We hypothesize that recent uses of the Internet as a public-participation mechanism in the United States fail to overcome the adversarial culture that characterizes the American regulatory process. Although the Internet has the potential to facilitate deliberative processes that could result in more widespread public involvement, greater transparency in government processes, and a more satisfied citizenry, we argue that efforts to implement Internet-based public participation have overlaid existing problematic government processes without fully harnessing the transformative power of information technologies. Public (...) comments submitted in two United States Department of Agriculture rulemaking processes—the National Organic Program’s organic standard and the Forest Service’s Roadless Area Conservation Rule—compose our data. We conclude that the Internet provides an arena for playing out three types of conflicts that have long plagued environmental decision-making processes: conflicts over trust of federal agencies, the use of science, and the role of public values. (shrink)

The “public charge” rule is a long-standing immigration policy that seeks to determine the likelihood that a prospective immigrant will become dependent on the government for subsistence. When the Trump administration sought to expand the criteria that would count against an applicant for permanent residency to include public benefits historically excluded from the calculation, thousands of commenters wrote to oppose or support the proposed changes. This paper explores the moral and practical reasons commenters provided for their position on the public (...) charge rule and considers the value of the public comment process for immigration, health, and social policy. (shrink)

Here I inquire into the status of the rules promulgated in the canonical pronouncements on human subjects research, such as the Declaration of Helsinki and the Belmont Report. The question is whether they are ethical rules or rules of policy. An ethical rule is supposed to accurately reflect the ethical fact (the fact that the action the rule prescribes is ethically obligatory), whereas rules of policy are implemented to achieve a goal. We should be skeptical, I argue, that the actions (...) prescribed by the rules are ethically obligatory, and consequently we should focus our attention on how to craft the rules so as to promote the legitimate goals of human subjects research. Unfortunately, this cannot be done without evidence about the likely effects of various candidate policies—evidence we currently lack. Therefore, we should take the rules as mere starting points, subject to revision as the evidence comes in. (shrink)

Philosophical Issues, Volume 31, Issue 1, Page 240-257, October 2021.

Bioethics, Volume 36, Issue 1, Page 18-24, January 2022.

Here I inquire into the status of the rules promulgated in the canonical pronouncements on human subjects research, such as the Declaration of Helsinki and the Belmont Report. The question is whether they are ethical rules or rules of policy. An ethical rule is supposed to accurately reflect the ethical fact, whereas rules of policy are implemented to achieve a goal. We should be skeptical, I argue, that the actions prescribed by the rules are ethically obligatory, and consequently we should (...) focus our attention on how to craft the rules so as to promote the legitimate goals of human subjects research. Unfortunately, this cannot be done without evidence about the likely effects of various candidate policies—evidence we currently lack. Therefore, we should take the rules as mere starting points, subject to revision as the evidence comes in. (shrink)

Digital communications technology isreconfiguring democratic governance. Federalagencies increasingly rely on Internet-basedapplications to improve citizen-governmentinteraction. Early efforts in the area ofdigital government have created newparticipatory opportunities as well asformidable governance challenges. Federalagencies are working within and across theirboundaries to find an e-rulemaking format thatis cost-effective, legally appropriate,user-friendly, and well suited to diverse modesof rulemaking activities. One of the overridingissues emerging from this process is thedefinition of meaningful public participationin rulemaking. An examination of an early caseinvolving the USDA's National (...) Organic Programproposed rule summarizes comments related togenetic engineering, biosolids, irradiation,and the role of the National Organic StandardsBoard. The USDA's experience suggests a numberof complex challenges that must be met toeffectively integrate Web-based communicationsinto the federal rulemaking process. (shrink)

This article examines the process for the eviction of tenants, which offers landlords a swift path for obtaining an eviction order against their tenants, as a case study exposing the politics of procedure. It shows that the PET is but one stage in a longstanding battle waged between two interest groups—landlords and tenants—involving both substantive law and procedural law. But while the story of their conflict over substantive law, fought in the parliament through the regular legislative process, is well-known, the (...) story of the procedural amendments, despite their immense impact, remains shrouded in mystery and is told here for the first time. The reason for that, we argue, is that despite the vast impact of procedure on substantive right, many in the Israeli legal system mistakenly view civil procedure rules as highly technical and neutral directives for the day-to-day operation of the litigation process. The conclusion from such a view is that rulemaking should be left to expert legal technicians and court administrators and that transparency mechanisms or public participation are to be avoided as unnecessary due to the costs and burdens they impose on the rulemaking process. The article concludes with a call for overhauling the rulemaking process in Israel. We argue that the secretive and opaque process is anathema to democracy. Bearing in mind that procedural rules are inevitably imbued with substantive values and have an enormous effect on the substantive rights of the citizenry, the rulemaking process should be radically altered to enable all interested parties to take part in the process, making it far more transparent and subject to public scrutiny in all its stages. (shrink)

