Evaluation of Operating Results for National Institute of Radiological Sciences Estimated at the End of the Third Medium to Long-Term Objective Period

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1 Evaluation of Operating Results for National Institute of Radiological Sciences Estimated at the End of the Third Medium to Long-Term Objective Period September 2015 Minister of Education, Culture, Sports, Science and Technology Nuclear Regulation Authority 1

2 Form / Estimated Evaluation / Overview of the Evaluation 1. Items related to the evaluation Agency National Institute of Radiological Sciences Evaluation period Estimated evaluation The third period of medium to long-term objectives (achievement evaluation of medium-long-term objective period) Period of medium to long-term objectives FY2011-FY Items related to the Assessor The competent Minister Minister of Education, Culture, Sports, Science and Technology Incorporated jurisdiction dept. Research Promotion Bureau Dept. and person in charge Director, Advanced Medical and Radiological Science Division,, Takayuki Aso Evaluation and Science and Technology Policy Bureau Dept. and person in charge Planning and Evaluation Division, Takahisa Murakami Inspection dept. The Competent Minister Nuclear Regulation Authority Incorporated jurisdiction dept. Secretary-General s Secretariat, Radiation Protection Department, Secretariat of Nuclear Regulation Authority Dept. and person in charge Emergency Preparedness/Response and Nuclear Security Division, Shinichi Araki Evaluation and Inspection dept. Secretary-General s Secretariat, Secretariat of Nuclear Regulation Authority Dept. and person in charge Policy Planning and Coordination Division,, Katsumi Matsuura 3. Items regarding implementation of evaluation Listening to opinions and hearings from the National Research and Development Agency Council (hereinafter referred to as "Council"). Based on the following procedures, the Council heard opinions from the Nuclear Regulatory Authority about the form of the evaluation estimated at the end of FY2014 third medium-long-term objective period of the National Institute of Radiological Sciences (hereafter referred to as the Agency ). On June 30,2015, the Council held a MEXT Council research sub-committee (hereafter referred to as Sub-Committee ) to hear opinions from the Agency and the members about radiation research for medical use, safety of radiation and medical research for acute exposure, and technology development in the basic radiology field. On July 16, 2015, the Council heard from the MEXT sub-committee about the form of the evaluation, including research on radiation for medical use, safety of radiation and medical research for acute exposure, and technology development in the basic radiology field. On July 27, 2015, the Council heard opinions from the members of the Nuclear Regulatory Authority Sub-committee about the safety of radiation and medical research for acute exposure, and heard opinions from the Agency as well. On July 31, 2015, the Council heard opinions from the members of the Nuclear Regulatory Authority about the form of the evaluation of the safety of radiation and medical research for acute exposure. At the 2 nd meeting of National Research and Development Agency Council, Ministry of Education Culture, Sports, Science and Technology-Japan (MEXT) on August 21, 2015, we received the advice in line with scientific knowledge from the committee, regarding the implementation of evaluation conducted by the Competent Minister. 2

3 4. Important items and others relating to the evaluation * Evaluations up to FY 2013 were made based on the basic policy regarding business results evaluation for Incorporated Administrative Agency under MEXT s jurisdiction (The Evaluation Committee for incorporated administrative agency under MEXT s jurisdiction on March 22, 2002). The Agency s self-evaluation for FY2014 is also based on the above policy. * The evaluations after FY2014 are made based on criteria relating to the evaluation for Incorporative Administrative Agency under MEXT s jurisdiction (decided by the Minister of MEXT in June, 2015). The details are as follows: Ratings up to FY2013 S: Outstanding achievements are fulfilled (the evaluations are made based on the agency s characteristics without setting up prior agency wide criteria.). A: Achievements are in line with the plan for medium-term, or beyond, or are steadily being implemented toward a medium-term objective, or beyond (achievement rate for the medium-term objective should be over 100% in a given FY.). B: In some ways the plan is not being implemented in line with medium-term-objectives, however, the plan may be achieved by means of ideas and efforts (achievement rate for the medium-term objective should be 70% to 100%.). C: The implementation of the plan is behind the medium-term objective, therefore, improvement of business is necessary in order to realize the achievement of the medium-term objective (achievement rate for the medium-term objective in a given FY is less than 70%) F: The evaluation committee needs to warn an agency concerning the improvement of its