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At least 19 records

Email-Based Informed Consent: Innovative Method for Reaching Large Numbers of Subjects for Data Mining Research

Since the 2010 NASA authorization to make the Life Sciences Data Archive (LSDA) and Lifetime Surveillance of Astronaut Health (LSAH) data archives more accessible by the research and operational communities, demand for data has greatly increased. Correspondingly, both the number and scope of requests have increased, from 142 requests fulfilled in 2011 to 224 in 2014, and with some datasets comprising up to 1 million data points. To meet the demand, the LSAH and LSDA Repositories project was launched, which allows active and retired astronauts to authorize full, partial, or no access to their data for research without individual, study-specific informed consent. A one-on-one personal informed consent briefing is required to fully communicate the implications of the several tiers of consent. Due to the need for personal contact to conduct Repositories consent meetings, the rate of consenting has not kept up with demand for individualized, possibly attributable data. As a result, other methods had to be implemented to allow the release of large datasets, such as release of only de-identified data. However the compilation of large, de-identified data sets places a significant resource burden on LSAH and LSDA and may result in diminished scientific usefulness of the dataset. As a result, LSAH and LSDA worked with the JSC Institutional Review Board Chair, Astronaut Office physicians, and NASA Office of General Counsel personnel to develop a "Remote Consenting" process for retrospective data mining studies. This is particularly useful since the majority of the astronaut cohort is retired from the agency and living outside the Houston area. Originally planned as a method to send informed consent briefing slides and consent forms only by mail, Remote Consenting has evolved into a means to accept crewmember decisions on individual studies via their method of choice: email or paper copy by mail. To date, 100 emails have been sent to request participation in eight HRP-funded studies. The development of the Remote Consent process, the laws allowing transmission of consent via electronic means, total metrics to date, and remaining challenges (e.g., response issues, use of International Partner data, biospecimens/genetic data) for the research use of LSAH/LSDA data will be described.

Lee, Lesley R.↗

System Analysis Support of Consent-Based Siting Efforts - 23400

To better enable informed decision-making regarding the back end of the nuclear fuel cycle, the Integrated Waste Management (IWM) program within the U.S. Department of Energy, Office of Nuclear Energy (DOE-NE) has been sponsoring the development and application of system analysis tools capable of analyzing various system options for the management of spent nuclear fuel (SNF) and high-level radioactive waste. With these tools, integrated waste management system (IWMS) architecture analyses are being conducted to support the future deployment of a comprehensive nuclear waste management system that considers all major back-end aspects of the nuclear fuel cycle (i.e., transportation, storage, and disposal). System analyses and assessments typically use these modeling and simulation tools to investigate things like the implications of changes in various assumptions and parameters such as acceptance rates, receipt logic, facility capacities and capabilities, use of standardized canisters, and different assumed system operation start dates. Some example system analysis results have been published previously. With the passage of the consolidated appropriations acts for fiscal years 2021 and 2022, Congress provided funding and direction for the DOE to move forward with interim storage to support near-term action in managing the nation’s SNF as an important component of an IWMS. Consent-based siting is a phased, adaptive, and collaborative approach to siting facilities that focuses on the needs and concerns of people and communities. Communities participate in the siting process by working carefully through a series of phases and steps with the DOE (as the implementing organization). Each step and phase helps a community determine whether and how hosting a facility to manage SNF is aligned to the community’s goals. By its nature, a consent-based siting process must be transparent, flexible, adaptive, and responsive to community concerns. Thus, the phases and steps are intended to serve as a guide, not a prescriptive set of instructions. System analysis research analysts interface with DOE’s consent-based siting for a federal interim storage program and can perform preliminary system analyses as requested to support various aspects of the consent-based siting team’s work. This paper provides an overview of IWM program’s system analysis activities that support the ongoing consent-based siting process. The questions that decision-makers, planners, communities, and stakeholders might have during the consent-based siting process are similar to questions that have been explored by system analysts previously. Specifically, this paper discusses work that will inform consent-based siting efforts in the areas of community impacts, cost estimates, various SNF acceptance rates by potential facilities, potential consolidated interim storage facility (CISF) capacities and configurations, and the implications of a CISF on the overall waste management system. It is expected that system analysis will continue to be performed to support the consent-based siting process in the future.

11 NUCLEAR FUEL CYCLE AND FUEL MATERIALS↗

Moving from scientific research to consenting guidance for MRE environmental risk

Potential environmental effects from tidal and wave devices are of concern to regulators, advisors, and other stakeholders in many nations. Monitoring results from early deployments and the first commercial arrays, coupled with targeted research studies, are providing a growing base of knowledge of how components of tidal turbines and wave energy converters might interact with marine animals and habitats. Efforts are underway to organize and direct these findings towards facilitating consenting that allays concerns and allows the marine renewable energy (MRE) industry to move forward. The OES-Environmental international initiative has developed scientific evidence bases for several key interactions from MRE devices, organized around stressors (portions of MRE systems that may cause injury or stress to the marine ecosystem), and receptors (the animals, habitats, and ecosystem processes that may be affected). This paper summarizes the evidence bases for four stressors (underwater noise, electromagnetic fields, habitat change, and changes in oceanographic systems) and presents the process of moving from the scientific knowledge into guidance documents to support the regulatory process. The guidance documents will serve as a broad guide that can be used internationally to look at stressor-receptor interactions of interest within a regulatory context. The evidence bases and guidance documents aim to assist MRE developers, regulators, and advisors with project scoping, consenting, and licensing processes.

