has plans in place to address it. Specifically, VA noted it would improve how it communicates decisions to veterans and is in the process of updating its guidance to the regional offices to clarify the language required for its Gulf War Illness decision letters.
    Recommendation: To increase the likelihood of making progress toward developing a single case definition of Gulf War Illness, the Secretary of Veterans Affairs should direct the Under Secretary for Health to prepare and document a plan to develop a single case definition of Gulf War Illness. This plan should include near- and long-term specific actions, such as analyzing and leveraging information in existing datasets and identifying any areas for future research to help VA achieve this goal.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: VA agreed this recommendation and stated it has plans to address it. Specifically, VA noted it would convene a group of subject matter experts to work on a plan - as described in our report - to establish a single case definition of Gulf War Illness.
    Director: Persons, Timothy M
    Phone: (202) 512-6412

    5 open recommendations
    Recommendation: The Secretary of Health and Human Services should direct the Commissioner of the Food and Drug Administration to consolidate information from individual diagnostic test labels and make this information available in a form that enables users to more readily compare information across tests.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In August 2017, officials from the Department of Health and Human Services told us that the Food and Drug Administration is working to consolidate and make available on its website information for Zika virus diagnostic tests that have emergency use authorization.
    Recommendation: The Secretary of Health and Human Services should direct the Commissioner of the Food and Drug Administration to require manufacturers to list the identity of comparator assays on their diagnostic test labels.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In August 2017, officials from the Department of Health and Human Services told us that the Food and Drug Administration plans to recommend to sponsors of Zika virus diagnostic tests that they provide a description of the comparator assay.
    Recommendation: The Secretary of Health and Human Services should direct the Director of Centers for Disease Control and Prevention to establish a transparent process to provide CDC diagnostic tests, upon request, to manufacturers that are in the final stages of diagnostic test authorization.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In August 2017, officials from the Department of Health and Human Services told us that the Centers for Disease Control and Prevention (CDC) Technology Transfer Office is working to establish a transparent process that ensures CDC diagnostic tests can be provided to manufacturers.
    Recommendation: The Secretary of Health and Human Services should direct the Director of Centers for Disease Control and Prevention to include information on CDC-developed tests distributed to or shared with public health laboratories on CDC's website, including laboratory developed tests.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In August 2017, officials from the Department of Health and Human Services told us the Centers for Disease Control and Prevention (CDC) provides information on CDC-developed diagnostic tests on the Food and Drug Administration?s (FDA) website. CDC stated that their website will feature a direct link to FDA information on CDC-developed tests. CDC will continue to explore additional outlets for publication of information on CDC-developed diagnostic tests.
    Recommendation: The Secretary of Health and Human Services should direct the Director of Centers for Disease Control and Prevention to provide details such as collection records, dates, and data limitations on posted and disseminated mosquito distribution maps to better inform mosquito control experts and the general public.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In June 2016, the Centers for Disease Control and Prevention (CDC) published a report on the distribution of the mosquitos that can transmit Zika virus and other viruses in the United States. This report included new county collection records, collection dates, and summary maps for each species of mosquitos. In August 2017, officials from the Department of Health and Human Services told us the CDC is planning to update the mosquito distribution information on their website by the end of 2017, and it will include the underlying model predictions and country collection records.
    Director: Marcia Crosse
    Phone: (202) 512-7114

    2 open recommendations
    Recommendation: In order to improve FDA's strategic planning for regulatory science efforts, the Secretary of Health and Human Services should direct the Commissioner of FDA to develop and document measurable goals, such as targets and time frames, for its regulatory science efforts so it can consistently assess and report on the agency's progress in regulatory science efforts.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: On 9/6/16, FDA provided an update on its actions to address this recommendation. FDA concurred with the recommendation and reiterated that it plans to identify opportunities for setting measurable goals related to regulatory science. The agency indicated that it would provide an update by 3/6/17.
    Recommendation: In order to improve FDA's strategic planning for regulatory science efforts, the Secretary of Health and Human Services should direct the Commissioner of FDA to systematically track funding of regulatory science projects across each of its priority areas.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: On 9/6/16, FDA provided an update on its actions to address this recommendation. FDA concurred with the recommendation and reiterated that it is identifying mechanisms to improve its tracking of funding across the priority areas. The agency indicated that it would provide an update by 3/6/17.
    Director: Andrew Sherrill
    Phone: (202) 512-7215