During the past decade, a small but rapidly growing number of Law&Tech scholars have been applying algorithmic methods in their legal research. This Article does it too, for the sake of saving disclosure regulation failure: a normative strategy that has long been considered dead by legal scholars, but conspicuously abused by rule-makers. Existing proposals to revive disclosure duties, however, either focus on the industry policies (e.g. seeking to reduce consumers’ costs of reading) or on rulemaking (e.g. by simplifying linguistic (...) intricacies). But failure may well depend on both. Therefore, this Article develops a `comprehensive approach', suggesting to use computational tools to cope with linguistic and behavioral failures at both the enactment and implementation phases of disclosure duties, thus filling a void in the Law & Tech scholarship. Specifically, it outlines how algorithmic tools can be used in a holistic manner to address the many failures of disclosures from the rulemaking in parliament to consumer screens. It suggests a multi-layered design where lawmakers deploy three tools in order to produce optimal disclosure rules: machine learning, natural language processing, and behavioral experimentation through regulatory sandboxes. To clarify how and why these tasks should be performed, disclosures in the contexts of online contract terms and privacy online are taken as examples. Because algorithmic rulemaking is frequently met with well-justified skepticism, problems of its compatibility with legitimacy, efficacy and proportionality are also discussed. (shrink)

This study assessed whether and how government–business partnerships offer a unique platform that targets profound environmental impacts via the promotion of radical eco-innovation. It applied transactional cost and complementary logics to explain the rationale of GBP formation for radical eco-innovation, and further assessed the operation of GBPs from governance, learning, and rulemaking aspects. This study applied propensity score matching technique to empirically test these theoretical associations using 225 observations representing 166 U.S. firms’ participation in 192 environmental alliances between 1985 (...) and 2013. The study results confirmed GBPs’ role in channeling public and private efforts in pursuing transformative environmental change via the adoption of radical eco-innovation goals. Results highlight four critical elements of GBP operation—effective governance, exploration learning, cognitive learning, and rulemaking—that enable participants to embrace these radical environmental solutions. (shrink)

The proposed changes to the Common Rule, described in the recent Advanced Notice of Proposed Rulemaking, come more than 20 years after the U.S. Department of Health and Human Services adopted the Rule in 1991. Since that time, human subjects research has changed in significant ways. Not only has the volume of clinical research grown dramatically, this research is now regularly conducted at multiple collaborative sites that are often outside of the United States. Research takes place not only in (...) academic medical centers, but also at outpatient clinics, community hospitals, and other nontraditional venues. In addition, technological advances, such as sophisticated computer software programs, the Internet, social media, new research methods, and mobile applications have exponentially increased the volume of data available and the possibilities for accessing, analyzing, and sharing that data. (shrink)