Copping, Andrea E.↗

Federal Facility Agreement and Consent Order: Nevada National Security Site Use Restriction Management Plan with ROTC 1

This Use Restriction Management Plan (URMP) provides the information needed to create, modify, and manage use restrictions (URs) for sites on the Nevada National Security Site (NNSS), and sites accessed through the NNSS main gate, that were closed using the corrective action alternative (CAA) of closure in place under the Federal Facility Agreement and Consent Order (FFACO) (1996, as amended). (Note: This pertains to those FFACO sites not managed by the U.S. Department of Energy [DOE], Legacy Management.) The closure in place alternative is used for sites closed with residual contamination at levels requiring corrective action as determined using the FFACO process. The URs contain and control all requirements for long-term monitoring. This URMP also serves as the single repository of the URs implemented under the FFACO that identify use restricted areas and contain the current requirements for inspections, maintenance, and monitoring of the UR. The requirements in these URs replace all requirements listed in previous documentation. This consolidates post-closure monitoring requirements into a single source that ensures completeness and consistency of UR requirements and information. Standardized UR forms were developed to clearly document post-closure requirements that are consistent with current protocols and to ensure consistent information is contained in the URs. Standard notification, summary, and site controls statements were developed for all URs with provisions to insert site-specific options in the text. Current protocols for Industrial Sites and Soils URs are defined in this document and in the Soils Risk-Based Corrective Action (RBCA) Evaluation Process (DOE/EMNV, 2018). The standardized UR forms that have been approved to date are listed in Appendix A. Additional UR forms will be added once the review and approval process has been completed.

54 ENVIRONMENTAL SCIENCES↗

Federal Facility Agreement and Consent Order Nevada National Security Site Use Restriction Management Plan

This Use Restriction Management Plan (URMP) provides the information needed to create, modify, and manage use restrictions (URs) for sites on the Nevada National Security Site (NNSS), and sites accessed through the NNSS main gate, that were closed using the corrective action alternative (CAA) of closure in place under the Federal Facility Agreement and Consent Order (FFACO) (1996, as amended).

54 ENVIRONMENTAL SCIENCES↗

Consent Order Site Presentation For LANL Supplier Forum [Slides]

Consent Order Sites are contaminated and potentially contaminated sites in and around LANL that require further investigation and/or remediation. They are referred to as Solid Waste Management Units (SWMUs) and Areas of Concern (AOCs).

12 MANAGEMENT OF RADIOACTIVE AND NON-RADIOACTIVE W↗

2024 OES-Environmental 2024 State of the Science Report, Chapter 6: Strategies to Aid Consenting Processes for Marine Renewable Energy

While the marine renewable energy (MRE) industry has made positive strides in the past decade, challenges remain that stall forward progress, scaling up, and commercialization. For MRE to provide a viable solution to address the effects of climate change and achieve sustainable development and renewable energy goals, identifying and understanding barriers and opportunities to deployment is key. Barriers to date have included long consenting timelines, costly in-depth baseline data collection and monitoring requirements, and hesitancy in some countries to approve device and array deployments (Copping & Hemery 2020; Kramer et al. 2020). Some of the key drivers behind these barriers are 1) uncertainty about potential effects of MRE on marine animals, habitats, and the environment; 2) lack of familiarity with MRE technologies; or 3) challenges accessing available scientific information (Copping et al. 2020a).

16 TIDAL AND WAVE POWER↗

Federal Facility Agreement and Consent Order Nevada National Security Site Use Restriction Management Plan, Revision 2

This Use Restriction Management Plan (URMP) provides the information needed to create, modify, and manage use restrictions (URs) for sites on the Nevada National Security Site (NNSS), and sites accessed through the NNSS main gate, that were closed using the corrective action alternative (CAA) of closure in place under the Federal Facility Agreement and Consent Order (FFACO). It addresses URs established under the FFACO for releases related to the development, testing, and production of nuclear weapons that are located on the NNSS and that are accessed through the NNSS main gate. FFACO URs are established at sites where contamination remains at levels exceeding final action levels (FALs) or is forecasted to exceed Safe Drinking Water Act (SDWA) maximum contaminant levels (CFR, 2025a) over the next 1,000 years following completion of corrective actions. Administrative URs are established at Industrial Sites and Soils sites where contamination remains at levels exceeding industrial action levels as defined in the Soils RBCA document. All URs stipulate restrictions sufficient to ensure the protection of human health, safety, and the environment.

54 ENVIRONMENTAL SCIENCES↗

Panel Session 12: Effective Aspects of the 2016 Consent Order between DOE-EM-LA Field Office - NM Environment Department and Identifying Comparable Approaches

This panel focused on the extremely effective 2016 Compliance Order on Consent executed between the US Department of Energy (DOE) Office of Environmental Management - Los Alamos Field Office (EM-LA) and the New Mexico Environment Department (NMED) and highlights practices and concepts toward developing an environmental compliance agreement that is mutually productive to both the NMED and the DOE. To further demonstrate successful practices, the panel also highlighted another very effective compliance agreement with comparable approaches - the 1993 Savannah River Site (SRS) Federal Facility Agreement (FFA) executed between DOE, the South Carolina Department of Health and Environmental Control (SCDHEC), and the Environmental Protection Agency (EPA). EM-LA, NMED, SRS, and SCDHEC representatives provided attendees an opportunity to understand and compare extremely effective approaches to regulatory compliance across the complex.

12 MANAGEMENT OF RADIOACTIVE AND NON-RADIOACTIVE W↗

Consent insufficient for data release—Response

Nicol et al. make discerning comments on issues related to data sharing and ethics, regulations, and imbalance of power. We broadly share their concerns, and we did indeed mention some of them briefly in our Policy Forum. Our discussion pertained to all types of data, many or most of which do not include any personal information or do not involve individuals or humans in any way.

96 KNOWLEDGE MANAGEMENT AND PRESERVATION↗