business management and others. (F is rated as a result of judgement that a warning concerning business improvement is necessary.) Ratings after FY2014 S: Based on the National Research and Development Agency s aims, businesses, medium to long-term regarding the agency s business achievements, efforts and so on through its activities, especially the creation of considerable achievements, anticipated creation of special achievements in the future and so on toward maximization of research and development under the conditions of appropriate, effective and efficient business management are recognized. A: Based on the National Research and Development Agency s aims, businesses, medium to long-term regarding the agency s business achievements, efforts and so on through its activities, the creation of considerable achievements, anticipated creation of achievements in the future and so on toward maximization of research and development under the conditions of appropriate, effective and efficient business management are recognized. B: Based on the National Research and Development Agency s aims, business, medium to long-term regarding the agency s business achievement, efforts and so on through its activities, a certain degree of expectation for the creation of achievement and creation of achievement in the future toward maximizing the achievements of research and development were recognized, and steady business operations have been also recognized. C: Based on the National Research and Development Agency s aims, businesses, medium to long-term regarding the agency s business achievements, efforts and so on through its activities, the creation of achievements, further drastic efforts and improvements toward maximization of research and development or the appropriate, effective and efficient administration of the operations are anticipated. D: Based on the National Research and Development Agency's aims, businesses, medium to long-term regarding the agency's business achievements, efforts and so on through its activities, special efforts and improvements including a fundamental drastic review, toward "maximization of research and development" or the appropriate, effective and efficient administration of the operations are required. 3

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5 Form / Estimated Evaluation / Overall Rating 1. Overall evaluation Rating* 1 (S, A, B, C, D) B: Based on the National Research and Development Agency s aims, business, medium to long-term objectives and so on, as a result of comprehensive consideration based on some circumstances regarding the agency s business achievement, efforts and so on through its activities, a certain degree of expectation for the creation of achievement and creation of achievement in the future toward maximizing the achievements of research and development were recognized, and steady business operations have been also recognized. (Reference: estimated evaluation) Reasons for rating The National Institute of Radiological Sciences (hereafter referred to as the Agency ) has comprehensively been tackling radiation medical science as a mission, such as study of medical uses of radiation, safety of radiation and medical study of acute exposure, as well as recovery and restoration from the accident at TEPCO Fukushima Daiichi Nuclear Power Station. The Minister of Education, Culture, Sports, Science and Technology confirmed that the Agency would successfully achieve the third period medium-term objectives through such operations. 2. Evaluation of the whole agency The Agency has established a heavy particle ion facility network (J-CROS) for heavy ion radiotherapy for cancer to carry out a multinational multicenter clinical study, steadily developing elemental technology toward miniaturizing superconducting synchrotron. In the disease diagnostic study using molecular imaging technology, the Agency has been achieving beyond the scope of the plan for the development and production of molecular probes, development of Open-PET, and utilization of disease diagnostic technology. For the safety of radiation, an empirical study has been steadily carried out using animals to assess children s radiation sensitivity quantitatively. Also, in an acute exposure medical research, the research of diagnosis of radiation damage and treatment has steadily proceeded. In the basic R&D activity, the development of detecting devices, technology transfer to industry, and technological support necessary for the Agency s research operations have steadily proceeded. The Agency s operational management under the leadership of the chief director can be judged to be appropriate as a whole for the prevention of fraudulent research and effective management of general administrative expenses. The response to the recovery and restoration from the accident at TEPCO Fukushima Daiichi Nuclear Power Station has been proceeded beyond the scope of the plan, in the research of long-term low-dose exposure, investigation of environmental dynamics and impacts, and follow-up investigations of health effects on restoration workers. As a public institute, the Agency is expected to create more achievements to return them to the public. 