Changes In Federal Regulations Research Articles

Three decades of research in substance use disorder treatment for syringe services program participants: a scoping review of the literature

BackgroundSyringe services programs (SSPs) provide a spectrum of health services to people who use drugs, with many providing referral and linkage to substance use disorder (SUD) treatment, and some offering co-located treatment with medications for opioid use disorder (MOUD). The objective of this study was to review the evidence for SSPs as an entry point for SUD treatment with particular attention to co-located (onsite) MOUD.MethodsWe performed a scoping review of the literature on SUD treatment for SSP participants. Our initial query in PubMed led to title and abstract screening of 3587 articles, followed by full text review of 173, leading to a final total of 51 relevant articles. Most articles fell into four categories: (1) description of SSP participants’ SUD treatment utilization; (2) interventions to link SSP participants to SUD treatment; (3) post-linkage SUD treatment outcomes; (4) onsite MOUD at SSPs.ResultsSSP participation is associated with entering SUD treatment. Barriers to treatment entry for SSP participants include: use of stimulants, lack of health insurance, residing far from treatment programs, lack of available appointments, and work or childcare responsibilities. A small number of clinical trials demonstrate that two interventions (motivational enhancement therapy with financial incentives and strength-based case management) are effective for linking SSP participants to MOUD or any SUD treatment. SSP participants who initiate MOUD reduce their substance use, risk behaviors, and have moderate retention in treatment. An increasing number of SSPs across the United States offer onsite buprenorphine treatment, and a number of single-site studies demonstrate that patients who initiate buprenorphine treatment at SSPs reduce opioid use, risk behaviors, and have similar retention in treatment to patients in office-based treatment programs.ConclusionsSSPs can successfully refer participants to SUD treatment and deliver onsite buprenorphine treatment. Future studies should explore strategies to optimize the implementation of onsite buprenorphine. Because linkage rates were suboptimal for methadone, offering onsite methadone treatment at SSPs may be an appealing solution, but would require changes in federal regulations. In tandem with continuing to develop onsite treatment capacity, funding should support evidence-based linkage interventions and increasing accessibility, availability, affordability and acceptability of SUD treatment programs.

The SMART IRB platform: A national resource for IRB review for multisite studies.

Single institutional review board (IRB) review of multisite research increased in frequency over a decade ago with a proliferation of master IRB reliance agreements supporting statewide and regional consortia and disease- and population-specific networks. Although successful, the increasing number of agreements presented significant challenges and illuminated potential benefits of a single, nationwide agreement. Anticipated changes in federal regulations highlighted the need to systematize and simplify IRB reliance. To address these challenges, the NIH National Center for Advancing Translational Sciences funded a project to establish a national IRB reliance network that would support national adoption of single IRB (sIRB) review. The Streamlined, Multisite, Accelerated Resources for Trials (SMART) IRB Platform launched in July 2016 to facilitate dissemination, adoption, and implementation of a collaboratively developed master IRB reliance agreement and supportive tools and resources. More than 580 institutions have joined SMART IRB's Master Common Reciprocal Institutional Review Board Authorization Agreement and begun using the SMART IRB platform to support sIRB arrangements. Here, we describe the tenets of the agreement and operational benefits and challenges of its use. SMART IRB's early success affirms the utility of collaborative, flexible, and centralized approaches to supporting sIRB review while highlighting the need for further national harmonization.

Digital Breast Tomosynthesis: Clinical Operations.

Digital breast tomosynthesis (DBT) is rapidly becoming the standard of care for breast cancer screening. Implementing DBT into practice is relatively straightforward. However, there are important elements of the transition that one must consider to facilitate this process. Understanding the Digital Imaging and Communications in Medicine (DICOM) standard for DBT, as well as how images are displayed, is critical to a successful transition. Standardization of these processes will allow easier transmission of images from facility to facility, and limit the potential for errors in interpretation. Additionally, recent changes in federal regulations will require compliance with mandated training for the radiologist, technologist, and physicist, as well as accreditation for each DBT unit. These regulations aim to ensure high-quality imaging across the country as has been previously seen with standard digital mammography. Synthesized imaging is the most recent improvement for DBT, potentially obviating the need for a simultaneous traditional digital mammogram exposure. Studies have demonstrated near equivalent performance when comparing the combination imaging of DBT and digital mammography versus DBT combined with synthetic imaging. As the quality of the synthetic images continues to improve, it is increasingly likely that it will replace the traditional mammogram. Adherence to DBT-specific parameters will enhance the physician experience and ultimately translate to increased cancer detection and fewer false positive examinations, benefiting all women who are screened for breast cancer.

