Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States (2022) / Chapter Skim
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6 Essential Components of the Low-Dose Radiation Program
6 Essential Components of the Low-Dose Radiation Program
Pages 189-220
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The committee identified eight essential elements of a robust, multidisciplinary low-dose radiation program: (1) programmatic commitment, (2)
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Commitment at the highest levels is also necessary for the agency staff to see this research as an important and rewarding aspect of the agency's programs and activities; this, in turn, ensures that adequate resources -- both personnel and finances -- will be devoted to the program. Commitment at the program management level is needed to develop and nurture the overall research program that must be developed neutral to outcome in terms of the impact of the research on assessment of radiation health risk and consequently its potential impact on radiation protection policy and practice in the United States, and to coordinate program activities with complementary activities underway worldwide.
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The committee has identified the following specific functions for the low-dose radiation program independent advisory committee: • Address recommendations of this committee on the research agenda and develop specific objectives, a strategic plan, and metrics of evaluation including milestones. • Monitor the implementation of the strategic plan and research progress.
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The independent advisory committee members would be required to meet conditions described under the Federal Advisory Committee Act, including a disclosure of conflicts annually and on an ongoing basis, as potential conflicts may arise. The activities and functions of four previous independent advisory committees might be considered when establishing an advisory committee for the revitalized low-dose radiation research program in the United States: 1.
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This National Academies committee envisions that the majority of an advisory committee's members will be technical experts who can advise on scientific and research management issues. Community members selected to serve on the independent advisory committee are unlikely to fully reflect the range of people impacted by radiation exposures, though they would have a broad understanding of these issues or the views of these communities.
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.3 According to this group, both MTA and CIF functioned well and provided grants for important independent studies related to DOE's nuclear weapons complex that advanced efforts to protect impacted communities from the adverse effects of radiation. The committee agrees with the group that MTA and CIF proved useful in the context of studies related to DOE's nuclear weapons complex, which was their specific function.
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government has failed to accept responsibility for past radiation exposures and has failed to develop programs that adequately compensate all impacted communities. In addition to the impacted communities and the public, the other important audience for radiation research is the scientific community.
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. The committee anticipates that the new low-dose radiation program will use this recommended agenda, along with other recommendations presented in this chapter, to develop the overall framework for a successful multidisciplinary program.
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6.5.2 Review of Applications The cornerstone of research funding procedures is external application review, with the objective to evaluate the proposed projects using a process that ensures scientific merit and is also considered fair, equitable, timely, and free of bias.8 The steps and criteria for the review process need to be transparent to the applicants and other interested parties. External project review, by a group of experts who are outside the funding agencies, helps determine whether the proposed activities and supporting methodologies and technologies represent a technically valid, cost-effective, and realistic means of accomplishing the project's stated objectives within a given budget and time constraint.
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As the committee outlined in Chapter 5, the complexity and scope of the scientific problems involved in low-dose radiation research favor funding mechanisms that support well-planned and integrated teams of specialists from different disciplines and institutions, such as NIH's U-type awards, which support a research program of multiple projects directed toward a specific major objective.10 The current National Institute of Allergy and Infectious Diseases' (NIAID's) Radiation and Nuclear Countermeasures Program (see Section 4.1.3)
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typically involve extensive effort on the part of the sponsoring agency staff in terms of research oversight. This ensures that the direction of research is consistent with the goals agreed upon in advance and any midcourse adjustments are made with the agreement of all parties.
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Finally, data sharing is an aspect of transparency, and this will also help the agency build a trusted relationship with various communities. In addition to data management and sharing, the agency will also need to develop protocols for applications to access biosamples collected by low-dose radiation program–funded projects, processes for reviewing the applications, and biosample use agreements.
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Unlike training courses in Europe, those in the United States are geared toward higher doses and not at low doses and low dose rates to be addressed by the revitalized low-dose radiation program described in this report. Also, most available courses are not 16 The committee's observation is that several organizations that engaged in low-dose radia tion research in the past, notably the national laboratories, have lost their radiation expertise because work has refocused on other research topics.
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NRC, DOE, national Dosimetry laboratories, professional organizations, and industry REAC/TS Medical management of radiological/nuclear incidents; early evaluation and treatment of acute radiation syndrome; decontamination techniques Radiation oncology departments Fundamentals of radiation and radiation biology MELODI (European Radiation Radiation biology, radiation measurements, Protection Week) , EURADOS radiation health effects, and radiation protection (winter school)
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ESSENTIAL COMPONENTS OF THE LOW-DOSE RADIATION PROGRAM 203 Low-Dose Radiation Issues Coverage Main Audience Duration/Periodicity Yes but not explicitly Scientists, industry, Week-long course provided once medical practitioners, every 4 years at NCI's offices in other Rockville, Maryland Yes but not explicitly Public health Annually at conferences and CDC professionals campus in Atlanta, Georgia No DoD military and 3-day course provided annually civilian personnel at AFRRI's campus in Bethesda, Maryland No Radiation research Two to three times per year community No Government partners Monthly only Yes but not explicitly Principal investigators, Virtual courses spread out over 6 senior research scientists, months taking place annually and postdoctoral scholars with interest in space radiation research Yes but not explicitly Federal, state, and local Varies government officials No Health care 2–3 days annually professionals, emergency responders, and health physicists Typically geared Residents and graduate 2–3 hours per semester toward higher students (therapeutic) radiation doses Yes Radiation protection 3–5 days annually professionals and radiation researchers
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6.7 ENGAGEMENT AND COMMUNICATIONS WITH STAKEHOLDERS The low-dose radiation program will interest diverse audiences and stakeholder groups including federal agencies with radiation protection or radiation research responsibilities and policy makers, the radiation research and other scientific communities both within the United States and internationally, members of impacted communities and advocacy groups, and members of the general public. The technical knowledge of low-dose and
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Incorporating the concerns, views, and experiences of the diverse stakeholder communities while maintaining a high standard of scientific work will be essential to the program's success. The committee held a 2-day meeting to receive information and perspectives from social scientists, government representatives, researchers, and members of the impacted communities and advocacy groups on how the low-dose radiation program can effectively engage and communicate with its stakeholders.
