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Bureaucratic rulemaking is a key feature of American policymaking. However, rulemaking activities do not occur uniformly, but fluctuate throughout the year. We consider three mechanisms to explain these changes in rule volume, each of which produces unique expectations for rulemaking during periods of divided government and legislative recess. To test these expectations, we leverage an original dataset including all rules proposed by bureaucratic agencies in three U.S. states from 2004 to 2013 matched with data tracking periods of divided government and legislative recess. We find that state bureaucracies publish significantly more proposed rules during periods of divided government or a split legislature and are most productive in the months immediately following legislative recess. These results underscore the importance of bureaucratic policymaking and improve our understanding of the balance of power between branches of state governments. [ABSTRACT FROM AUTHOR]

Research summary: This study investigates how information about public opinion and peer practices influences police executives' views on civilian review boards. We applied structural topic modeling in an experimental paradigm, a novel approach diverging from traditional experimental survey methods, to the open‐ended responses of 1331 police executives collected in an original survey experiment. This technique enables the capture of subtle shifts in belief directly from the executives' own words. The experiment systematically varied the information provided to police executives, including state‐level public opinion data from a representative sample of 16,840 U.S. residents, and peer practices in major city police agencies. Our findings reveal that police executives, although generally aligned in their views, demonstrate a readiness to update their beliefs when presented with cohesive local public opinion and information about peer practices in policing. Policy implications: In a democratic society, the core policy beliefs of police executives critically shape the existence and efficacy of civilian oversight mechanisms. Our findings demonstrate the adaptability of police executives in updating their policy positions, reflecting their commitment to informed decision making in response to the dynamic nature of police governance. We find that police executives are willing to update their beliefs related to the public's ability to oversee policing in an unbiased and qualified manner when presented with information about reforms adopted by peer agencies. In contrast, information about public demand for more aggressive forms of oversight can lead to a backlash, increasing the likelihood of police executives to favor existing oversight mechanisms and to doubt the public's qualification. For executives, reformers, and scholars, these findings highlight the limitations of public opinion and benefits of peer influence as mechanisms for policy learning in policing. [ABSTRACT FROM AUTHOR]

Dissection of human body donors is a valuable part of anatomical education, research, and clinical training. In the United States, deceased human bodies are predominantly sourced through whole‐body donation programs (BDPs) housed by academic institutions. Due to the lack of information regarding BDPs, the aim of this study was to gather information from US BDPs through a survey to better understand the donation process and standard operating procedures of these programs. In 2021, a Qualtrics survey was distributed to 125 BDPs and yielded responses from 72 program leaders. Collectively, these programs received more than 26,000 whole‐body donations annually. Findings show that 70% typically receive enough donations to fit the needs of their institutions, 17% receive a surplus of donations, and 13% receive too few donations. Sixty‐eight percent of programs permit next of kin body donation regularly or in times of need, and 44% allow next of kin to make changes to a donor's donation form after death. On average, over 85% of the registered donor population is composed of white individuals, and only 6 institutions have methods in place to promote diversity among their donor population. Overall, there is considerable variability in the operation of BDPs across the United States. These findings can be used to make recommendations about donor enrollment and program operations to ultimately improve the donation process. Future research needs to investigate the opinions and preferences of body donors along with their next of kin on the body donation process and associated policies. [ABSTRACT FROM AUTHOR]

In response to concerns regarding numerous complex issues facing the veterinary specialty profession, several organizations, including the American College of Veterinary Internal Medicine, have made a clarion call to the American Veterinary Medical Association to begin discussions surrounding the formation of an accrediting body for internships, residencies, and fellowships. A proposed name for such a body is the Accreditation Council on Graduate Veterinary Medical Education, in alignment with the Accreditation Council on Graduate Medical Education (ACGME); the term "graduate" refers to specialty education that occurs after the first 4 years of the MD or DVM degree. Although the structure and financing of graduate education differ between the human medical and veterinary professions, we can nevertheless learn much from the history of evolution of human medical specialization as we navigate the path ahead. [ABSTRACT FROM AUTHOR]

The National Institutes of Health (NIH) requires use of a single institutional review board (sIRB) for multisite, nonexempt, NIH‐funded research with human participants. The Clinical Trials Transformation Initiative (CTTI) conducted in‐depth interviews with 34 stakeholders at two universities and in research administration leadership positions at multiple institutions about their experiences implementing the sIRB model, focusing on the NIH policy's goals soon after the policy was enacted. While some stakeholders suggested that using an sIRB has streamlined and reduced inefficiencies associated with the local IRB model, more stakeholders indicated that the sIRB model has not simplified the ethics review process and instead created new inefficiencies due to unclear roles and responsibilities for staff and institutions; a lack of systems and processes for implementing the sIRB model, including communication systems; and increased workloads. CTTI used these findings to propose a new framework for evaluating the NIH sIRB policy. [ABSTRACT FROM AUTHOR]