    2 open recommendations
    Recommendation: To enhance consistency with DOL policy and procedures in adjudicating EEOICPA Part E claims, the Secretary of Labor should strengthen internal controls by requiring district offices to take steps to ensure that all claimant correspondence for Recommended and Final Decisions receives supervisory review.

    Agency: Department of Labor
    Status: Open

    Comments: The Department of Labor agreed with our recommendation that a second level review will provide a higher degree of internal quality control. However, upon evaluating our recommendation, Labor determined that given its current staffing levels it would not be possible to conduct a supervisory review of all Recommended and Final Decisions without having an adverse impact on the issuance of timely decisions for claimants. Instead, Labor is implementing a process to review a sample of decision letters - initially 10 percent - and make procedural adjustments based on the results of those reviews. We will revisit the status of this recommendation pending the results of Labor's supervisory reviews of selected decision letters.
    Recommendation: To enhance consistency with DOL policy and procedures in adjudicating EEOICPA Part E claims, the Secretary of Labor should strengthen internal controls by requiring district offices to document that the SEM was checked for updates just prior to issuing a Recommended Decision to deny a claim in cases in which the date of the last SEM update has not changed since the claims examiner's prior check.

    Agency: Department of Labor
    Status: Open

    Comments: The Department of Labor agreed with our recommendation pertaining to documenting searches of the Site Exposure Matrix during claims processing. Labor stated that it has implemented the recommendation by updating relevant guidance in the Federal EEOICPA Procedure Manual. We will update the status of this recommendation pending verification that the Procedure Manual was revised to require claims examiners to document that, before denying a claim they checked the Site Exposure Matrix to ensure pertinent information had not changed since the examiner's prior check.
    Director: John Neumann
    Phone: (202) 512-3841

    2 open recommendations
    Recommendation: The Secretaries of Energy, Defense, and Health and Human Services should develop detailed guidance to ensure that ORISE program coordinators, mentors, and research participants are fully informed of the prohibition on nonfederal employees performing inherently governmental functions.

    Agency: Department of Defense
    Status: Open

    Comments: In 2017 DOD developed a terms of agreement to be signed by each mentor and research participant, in which they acknowledge that they fully understand the restrictions on performing inherently governmental functions. However, DOD intended the terms of agreement to be used by a subset of the ORISE research participants at DOD (those participating in the Science and Technology Policy Fellowships program). To fully address this recommendation, DOD needs to take similar action for ORISE research participants not participating in this program.
    Recommendation: The Secretaries of Energy, Defense, and Health and Human Services should develop detailed guidance to ensure that ORISE program coordinators, mentors, and research participants are fully informed of the prohibition on nonfederal employees performing inherently governmental functions.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: HHS had not provided information as of July 2017 on steps it has taken to address the recommendation.
    Director: Linda Kohn
    Phone: (202) 512-7114

    3 open recommendations
    Recommendation: To ensure effective implementation of the Inclusion Policy in a manner consistent with the Revitalization Act's provisions regarding the design of certain clinical trials, the NIH Director should examine approaches for aggregating more detailed enrollment data at the disease and condition level, and report on the status of this examination to key stakeholders and through its regular biennial report to Congress on the inclusion of women in research.