Can new technology enhance purpose-driven, democratic dialogue in groups, governments, and societies? Online Deliberation: Design, Research, and Practice is the first book that attempts to sample the full range of work on online deliberation, forging new connections between academic research, technology designers, and practitioners. Since some of the most exciting innovations have occurred outside of traditional institutions, and those involved have often worked in relative isolation from each other, work in this growing field has often failed to reflect the full (...) set of perspectives on online deliberation. This volume is aimed at those working at the crossroads of information/communication technology and social science, and documents early findings in, and perspectives on, this new field by many of its pioneers. -/- CONTENTS: -/- Introduction: The Blossoming Field of Online Deliberation (Todd Davies, pp. 1-19) -/- Part I - Prospects for Online Civic Engagement -/- Chapter 1: Virtual Public Consultation: Prospects for Internet Deliberative Democracy (James S. Fishkin, pp. 23-35) -/- Chapter 2: Citizens Deliberating Online: Theory and Some Evidence (Vincent Price, pp. 37-58) -/- Chapter 3: Can Online Deliberation Improve Politics? Scientific Foundations for Success (Arthur Lupia, pp. 59-69) -/- Chapter 4: Deliberative Democracy, Online Discussion, and Project PICOLA (Public Informed Citizen Online Assembly) (Robert Cavalier with Miso Kim and Zachary Sam Zaiss, pp. 71-79) -/- Part II - Online Dialogue in the Wild -/- Chapter 5: Friends, Foes, and Fringe: Norms and Structure in Political Discussion Networks (John Kelly, Danyel Fisher, and Marc Smith, pp. 83-93) -/- Chapter 6: Searching the Net for Differences of Opinion (Warren Sack, John Kelly, and Michael Dale, pp. 95-104) -/- Chapter 7: Happy Accidents: Deliberation and Online Exposure to Opposing Views (Azi Lev-On and Bernard Manin, pp. 105-122) -/- Chapter 8: Rethinking Local Conversations on the Web (Sameer Ahuja, Manuel Pérez-Quiñones, and Andrea Kavanaugh, pp. 123-129) -/- Part III - Online Public Consultation -/- Chapter 9: Deliberation in E-Rulemaking? The Problem of Mass Participation (David Schlosberg, Steve Zavestoski, and Stuart Shulman, pp. 133-148) -/- Chapter 10: Turning GOLD into EPG: Lessons from Low-Tech Democratic Experimentalism for Electronic Rulemaking and Other Ventures in Cyberdemocracy (Peter M. Shane, pp. 149-162) -/- Chapter 11: Baudrillard and the Virtual Cow: Simulation Games and Citizen Participation (Hélène Michel and Dominique Kreziak, pp. 163-166) -/- Chapter 12: Using Web-Based Group Support Systems to Enhance Procedural Fairness in Administrative Decision Making in South Africa (Hossana Twinomurinzi and Jackie Phahlamohlaka, pp. 167-169) -/- Chapter 13: Citizen Participation Is Critical: An Example from Sweden (Tomas Ohlin, pp. 171-173) -/- Part IV - Online Deliberation in Organizations -/- Chapter 14: Online Deliberation in the Government of Canada: Organizing the Back Office (Elisabeth Richard, pp. 177-191) -/- Chapter 15: Political Action and Organization Building: An Internet-Based Engagement Model (Mark Cooper, pp. 193-202) -/- Chapter 16: Wiki Collaboration Within Political Parties: Benefits and Challenges (Kate Raynes-Goldie and David Fono, pp. 203-205) -/- Chapter 17: Debian’s Democracy (Gunnar Ristroph, pp. 207-211) -/- Chapter 18: Software Support for Face-to-Face Parliamentary Procedure (Dana Dahlstrom and Bayle Shanks, pp. 213-220) -/- Part V - Online Facilitation -/- Chapter 19: Deliberation on the Net: Lessons from a Field Experiment (June Woong Rhee and Eun-mee Kim, pp. 223-232) -/- Chapter 20: The Role of the Moderator: Problems and Possibilities for Government-Run Online Discussion Forums (Scott Wright, pp. 233-242) -/- Chapter 21: Silencing the Clatter: Removing Anonymity from a Corporate Online Community (Gilly Leshed, pp. 243-251) -/- Chapter 22: Facilitation and Inclusive Deliberation (Matthias Trénel, pp. 253-257) -/- Chapter 23: Rethinking the ‘Informed’ Participant: Precautions and Recommendations for the Design of Online Deliberation (Kevin S. Ramsey and Matthew W. Wilson, pp. 259-267) -/- Chapter 24: PerlNomic: Rule Making and Enforcement in Digital Shared Spaces (Mark E. Phair and Adam Bliss, pp. 269-271) -/- Part VI - Design of Deliberation Tools -/- Chapter 25: An Online Environment for Democratic Deliberation: Motivations, Principles, and Design (Todd Davies, Brendan O’Connor, Alex Cochran, Jonathan J. Effrat, Andrew Parker, Benjamin Newman, and Aaron Tam, pp. 275-292) -/- Chapter 26: Online Civic Deliberation with E-Liberate (Douglas Schuler, pp. 293-302) -/- Chapter 27: Parliament: A Module for Parliamentary Procedure Software (Bayle Shanks and Dana Dahlstrom, pp. 303-307) -/- Chapter 28: Decision Structure: A New Approach to Three Problems in Deliberation (Raymond J. Pingree, pp. 309-316) -/- Chapter 29: Design Requirements of Argument Mapping Software for Teaching Deliberation (Matthew W. Easterday, Jordan S. Kanarek, and Maralee Harrell, pp. 317-323) -/- Chapter 30: Email-Embedded Voting with eVote/Clerk (Marilyn Davis, pp. 325-327) -/- Epilogue: Understanding Diversity in the Field of Online Deliberation (Seeta Peña Gangadharan, pp. 329-358). -/- For individual chapter downloads, go to odbook.stanford.edu. (shrink)

The HIPAA Privacy Rule is notoriously weak because of its incomplete coverage, numerous exclusions and exemptions, and limited rights for individuals. The three areas in which it provides the most protection are fundraising, marketing, and research. Provisions of the 21st Century Cures Act, pending in Congress, and the Notice of Proposed Rulemaking to amend the federal research regulations, awaiting final regulatory action, would weaken the privacy protections for research. If these measures are adopted, the HIPAA Privacy Rule would have (...) so little value that it might not be worth the aggravation and burden. (shrink)

Transparency requires more than disclosure of data. It requires a mechanism and policy for conveying information to the public. In order for the aims of the excellent report of the FDA Transparency Working Group to be realized, a publicity initiative will need to accompany the plan of action. The FDA will need to actively convey information about the evidence concerning benefit-risk profiles of drugs, sometimes pointing out misleading claims by manufacturers or sponsors. In other cases, the FDA will need to (...) make available its procedures, including possible conflicts of interest, not only in drug approval, but also in guidance documents and in rulemaking. Transparency as a process of letting the public see into the agency should be accompanied by a proactive strategy of distributing information about the products regulated by the agency. (shrink)