Congress has long exercised its power to oversee the executive branch. Important research has examined empirical patterns in congressional investigations, finding institutional, individual, policy, and partisan incentives motivate legislative inquiry. Yet, scholars largely have overlooked one fundamental question: what is oversight? We use new quantitative and qualitative data to highlight the importance of considering oversight as a series of actions designed to serve both as a symbol and signal in the American separation of powers system. Our exploratory analysis suggests that Congress oversees the executive branch much more frequently and in more ways than previously considered by scholars. [ABSTRACT FROM AUTHOR]

This article is the lead piece in a special report that presents the results of a bioethical investigation into chimeric research, which involves the insertion of human cells into nonhuman animals and nonhuman animal embryos, including into their brains. Rapid scientific developments in this field may advance knowledge and could lead to new therapies for humans. They also reveal the conceptual, ethical, and procedural limitations of existing ethics guidance for human‐nonhuman chimeric research. Led by bioethics researchers working closely with an interdisciplinary work group, the investigation focused on generating conceptual clarity and identifying improvements to governance approaches, with the goal of helping scholars, funders, scientists, institutional leaders, and oversight bodies (embryonic stem cell research oversight [ESCRO] committees and institutional animal care and use committees [IACUCs]) deliver principled and trustworthy oversight of this area of science. The article, which focuses on human‐nonhuman animal chimeric research that is stem cell based, identifies key ethical issues in and offers ten recommendations regarding the ethics and oversight of this research. Turning from bioethics' previous focus on human‐centered questions about the ethics of "humanization" and this research's potential impact on concepts like human dignity, this article emphasizes the importance of nonhuman animal welfare concerns in chimeric research and argues for less‐siloed governance and oversight and more‐comprehensive public communication. [ABSTRACT FROM AUTHOR]

Background/objectives: Regulatory oversight has been a central strategy to assure nursing home quality of care for decades. In response to COVID‐19, traditional elements of oversight that relate to resident care have been curtailed in favor of implementing limited infection control surveys and targeted complaint investigations. We seek to describe the state of nursing home oversight during the pandemic to facilitate a discussion of whether and how these activities should be altered going forward. Design and setting: In a retrospective study, we describe national oversight activities in January–June 2020 and compare these activities to the same time period from 2019. We also examine state‐level oversight activities during the peak months of the pandemic. Participants: United States nursing homes. Data Publicly available Quality, Certification, and Oversight Reports (QCOR) data from the Centers for Medicare and Medicaid Services (CMS). Measurements Number of standard, complaint, and onsite infection surveys, number of deficiencies from standard and complaint surveys, number of citations by deficiency tag, and number and amount of civil monetary penalties. Results: The number of standard and complaint surveys declined considerably in the second quarter of 2020 relative to the same time frame in 2019. Deficiency citations generally decreased to near zero by April 2020 with the exception of infection prevention and control deficiencies and citations for failure to report COVID‐19 data to the national health safety network. Related enforcement actions were down considerably in 2020, relative to 2019. Conclusion: In the months since COVID‐19 first impacted nursing homes, regulatory oversight efforts have fallen off considerably. While CMS implemented universal infection control surveys and targeted complaint investigations, other routine aspects of oversight dropped in light of justifiable limits on nursing home entry. Going forward, we must develop policies that allow regulators to balance the demands of the pandemic while fulfilling their responsibilities effectively. [ABSTRACT FROM AUTHOR]

The regulation of digital technology is gaining increased attention within policy making circles. With growing recognition of the power held by digital media companies and the need to enforce democratic values online, policy makers are reviewing opportunities for oversight. Introducing a special section looking at the regulation of digital election campaigning, this article reviews the case for regulatory reform, the proposed type of regulatory change, and the practice of regulatory innovation. Noting the pace of digital change, it argues that there is a need to think more extensively about the design of any regulatory response in order to prevent systems of oversight becoming obsolete. [ABSTRACT FROM AUTHOR]

