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Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States (2022)

Chapter: 6 Essential Components of the Low-Dose Radiation Program

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Suggested Citation:"6 Essential Components of the Low-Dose Radiation Program." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
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6

Essential Components of the Low-Dose Radiation Program

This chapter addresses the fifth charge of the Statement of Task, which calls for defining the essential components of the low-dose radiation research program that would address the prioritized research agenda recommended by the committee in Chapter 5. This chapter also addresses the sixth charge of the Statement of Task regarding coordination between federal agencies and with other national and international efforts to achieve the program’s scientific objectives.

The committee identified eight essential elements of a robust, multidisciplinary low-dose radiation program: (1) programmatic commitment, (2) independent advice and evaluation, (3) transparency, (4) prioritized strategic research agenda, (5) appropriate research-sponsorship mechanisms, (6) training, (7) engagement and communications with relevant stakeholder communities, and (8) coordination. A description of these elements and the committee’s views on how to incorporate them in the low-dose radiation program are described in Sections 6.16.8.

Recognizing that the research agenda proposed by this committee extends beyond the resources of a single federal agency and will require coordination across several agencies, these elements apply to any agency that is involved or will be involved in low-dose and low-dose-rate radiation research. The committee also summarizes its views on a possible model for leadership of the coordination of low-dose radiation research in the United States (see Section 6.8) and discusses whether the Department of Energy (DOE) is the appropriate entity to manage the low-dose radiation program (see Section 6.9).

Suggested Citation:"6 Essential Components of the Low-Dose Radiation Program." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
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Relevant to the discussion of the essential elements and effective management of the program is a clear understanding that multidisciplinary researchers will be needed to effectively address the strategic agenda recommended by the committee. Expertise from different disciplines that contribute to understanding low-dose radiation issues includes but is not limited to biology, epidemiology, statistics, -omics and data science, imaging, and physics and dosimetry. Intellectual input from those with broader expertise not directly associated with radiation research is also needed; for example, improved knowledge about the impact of low-dose and low-dose-rate exposures on epigenetic effects may come from those who have not previously studied radiation effects as long as there is access to the required radiation exposure equipment or data. Additionally, immunologists, modelers, social scientists, and specialty clinicians such as cardiologists, neurologists, and ophthalmologists are also expected to contribute to multidisciplinary low-dose radiation research; therefore, the program needs to identify ways to attract them to radiation research and offer appropriate training.

6.1 PROGRAMMATIC COMMITMENT

A long-term commitment—over several decades—to low-dose radiation research is essential to address the research priorities discussed by the committee in this report and to take advantage of the continuing technological and biological advances (see Chapter 5). This will enable the agency or agencies involved in low-dose radiation research to develop a strategic vision for the research, formulate specific plans to meet the vision, implement the plans and fund the research, communicate the findings, evaluate the progress toward achieving the research priorities, and make any midcourse adjustments necessary to meet the goals. Importantly, the programmatic commitment for low-dose research needs to be evident at all levels of the agency that carries out the research. Commitment at the highest level signals a priority for such research within the agency’s overall mission and activities, and it is important in the agency’s representation at the congressional and interagency levels to advocate for resources, as necessary. 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.

Suggested Citation:"6 Essential Components of the Low-Dose Radiation Program." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
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6.2 INDEPENDENT ADVICE AND EVALUATION

The success and long-term viability and credibility of the low-dose program will require independent expert advice that (1) helps ensure that the program supports research based on modern science, (2) is relevant not only to the managing agency’s or leading agencies’ interests but also to those of other stakeholders, (3) provides ongoing strategic direction to increase the program’s impact, (4) helps navigate difficult challenges of distrust toward some government-led research in radiation and maintain a research program neutral to outcome, (5) enhances overall confidence of all stakeholders in the program and its findings, and (6) ensures that all research results are communicated in appropriate ways to experts, stakeholder communities, and the general public. When government alone cannot provide the solution to the problem, particularly because of issues of distrust and conflicts as well as scientific complexity, independent advice and evaluation from a trusted entity are important to enhance the program’s viability and credibility.

Advisory committees are often used to bring in experts to provide nonbinding strategic direction to an agency, which is generally followed, although the agency is not legally bound to do so. The committee recommends that an independent advisory committee should be formed at the beginning of the program and be maintained throughout its operations. Although the advisory committee will not be directly responsible for managing program activities nor will it have any operational responsibilities, it will be a valuable resource and make important contributions to the program, using processes that are transparent and open to the public. For example, material prepared by the independent advisory committee can be made available to the public and its meetings can allow public access.

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.
  • Propose updates and adjustments to the strategic plan based on research progress and on new circumstances, including scientific advances and policies and stakeholder needs, to improve both the relevance and the timeliness of the program’s research activities.
  • Provide advice on programmatic processes that are transparent and that include the call for proposals, project selection and funding mechanisms, research oversight and coordination, training, stakeholder engagement, and the reporting of research results.
Suggested Citation:"6 Essential Components of the Low-Dose Radiation Program." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
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  • Engage with the scientific and other relevant communities nationally and internationally through annual workshops and other meetings of opportunity to receive input on the program’s management and strategic plan, and to further promote coordination, partnerships, and awareness.
  • Contribute to the periodic evaluation of the program, according to proposed metrics, and its impact and assess adequacy of funding.
  • Assist with dissemination of research findings in effective ways for the diverse audiences. Effective ways may include but are not limited to presentations at annual workshops, traditional and social media, and websites.

Membership of an advisory committee is key to its effectiveness and needs to convey to the stakeholders that it can be trusted. The advisory committee needs to include members who are accomplished in diverse disciplines relevant to low-dose radiation health effects research as defined by the research priorities identified in Chapter 5. It also needs other (nontechnical expert) stakeholder representation including members of impacted communities. 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. The Advisory Committee for Energy-Related Epidemiological Research (ACERER) was created to provide advice and strategic direction in conducting the program as outlined in the memorandum of understanding (MOU) between DOE and the Department of Health and Human Services (HHS; 1990–2005). The first meeting of ACERER was in 1993, and ACERER continued to meet periodically between 1994 and 2000. Members of ACERER were selected by the Secretary of HHS and included research scientists, public health officials, representatives of public interest groups, and representatives of impacted communities. Both DOE and HHS had nonvoting representatives on the advisory committee (U.S. Congress, Senate, 1998). The ACERER Subcommittee for Community Affairs helped to ensure community engagement and advised ACERER on matters related to community needs.
  2. The Santa Susana Field Laboratory Advisory Panel of independent experts was created in response to community calls for independent health studies of the health consequences of radioactive releases
Suggested Citation:"6 Essential Components of the Low-Dose Radiation Program." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
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    and contamination from the Santa Susana Field Laboratory operations.1 The panel and its consultants conducted a series of studies about the potential offsite impacts of contamination from accidents at the site. These studies were initiated by the local community, which played an active role in determining priorities among the questions to be explored (SSFL Advisory Panel, 2006).