Today's Hearing Technologies: Definitions, Regulations, Overlaps

Today's Hearing Technologies: Definitions, Regulations, Overlaps

Nursing Home Residents' Legal Access to Onsite Professional Psychosocial Care: Federal and State Regulations Do Not Meet Minimum Professional Social Work Standards.

The federal government holds nursing homes (NHs) responsible for assessing and addressing resident psychosocial needs. The staff person most responsible for psychosocial care planning is the social worker. However, the federal government requires only NHs with 120+ beds to employ one full-time social worker, and that person need not hold a social work degree. We compare/contrast state laws against federal laws and professional standards in terms of the minimum qualifications of NH social workers to determine in which states NH residents are legally entitled to receive services from a professional social work staff member. Qualitative content analysis of language regarding NH social worker qualifications in state (and DC) administrative codes. Twelve states do not address NH social worker qualifications. Up to 25 states appear to be out of federal compliance. Only Maine appears to meet the NASW professional standards. Other states approaching the standards include: Alaska, Arkansas, Connecticut, Illinois, Massachusetts, Minnesota, and West Virginia. The vast majority of the 3 million residents a year served by U.S. NHs are not entitled to social work staff who meet minimum professional standards, despite new federal regulations calling for trauma-informed and culturally competent care planning and the recognition that the needs of residents (including psychosocial needs) have continued to increase over past decades. Changes in federal regulations are recommended so that all NH residents have access to professional psychosocial services provided by a staff person who has earned at least a bachelor's degree in social work and who carries a reasonable caseload.

Sexual misconduct policies and administrator perceptions among 4-year colleges and universities in Georgia

ABSTRACTObjectives: Following changes in federal regulations, the current study was an examination of differences in institutional responses to sexual violence among Georgia colleges and universities during 2013 and 2014. Participants: A total of 24 four-year institutions located in the state of Georgia were included. Method: Data were collected from various sources in phases from March 2013 to December 2015 and included institutional characteristics from each college website, a content analysis of college annual security reports and sexual misconduct policies, and a college administrator online survey. Results: Seventy percent of the institutions were deemed “Clery compliant” in 2013 but only 12%, in 2014. There was substantial variability in definitions used in sexual misconduct policies and with respect to the description of investigation and adjudication procedures. Conclusions: There is extensive variability in institutional responses to sexual violence across universities and colleges despite recent media attention and federal guidance.

The Rise of the Internal Auditor

Internal auditors of large organizations have historically been dominated by managers. Recent changes in federal regulation of financial reporting require managers of publicly held corporations to be dominated by directors. These requirements require a fundamental change in the relationship between managers and internal auditors, and create an expectation of internal auditor objectivity. This paper will describe the history of internal auditing services and objectivity, and identify reasons why internal auditors have not been objective in the past. This history has continuing relevance to agency theory, the rule of law, and governance of publicly held corporations.

Completing the Bridge to Nowhere: Prioritizing Oil and Gas Emissions Regulations in Western States

Completing the Bridge to Nowhere: Prioritizing Oil and Gas Emissions Regulations in Western States

Converting Traditional Defined Benefit Plans to Hybrid Plans:A Decade of Change

Over the past two and a half decades, a number of large employers have converted their traditional defined benefit plans to hybrid plans. Plan conversions are based on employer and employee preferences, and the desirability of hybrid plans depends on economic conditions, the regulatory environment, and legal uncertainty. The authors examine the factors that affected plan sponsors’ decisions to convert traditional DB plans to hybrid plans during years 2000–2009, a period characterized by adverse economic conditions, legal controversies, and regulatory change. They examine the pension choices of Fortune 1000 companies and estimate the likelihood of plan conversions as a function of the financial status of the plan sponsor, pension plan funding, and costs. The timing of plan conversions relative to major changes in federal regulations, specifically the passage of the Pension Protection Act of 2006 and the economic crisis, are explored. Finally, they examine whether the factors that prompted conversions in the early part of the decade were the same as those that prompted similar conversions later in the decade.