Theory suggests that Congress should delegate more policymaking authority to the bureaucracy under unified government, where lawmakers are less worried about the president orchestrating "bureaucratic drift." Yet, all unified governments come to an end, making broad delegations potentially advantageous to future lawmaking coalitions ("coalitional drift"). We seek to assess how lawmakers simultaneously limit the risk of each of these pitfalls of delegation. Our answer is rooted in Congress's ability to spur agency rulemaking activity under unified government. Specifically, we expect statutes passed under unified government to require agencies to issue regulations quickly and for enacting coalitions to use oversight tools to influence agency policy choices. Such "proximate oversight" allows coalitions to cement policy decisions before a new election changes the configuration of preferences within Congress and the executive branch. We assess our argument using unique data on both congressional rulemaking deadlines (1995–2014) and the speed with which agencies issue regulations (1997–2014). [ABSTRACT FROM AUTHOR]

Oversight is necessary for evaluating the performance of contractors building complex systems for the U.S. government, but it can also result in additional program costs. In order to accurately measure the extent of these additional costs, stakeholders need to understand how oversight‐required activities add time to work. To that end, this paper presents the data from a qualitative research study to investigate how oversight adds time to contractor engineering work at a major U.S. aerospace company. We observed that oversight activities require many tasks to complete, which can add cascades of new activities that are performed in multiple iterations. Oversight activities cannot be accounted for in a binary way—oversight adds time to parts of all activities that the contractor performs. We describe the mechanisms through which oversight impacts work by extending the time spent on all activities. Understanding how added time occurs could help both contractors and government program managers determine ways to reduce unnecessary costs. Implications of these findings for systems engineers interested in conducting studies to measure the impact of oversight are discussed. [ABSTRACT FROM AUTHOR]

Although animal research requires adherence to various regulations and standards, the manner in which compliance is maintained and the degree of additional constraints varies between institutions. Regulatory burden, particularly if institutionally imposed, has become a concern for institutions as increased regulatory expectations result in decreased resources available for research efforts. Faculty, research staff, and support staff engaged in animal research were surveyed to determine what institutional animal care and use committee (IACUC) processes were considered burdensome, the perceived value of some suggested modifications, and satisfaction with the IACUC administrative office and the animal resource unit. Although the results revealed overwhelming satisfaction with the IACUC administrative office and the animal resource unit, several IACUC processes were deemed burdensome, and therefore there would be value in modifying IACUC processes. When comparing the value of modifying IACUC processes, different groups within the animal care and use program (ACUP) tended to have different responses on many of the topics. This survey identified several perceived burdensome IACUC processes that would likely benefit individuals if modified. In today's environment of shrinking budgets for biomedical research, minimizing regulatory burden--particularly unnecessary, self-imposed burden--in the ACUP is particularly important to ensure that costs, time, and effort are appropriate to achieve animal welfare and quality of research endeavors. [ABSTRACT FROM AUTHOR]

Abstract With government's response to child abuse and neglect seen as one of the most daunting challenges for public policy and law, legislative reform on this issue struggles to adequately protect children while preserving the integrity of family. The authors utilize the Child Abuse Prevention and Treatment Act ( CAPTA) as an example of the funding and policy challenges in reforming federal child welfare law, as well as a lens through which advocates can locate both conventional and unconventional tools to move forward. CAPTA is examined as an important but weak and flawed federal statute. Authors present an array of opportunities to improve CAPTA during the next reauthorization cycle. Noting exemplary successes, in other recent and related legislation reforms, are suggested for CAPTA to more effectively address ongoing challenges of child welfare. [ABSTRACT FROM AUTHOR]

The fallibility of forensic science consultation is an ongoing and major justice concern. Prospective peer-reviewed forensic consultation has over 10 years of application in American criminal and civil courts, adapting from the traditional oversight of teaching hospitals, rules of evidence and discovery, conventions of testimony of expert witnesses, and attorneys' overall trial strategy. In systematizing heightened oversight, this process ensures greater accountability in forensic science consultation. The integration of peer reviewers' complementary expertise and experience enhances the sophistication and overall quality of assessment. Forensic examination frequently involves the interface of different specialties. Multidisciplinary peer review augments expert proficiency with that of professional peers having different vantage points from relevant scientific disciplines. This approach ensures greater sophistication of a case inquiry, built-in accountability, and streamlined processes when multiple experts are necessitated. Here, the authors present examples of several cases and the primary and secondary benefits of this collaborative, rigorous, cross-disciplinary exercise. [ABSTRACT FROM AUTHOR]