  1. An independent technical steering panel was created to provide technical direction to the Hanford Environmental Dose Reconstruction project, established to estimate radiation doses to the public from operations at the Hanford Site. The steering panel evaluated and approved all technical decisions and reports. Panel members included technical experts and representatives from the states of Washington and Oregon, the Indian tribes, and the public. The panel hosted public meetings and provided access to the data used in reconstructing doses (Haerer et al., 1989).
  2. A Committee on Research Priorities for Airborne Particulate Matter was created by the National Research Council to advise the Environmental Protection Agency (EPA) administrator on the development of a research agenda on airborne particulate matter and to monitor implementation and research progress. The committee authored four reports to address its task (NRC, 1998a, 1999b, 2001, 2004) but had no operational responsibilities. After outlining research priorities and approaches in the 1998 report, it met every few years to evaluate progress and to provide additional guidance to EPA.

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. Research that involves a specified exposed human population or community needs to include additional engagement from members of the exposed populations or communities in designing and implementing these research activities. This additional engagement can be accomplished by the establishment of special advisory subcommittees specific to the research activities. For example, participation of patients, patient advocates, and health care professionals on these special advisory subcommittees would be necessary

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1 The Santa Susana Field Laboratory in southern California was a complex of industrial research and development facilities that operated about 10 low-power nuclear reactors with a history of accidents and releases.

Suggested Citation:"6 Essential Components of the Low-Dose Radiation Program." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
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to provide advice on research that involves studies of medically exposed populations; similarly, participation of members of impacted communities and technical experts whose work has focused on research on the impacted communities would be necessary to provide advice on research that involves communities impacted by the nuclear weapons program.

In two follow-on written communications, a group of impacted community members and advocates who also briefed the committee during its October 28, 2021, meeting (see Section 6.7) proposed reinstitution of the community Monitoring and Technical Assistance (MTA) Fund2 and its successor the Community Involvement Fund (CIF).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. However, the research program described by the committee in this report includes but is not limited to studies related to exposures from the nuclear weapons complex. Instead, the research program described in this report is a comprehensive biology and epidemiology research program, which requires the organizational structure of an advisory committee that is described in this section. The group of impacted community members and advocates also provided recommendations for best practices for working with Indigenous nations and communities.4 Among these suggestions, the committee found useful ideas that need to be considered when research activities that involve these communities are proposed. The committee received additional input on this issue during its information-gathering meetings.5

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2 The fund was established in 1998 as part of a national settlement with community groups about cleanup at DOE sites. The fund helps nonprofit nongovernmental organizations and federally recognized tribal governments procure technical and scientific assistance to perform independent reviews and analyses of environmental management activities at DOE sites.

3 Letters to the committee from impacted community members and members of advocacy groups on January 6, 2022, and February 1, 2022.

4 For example, the group notes that any research relating to Indigenous communities must undertake government-to-government consultation and comply with the necessary permissions and protocols set up by the Indigenous governments. The group also notes that research relating to Indigenous communities and nations should prioritize trust building and make use of local community expertise. (Letter to the committee from impacted community members and members of advocacy groups on February 1, 2022.)

5 Johnnye Lewis, University of New Mexico, presentation to the committee on November 16, 2021.

Suggested Citation:"6 Essential Components of the Low-Dose Radiation Program." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
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6.3 TRANSPARENCY

Since its start in the 1940s, research on adverse health effects of radiation exposure has been marred by deep mistrust among the public of the government sponsors of that research. Reasons for this mistrust are addressed in Section 2.1.6 and as discussed in Section 6.7, the public’s misgiving about the impartiality of government agencies and their sponsored research persists and runs very deep. Based on the input of community representatives to the committee, it is apparent that there is continuing distrust toward the U.S. government and there is a belief that the U.S. 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. Although some degree of tension between any research sponsor and the investigator community is understandable, in the case of radiation health research sponsorship by DOE, these tensions have been palpable (see Section 6.9). Without a long-term commitment to low-dose radiation research, the agency’s priorities and milestones were not known, creating an atmosphere of uncertainty and doubt. There was also a genuine concern among some investigators that DOE was less interested in the science than in the bottom line of how the results they obtained would impact regulations, particularly at the DOE cleanup facilities. This was inevitably viewed as having an influence on the research activities supported by the program.6

The committee offers recommendations for both research priorities (see Chapter 5) and the organizational framework for such research (this chapter). The committee also judges that for the low-dose program to succeed, the establishment of trust among the government agency, the impacted communities, and scientific researchers is critical. This chapter presents the many processes that would play roles in creating trusted relationships; transparency of the entire research enterprise will be essential.

Transparency in this context is not limited to disclosure of conflicts of interest or responses to Freedom of Information Act requests, which are very important and statutorily mandated; it also entails dedication to openness and communication at every step, including processes for public participation and engagement, clear statements and communication of plans and milestones for research, and communication of all findings irrespective of their implications, to name just a few.

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6 Experience of some committee members, some of them recipients of awards from the previous low-dose program.

Suggested Citation:"6 Essential Components of the Low-Dose Radiation Program." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
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6.4 A PRIORITIZED STRATEGIC RESEARCH AGENDA

A strategic research agenda is an essential element for any large-scope scientific undertaking. The agenda must identify and prioritize research questions, appraise appropriate methodologies and technologies, and lay out budgetary outlays necessary to meet the scientific goals. Moreover, any such plan—especially when it spans a period of time—must make allowances for scientific discoveries, unanticipated results or events, and new questions that may arise during the course of research while maintaining neutrality to the research outcomes.

In this report, the committee has recommended a prioritized strategic research agenda (see Chapter 5) that is a path forward for the scientific understanding of the health effects of low levels of radiation exposure. Unlike some other efforts in radiation health, the committee’s recommendations constitute a comprehensive, multidisciplinary program that is likely to span several decades. Importantly, the committee’s recommended research priorities are informed by input from over 80 scientific experts and members of the stakeholder and public interest communities (see Appendix C). 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. As noted in Chapter 5, a number of the recommended research priorities are intentionally nonprescriptive; additional specificity and decisions, for example, on what populations need to be examined (see Section 5.2.1, priority E1) will need to be made in consultation with the stakeholder communities including impacted communities. As the program matures, the committee expects that appropriate revisions and updates to specific aspects of the prioritized research agenda may be needed. Again, these updates will be made in consultation with the stakeholder communities.

6.5 RESEARCH-SPONSORSHIP MECHANISMS

During the past several decades, the practices and policies relevant to the research enterprise—including solicitation, selection and funding of research applications, coordination and oversight of the research, and communication of findings—have matured, and today most government agencies use similarly robust and transparent procedures.7 Any agency that manages and supports the low-dose radiation program needs to follow these established procedures. The committee leaves the myriad details

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7 See https://grants.nih.gov/grants/grants_process.htm; https://www.nsf.gov/publications/pub_summ.jsp?ods_key=pappg.