Constitutional Change and Responsibilities of Governance Pertaining to the Faith-Based and Community Initiative

This paper, commissioned and published in June 2008 in connection with the White House-sponsored Conference on Innovations in Effective Compassion, addresses the changing legal environment relevant to government partnerships with religious providers of social services. In particular, the paper maps the federal government's regulatory agenda in connection with the Faith-Based and Community Initiative (FBCI) onto the changes in constitutional law over the past several decades. After briefly surveying the key developmental points in the relevant constitutional law, the paper explores specific changes in federal regulations governing aid to religious providers of welfare services, and considers the litigation efforts that have occurred in conjunction with the FBCI. Some of the litigation may be traced, at least in part, to inadequacies in the FBCI's regulatory reform. In addition, the paper provides recommendations for federal and state regulatory language that could be used to facilitate the FBCI while keeping it within constitutional bounds. The paper includes a research bibliography and a table of all litigation that bears on the Initiative.

Beyond Terminology: The Policy Impact of a Grassroots Movement

This article discusses the history of the grassroots movement led by self-advocates and their families to replace the stigmatizing term "mental retardation" with "intellectual disability" in federal statute. It also describes recent and pending changes in federal regulations and policy to adopt the new terminology for Social Security and Medicaid.

Preserving and Enhancing the Responsible Conduct of Research Involving Children and Youth: A Response to Proposed Changes in Federal Regulations and commentaries

Preserving and Enhancing the Responsible Conduct of Research Involving Children and Youth: A Response to Proposed Changes in Federal Regulations and commentaries

Biosimilars: a regulatory perspective from America

Biosimilars are protein products that are sufficiently similar to a biopharmaceutical already approved by a regulatory agency. Several biotechnology companies and generic drug manufacturers in Asia and Europe are developing biosimilars of tumor necrosis factor inhibitors and rituximab. A biosimilar etanercept is already being marketed in Colombia and China. In the US, several natural source products and recombinant proteins have been approved as generic drugs under Section 505(b)(2) of the Food, Drug, and Cosmetic Act. However, because the complexity of large biopharmaceuticals makes it difficult to demonstrate that a biosimilar is structurally identical to an already approved biopharmaceutical, this Act does not apply to biosimilars of large biopharmaceuticals. Section 7002 of the Patient Protection and Affordable Care Act of 2010, which is referred to as the Biologics Price Competition and Innovation Act of 2009, amends Section 351 of the Public Health Service Act to create an abbreviated pathway that permits a biosimilar to be evaluated by comparing it with only a single reference biological product. This paper reviews the processes for approval of biosimilars in the US and the European Union and highlights recent changes in federal regulations governing the approval of biosimilars in the US.

Hidden in plain sight marketing prescription drugs to consumers in the twentieth century.

Although the public health impact of direct-to-consumer (DTC) pharmaceutical advertising remains a subject of great controversy, such promotion is typically understood as a recent phenomenon permitted only by changes in federal regulation of print and broadcast advertising over the past two decades. But today's omnipresent ads are only the most recent chapter in a longer history of DTC pharmaceutical promotion (including the ghostwriting of popular articles, organization of public-relations events, and implicit advertising of products to consumers) stretching back over the twentieth century. We use trade literature and archival materials to examine the continuity of efforts to promote prescription drugs to consumers and to better grapple with the public health significance of contemporary pharmaceutical marketing practices.

‘Dangerous presumptions’: how single‐sex schooling reifies false notions of sex, gender, and sexuality

Due to the recent changes in federal regulations about gender equity in education in the USA, some policy makers have resurrected single‐sex public education. Because single‐sex schooling ignores the complexity of sex, gender, and sexuality, it sets up a ‘separate but equal’ system that is anything but. Discounting the ways in which gender is negotiated, constructed, and performed, and the variability of anatomical sex, current arguments for single‐sex schooling reify the false binaries of sex and gender, rely on assumptions of heteronormativity and, in turn, negate the existence of multiple sexes, genders, and sexual orientations.

Do differences in presidential economic advisers matter?

