• 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

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).

3. 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).
4. 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.

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.

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

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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.

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.

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.

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.

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.

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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.

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

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.

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.

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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).

• 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.

• 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

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.

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.

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).

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.

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.

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

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

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.