Suggested Citation:"6 Essential Components of the Low-Dose Radiation Program." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
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of processes for research management to the sponsoring agency, but some highlights of the best practices for such management are provided below.

6.5.1 Development of Research Solicitation

The sponsoring agency needs to work with the recommended independent advisory committee to develop a specific strategic plan, using this report as the starting point (see Section 6.2). Such a plan would also include the optimum order in which specific research topics may be pursued as well as milestones for the process. These mechanisms and milestones need to offer flexibility to support projects with a range of scope and duration, from pilot or focused studies that require short-term funding (2–3 years) to projects with longer-term objectives that require long-term funding (5 years or more). After conducting literature reviews or holding workshops for information gathering as needed, agency staff can then take the steps necessary to develop specific research solicitations (or calls for applications) that are aligned to the strategic plan. It is also a common practice to have the draft solicitation reviewed either by advisory committee members or outside experts, being careful to avoid any conflicts that could arise by asking the reviewers in advance to commit to not responding to the solicitation.

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. This external project review may also provide constructive recommendations for improvements to the proposed projects. The review process results in scores or rank-order of all applications, which can then provide the basis for funding of applications.

6.5.3 Funding Mechanisms

The National Institutes of Health (NIH) is a model agency for its well-documented and diverse funding mechanisms that generally fall into

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8 See https://grants.nih.gov/grants/peer-review.htm.

Suggested Citation:"6 Essential Components of the Low-Dose Radiation Program." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
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three categories: grants, contracts, and cooperative agreements.9 For NIH grants, investigators are generally responsible for developing the concepts, methods, and approach for a research project and, once funded, are left alone to conduct the research. For contracts, the awarding unit is responsible for establishing the detailed prerequisites for accomplishing certain tasks, and the agency then directs the best-qualified group to perform the specific tasks. For cooperative agreements, both the awarding unit and the recipient have substantial responsibility in developing the concepts, methods, and approaches for a research project, and the research is generally conducted with ongoing interactions and feedback. Within these funding mechanisms, different NIH activity codes identify categories (e.g., research, training, cooperative agreements) to be funded. Other federal agencies, including DOE’s Office of Science, also have diverse funding mechanisms to support research but do not differentiate across categories using activity codes. Instead, the solicitation will describe any limitations on eligibility for a specific funding mechanism. DOE also issues program announcements, but these are only available to DOE national laboratories.

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) provides an excellent model that demonstrates the strengths of this approach. A second example is the National Cancer Institute’s (NCI’s) RAS Initiative which aims to better understand the RAS oncogene and RAS-driven cancer development.11 The initiative, headquartered at the Frederick National Laboratory, built an open model of research collaborations across government, academia, and industry to reenergize efforts to develop RAS therapeutics.

Funding mechanisms also need to promote the training and development of early-career investigators in radiation research across different disciplines (see below). Promotion of training can be achieved by allowing funding for investigators at graduate and postgraduate levels and ensuring their inclusion in U-type awards. This is a change from the previous low-dose DOE program, which expected projects to include graduate students and postdoctoral trainees to enhance training but did not provide dedicated training grants. In addition, similar to the R25 or T32 awards to support

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9 See https://grants.nih.gov/grants/funding/ac_search_results.htm.

10 See https://grants.nih.gov/grants/funding/ac_search_results.htm.

11 See https://www.cancer.gov/research/key-initiatives/ras.

Suggested Citation:"6 Essential Components of the Low-Dose Radiation Program." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
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research education activities, establishment of predoctoral training programs in radiation epidemiology, biostatistics, and related disciplines would be essential to prepare the necessary workforce for the epidemiological studies supported by this committee (see Section 5.2).

6.5.4 Research Oversight

Cooperative agreements (U-class of grants) 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. Also, when research is conducted by multidisciplinary teams, the staff is needed to facilitate the various teams working together. Therefore, the committee envisions that the role of the funding agency staff will continue after the initial funding decisions have been made, and the agency needs to appreciate this as it assigns staff.

6.5.5 Data Management and Sharing

During the past two decades, there has been an evolution in thinking about data management and data sharing policies, resulting in recent policies and recommendations and exemplified by a final NIH policy,12 the FAIR (findable, accessible, interoperable, and reusable) guidelines (Wilkinson et al., 2016), and a recent National Academies of Sciences, Engineering, and Medicine workshop.13 The deepening interest in this area comes from the recognition that the interpretation of publicly available large-scale data benefits from analysis and integration by the extended bioinformatics and computational biology communities and from the associated transparency of analysis. Recent reanalyses of data generated by The Cancer Genome Atlas program by the PanCancer initiative14 illustrates the power of the process. These public processes should also facilitate assessment and reanalyses of data used for policy making. Thus, in epidemiology, the interest in data sharing is rooted in the desire to validate findings (i.e., repeating the original investigator’s analyses), to extend the analyses (using alternative methods), and to combine the findings of multiple studies (for meta-analyses or pooled analyses). In view of these developments, investigators applying to NIH for support today are required in their application to outline a plan and budget for data

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12 See https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-013.html.

13 See https://www.nationalacademies.org/event/04-29-2021/changing-the-culture-of-data-management-and-sharing-a-workshop#sectionWebFriendly.

14 See https://gdc.cancer.gov/about-data/publications/pancanatlas.

Suggested Citation:"6 Essential Components of the Low-Dose Radiation Program." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
×

stewardship and management. Several scientific journals also require or strongly recommend that authors of papers reference the data repository where the original data, metadata, and codes may be found. The committee expects that the new low-dose radiation program would conform to contemporary standards for data management and sharing. At the same time, the committee is aware that adhering to such guidelines can be challenging—for example, when working with historical data for which data management and sharing agreements were not in place—and expects that some flexibility would be needed in certain situations. 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. Support from an external review panel, similar to the process followed by the Chernobyl Tissue Bank, may be appropriate to ensure the scientific merit and appropriate use of resources.15

6.5.6 Dissemination of Scientific Results

Dissemination of scientific results comes naturally to scientists who are used to publishing articles in peer-reviewed professional journals when one or more observations can be interpreted to confirm or refute a hypothesis. Such publications are valuable in communicating results and conclusions with other scientists working in the same or adjacent fields. However, by necessity such publications tend to be dense and complex or have other features that make them difficult for the public or scientists working outside of the field to understand. Therefore, it is important that the agency provide opportunities where the results of its sponsored research are presented in a comprehensible fashion to the impacted communities (see also Section 6.7). For improved understanding, it would also be desirable to have independent experts comment on the results and put them in the broader context of knowledge about radiation and health. In this context, since editors often favor publishing positive results because they are more interesting and ultimately more citable (Duyx et al., 2017) and scientists may choose to only publish results that confirm their prior views or hypotheses, it is important that the agency identifies mechanisms for all results—whether positive or not—to be published.