BackgroundThe U.S. Food and Drug Administration traditionally has kept confidential significant amounts of information relevant to the approval or non-approval of specific drugs, devices, and biologics and about the regulatory status of such medical products in FDA’s pipeline.ObjectiveTo develop practical recommendations for FDA to improve its transparency to the public that FDA could implement by rulemaking or other regulatory processes without further congressional authorization. These recommendations would build on the work of FDA’s Transparency Task Force in 2010.MethodsIn 2016-2017, we (...) convened a team of academic faculty from Harvard Medical School, Brigham and Women’s Hospital, Yale Medical School, Yale Law School, and Johns Hopkins Bloomberg School of Public Health to develop recommendations through an iterative process of reviewing FDA’s practices, considering the legal and policy constraints on FDA in expanding transparency, and obtaining insights from independent observers of FDA.ResultsThe team developed 18 specific recommendations for improving FDA’s transparency to the public. FDA could adopt all these recommendations without further congressional action.FundingThe development of the Blueprint for Transparency at the U.S. Food and Drug Administration was funded by the Laura and John Arnold Foundation. (shrink)

The U.S. Department of Health and Human Services has proposed substantial changes to the current regulatory system governing human subjects research in its Advanced Notice of Proposed Rulemaking, entitled “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators.” Some of the most significant proposed changes concern the use of biospecimens in research. Because research involving biological materials begins with an initial interaction with an individual, such research falls squarely within the human (...) subjects research regulatory framework known as the “Common Rule,” which applies to research conducted or funded by the HHS and the other signatory agencies and departments. However, as described in detail below, much biospecimen research may fall within exemptions and exceptions under the Common Rule and, thus, may be conducted without consent. The ANPRM proposes requiring written consent for research use of biospecimens, even if the biospecimens were initially collected for a purpose other than research or have been stripped of identifiers. (shrink)

The main aim of this research is to examine teachers? opinions about functions of school rules, reasons for rule-breaking and results of rule-breaking in relation to their locus of control, gender, age, seniority and branch. 350 public elementary school teachers in Ankara are included in the correlational survey model study. According to the teachers, the main function of school rules is to ?provide regularity?. Classroom teachers find school rules more functional than branch teachers. Teachers with internal locus of control find (...) school rules more functional than externals and junior teachers find school rules more functional than senior teachers. The main reason for teachers? rule-breaking is ?being uninvolved in rulemaking process?. When teachers do not follow school rules, they come across with cold behaviours of the school administrators. (shrink)

This paper examines the drive for consensus from the perspective of the good government framework for federal advisory commissions in the United States. Specifically, the paper examines the Federal Advisory Committee Act (FACA) – the statute, its regulations, and case law. It shows that the FACA was intended to be an antidote to abuses in consensus‐making processes, including the failure to fully include competing views on commissions. The index of suspicion in the FACA scheme rises when a group work product (...) – including a consensus report – is to be the basis of recommendations to federal officials. Once FACA's requirements regarding committee composition are satisfied, the index of suspicion drops and FACA is indifferent to consensus‐making; but the conditions for informed, meaningful participation apply to members who dissent from, as well as those who participate in, consensus. In negotiated rulemaking, the push for consensus and closure creates unacceptable tension with the good government goals of openness and accountability. Proponents of consensus‐only bioethics commissions can learn from FACA‐related legislative, agency, and judicial insights that consensus‐seeking is not always desired by government officials; is rarely cost free; and that diversity and dissent enhance openness, accountability, and fairness. The burden of proof is therefore on proponents of a consensus‐only standard for bioethics commissions to demonstrate that a drive for consensus furthers sound decision‐making by government officials more than it sets back openness and accountability to a diverse public. (shrink)

This article describes why a constitutional test that relies exclusively on history and tradition for deciding modern firearm regulations is woefully inadequate when applied to modern technologies. It explains the unique advancements in firearm technology — specifically, ghost guns — that challenge the viability of a purely historical test, even if legal scholars or judges attempt to reason by analogy. This article argues that the prevailing, two-step approach, which incorporates both history and tradition, and requires a judicial examination of the (...) purposes and methods supporting a challenged firearm regulation, should apply nationwide. That a dissenting faction of conservative judges seeks to ignore the prevailing approach presents a potentially dangerous path for Second Amendment jurisprudence. This article draws from certain historical gun laws to illustrate the difficult legwork that analogies must do under a purely historical test. It uses the advent of ghost guns as a case study to offer guidance for judges in their rulemaking practices regarding Second Amendment cases. (shrink)

Brouwer defended the view that the autonomy of the individual citizen is furthered by articulated, precise and clear legislation. The question arises whether all kinds of rules can be said to enhance such autonomy. It is argued that a distinction should be drawn between rules that dictate desirable outcomes, on the one hand, and rules that determine the way the game is played, on the other. Rules of the game often reflect the way they were drafted and can be seen (...) as the embodiment of power relations between rule-makers. Rules that dictate outcomes, on the other hand, are often drafted by experts who analyse the goals to be reached. The view is defended that only rules of the game – potentially – enhance the autonomy of the citizen, whereas outcome-rules are potentially manipulative, tending to exclude those who are ill-equipped to realize the prescribed outcomes. The virtues of rules therefore do not merely reside in their clear and precise nature, but are largely derived from their capacity to regulate the relations amongst citizens who were included in the process of rulemaking. (shrink)