Using data on members on the Council of Economic Advisors as well as US Treasury secretaries and OMB directors from 1952 through 2005, I investigate the effect of economic advisors’ educational and employment backgrounds on the time series performance of several policy variables. Ivy League advisors appear to raise non-defense government spending, although the size of the impact differs by president. While voter preferences appear to matter for a wider variety of policy variables (changes in federal regulation and marginal tax rates), the share of Ivy League advisors is at least as important as voter preferences in explaining non-defense spending.

Over-the-Counter Hearing Aids

Over-the-Counter Hearing Aids

Pharmacologic treatment of depression in nursing home residents: a mental health services perspective.

Over the past 10 to 15 years, there has been marked progress in clinical research on depression in nursing home residents. There have also been significant changes in federal regulations designed to improve the quality of care. In 1987, only 10% of nursing home residents diagnosed with depression were receiving treatment, but by 1999,25% of all residents were receiving antidepressants. We report on two studies: one demonstrating that treatment for depression has a substantial, ecologically relevant impact in the nursing home and another demonstrating that profound changes have occurred in the clinical epidemiology of depression and its treatment in the nursing home. Although the numbers of nursing home residents receiving antidepressants have increased dramatically, there are now second-generation problems that must be addressed to ensure the delivery of effective treatment. Developing models to ensure quality of care will require focused mental health services research.

Research Consent by Adolescent Minors and Institutional Review Boards

Purpose: A national survey of institutional review boards (IRBs) was conducted to determine: (1) the current practices of IRBs concerning consent for adolescent minors; and (2) the existence of support for changes in the federal regulations for research on adolescents. Methods: Six hundred surveys were mailed in two waves to all IRB chairs in the United States, with the exception of highly specialized institutions. The survey consisted of three sections. Section 1 assessed demographic data, such as institution type; presence of personnel trained in adolescent health; and number of protocols involving adolescents reviewed annually. Section 2 presented a series of twelve scenarios for which respondents stated whether their IRB would waive parental consent under present federal regulations. These scenarios varied the sensitivity of information and procedural invasiveness, and ranged from simple satisfaction surveys to experimental drug treatment for AIDS. Section 3 assessed whether respondents would recommend changes in current federal regulations that would enable adolescent minors to provide their own consent to research participation. To this end, respondents indicated whether minor consent alone is sufficient or if parental consent should be required for 10 general research categories that paralleled the level of invasiveness of the scenarios presented in Section 2. Results: Two hundred and thirty-three surveys (39%) were returned and 183 (30%) were fully scorable. Within group comparisons for IRBs were conducted using Chisquare statistics. Seventy percent of respondent IRBs required parental consent for all research on minors, and IRBs reviewing more than 10 adolescent protocols per year were less likely to require parental consent ( p < .01). Responses did not differ by institution type or presence of personnel trained in adolescent health. Fifty-two percent of respondent IRBs required parental consent for a simple satisfaction survey, and only 29% of IRBs would waive parental consent for an anonymous HIV seroprevalence study. Over one-half of IRBs supported changes in regulations that would enable minors to provide informed self-consent for seven of 10 general research categories: anonymous surveys (supported by 93%), research involving sensitive material if nothing more than survey (89%) or venipuncture (53%) were involved, and research on diseases for which minors may consent to treatment including survey (93%), venipuncture (68%), or medication approved for use in pediatric patients (57%). Conclusion: Even though IRBs practice under the same federal regulations there is a broad spectrum of interpretation. Considerable support exists for changing the guidelines for certain categories of research involving adolescents. Federal regulations need to be clarified for meaningful and necessary research on adolescents to take place.

Emerging Solder Technologies

Sweeping changes in federal regulations concerning solder assembly of electronic circuitry have stimulated considerable effort to find new and environmentally acceptable materials and processes. This work has led to solvents that are effective and efficient in removing flux residues from the surfaces of assembled printed wiring boards. Cleaning technologies are described that use recyclable solvents, such as supercritical CO2, and no solvents at all, such as laser ablative cleaning. Fluxless soldering with lasers is shown to be an attractive process for certain product applications. The results of a study designed to evaluate the reliability of circuits soldered with the use of “low solids “fluxes are presented along with initial results of a large effort to develop Pb-free alloys for soldering. Advanced soldering technologies, such as laser soldering, are discussed and results from continuing efforts in this area are presented.