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15 See https://www.chernobyltissuebank.com/access-to-materials.

Suggested Citation:"6 Essential Components of the Low-Dose Radiation Program." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
×

6.6 TRAINING

A decline in the number of professionals with expertise in radiation-related research and applications was recognized by the National Council on Radiation Protection and Measurements almost a decade ago (NCRP, 2015b) and the same organization is working toward understanding whether the downward trend continues today.16 Establishing a low-dose radiation community of scientists including physicists, biologists, and epidemiologists, as well as medical professionals, communicators, and risk management experts by providing the appropriate training in low-dose and low-dose-rate radiation health effects and radiation protection principles will be needed to (1) support the proposed multi-decade research, (2) engage experts who are not already engaged in radiation research, (3) manage exposures to the U.S. population, and (4) communicate and engage with exposed populations. Establishing this low-dose radiation community of scientists and medical professionals will require dedicating considerable resources toward training at all career levels while promoting diversity, equity, and inclusion. Training of individuals in communities that are traditionally underserved or underrepresented will be important because these communities may be more likely to be exposed to radiation in the environment.

Training of students, faculty, and management at all levels will be needed to support the multi-decade research proposed and engage experts who are not already engaged in radiation research. Several funding options directed toward training are discussed in Section 6.5.3. These may include training grants, visiting fellowships similar to those provided by the Radiation Epidemiology Branch,17 or partnerships such as those between the Radiation Effects Research Foundation and several universities in Japan and the University of Washington.18 Additionally, training can be in the form of informal collaborations between radiation experts and those outside the field, as well as through courses offered by institutions involved in radiation research. The committee was informed about several such courses (see Table 6.1), and additional courses may exist that were not brought to the committee’s attention. 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

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16 The committee’s observation is that several organizations that engaged in low-dose radiation research in the past, notably the national laboratories, have lost their radiation expertise because work has refocused on other research topics. That said, it is likely that the downward trend of radiation professionals, at least in research settings, continues today.

17 See https://dceg.cancer.gov/fellowship-training/apply/reb.

18 See https://www.rerf.or.jp/en/programs/general_research_e/partners_e.

Suggested Citation:"6 Essential Components of the Low-Dose Radiation Program." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
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TABLE 6.1 Examples of Radiation Courses Available in the United States and Internationally

Course Topics Covered
NCI’s Radiation Epidemiology and Dosimetry training course Fundamentals of radiation epidemiology, dosimetry, and risk modeling; radiation health effects and exposure assessment; medical radiation exposure (diagnostic and therapeutic); environmental and occupational exposures; and susceptibility to radiation health effects
CDC’s Radiation Studies Section Radiation emergency response; radiation risk, health effects, and risk communication
AFRRI’s Medical Effects of Ionizing Radiation Biomedical consequences of radiation exposure and management of radiation effects
NIAID scientific meetings Animal models of radiation injuries, medical countermeasures, biodosimetry, and decorporation following radiation scenarios; regulatory approaches
NIAID’s Radiation and Nuclear Group Medical countermeasures, biodosimetry, and decorporation following radiation scenarios
NASA’s STAR Program Fundamental space biology and its practical applications, including technical and logistical considerations, opportunities, and the unique advantages and limitations of conducting an experiment in space
U.S. NRC, DOE, national laboratories, professional organizations, and industry Dosimetry
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 Protection Week), EURADOS (winter school), and NEA/OECD (International Radiological Protection School) Radiation biology, radiation measurements, radiation health effects, and radiation protection

NOTES: Descriptions of duration and periodicity are pre-pandemic. Adjustments to virtual learning during the pandemic are not reflected in this table. AFRRI = Armed Forces Radiobiology Research Institute; CDC = Centers for Disease Control and Prevention; DoD = Department of Defense; DOE = Department of Energy; EURADOS = European Radiation Dosimetry Group; MELODI = Multidisciplinary European Low-Dose Initiative; NASA = National Aeronautics and Space Administration; NCI = National Cancer Institute; NIAID = National Institute of Allergy and Infectious Diseases; NRC = U.S. Nuclear Regulatory Commission; NEA/OECD = Nuclear Energy Agency and Organisation for Economic Co-operation and Development; REAC/TS = Radiation Emergency Assistance Center/Training Site.

Suggested Citation:"6 Essential Components of the Low-Dose Radiation Program." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
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Low-Dose Radiation Issues Coverage Main Audience Duration/Periodicity
Yes but not explicitly Scientists, industry, medical practitioners, other Week-long course provided once every 4 years at NCI’s offices in Rockville, Maryland
Yes but not explicitly Public health professionals Annually at conferences and CDC campus in Atlanta, Georgia
No DoD military and civilian personnel 3-day course provided annually at AFRRI’s campus in Bethesda, Maryland
No Radiation research community Two to three times per year
No Government partners only Monthly
Yes but not explicitly Principal investigators, senior research scientists, and postdoctoral scholars with interest in space radiation research Virtual courses spread out over 6 months taking place annually
Yes but not explicitly Federal, state, and local government officials Varies
No Health care professionals, emergency responders, and health physicists 2–3 days annually
Typically geared toward higher (therapeutic) radiation doses Residents and graduate students 2–3 hours per semester
Yes Radiation protection professionals and radiation researchers 3–5 days annually
Suggested Citation:"6 Essential Components of the Low-Dose Radiation Program." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
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targeted toward the radiation health research community. Although most of the international courses are available to interested participants and U.S. participants can benefit from them, especially via remote participation, there is an obvious need for easy access to in-person learning on low-dose radiation issues in the United States.

Training for individuals engaged in risk management and development of public policy related to low-dose and low-dose-rate radiation exposures will ensure that policies and guidelines are based on best available and current scientific information on the adverse effects of these exposures. Specific courses need to be developed that address scientific understanding and how this is incorporated in supporting analyses of risks and benefits associated with regulations and guidelines. Training in this area will be enhanced by funding mechanisms that support studies of radiation exposure in specific U.S. populations.

Improving communications about the adverse health effects of low-dose and low-dose-rate exposures is critical to building public trust. This requires establishing a community of experts trained to inform (a) the public in plain language about current knowledge about adverse health effects, knowledge gaps, ongoing research and public policy development through public meetings, traditional media and social media; (b) the scientific and medical communities about current knowledge, knowledge gaps, and ongoing research; (c) policy makers including Congress on current knowledge and processes for analyses of risks and benefits associated with regulations and guidelines that focus on specific impacted U.S. populations.

Trainers and curricula for these training activities will need to be developed and sustained. The low-dose radiation program needs to create a centralized database for cataloguing available training opportunities in radiation science with emphasis on low-dose radiation. These may include modules for research, communication, and policy making; formal training programs that emphasize and integrate all of these areas; and websites that curate information about low-dose and low-dose-rate radiation exposures, adverse health effects, and cost-benefit analyses that have been used during the development of public protection policies.