U.S. federal regulations and standards governing the care and use of research animals enacted in the mid- to late 1980s, while having positive effects on the welfare and quality of the animals, have resulted in dramatic increases in overall research costs. In addition to the expenses of housing and caring for animals according to the standards, establishing the requisite internal compliance bureaucracies has markedly driven up costs, in both institutional monetary expenditures and lost research effort. However, many institutions are increasing these costs even further through additional self-imposed regulatory burden, typically characterized by overly complex compliance organizations and unnecessary policies and procedures. We discuss the sources of this self-imposed burden and recommend strategies for avoiding it while preserving an appropriate focus on animal well-being and research success. [ABSTRACT FROM AUTHOR]

ABSTRACT The United States Food and Drug Administration's recent approval of the commercial use of Deep Brain Stimulation (DBS) as a treatment for Obsessive Compulsive Disorder (OCD) will be discussed within the context of the existing USA regulatory framework. The purpose will be to illustrate the current lack of regulation and oversight of the DBS market, which has resulted in the violation of basic ethical norms. The discussion will focus on: 1) the lack of available evidence on procedural safety and efficacy, 2) the numerous conflicts of interest held by research investigators, and 3) the ambiguity of both aforementioned categories due to an inherent lack of transparency in the research. It is argued that in order to address these issues, ethical analyses of DBS for psychiatric disorders must include the role of the industry forces that have become the primary impetus for this research. As such, DBS for OCD serves as an important case example in studies of neurotechnology and innovative surgery. [ABSTRACT FROM AUTHOR]

Emerging technologies are defined by their novelty and thus are accompanied by significant uncertainty in determining appropriate ways to manage risks associated with them. Yet, there is a body of prior knowledge about risk management and oversight policy for other technologies that have already permeated society. Here, we describe two ways in which prospective oversight policy analysis for emerging technologies can draw upon these past experiences. One involves comparing specific products that have already been marketed to similar products of the emerging technology (cognate-product approach). The other treats the emerging technology as a body of products and methods and relates it to another technological field that has already emerged and penetrated markets (whole-technology approach). In this article, we describe our work using these approaches to inform risk and oversight policy for nanotechnology and its products. We draw parallels between biotechnology and nanotechnology as whole fields of development and also between genetically engineered organisms in the food supply and agricultural products of nanotechnology. Through these comparisons, we find that both approaches to historical learning have value and present lessons that could be applied to nanotechnology. [ABSTRACT FROM AUTHOR]

The emerging field of synthetic biology (SB) is just entering policy debates. Reports from non-governmental organizations, such as the ETC Group and the International Risk Governance Council, have recently been issued, but there have been few systematic analyses of the policy problems that we will likely face as this area develops. Biosecurity issues are the most defined; other societal oversight issues and implications have not been well explored. Although SB could assist in addressing pressing global challenges, such as sustainable and renewable energy, there are considerable societal concerns that accompany its development and applications. This article is designed to anticipate and prepare for these concerns by identifying policy problems associated with SB oversight, upstream of its development. Projected applications of SB are reviewed and a typology of them is developed. Key oversight policy problems are then identified based on historical experiences with other emerging technologies, such as nanotechnology and biotechnology. Problems associated with biosecurity, biosafety, intellectual property, and ethics are discussed in relation to the typology of SB applications to identify applications of the highest potential concern. Finally, policy options for SB oversight are considered, preventative to promotional. We propose that different categories of SB application may warrant different oversight regimes: there might not be an appropriate “one size fits all” approach. We stop short of making specific recommendations, but suggest that the typology, problems, and oversight options identified in this article be used as a starting point for deliberative, democratic decisionmaking processes that take into account a wide range of perspectives about risk, economic impact, scientific progress, and moral reasoning in the design of oversight systems. [ABSTRACT FROM AUTHOR]

Although nanotechnology is broadly receiving attention in public and academic circles, oversight issues associated with applications for agriculture and food remain largely unexplored. Agrifood nanotechnology is at a critical stage in which informed analysis can help shape funding priorities, risk assessment, and oversight activities. This analysis is designed to help society and policymakers anticipate and prepare for challenges posed by complicated, convergent applications of agrifood nanotechnology. The goal is to identify data, risk assessment, regulatory policy, and engagement needs for overseeing these products so they can be addressed prior to market entry. Our approach, termed upstream oversight assessment (UOA), has potential as a key element of anticipatory governance. It relies on distinct case studies of proposed applications of agrifood nanotechnology to highlight areas that need study and attention. As a tool for preparation, UOA anticipates the types and features of emerging applications; their endpoints of use in society; the extent to which users, workers, ecosystems, or consumers will be exposed; the nature of the material and its safety; whether and where the technologies might fit into current regulatory system(s); the strengths and weaknesses of the system(s) in light of these novel applications; and the possible social concerns related to oversight for them. [ABSTRACT FROM AUTHOR]