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

    Comments: NIH agreed with our recommendation and began discussions in November 2015 regarding conducting these types of analyses. In April and May 2016, NIH officials identified a preliminary strategy for summarizing inclusion data at the disease and condition level. As of August 2017, NIH officials said that due to potential data limitations, NIH will continue to refine methods of reporting at this level, and the agency plans to report enrollment data at the disease and condition level in its next triennial NIH report to Congress, covering fiscal years 2015-2017, to be drafted in fiscal year 2018.
    Recommendation: To ensure effective implementation of the Inclusion Policy in a manner consistent with the Revitalization Act's provisions regarding the design of certain clinical trials, the NIH Director should, on a regular basis, systematically collect and analyze summary data regarding awardees' plans to conduct analyses of potential sex differences, such as the proportion of trials being conducted that intend to analyze differences in outcomes for men and women.

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

    Comments: In August 2017, NIH reiterated that the agency has established a number of policies and processes to ensure that sex differences are considered in the design of research, but has not taken action specific to this recommendation. We continue to believe that thoughtful, useful analysis and summary reporting would improve NIH's oversight of this aspect of the Inclusion Policy.
    Recommendation: To ensure effective implementation of the Inclusion Policy in a manner consistent with the Revitalization Act's provisions regarding the design of certain clinical trials, the NIH Director should report on this summary data and the results of this analysis in NIH's regular biennial report to Congress on the inclusion of women in research.

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

    Comments: NIH agreed with our recommendation in commenting on our report. In August 2017, NIH reiterated that the agency has established a number of policies and processes to ensure that sex differences are considered in the design of research, but has not taken action specific to this recommendation. We continue to believe that thoughtful, useful analysis and summary reporting would improve NIH's oversight of this aspect of the Inclusion Policy.
    Director: Joseph Kirschbaum
    Phone: (202) 512-9971

    3 open recommendations
    Recommendation: To improve the identification, alignment, and management of DOD's chemical and biological defense infrastructure and to fully institutionalize the use of risk assessments to support future investment decisions, the Secretary of Defense should direct the Under Secretary of Defense for Acquisition, Technology and Logistics to update the roles and responsibilities guidance in DOD Directive 5160.05E to identify which organizations are responsible for conducting and participating in CBDP Enterprise risk assessments.

    Agency: Department of Defense
    Status: Open

    Comments: DOD concurred with this recommendation but has not yet completed actions to implement it. As of August 2017, DOD was still waiting to release the final version of DOO Directive 5160.05E.
    Recommendation: To improve the identification, alignment, and management of DOD's chemical and biological defense infrastructure and to fully institutionalize the use of risk assessments to support future investment decisions, the Secretary of Defense should direct the Under Secretary of Defense for Acquisition, Technology and Logistics to update the CBDP Enterprise's portfolio planning process, to include when risk assessments will be conducted.

    Agency: Department of Defense
    Status: Open

    Comments: DOD concurred with this recommendation but has not yet completed actions to implement it. On 6/8/16, DOD reported that the risk assessment process was initially piloted in 2014 to determine its utility for informing CBDP Enterprise portfolio planning and guidance. Moving forward, the CBDP Enterprise plans to conduct risk assessments annually to support portfolio planning and guidance. As of August 2017, DOD reported that the department was beginning an approximately 12-month process to revise the CBDP Business Plan, which would likely be published as a DOD Instruction. This plan should address the risk assessment recommendation.
    Recommendation: To improve the identification, alignment, and management of DOD's chemical and biological defense infrastructure and to enhance PAIO's ongoing analysis of potential infrastructure duplication in the CBDP Enterprise and gain potential efficiencies, the Secretary of Defense should direct the Under Secretary of Defense for Acquisition, Technology and Logistics to identify, request, and consider any information from existing infrastructure studies from other federal agencies with chemical and biological research and development and test and evaluation infrastructure.