The federal regulations that govern biomedical research, most notably those enshrined in the Common Rule, express a protectionist ethos aimed at safeguarding subjects of human experimentation from the potential harms of research participation. In at least one critical way, however, the regulations have always fallen short of this promise: if a subject suffers a research-related injury, then neither the investigator nor the sponsor has any legal obligation under the regulations to care for or compensate the subject. Because very few subjects (...) with research-related injuries can meet the financial or evidentiary requirements associated with a successful legal claim to recover the costs associated with their injuries, most injured subjects must shoulder the burden of those expenses alone. For 40 years, national advisory panels have concluded that this result is out of step with the Common Rule's otherwise protectionist promise. When the Department of Health and Human Services released an Advance Notice of Proposed Rulemaking (ANPRM) in 2011, suggesting potential changes to the Common Rule, the time seemed ripe to address research-related injuries. The ANPRM, however, makes no mention of compensation for research-related injuries, and the federal government once again seems poised to stop short of addressing what has arguably become the most longstanding, frequent, and consistent plea for regulatory reform of research: protections for injured subjects. This article asks why, despite decades of federal-level panels recommending no-fault compensation for research-related injuries, the United States has so strongly resisted change. I suggest that a central reason for our current impasse is that, despite consensus among federal advisory committees that there is an obligation to compensate injured subjects, the committees have not coalesced around a moral justification for that duty. Although multiple justifications can support and even strengthen a single ethical obligation, the reverse has occurred in this context. I demonstrate that the committees' articulation of multiple ethical principles – including humanitarianism, professional beneficence, and compensatory justice – results in incongruent obligations that favor different kinds of compensation systems. This outcome, which I call “moral gridlock,” makes it extremely difficult to determine what kind of compensation scheme to implement. Recognizing that each moral argument for compensation creates a slightly different trajectory is, however, an important first step in moving toward a more systematic approach to compensating injured research subjects. (shrink)

Canada’s Tri-Council Policy Statement: Ethical conduct for research involving humans, first published in 1998, has recently been updated.1 The US Department of Health and Human Services has just issued an Advance Notice of Proposed Rulemaking that would substantially change the 20-year-old Common Rule governing most federally funded research involving human participants.2 A comparison of the two countries’ systems for protecting human research participants is therefore timely. This analysis situates the Canadian system in an international context, with particular attention to (...) its similarities and differences to the US system and their shared challenges going forward with their changes. (shrink)

Julia Black's book is the first authoritative study of rulemaking in one of the most important areas of economic life: financial services. The books has three main aims: first, to build a jurisprudential and linguistic analysis of rules and interpretation, drawing out the implication of theseanalyses and developing quality proposals for how rules could be used as instruments of regulation. Second, it interprets that analysis and set of proposals with an empirical study of the formation and use of rules (...) in a particular regulatory system: financial services, and third, it evaluates thenature of the rulemaking process. The author's main case study, examining the use of self-regulation in the financial services sector, complements the detailed analysis of rule formation and uses. The book will be an invaluable addition to the libararies of all administrative lawyers and anyone withan interest in the provision and regulation of financial services. (shrink)

In revising the Federal Policy for the Protection of Human Subjects between 2009 and 2018, regulators devoted the vast bulk of their attention to debates over biomedical research. They lacked both expertise in and concern about the social sciences and humanities, yet they imposed their will on experts in those fields. The revision process was secretive, spasmodic, and unrepresentative, especially compared to rulemaking in Canada, where social scientists participate in the process, and revisions take place every few years. The (...) result was a final rule that offers some wins for social science and the humanities, but that fails to solve the problems identified by Ezekiel Emanuel and in the 2011 advance notice of proposed rulemaking. (shrink)

Crowdsourced regulation has been discussed to date by legal and social science scholars mainly in the context of legislation and rulemaking, without paying sufficient attention to non-legislative regulatory functions. This article provides a richer theory of crowdsourced regulation which extends to all regulatory functions, focusing on monitoring and enforcement. Regulatory agencies worldwide harness the power of the public using digital platforms to carry out monitoring and enforcement tasks in regulated markets and sectors. For example, agencies operate online complaint databases (...) that invite the public to report mistreatment of consumers and environmental nuisances by regulated firms. Agencies also publish information concerning corporate misbehavior to publicly shame companies into compliance. Crowdsourcing regulatory monitoring and enforcement can help minimize some prominent ailments of the regulatory task, such as poor resources, diminishing deterrence, declining legitimacy, and capture. It can also promote goals and values such as public participation, increased transparency, public trust in regulators, administrative efficiency, and effectiveness in achieving regulatory objectives. However, crowdsourcing regulatory monitoring and enforcement is subject to a new set of legal, administrative, and democratic failures that need to be acknowledged and addressed. The article develops a theory of crowdsourced regulation that supplies justifications and rationales for crowdsourced regulatory monitoring and enforcement, points out its main pitfalls, and normatively evaluates law and policy implications. (shrink)