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

Suggested Citation:"6 Essential Components of the Low-Dose Radiation Program." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
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low-dose-rate radiation, the direct or indirect impacts of this research, and the acceptability of the findings will vary considerably across the different stakeholder groups. Therefore, the committee considers it important that the new low-dose radiation program dedicates resources to establish and maintain appropriate processes for stakeholder engagement and communication. 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.

An invited speaker noted that low-dose radiation is not judged in the abstract but in the contexts where people encounter it. Each encounter shapes public beliefs and attitudes toward low-dose radiation research and the people and institutions responsible for it. The speaker noted that effective communication needs to be coordinated by creating a common picture, sharing knowledge and uncertainty accurately, being cogent by avoiding confusion and overload, and acting respectfully by accepting the right to know and to disagree. The speaker emphasized that the process for engaging stakeholders and the content—what stakeholders are told—reveals how well those responsible for communicating understand public concerns and are willing and able to address them.19

Those who attempt to communicate have limited knowledge about their diverse audiences and limited capacity for learning about their concerns; as a result, they often overestimate how well they understand others and are understood by them. Organizations without expertise in communication have difficulty either recognizing when they need help to convey their messages or finding help when they recognize the need. The speaker pointed to the work of the Institute of Medicine on risk communication (Fischhoff and Scheufele, 2013, 2014; NRC, 1989, 2009) and on community engagement in public health research for environmental justice issues (IOM, 1999). The 1999 report identified principles to guide the research (IOM, 1999). Relevant to this committee’s task is the view that members of the impacted communities of concern need to participate in the design and execution of research.

The committee also heard presentations from the staff of federal (DOE, the U.S. Nuclear Regulatory Commission [U.S. NRC], EPA, and the Department of Homeland Security) and state agencies concerning their risk

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19 Baruch Fischhoff, Carnegie Mellon University, presentation to the committee on October 27, 2021.

Suggested Citation:"6 Essential Components of the Low-Dose Radiation Program." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
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communication and stakeholder interaction practices. The committee appreciated the general recognition of the ongoing challenges and the amount of effort that has been put into improving communications as well as the awareness of these staff members of the importance of working closely with stakeholders. But based on presentations from impacted communities and advocacy groups, the committee also saw that much effort is still needed to develop mutual trust and understanding. The committee also appreciates that a lack of public trust has been a longstanding challenge for DOE’s radiation programs, originating from the Atomic Energy Commission’s (AEC’s) and later DOE’s secrecy during the nuclear weapons program activities; such mistrust has persisted over multiple generations and hampers effective engagement (see Section 2.1.6).

Invited speakers from community and advocacy groups included leaders of the Navajo Nation, atomic veterans, nuclear workers, and those impacted by nuclear weapons testing and nuclear weapons production sites and nuclear waste cleanup. These speakers pointed the committee to several sources of information relevant to its task and also offered views on specific topics that need to be addressed by the low-dose radiation program. Many of these messages were also echoed in comments submitted to the committee by other members of the public in writing and are summarized in Box 6.1. The comments generally fell into one of the three categories: suggestions for research priorities, suggestions for program management, and suggestions for radiation protection policies. Although proposing changes or otherwise providing advice on radiation protection policies was outside the scope and expertise of this committee, these policy suggestions are also listed in Box 6.1.

Testimonies from community speakers included stories of personal and community member diseases considered attributable to radiation and expression of strong emotions—including frustration, feelings of betrayal, and distrust toward DOE—originating from DOE’s and predecessor agencies’ handling of releases from the nuclear weapons program. The committee heard repeatedly from the speakers about the conflict of interest that DOE has to both regulate radiation protection and lead research on radiation health effects. The history of conflicts is also documented in several reports (see, e.g., DOE-EHHS Openness, 1995; Geiger et al., 1992). 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

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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.

Suggested Citation:"6 Essential Components of the Low-Dose Radiation Program." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
×
Suggested Citation:"6 Essential Components of the Low-Dose Radiation Program." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
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During the 2-day meeting and in subsequent meetings and public comments received in writing, the committee observed that—generally speaking—there was a noticeable difference between the perception of people with and without technical expertise about the certainty of adverse effects of low doses of radiation. Experts typically perceive low doses of radiation from nuclear power and nuclear waste as less risky than non-experts (Slovic, 2012).21 However, experts may rate risks from medical X-rays and radon higher compared to non-experts (Slovic, 2012).

Experience over many years and in many fields, including the chemical and petrochemical industries, has shown that perceptions are not easily changed simply by presenting scientific facts and information. This understanding has led to a reformulation of the risk assessment/risk management paradigm to include stakeholder participation in every step of a six-step framework: problem formulation, risk assessment, options development, decisions, actions, and evaluation (Commission on Risk Assessment and Risk Management, 1997; NRC, 2009). The scientific uncertainties related to risks from low doses of radiation complicate non-experts’ understanding of the risks, but existing research argues that these uncertainties need to be effectively communicated to allow informed decisions considering the risks and benefits of exposures to radiation (Allisy-Roberts and Day, 2008; Fischhoff and Davis, 2014; Osman et al., 2019).

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. The low-dose radiation program needs to do the following:

  • Develop transparent processes for stakeholder identification, engagement, and communication.
  • Identify stakeholders and solicit their perspectives and expectations related to the low-dose radiation program.
  • Commit to engaging with all stakeholders, including those from the impacted communities, in meaningful ways.
  • Include members of the impacted communities in the independent advisory committee (see Section 6.2) so that they may participate in various aspects of research planning and implementation.
  • Set up additional advisory subcommittees with substantial stakeholder participation to advise on specific projects that involve human populations or populations exposed to low-dose radiation.

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21 One invited expert thought that the public attitude toward radiation from these sources is irrational fear and termed it radiophobia (Gerry Thomas, Imperial College London, presentation to the committee on October 27, 2021).

Suggested Citation:"6 Essential Components of the Low-Dose Radiation Program." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
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  • Develop communication and engagement strategies for the diverse audiences and test them for their effectiveness. Specific activities may include but not be limited to maintaining a dedicated website with information on funded projects, links to scientific groups that carry out low-dose radiation research, links to scientific publications, and reports on research findings written in lay language. Communication and engagement strategies may also include collaborating with groups who have expertise in environmental risk communication even if they are not working on radiation issues and providing support for modest communication projects.
  • Host public meetings, issue press releases, and take other opportunities for engagement to discuss aspects of the low-dose radiation program of interest to the stakeholders.
  • Work with community educators such as school science teachers and local community-based organizations that are not usually involved in radiation-related activities.