    Agency: Department of Defense
    Status: Open

    Comments: DOD concurred with this recommendation but has not yet completed actions to implement it. As of July 2017, DOD has requested, but not received, such studies from other federal agencies. However, DOD is currently engaged in phase two of a three-phase effort regarding its chemical and biological defense infrastructure program (CBDP), which includes a review of the department's interagency roles and responsibilities for its chemical and biological defense Infrastructure Manager. Targeted completion for this phase is December 2017, at which time, DOD may have obtained relevant information from other federal agencies.
    Director: Vijay A. D'Souza
    Phone: (202) 512-7114

    1 open recommendations
    Recommendation: In order to ensure that efforts to address prenatal opioid use and NAS are systematically and effectively planned and coordinated across the federal government, the Director of ONDCP should document the process, including discussions held and information considered, of developing action items on prenatal opioid use and NAS. This may include documenting gaps that were considered in developing action items.

    Agency: Executive Office of the President: Office of National Drug Control Policy
    Status: Open

    Comments: In May 2017 and July 2017, ONDCP officials described the process used to develop the action items related to prenatal opioid use and NAS for the 2015 National Drug Control Strategy report. Specifically, officials described working directly with federal agencies to identify proposals for action items and review proposals during an interagency working group meeting in March 2015. However, ONDCP officials could not provide us any formal documentation, such as meeting minutes, showing the process used or what gaps were considered in developing the action items. ONDCP officials also told us the action items related to prenatal opioid use and NAS for the 2015 Strategy have been generally completed. No action items related to prenatal opioid use and NAS were included in the 2016 Strategy and ONDCP officials said they did not know whether any related action items will be included for the 2017 Strategy. We will update the status of this recommendation after future Strategy reports are published.
    Director: Joseph Kirschbaum
    Phone: (202) 512-9971

    1 open recommendations
    Recommendation: To help ensure that DOD's investments are being applied toward developing medical countermeasures to respond to the most serious and likely biological threat agents, the Secretary of Defense should direct the appropriate DOD officials to develop and implement a process to update and validate DOD's list of biological threats, as required by DOD Directives 5160.05E and 6205.3, or implement a process that aligns with the department's current policies, practices, and priorities as reflected in the 2001 and 2010 Quadrennial Defense Reviews .

    Agency: Department of Defense
    Status: Open

    Comments: DOD concurred with the recommendation. DOD has been reviewing directives addressing biological warfare threats and is in the process of revising DOD Directive 5160.05E to ensure that the directive appropriately captures and institutionalizes the use of risk assessments to support research, development, and acquisition of chemical and biological defense capabilities. The Chemical and Biological Defense Program (CBDP) piloted the risk assessment process in 2014 and will continue to conduct annual risk assessments to support portfolio planning and guidance. In addition to this revision, the CBDP continues to improve stakeholder awareness and discussions on threats through the utilization of an annual threat day review and on-going Joint Service discussions on chemical and biological threats and capabilities to address those threats. Alignment of the threat information and medical countermeasure capabilities are discussed through the CBDP Medical Prime/Non-Prime Working Group, which was established in February 2015 to ensure the CBDP medical portfolio is addressing the highest priority threats considering available candidates and resources. The group meets quarterly to address key programmatic changes, discuss program strategic guidance, and to address information presented and discussed at the annual threat review sessions. In total, these efforts have improved the Department's ability to ensure biological threats are aligned and considered through holistic, threat-informed, risk-based assessments. DOD is also taking actions to improve the development of medical countermeasures against priority threats through a number of actions such as developing a process guide, holding threat days, and performing in-depth analyses on medical science and technology solutions. Once DOD completes and issues Directive 5160.05E, we will assess the extent to which DOD's combined actions address the recommendation.
    Director: Crosse, Marcia G
    Phone: (202) 512-7114