The recent Common Rule revision process took almost a decade and the resulting changes are fairly modest, particularly when compared to the ambitious ideas proposed in the advance notice of proposed rulemaking and notice of proposed rulemaking. Furthermore, the revision process did not even attempt to tackle any of the Common Rule subparts pertaining to vulnerable populations where commentators think the rules unduly restrict important research. We believe that this was a missed opportunity to make desirable changes, and (...) that given the usual process the next opportunity to revisit the Common Rule is unacceptably remote. In this article, we argue that the Common Rule should be regularly reassessed, with a mechanism for making substantive changes. Drawing on lessons learned from the recent revision process, we make recommendations about ways to structure future attempts to maximize the ability to make timely and necessary changes. (shrink)

On January 22, 2002, California Governor Gray Davis released the state's long-anticipated, proposed regulations establishing hospital nurse-to-patient ratio requirements. The Safe Staffing Law mandating minimum ratios was enacted in October 1999 in response to legislators concerns that [q]uality of patient care is jeopardized because of staffing changes implemented in response to managed care. While the law was scheduled to take effect by January 1, 2002, conflict within the medical community regarding appropriate ratios slowed down the rulemaking process. Lawmakers now (...) anticipate that the rule will be implemented by January 2003. Approximately 5,000 new nurses will need to be hired for California's hospitals to come into compliance with the proposed regulation. (shrink)

In July, the Department of Health and Human Services and the Office of Science and Technology Policy published an advance notice of proposed rulemaking proposing sweeping changes to the rules governing oversight of research on human subjects—changes aimed at “better protect[ing] human subjects who are involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators.”1 The process is likely to amend not only the core regulation on human-subjects research , but also regulations governing vulnerable (...) subjects, IRB registration requirements, research regulations of the Food and Drug Administration, and the “privacy rule” of the .. (shrink)

How can we enhance police integrity? The authors surveyed over 3000 police officers from 30 U.S. police departments on how they would respond to typical scenarios where integrity is challenged. They studied three police agencies which scored highly on the integrity scale: Charlotte-Mecklenburg, North Carolina; Charleston, South Carolina; and St. Petersburg, Florida. The authors conclude that enhancing police integrity goes well beyond culling out "bad apple" police officers. Police administrators should focus on four aspects: organizational rulemaking; detecting, investigating and (...) disciplining rule violations; circumscribing the informal "code of silence" that prohibits police from reporting the misconduct of their colleagues; and understanding the influence of public expectations and agency history. (shrink)

This Article traces the trajectory of negotiated rulemaking within American administrative law. The popularity of negotiated rulemaking - among scholars, politicians, and regulators - has waxed and waned since its start in the 1980s. This Article describes and assesses these shifts, charting the birth of negotiated rulemaking, its incorporation into the APA, and its infrequent use in recent years. In mapping the rise and fall of negotiated rulemaking, we focus on two particular critiques - that it (...) violates normative commitments to expertise and rationality in bureaucratic decision making, and that it fails to deliver on its promises of faster rulemaking and less litigation. This Article contends that the first critique is overblown and that the second is true in some instances but not in others. We argue that negotiated rulemaking is most valuable when the appropriate negotiating parties can be easily identified, when they are likely to make concessions and build rapport with each other, and when traditional methods of rulemaking have become ossified. (shrink)

The decades before and after the turn of the twentieth century, like those surrounding the turn of the twenty-first, are often understood as periods of globalization. The two periods share key features that characterize the global as a motif, including high mobility of goods, services, people, ideas and, perhaps most centrally, capital. An important distinguishing feature between the periods is the monetary regime: the gold standard for the turn of the twentieth century; managed flexibility for the turn of the twenty-first. (...) This paper examines the legal infrastructure of these two monetary regimes in order to illuminate two distinct yet related issues. The first is the connection between the form of rulemaking and the means of isolating monetary policy decisions from political influence. The second is the role of the monetary regime in mediating value. Both the gold standard and the managed flexibility regime aim to shield money from partisan intervention, but they do so in different ways; attention to the legal framework sheds light on how these differing regimes pursue the goal of insulating money from politics. (shrink)

This paper examines the drive for consensus from the perspective of the good government framework for federal advisory commissions in the United States. Specifically, the paper examines the Federal Advisory Committee Act (FACA) – the statute, its regulations, and case law. It shows that the FACA was intended to be an antidote to abuses in consensus‐making processes, including the failure to fully include competing views on commissions. The index of suspicion in the FACA scheme rises when a group work product (...) – including a consensus report – is to be the basis of recommendations to federal officials. Once FACA's requirements regarding committee composition are satisfied, the index of suspicion drops and FACA is indifferent to consensus‐making; but the conditions for informed, meaningful participation apply to members who dissent from, as well as those who participate in, consensus. In negotiated rulemaking, the push for consensus and closure creates unacceptable tension with the good government goals of openness and accountability. Proponents of consensus‐only bioethics commissions can learn from FACA‐related legislative, agency, and judicial insights that consensus‐seeking is not always desired by government officials; is rarely cost free; and that diversity and dissent enhance openness, accountability, and fairness. The burden of proof is therefore on proponents of a consensus‐only standard for bioethics commissions to demonstrate that a drive for consensus furthers sound decision‐making by government officials more than it sets back openness and accountability to a diverse public. (shrink)