Past experience indicates that studies that involve dose reconstruction and risk assessments of impacted communities are likely to be scrutinized (Hoffman et al., 2001; McEwan et al., 1997). The committee recognizes that even with the above-mentioned processes in place, acceptance of the program’s credibility and trust toward its scientific findings will take substantial and sustained effort.

6.8 COORDINATION

Coordination is key to increasing innovative capacity, harnessing the expertise and competencies of specialized groups, avoiding unnecessary duplication of efforts, and ultimately meeting research goals faster while efficiently using available resources, including funds. In this section, the committee describes various mechanisms for coordination and a proposed model for leading the coordinated effort.

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) research.

Suggested Citation:"6 Essential Components of the Low-Dose Radiation Program." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
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During the previous low-dose radiation program, there appeared to be little coordination between DOE and other federal organizations except the National Aeronautics and Space Administration. Most government representatives who briefed the committee, including those from NCI, NIAID, the Centers for Disease Control and Prevention, the National Institute for Occupational Safety and Health, and the Armed Forces Radiobiology Research Institute, described rather unplanned and spontaneous interactions with DOE staff, typically occurring during scientific conferences, as opposed to intentionally institutionalizing and scheduling coordinating efforts to look for opportunities for collaboration in radiation research. Similarly, little systematic coordination occurred with international organizations except when interested U.S. or foreign scientists happened to reach out for collaboration. Although these informal interactions are important, there is a need for more systematic efforts to institutionalize coordination.

During the committee’s meetings, several representatives of federal agencies and other national and international organizations provided perspectives on opportunities for coordination with the new low-dose radiation program. These included the following:

  • Hosting annual meetings or workshops with relevant agencies and national and international organizations, along with appropriate experts and funded researchers, to exchange views on research priorities; report progress; and identify areas of shared, overlapping, or closely related interests relevant to low-dose radiation research.
  • Co-supporting technical sessions at scientific meetings organized by professional societies or other opportunities to increase awareness about the activities of common interest in low-dose radiation science.
  • Making specific budget allocations to incentivize agencies and national and international organizations to work together on a variety of projects.
  • Using MOUs and interagency agreements to divide tasks appropriately based on agency missions and expertise (see Section 4.1.3 for discussion of an MOU in support of radiation health research), and provide mechanisms for temporary assignment of personnel to learn new methodologies or use resources.
  • Participating in national and international data sharing platforms to increase awareness about funded low-dose radiation research (see Section 4.5.4 for current NEA/OECD data sharing platform).
  • Carrying out joint projects with international low-dose radiation programs and sharing costs.
Suggested Citation:"6 Essential Components of the Low-Dose Radiation Program." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
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  • Providing access to study datasets to allow for meta-analysis and pooled analysis of archived data.
  • Facilitating use of research infrastructure including facilities, computational capabilities, and dosimetry tools (see Section 5.4.4 for discussion of facilities).
  • Leveraging expertise for input on requests for proposals, project review, service on advisory committees, and other activities.

The committee agrees that these opportunities for coordination will benefit the revitalized low-dose radiation program and there is a need to establish processes to allow for these coordinating mechanisms to succeed. Coordination can absorb substantial amounts of time and effort and requires sufficient resources. It can be instituted by Congress, interagency committees, task forces, or by the agencies and organizations themselves.

For example, the Consolidated Appropriations Act, 2021 specifically states, “The Secretary of Energy shall continue and strengthen collaboration with the Administrator of the National Aeronautics and Space Administration on basic research to understand the effects and risks of human exposure to ionizing radiation in low Earth orbit, and in the space environment.’’ Also, the American Innovation and Competitiveness Act of 2017 tasked the National Science and Technology Council (NSTC) to coordinate government research within the U.S. government (NSTC, 2022). Finally, the Consolidated Appropriations Act, 2021 asks for coordination between the low-dose radiation program and the NSTC effort.

Today, there is no coordinating mechanism for low-dose radiation research in the United States. A historic model for radiation research and policy coordination, the Committee on Interagency Radiation Research and Policy Coordination (CIRRPC; see Section 4.1.6), which became a subcommittee of the Committee on Health, Safety and Food under NSTC (Young, 2020), was recently supported as a means to coordinate radiation biology research within the U.S. government (NSTC, 2022). CIRRPC was challenged by lack of consensus across federal agencies that constituted its membership and was terminated after 11 years of operation. NSTC in its recent report does not discuss to what extent a CIRRPC-type committee can engage with nongovernmental and international partners and meaningfully engage all stakeholders, including members of the impacted communities in its processes, and be seen as a trusted non-politicized scientific entity.

The U.S. Global Change Research Program (USGCRP) is an existing example of a large, complex, and multidisciplinary effort involving many agencies of the federal government that is coordinated through the NSTC. Established in 1989 by presidential initiative and mandated by Congress in the Global Change Research Act of 1990, USGCRP “assist[s] the Nation

Suggested Citation:"6 Essential Components of the Low-Dose Radiation Program." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
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and the world to understand, assess, predict, and respond to human-induced and natural processes of global change.”22 USGCRP coordinates federal research and investments of 13 federal member agencies and has strong coordination with equivalent programs across the world. The National Academies provide advice and strategic direction to USGCRP by convening technical experts and decision-makers at semiannual meetings, and reviewing draft plans for the program (NASEM, 2021a).

There are several examples of successful multidisciplinary efforts coordinated at the agency level, albeit they involve a smaller number of participating agencies, with a few others peripherally engaged. Such was the Human Genome Project (Patrinos and Drell, 1997), involving NIH and DOE, with a well-defined objective, the delivery of the complete genetic sequence of the human genome. Given that DOE and NIH have traditionally supported most of the low-dose radiation research, this model for interagency coordination could be used as an alternative model to the NSTC-coordinated approach. For additional discussion, see Section 6.8.2.

6.8.2 Leadership

In addition to the agencies that have direct responsibility for radiation protection (e.g., EPA, the U.S. NRC, and DOE), other agencies within the U.S. government carry out or may carry out research in low-dose radiation, and there are other agencies whose work will benefit from a better understanding of adverse health effects from low levels of radiation exposure (see Figure 1.4 and Section 3.2). Therefore, the committee identified the need to establish leadership and scope of low-dose radiation research coordination.

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 low-dose 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). In addition, the research agenda proposed by the committee extends beyond any single agency’s capabilities, and a partnership with an agency whose mission is to enhance health would be warranted.

Among various federal agencies with missions to enhance or protect health, NIH is widely trusted by the scientific community and members of the public and does not have any regulatory responsibilities related to setting or implementing radiation protection standards; therefore, it has no perceived conflict of interest with leading low-dose radiation research

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22 See https://www.globalchange.gov/about/legal-mandate.