3. Issues to be solved and/or improved for each subject (1) Matters on project plan In the study of heavy ion radiotherapy for cancer, the accumulation and analysis of the case data for the safety and efficacy of treatments shall be carried out for early coverage of public medical insurance. Also, the next medium-long-term plan should clarify the combined metastasis inhibition treatments for clinical application in the form of a strategic roadmap to reflect the basic research achievements regarding the effectiveness of the individual radiotherapy. The molecular imaging study should be specified in more detail in order to link the achievements in Open-PET and real time image analysis to clinical applications. Although the study of diagnosis and treatment of radiation damage (complications) from acute exposure has been limited to wide-range dose evaluations, exploration of treatment drugs, and application of regenerative medicine, the Agency should clarify and scrutinize its purposes more specifically. (2) Matters on business operations Management methods of notebooks, notebook owners, and study data should be considered for risk management. (3) Others In the effort toward recovery and restoration from the accident at TEPCO Fukushima Daiichi Nuclear Power Station, important tasks include how to apply the effect of low-dose-exposure on experimental mice to that on human bodies, and convey the results to community people correctly. For this purpose, the Agency should evaluate obtained data objectively, and consider how to give the information correctly to these people. 4. Other items 5

6 Main opinions from National Research and Development Agency Council Auditor s special comments No comments No comments *1 S: Based on the National Research and Development Agency s aims, businesses, medium to long-term regarding the agency s business achievements, efforts and so on through its activities, especially the creation of considerable achievements, anticipated creation of special achievements in the future and so on toward maximization of research and development under the conditions of appropriate, effective and efficient business management are recognized. A: Based on the National Research and Development Agency s aims, businesses, medium to long-term regarding the agency s business achievements, efforts and so on through its activities, the creation of considerable achievements, anticipated creation of achievements in the future and so on toward maximization of research and development under the conditions of appropriate, effective and efficient business management are recognized. B: Based on the National Research and Development Agency s aims, business, medium to long-term objectives and so on, as a result of, comprehensive consideration based on some circumstances regarding the agency s business achievement, efforts and so on through its activities, a certain degree of expectation for the creation of achievement and creation of achievement in the future toward maximizing the achievements of research and development were recognized, and steady business operations have been also recognized. C: Based on the National Research and Development Agency s aims, businesses, medium to long-term regarding the agency s business achievements, efforts and so on through its activities, the creation of achievements, further drastic efforts and improvements toward maximization of research and development or the appropriate, effective and efficient administration of the operations are anticipated. D: Based on the National Research and Development Agency's aims, businesses, medium to long-term regarding the agency's business achievements, efforts and so on through its activities, special efforts and improvements including a fundamental drastic review, toward "maximization of research and development" or the appropriate, effective and efficient administration of the operations are required. *2 Until FY2013, MEXT Incorporated Administrative Agency Evaluation Committee has not made comprehensive evaluation but based on wide-ranged items for each stage, therefore instead of it this evaluation is presented as a previous year s evaluation. 6

7 Form / Estimated Evaluation / Ratings Summary Table by Each Item Medium to long-term objectives (Medium to long-term plan) FY Ratings Interim evaluation of medium to long-term objectives FY2011 FY2012 FY2013 FY2014 FY2015 Estimated rating I. Measures to be taken for achieving the objectives concerning the improvement of the service to the nation and the S A A B B quality of the operations 1. R&D for the effects of radiation on human bodies, prevention of harm to human bodies from radiation, and diagnosis, treatment and medical use of radiation 1. Study of medical use of radiation 1. Study of heavy ion radiotherapy for cancer A A A B B (1) Study for standardization of heavy ion radiotherapy and clarification of its indication A A A B B (2) R&D of next-generational heavy ion radiotherapy systems S S S A A (3) Basic study of radiotherapy to predict the effects on individuals A A A B B (4) R&D for heavy ion radiotherapy for