    3 open recommendations
    Recommendation: To improve the usefulness of IACC data and enhance its efforts to coordinate HHS autism activities and monitor all federally funded autism activities, the Secretary of Health and Human Services should direct the IACC and NIH, in support of the IACC, to provide consistent guidance to federal agencies when collecting data for the portfolio analysis and web tool so that information can be more easily and accurately compared over multiple years.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: HHS continues to disagree with this recommendation. In the spring of 2016 NIH released fiscal years 2011 and 2012 data, and in the spring of 2017, it released fiscal year 2013 data and made these data available through the IACC Web Tool. GAO continues to believe that the issuance of consistent guidance could enhance coordination and monitoring and that implementing this recommendation would be beneficial.
    Recommendation: To improve the usefulness of IACC data and enhance its efforts to coordinate HHS autism activities and monitor all federally funded autism activities, the Secretary of Health and Human Services should direct the IACC and NIH, in support of the IACC, to create a document or database that provides information on non-research autism-related activities funded by the federal government and make this document or database publicly available.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: HHS continues to disagree with this recommendation. However, GAO believes that having a document or database that contains current information on these non-research activities is an important aspect of fulfilling the IACC's responsibility to monitor all federal autism activities, not just research. In May 2016, we issued another report on federal autism activities (GAO-16-446). During our work for this engagement, we found that HHS and the IACC have recently taken actions required by the Autism CARES Act that could help coordinate federal non-research autism activities and implement our November 2013 recommendation. First, as directed by the act, in April 2016, the Secretary of Health and Human Services designated an official to serve as the Autism Coordinator to oversee national autism research, services, and support activities and ensure that autism activities funded by HHS and other federal agencies are not unnecessarily duplicative. Secondly, the Act required the development of a strategic plan for autism research, including for services and supports as practicable, for individuals with autism and the families of such individuals. The plan is to include recommendations to ensure that autism research, and services and support activities to the extent practicable, of HHS and other federal departments and agencies are not unnecessarily duplicative. During IACC meetings in 2016, NIH staff and IACC members discussed updating the strategic plan to include services and supports. This plan is expected to be published in calendar year 2017. We acknowledge the steps taken by HHS and the IACC in response to the Autism CARES Act; however, we believe continued action is needed to develop these initial steps into methods for identifying and monitoring non-research autism-related activities funded by the federal government. We believe that continued fulfillment of provisions in the Autism CARES Act could help the department implement GAO's 2013 recommendation.
    Recommendation: To improve the usefulness of IACC data and enhance its efforts to coordinate HHS autism activities and monitor all federally funded autism activities, the Secretary of Health and Human Services should direct the IACC and NIH, in support of the IACC, to identify projects through its monitoring of federal autism activities--including Office of Autism Research Coordination's annual collection of data for the portfolio analysis and the IACC's annual process to update the strategic plan--that may result in unnecessary duplication and thus may be candidates for consolidation or elimination, and identify potential coordination opportunities among agencies.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: HHS continues to disagree with this recommendation. However, GAO questions the purpose and value of devoting federal resources to collecting these data, if they are not then used to ensure federal funds are used appropriately. In May 2016, we issued another report on federal autism activities (GAO-16-446), which among other topics, examined the steps HHS and other federal agencies have taken to improve coordination and help avoid unnecessary duplication in autism research. We reported that HHS has recently taken actions required by the Autism CARES Act that could help coordinate federal autism research and implement our November 2013 recommendation. First, as directed by the act, in April 2016 the Secretary of Health and Human Services designated an official to serve as the Autism Coordinator to oversee national autism research, services, and support activities and ensure that autism activities funded by HHS and other federal agencies are not unnecessarily duplicative. Second, the Autism Cares Act requires that the IACC's strategic plan include recommendations to ensure that autism research funded by HHS and other federal agencies is not unnecessarily duplicative. During IACC meetings in 2016, NIH staff and IACC members discussed updating the strategic plan, including the aforementioned requirement. This plan is expected to be published in calendar year 2017. We acknowledge the steps taken by HHS and the IACC in response to the Autism CARES Act; however, until the designated Autism Coordinator takes steps to meet the act's requirements and the forthcoming strategic plan is published, there is a risk that opportunities to coordinate and create efficiencies and avoid unnecessary duplication in federal autism research will not be seized. We believe that continued fulfillment of provisions in the Autism CARES Act could help the department implement GAO's 2013 recommendation.
    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.