Suggested Citation:"6 Essential Components of the Low-Dose Radiation Program." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
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through a cross-institutional effort. In addition, it has well-established and transparent processes for soliciting, reviewing, and funding research. Within NIH, NIAID’s Radiation and Nuclear Countermeasures Program (RNCP; see Section 4.1.3) could be suitable to support low-dose radiation research through a cross-institutional effort. Although RNCP currently supports research in moderate and high doses starting at about 1 gray and supports limited research on cancer (which is the primary focus of NCI), the committee was impressed with the program management’s commitment and transparency as well as engagement with its stakeholder communities. NCI has processes similar to NIAID’s and by virtue of its mission it focuses on cancer research. The Advanced Research Projects Agency for Health (ARPA-H), a proposed agency tasked with building high-risk, high-reward capabilities to drive biomedical breakthroughs, could also contribute to innovative low-dose radiation research.23

DOE and NIH have traditionally supported most of the low-dose radiation research in the United States, and there is a precedent for a successful coordination by the two agencies to complete the Human Genome Project (Patrinos and Drell, 1997). 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), and NIH, through a cross-institutional effort that can involve NIAID and NCI, leading the epidemiological and biological research, but with mechanisms in place to allow for integration of the different research lines.

The committee recognizes the operational complexities of this arrangement and the interagency agreement between DOE and HHS, which was put in place in 1990 because of concerns regarding DOE’s independence and objectivity in conducting research related to radiation health effects (see Section 4.1.4), provides some lessons learned. Factors that can help make interagency program management effective include (NRC, 2006b) (1) substantial support from the top, (2) effective communication and cooperation within each of the agencies and between the agencies at all levels, (3) a detailed agreement on what is to be accomplished and how, (4) continuous feedback mechanisms to ensure that priorities are agreed upon and funding

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23 See https://www.nih.gov/arpa-h. Currently, ARPA-H is included in the fiscal year 2022 budget as a component of the NIH.

24 See https://datascience.cancer.gov/collaborations/nci-doe-capabilities.

Suggested Citation:"6 Essential Components of the Low-Dose Radiation Program." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
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is adequate, and (5) the ability of both agencies to take credit for the success of the program.

The committee also recognizes the organizational complexities of this arrangement. In Congress, DOE and NIH report to different authorization committees and appropriation subcommittees. In the executive branch, NIH’s and DOE’s research leadership report to different Cabinet secretaries. At the Office of Management and Budget, which is the White House lead on appropriation requests, NIH and DOE are overseen by different budget examiners. 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. These views and perspectives of the different

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25 Email communication from Alyse Huffman and Adam Rosenberg, Committee on Science, Space, and Technology, Energy Subcommittee, U.S. House of Representatives, to Ourania Kosti, National Academies, on January 24, 2022.

26 Alyse Huffman and Adam Rosenberg, Committee on Science, Space, and Technology, Energy Subcommittee, U.S. House of Representatives, presentations to the committee on August 26, 2021.

27 Todd Anderson, DOE, presentation to the committee on July 21, 2021.

28 Panel discussion on August 26, 2021, with Edouard Azzam, Canadian Nuclear Laboratories; David Brenner, Columbia University; Albert Fornace, Jr., Georgetown University; Amy Kronenberg, Lawrence Berkeley National Laboratory; and Zhi-Min Yuan, Harvard T.H. Chan School of Public Health.

29 Stakeholder engagement panel discussion on October 28, 2021, with President Jonathan Nez, Navajo Nation; Jill Jim, Navajo Nation Department of Health; Mary Dickson, representative of downwinders of U.S. nuclear tests; Keith Kiefer, National Commander of the National Association of Atomic Veterans; Benetick Maddison, Marshallese Educational Initiative (prerecorded presentation); Arjun Makhijani, Institute for Energy and Environmental Research; Trisha Pritikin, Hanford Downwinder, author of The Hanford Plaintiffs: Voices from the Fight for Atomic Justice; and Beata Tsosie-Peña, Environmental Health and Justice Program at Tewa Women United in New Mexico (prerecorded presentation).

Suggested Citation:"6 Essential Components of the Low-Dose Radiation Program." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
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stakeholders as presented to the committee during the public meetings are summarized in the following sections.

6.9.1 Congress’s Views

In the Consolidated Appropriations Act, 2021, Congress identifies DOE as the manager for the program primarily because of its history of managing the previous program and its overall responsibility on nuclear issues. However, DOE’s Office of Science, where the previous program was housed, does not currently have in-house experts in radiation sciences who are experienced in the challenges of low-dose radiation health research or who interact with the radiation health research community on a regular basis. In addition, little infrastructure remains in the national laboratories from the previous low-dose program. Still, when asked, congressional staff members who briefed the committee reiterated the position that DOE needs to comply with the congressional directive and establish the new program. Congressional staff also noted that, although they would be interested in the committee’s views on other government agencies that could be more suitable to manage the program, they would not support outsourcing management of the program to an independent nonprofit organization outside of the U.S. government,30 such as the Health Effects Institute,31 which is well recognized for its role in air pollution research.

6.9.2 DOE’s Views

DOE’s Office of Science briefed the committee twice during the study. 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. At the second briefing, in January 2022,33 the same DOE representative provided a stronger ra-

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30 Adam Rosenberg, Committee on Science, Space, and Technology, Energy Subcommittee, U.S. House of Representatives, presentation to the committee on August 26, 2021.

31 See www.healtheffects.org.

32 Todd Anderson, DOE, presentation to the committee on July 21, 2021.

33 Todd Anderson, DOE, presentation to the committee on January 24, 2022.

Suggested Citation:"6 Essential Components of the Low-Dose Radiation Program." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
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tionale for supporting the computational and information science research capabilities at the national laboratories and argued that this research will contribute toward improved understanding of low-dose radiation health effects.

6.9.3 Views of Members of the Scientific Community

Members of the scientific community have expressed concerns about the unpredictable nature of DOE’s management and funding of the previous low-dose radiation program.34 In addition, some scientists involved in the program indicated a lack of cohesion in the portfolio of the funded work, and a lack of strategic direction and independent review by experts that could enhance the quality of the science selected for funding and the cohesiveness of the program. Frustration of the research community toward DOE has continued after termination of the previous low-dose program and following allocation of appropriated funds from the Energy Act of 2019 and Consolidated Appropriations Act, 2021 to support a single project carried out in three national laboratories for the exploration of the potential for artificial intelligence and machine learning (see Section 4.1.1).

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. As noted in Section 2.1.6, much of this distrust that has persisted over multiple generations originates from the AEC’s and DOE’s secrecy during the nuclear weapons program activities and cleanup operations.

6.9.5 The Committee’s Views

The committee was not tasked with assessing the suitability of DOE to manage the low-dose program or with recommending an alternative management structure. But congressional staff told the committee that it would be interested in its views and possible alternative options for the management of the low-dose program. The committee is concerned that DOE does not currently meet important criteria for an effective managing

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34 Observation of committee members who are also members of the radiation research community.