cancer to strengthen global competitiveness A A A B B 2. Study of disease diagnosis using molecular imaging technology A A A A A (1) R&D for PET probe and its standardization and dissemination A A A B A (2) Development and applied research of advanced biometric and analyzing systems S A A A A (3) Study of disease diagnosis, such as cancer, using molecular imaging technology A A A B B (4) Diagnosis study of mental and nervous diseases using molecular imaging technology A S S A A 2. Medical research of safety of radiation and acute exposure 1. Study of radiation safety A A A B B (1) Empirical study of protection of children from radiation A A A B B (2) Systematic study aimed at radiation risk reduction A A A B B (3) Regulatory study linking between scientific knowledge and society A A A B B 2. Medical study of acute exposure S A A B A (1) Study of diagnosis and treatment of radiation damage (complications) developed by traumas and A A A B B burns (2) As a major institute, improvement of the system for acute exposure medicine and its related tasks S A A A A (3) Deployment of acute exposure medicine in Asian countries A A S B A 3. Evaluation study of medical exposure A A A B B 3. Basic technology development in the radiological field A A A B B (1) R&D of basic technology for the use of radiation A A A B B (2) Technological support and improvement of infrastructure for radiation science research A A A B B 4. Budding and creative research A A A B B 2. Dissemination of R&D archievements and promotion of its utilization A A A B B 1. Transmission of R&D achievements B A A B B 2. Promotion of utilization of R&D achievements A A A B B 7 No. of document each item Remarks

8 3. PR activities S A A B A 3. International cooperation, and collaboration with domestic and foreign organizations and universities A A A B B 1. Collaboration with international organizations A A A B B 2. Research cooperation and joint study with domestic and foreign institutes A A A B B 4. Function as a core institute in Japan A A S B A 1. Shared use of facilities and equipment A A A B B Medium to long-term objectives (Medium to long-term plan) FY evaluation Interim evaluation medium-long-term objectives FY2011 FY2012 FY2013 FY2014 FY2015 Estimated rating 2. Quality control and assurance of radiological technology A A A B B 3. Enhancement and maintenance of intellectual infrastructure of radiological technology A A A B B 4. Development of human resources S S S A A 5. Compliance with national policies, objectives and social needs S A S A S II. Measures to be taken for achieving the objectives concerning the efficiency of the administration of the A A A B B operations 1. Improvement of management S A A B A 1. Flexible and efficient system operations S A A B A 2. Enhancement of internal control A A A B B 2. Self-inspection and evaluation A A A B B 3. Risk management A A A B B 4. Efficient operations A A A B B 5. Effective use of heavy-particle-ion-medical-center hospitals and efficient managements A S A B B 6. Acquisition of own income A A A B B 7. Appropriateness of contract A A B B B 8. Review of holdings A A A B B 9. Promotion of information disclosure A A A B B III. Budget (Including personnel expenses)/ income and expenditure plan, and funding plan A A A B B IV. Limit amount of short-term borrowing V. If the agency has any Unnecessary Property or any property that is expected to be Unnecessary Property, a plan for disposal of such property VI. If the agency intends to transfer or provide as collateral any important property other than the property provided for in the preceding item, a plan therefor; VII. Purpose of using accumulated profit A A A B B VIII. Other matters concerning the administration of the operations specified by ordinance of the competent A A A B B ministry 1. Plans for equipment and facilities A A A B B 2. Plans for personnel A A A B B Item by item working paper No. Remarks 8

9 3. Debt burden over the medium to long-term objective period A A A B B 4. Use of a reserve fund A A A B B IX. Special note (Efforts for recovery and restoration from the accident at TEPCO Fukushima Daiichi Nuclear Power Station in the Great East Japan Earthquake) S A A A A * For items that are set to "high" level of importance, a circle shall be marked next to each comment. For items that are set to "high" level of difficulty, each comment shall be underlined. * Evaluations up to FY 2013 were made based on the basic guideline regarding business results evaluation for Incorporated Administrative Agency under MEXT s jurisdiction (The evaluation committee for incorporated administrative agency under MEXT s jurisdiction on March 22, 2002). Also, the evaluations after FY2014 are made based on criteria relating to the evaluation for Incorporative Administrative Agency under MEXT s jurisdiction (decided by the Minister of MEXT in June, 2015). The details are as follow: Ratings up to FY2013 S: : Outstanding achievements are fulfilled. (Without providing a cross-cutting objective standard for the agency in advance, S is rated according to the characteristics of the agency's business operations.) A: Achievements are in line with the