The use of Genetic Modification in food is the subject of deep political disagreement. Much of the disagreement involves different perceptions of the kinds of risks posed by pursuing GM food, and how these are to be tolerated and regulated. As a result, a primary institutional site of GM food politics is regulatory agencies tasked with risk assessment and regulation. Locating GM food politics in administrative areas of governance regimes produces unique challenges of democratic legitimacy, conventionally secured through legislative channels. (...) In particular, debate over the ends of a society’s policy on GM food inevitably continues in these institutional locations, despite conventional instrumental understandings of administrative legitimacy resting on effective application of ‘ends-means’ norms. This paper assesses the two major regulatory frameworks currently applied to GM food—the ‘precautious’ and ‘proof of harm’ approaches—and presents their respective limits in securing the procedural and substantive dimensions of the legitimacy of administrative deference in democratic societies. On the basis of these criticisms, a synthesized and emergent approach—‘experiential precaution’—is presented as having the resources to deepen the legitimacy of risk governance institutions in the case of GM food. It is characterized by deepened participatory practices of negotiated rulemaking and inclusion of further substantive requirements in approval criteria. (shrink)

Law, broadly defined to include group-directed rulemaking and coercion, has plainly grown over time. There are many explanations for this growth, and the evolution from self-help to law. This Article develops the idea that an important contributor to the growth of law has been the fact that law begets law, and it seeks to combine this new explanation with both traditional and more intuitive explanations for law’s expansion. That law brings on more law in an addictive way means that (...) a society finds itself with laws, rather than personal interactions, in ways that it would have wished to avoid had it known earlier in time that law’s spectacular growth was in the making. The growth of law is thus much more than a product of specialization or wealth effects. For a variety of reasons, people prefer to avoid personal confrontation and to outsource their means of social control. This Article suggests that much of this addictive growth is inefficient and otherwise undesirable. The addiction might be controlled by rewarding some kinds of personal involvement in order to overcome the inclination to outsource. (shrink)

The Telecommunications Act of 1996 is considered landmark legislation, especially in the area of universal service. However, the FCC performed even more groundbreaking activity. The FCC was given wide latitude by the Act to interpret the universal service provisions of the Act either narrowly or broadly; the FCC chose the latter. The FCC's interpretation of the Act will have a significant impact on the level of technology implementation and use in American classrooms and libraries. In March 1996, the FCC issued (...) a Notice of Proposed Rulemaking on Universal Service. The NPRM also established a Federal-State Joint Board composed of three FCC Commissioners, four state public service commission representatives nominated by the National Association of Regulatory Utility Commissioners, and one utility consumer advocate nominated by the National Association of State Utility Consumer Advocates. On November 8, 1996, the Joint Board released its Recommended Decision and the FCC adopted its rules based on that recommendation in May 1997. The FCC ruled that all eligible schools and libraties should receive discounts of between 20 and 90 percent on all telecommunications services, Internet access, and internal connections, subject to a $2.25 billion annual cap. In addition, any funds not disbursed in a given year may be carried forward and disbursed in subsequent years without regard to the cap. This provision, according to the FCC, will provide schools and libraries with the maximum flexibility to purchase the services that will meet their communications needs most effectively. In a separate section of the rules, the FCC defined "core services" as: • Voice-grade access to the public switched network, with the ability to place and receive calls • Dual Tone Multifrequency signaling or its functional equivalent • Single-party service • Access to emergency services • Access to operator services • Access to interexchange services • Access to directory assistance. • Support for toll limitation services for low-income consumers. However, as stated in the Act, the FCC was given the latitude to include additional services for schools and libraries. It could have chosen to provide schools and libraries with discounts on only core telecommunications services; core services plus some complement of additional services; or all telecommunications services. The FCC adopted the third option, that discounts be provided on all telecommunications services. It stated that this guideline would provide schools and libraries the maximum flexibility to purchase whatever package of telecommunications services they believe would meet their telecommunications service needs most effectively and efficiently. _Current Status:_ The FCC ruled that it will permit schools to begin using discounted services on January 1, 1998. The presentation will discuss the current status of this legislation. (shrink)

How can free and equal people cooperate to solve conflicts and common problems in a rational and legitimate way? In this article I deduce principles for doing so from the requirements of rational communication set out in the discourse theory of Jürgen Habermas. I apply them in defining a process of efficient decision making. What I call ‘communicative design’ denotes the design of a reason giving process in which the practice of proposing and assessing claims with regard to rulemaking (...) and problem solving is undertaken on an equal and autonomous basis. Two sets of prescriptions are given: organisational principles for the composition of groups and argumentative principles for deliberation. However, any procedure aimed at achieving a rational consensus in decision making in organisations has to deal in practice with limitations of time, participation and the information available. Communicative design may not guarantee strictly rational decisions, then, but the procedure it constructs does promise relatively ‘more valid’ decisions than might be expected if another procedure had been adopted. (shrink)