Suggested Citation:"6 Essential Components of the Low-Dose Radiation Program." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
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agency, namely commitment to the program and absence of perceived conflicts with the research it supports.

In Section 6.8, the committee described the merits of NIH as a trusted research institution. Congress’s interest in transferring the responsibility for managing the program to NIH is currently unknown, and the committee is aware that enactment of relevant legislation could take years, potentially risking the loss of Congress’s interest altogether to support the program. Given such uncertainty and risk, DOE is the most viable option for immediately reestablishing a low-dose radiation program. The committee has detailed a prioritized research agenda and organizational elements that, if adopted by DOE, would go a long way toward meeting the scientific goals as well as establishing trust. Also, as outlined in this report, DOE would need to coordinate with other agencies that are engaged in low-dose radiation research or have relevant capabilities; this would ensure that the capabilities at DOE on genome biology, computational, and modeling research are complemented by capabilities in other parts of the government.

The committee estimates that to initiate the new low-dose program, DOE could implement most of the essential elements identified in this chapter within about 2 years given adequate funding. However, it may take a longer time to convince the skeptics about DOE’s long-term commitment to the program; therefore, DOE will need to take strong steps to mitigate the issues of distrust toward research that it manages.

DOE’s progress with implementing the essential elements recommended by this committee needs to be formally and transparently assessed early in the process. For example, Congress may use the scheduled Government Accountability Office review of the low-dose program mandated in the Consolidated Appropriations Act, 2021, § 11001 (see Appendix A) to assess DOE’s progress with implementing the recommended essential elements of the program. This review is scheduled to take place in 2023, 3 years after the enactment of the law. If Congress finds that DOE has failed to take steps to (1) initiate a low-dose radiation program of the scale and scope envisioned by Congress, (2) adopt the research agenda recommended by this committee, and (3) 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.

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

Suggested Citation:"6 Essential Components of the Low-Dose Radiation Program." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
×

agenda, appropriate research-sponsorship mechanisms, training, engagement and communications with relevant stakeholder communities, and coordination. Recognizing that the research agenda proposed by the committee extends beyond the resources of a single federal agency and will require coordination across several agencies, these elements apply to any agency that is involved or will be involved in low-dose radiation research.

Long-term commitment to the low-dose radiation program is needed to address the research priorities discussed by the committee in this report and to take advantage of the continuing technological and biological advances. 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. 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. In addition, the research agenda proposed by the committee extends beyond any single agency’s capabilities, and a partnership with an agency whose mission is to enhance health would be warranted.

Among various federal agencies with missions to enhance or protect health, NIH is widely trusted by the scientific community and members of the public and does not have any regulatory responsibilities related to setting or implementing radiation protection standards; therefore, it has no perceived conflict of interest with leading low-dose radiation research through a cross-institutional effort. In addition, it has well-established and transparent processes for soliciting, reviewing, and funding research. Within NIH, NIAID’s RNCP could be suitable to support low-dose radiation research through a cross-institutional effort. Although RNCP currently supports research in moderate and high doses starting at about 1 gray and supports limited research on cancer (which is the primary focus of NCI), the committee was impressed with the program management’s commitment and transparency as well as engagement with its stakeholder communities. NCI has processes similar to NIAID’s and by virtue of its mission it focuses on cancer research. ARPA-H, a proposed agency tasked with building high-risk, high-reward capabilities to drive biomedical breakthroughs, could also contribute to innovative low-dose radiation research leadership.

DOE and NIH have traditionally supported most of the low-dose radiation research in the United States, and there is a precedent for a successful

Suggested Citation:"6 Essential Components of the Low-Dose Radiation Program." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
×

coordination by the two agencies to complete the Human Genome Project. 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), and NIH, through a cross-institutional effort, leading the epidemiological and biological research, but with mechanisms in place to allow for integration of the different research lines.

The committee was not tasked with assessing the suitability of DOE to manage the low-dose radiation program or with recommending an alternative management structure. But congressional staff was interested in views and possible alternative options for the management of the low-dose program.

DOE does not currently meet important criteria for an effective managing agency, namely commitment to the program and absence of perceived conflicts with the research it supports. Among various federal agencies with experience with research funding, NIH is an example of a federal organization that meets these criteria.

The committee estimates that to initiate the new low-dose program, DOE could implement most of the essential elements identified by the committee within about 2 years given adequate funding. DOE’s progress with implementing the essential elements needs to be formally and transparently assessed. For example, Congress may use the scheduled Government Accountability Office review of the low-dose program mandated in the Consolidated Appropriations Act, 2021, § 11001. 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.

Finding 8: The Department of Energy’s (DOE’s) Office of Science has a long history leading and supporting radiation research at national laboratories and universities to advance knowledge of radiation health effects and mechanisms of these effects. However, since about 2016, the Office’s focus has been directed away from radiation health effects research, resulting in a lack of leadership and scientific activity in this area. Separate offices within DOE and within other federal agencies and national and international organizations have relevant expertise and have supported and continue to support research in radiation health effects. Except for the National Aeronautics and Space Administration, radiation research carried out by these other entities has not been coordinated with that supported by DOE’s Office of Science.

Suggested Citation:"6 Essential Components of the Low-Dose Radiation Program." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
×

Finding 9: Impacted communities exposed to radiation as a result of activities carried out as part of the U.S. nuclear weapons program (1942–1991) have strongly objected to the Department of Energy’s (DOE’s) management of the low-dose radiation program. They assert that the agency’s role in promoting nuclear technologies and its responsibility for management and cleanup of its nuclear sites conflict with its role as a manager of studies on low-dose and low-dose-rate radiation health effects that may serve as the basis for exposure management decisions. This conflict, and the legacy of DOE’s history of problematic community interactions, is a source of distrust of the agency by these communities.

Recommendation B: Agencies responsible for the management of the multidisciplinary low-dose radiation program should incorporate the following elements:

Suggested Citation:"6 Essential Components of the Low-Dose Radiation Program." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
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Radiation exposure at low doses (below 100 milligray) or low-dose rates (less than 5 milligray per hour) occurs in a wide range of medical, industrial, military, and commercial settings. The effects of exposure at these levels are not fully understood, but there are long-standing concerns that such exposure could negatively affect human health. Although cancer has been linked to low-dose radiation exposure for decades, there is increasing evidence that low-dose radiation exposure may also be associated with cardiovascular disease, neurological disorders, immune dysfunction, and cataracts.

Recent advances in research, new tools, and a coordinated multidisciplinary research program could help fill knowledge gaps about the health impacts of low-dose radiation exposures. This report calls for the development of a U.S. research program to study how low doses of radiation affect cancer, cardiovascular disease, neurological disorders, and other disease risks. Research should also better define the impacts of radiation doses, dose rates, types of radiation, and exposure duration. The report estimates $100 million annually for the next 15 years would be required to conduct epidemiological and biological research, and to establish an infrastructure for research.

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