plan for medium-term, or beyond, or are steadily being implemented toward a medium-term objective, or beyond (achievement rate for the medium-term objective should be over 100% in a given FY.). B: In some ways the plan is not being implemented in line with medium-term-objectives, however, the plan may be achieved by means of ideas and efforts (achievement rate for the medium-term objective should be 70% to 100%.). C: The implementation of the plan is behind the medium-term objective, therefore, improvement of business is necessary in order to realize the achievement of the medium-term objective (achievement rate for the medium-term objective in a given FY is less than 70%.). F: : The Evaluation Committee needs to warn an agency concerning the improvement of its business management and others (Without providing an objective standard in advance, F is rated as a result of judgement that a warning concerning business improvement is necessary.) Ratings after FY2014 [Administrative and projects research and development (1)] S: Based on the National Research and Development Agency s aims, businesses, medium to long-term objectives and so on, as a result of comprehensive consideration based on some circumstances regarding the agency s business achievements, efforts and so on through its activities, especially the creation of considerable achievements, anticipated creation of special achievements in the future and so on toward maximization of research and development under the conditions of appropriate, effective and efficient business management are recognized. A: Based on the National Research and Development Agency s aims, businesses, medium to long-term objectives and so on, as a result of comprehensive consideration based on some circumstances regarding the agency s business achievements, efforts and so on through its activities, the creation of considerable achievements, anticipated creation of achievements in the future and so on toward maximization of research and development under the conditions of appropriate, effective and efficient business management are recognized. B: Based on the National Research and Development Agency s aims, business, medium to long-term objectives and so on, as a result of comprehensive consideration based on some circumstances regarding the agency s business achievement, efforts and so on through its activities, a certain degree of expectation for the creation of achievement and creation of achievement in the future toward maximizing the achievements of research and development were recognized, and steady business operations have been also recognized. C: : Based on the National Research and Development Agency s aims, businesses, medium to long-term objectives and so on, as a result of comprehensive consideration based on some circumstances regarding the agency s business achievements, efforts and so on through its activities, the creation of achievements, further drastic efforts and improvements toward maximization of research and development or the appropriate, effective and efficient administration of the operations are anticipated. D: : Based on the National Research and Development Agency's aims, businesses, medium to long-term objectives and so on, as a result of comprehensive consideration based on some circumstances regarding the agency's business achievements, efforts and so on through its activities, special efforts and improvements including a fundamental drastic review, toward "maximization of research and development" or the appropriate, effective and efficient administration of the operations are required. [Other than administrative work and projects regarding research and development (After II)]S: Because of the activity of Agency Managed under the Medium-term Objectives, the medium-term objectives during the given period are recognized to have been achieved beyond the plan qualitatively and quantitatively. (This means that the achievement of the medium-term objectives is 120% or more in the quantitative index and remarkable qualitatively.) A: Because of the activity of Agency Managed under the Medium-term Objectives, the medium-term objectives during the given period are recognized to have been achieved beyond the plan. (This means that the achievement of the medium-term objectives is 120% or more in the quantitative index) B: The medium-term objectives during the given period are recognized to have been achieved. (This means that the quantitative index for achievement is more than 100% to less than 120% of the medium-term objectives) C: The given medium-term objectives during the given period are under achievement and required to be improved. (This means that the quantitative index for achievement is more than 80% to less than 100% of the medium-term objectives) D: The medium-term objectives during the given period are under achievement and required drastic improvement, or otherwise discontinuation of the operation. (This means that the achievement is less than 80% of the medium-term objectives in the quantitative index or that the competent minister recognizes that the operation need to be improved or other measures need to be taken) 9