The Patient Protection and Affordable Care Act (ACA) sets in motion a wide range of programs that substantially affected the health system in the United States and signify a moderate but important regulatory shift in the role of the federal government in public health. This article briefly addresses two interesting policy paradoxes about the ACA. First, while the legislation primarily addresses health care financing and insurance and establishes only a few initiatives directly targeting public health, the ACA nevertheless has the (...) potential to produce extensive public health benefits across the United States population by improving access to health care and services and reducing cost. Essentially, the ACA does not take the explicit form of a public health law but instead strives to advance public health indirectly through its effects. Second, while the ACA does not establish a right to health — or even a right to health insurance — in the United States, it does set in motion a number of significant structural and normative changes to United States law that comport with the attainment of the right to health. Most significantly, key provisions of the bill are designed to improve availability, accessibility, acceptability, and quality of conditions necessary for health, and to prompt the government to respect, protect, and fulfill these conditions. These developments mean that, to a degree, the United States essentially has undertaken the same types of legal and policy steps that a country would be required to take to uphold the right to health without actually recognizing the right to health in any formal or legally binding way.Despite these dual paradoxes and the upside potential for public health improvements resulting from the ACA, the public health impact of the law remains uncertain and will be decided by numerous subsequent regulatory and implementation decisions. The ACA authorizes multiple federal agencies to engage in rulemaking, a process that will largely dictate the systemic and health impacts that will become its legacy. This reality opens up ample opportunity to bolster public health aspects and interpretations of the law, and to simultaneously augment the corresponding components of the right to health. (shrink)

There isn’t much understanding in some marriages. My sister has six [children] and another has eight. I said to one of them that she shouldn’t have any more. And she said “What can I do? When my husband comes home drunk, he foxes me to sleep with him.” And that is what happens to a lot of women. And if the women don’t do it, the men hit them, or treat them badly. Or the men get jealous and think their (...) wives are with other men.—Rene, a 29-year old Peruvian womanGender violence is a major yet often underrecognized obstacle to reproductive choice. In both the abortion rights movement in the United States and the reproductive health movement globally, the “enemy” of self-determination and choice is usually seen as imposing from the top down. In the North, it is the government—through the courts, the legislature, and bureaucratic rulemaking—that threatens to “take away” women’s reproductive autonomy. The image is one of the public sphere invading that which is private—of the state interfering with a woman’s right to control her own body. (shrink)

There isn’t much understanding in some marriages. My sister has six [children] and another has eight. I said to one of them that she shouldn’t have any more. And she said “What can I do? When my husband comes home drunk, he foxes me to sleep with him.” And that is what happens to a lot of women. And if the women don’t do it, the men hit them, or treat them badly. Or the men get jealous and think their (...) wives are with other men.—Rene, a 29-year old Peruvian womanGender violence is a major yet often underrecognized obstacle to reproductive choice. In both the abortion rights movement in the United States and the reproductive health movement globally, the “enemy” of self-determination and choice is usually seen as imposing from the top down. In the North, it is the government—through the courts, the legislature, and bureaucratic rulemaking—that threatens to “take away” women’s reproductive autonomy. The image is one of the public sphere invading that which is private—of the state interfering with a woman’s right to control her own body. (shrink)

On January 18, 2011, President Obama signed Executive Order 13563, Improving Regulation and Regulatory Review, which instructs federal regulators to do the following: coordinate their agencies activities to simplify and harmonize rules that may be overlapping, inconsistent, or redundant; determine whether the present and future benefits of a proposed regulation justify its potential costs (including taking into account both quantitative and qualitative factors); increase participation of industry, experts, and the public (“stakeholders”) in the formal rule‐making process; encourage the use of (...) warnings, default rules, disclosure requirements, and provisions of information to the public as an alternative to traditional “command‐and‐control” rule‐making restricting consumer choice; and mandate a government‐wide review of all existing administrative rules to remove outdated regulations. Executive Order 13563 includes a qualitative “values” provision to be considered in the required cost–benefit analysis, which can potentially counteract the alleged regulatory reform rationale of President Obama. Furthermore, in Executive Order 13563, President Obama established a deadline of May 18, 2011, for all executive branch agencies to submit their plans to streamline their rulemaking operations and repeal those “overlapping, inconsistent, or redundant” rules. These two issues, along with complementary regulatory review proposals being discussed in the U.S. Congress, are evaluated in this essay. (shrink)

This essay explores three case studies that illustrate the exemplary use of economic analysis in environmental decision-making. These include: 1) the creation of a market in tradable grazing rights in the American West; 2) a cost analysis that facilitated a negotiated rulemaking at a power plant in Arizona; and 3) a conception of production-based pollution allowances that led to an agreement for regulating Intel microprocessor production plants. The paper argues that cost–benefit analysis may be less useful than other kinds (...) of economic analysis that can guide and inform rather than judge and second-guess the outcome of negotiated and collaborative decision-making. (shrink)