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. The committee also received a strong message that impacted communities need to be meaningfully engaged in setting priorities for the low-dose radiation program because of the direct impact on their lives and that members of the impacted communities need to be invited to provide advice, and even oversight, to the research.20 20 See Section 6.2 for the recommendation of the group of impacted community members and advocates about reinstitution of the MTA Fund or CIF to lead research that involves impacted communities.
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Low-Dose Radiation Program Management • The Department of Energy is not the appropriate agency to lead research on radiation health effects. • Impacted communities need to be meaningfully engaged in setting priorities for the low-dose radiation program because of the direct impact in their lives.
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. The committee concluded that the success of the low-dose radiation program will depend not only on its scientific integrity but also on its ability to meaningfully engage and communicate with the stakeholders.
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6.8.1 Mechanisms for Coordination Coordination can occur in many ways -- for example, by division of tasks, mutual awareness of activities to help exploit possible synergies, and sharing of resources such as facilities or data. For the low-dose radiation program to be successful and accomplish the scientific goals identified by this committee, it needs to establish mechanisms for coordination across federal agencies and other national and international organizations that carry out low-dose radiation research or have relevant expertise and entities that carry out relevant (non-radiation)
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. • Carrying out joint projects with international low-dose radiation programs and sharing costs.
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. Finally, the Consolidated Appropriations Act, 2021 asks for coordination between the low-dose radiation program and the NSTC effort.
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The only entity at this point that Congress has tasked with a focused low-dose radiation program is DOE; therefore, the committee saw a role for DOE in coordinating low-dose radiation research within the United States. However, the committee also recognized the concerns raised by members of impacted communities about DOE's inherent conflicts with leading lowdose radiation research and by the research community on DOE's shortcomings related to management of the previous low-dose radiation program (see Section 6.9)
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. More recently, DOE and NCI launched the Joint Design of Advanced Computing Solutions for Cancer program to accelerate developments in precision oncology and advanced scientific computing.24 The committee supports a similar approach to be used to lead the coordination of low-dose radiation research, with DOE leading a portion of the strategic research agenda (e.g., on genome biology, computational, and modeling research, and support for facilities for low-dose and low-dose-rate exposures)
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Given these complexities, adopting -- and sustaining over decades -- a workable DOE-NIH collaboration will require commitment from all entities involved in leading, providing oversight, and approving budgets for the two agencies. 6.9 DEPARTMENT OF ENERGY AND MANAGEMENT OF THE LOW-DOSE PROGRAM Congress has assigned the management of the low-dose radiation program to DOE, but congressional staff told the committee that other government agencies could initiate their own low-dose radiation programs, carry out research that is dedicated to low-dose radiation, or have a low-dose radiation research component.25 Following briefings by congressional staff,26 DOE,27 and members of the scientific28 and impacted communities,29 the committee observed that there are, in some cases, substantially different views and perspectives related to the suitability of DOE to manage the low-dose radiation program.
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At the first briefing, in July 2021, the DOE representative did not indicate an interest in or commitment to managing the new low-dose radiation program and noted that the program did not fit within the office's current research priorities and portfolio; moreover, the program's long-term sustainability was uncertain, and its adoption within the office would depend on leadership buy-in.32 The representative also told the committee that the funds from the 2021 appropriation had been used to support a computational research program at national laboratories (see more information about the project in Section 4.1.1) but provided little detail about the project or its relevance to low-dose radiation research.
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. 6.9.4 Views of Members of the Impacted Communities Members of the impacted communities and advocates have consistently criticized DOE for an inherent conflict of interest in conducting radiation health research and have repeatedly expressed their distrust toward DOE to manage the program because of its role as manager of radiation exposures in different settings.
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6.10 CHAPTER SUMMARY, FINDINGS, AND RECOMMENDATION The committee identified eight essential elements of a robust, multidisciplinary low-dose radiation program: programmatic commitment, independent advice and evaluation, transparency, prioritized strategic research
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Because the only entity at this point that Congress has tasked with a focused low-dose radiation program is DOE, the committee saw a role for DOE in coordinating low-dose radiation research within the United States. However, the committee also recognized the concerns raised by members of impacted communities about DOE's inherent conflicts with leading low-dose radiation research and by the research community on DOE's shortcomings related to management of the previous low-dose radiation program.
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This review is scheduled to take place in 2023, 3 years after the enactment of the law. If Congress finds that DOE failed to adopt the research agenda and implement the essential elements recommended by this committee, it may consider alternatives for placement and management of the low-dose radiation program, for example within NIH, likely as a cross-institutional effort, for example, by NIAID and/or NCI and/or the newly conceptualized ARPA-H.
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Recommendation B: Agencies responsible for the management of the multidisciplinary low-dose radiation program should incorporate the following elements: 1. Programmatic commitment to developing and maintaining a long-term multidisciplinary low-dose radiation research pro gram that leverages the advances in U.S.
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