scholarly journals NIH policy: Mandate goes too far

Nature ◽  
2014 ◽  
Vol 510 (7505) ◽  
pp. 340-340 ◽  
Author(s):  
R. Douglas Fields
Keyword(s):  
Nih Policy ◽  
Policy Mandate

Current Views on the Nature and Origins of Central Banks

2019 ◽  
pp. 8-29
Author(s):  
Ulrich Bindseil
Keyword(s):  
Nineteenth Century ◽  
Commercial Banks ◽  
Recent Literature ◽  
Central Banks ◽  
Central Banking ◽  
Lender Of Last Resort ◽  
Bank Of England ◽  
Policy Mandate

Chapter 1 first restates the present dominant view on the nature and origin of central banking, which can be summarized as follows: (1) Defining central banking is ‘by no means straightforward’; (2) the Riksens Ständers Bank and the Bank of England would have been the first sort-of central banks; (3) early central banks did not have a policy mandate and the orientation towards public objectives would go back only to the nineteenth century; (4) there has been no concept of central banking before 1800; (5) early central banking developed out of the largest commercial banks; (6) the lender of last resort (LOLR) would have developed only in the second half of the nineteenth century or even later. Second, the chapter reviews a recent literature which started again to question this view. It is explained how this book will take up the challenge to correct the myth about the origins of central banking.

Researcher Knowledge, Attitudes, and Communication Practices for Genomic Data Sharing

2020 ◽  
pp. 155626462096930
Author(s):  
Heather P. Nick ◽  
Kelsey Kehoe ◽  
Amanda Gammon ◽  
Jorge L. Contreras ◽  
Kimberly A. Kaphingst
Keyword(s):  
Data Sharing ◽  
Pediatric Patients ◽  
Genomic Data ◽  
Basic Knowledge ◽  
Structured Interviews ◽  
Principal Investigators ◽  
Qualitative Thematic Analysis ◽  
Communication Practices ◽  
Nih Policy ◽  
Cancer Studies

This study examines knowledge, attitudes, and communication practices toward genomic data sharing among principal investigators and research coordinators engaged in cancer and non-cancer studies. We conducted 25 individual semi-structured interviews and conducted a qualitative thematic analysis. Most interviewees had basic knowledge of data sharing requirements, but lacked specific details of recent changes to NIH policy. Principal investigators perceived more risks to participants for data sharing than the research coordinators who generally obtained consent. Interviewees perceived a trend toward providing fewer data sharing options to participants in the consent process, and had observed that parents of pediatric patients asked more questions than adult patients. Our findings highlight potential areas for improvement related to data sharing during consent processes.

scholarly journals 2557 Improving ClinicalTrials.gov compliance: A coordinated effort for success

2018 ◽  
Vol 2 (S1) ◽  
pp. 83-83
Author(s):  
Scott Patton ◽  
Elaine Basaca ◽  
Jennifer S. Brown
Keyword(s):  
Clinical Trial ◽  
Department Chairs ◽  
Compliance Rate ◽  
Research Quality ◽  
Stanford University ◽  
Senior Leadership ◽  
Associate Dean ◽  
Results Reporting ◽  
Nih Policy ◽  
High Degree

OBJECTIVES/SPECIFIC AIMS: ClinicalTrials.gov (CTgov) compliance has received much international attention as a significant regulatory, scientific, and ethical responsibility. Compliance rates for both industry and academia are held up for scrutiny by transparency advocates, but solutions for achieving compliance in academia have proven to be—because of its focus on innovation and multiple disciplines—significantly more complex than those employed by industry. Added challenges for academic medical centers (AMCs) are both increased researcher responsibilities under the new NIH Policy on Clinical Trial Dissemination and system-wide changes to requirements for “clinical trial only” Funding Opportunity Announcements. At Stanford University, a multifaceted approach toward improving CTgov outreach, education, and reporting led to a dramatic turnaround in compliance over 17-month period. METHODS/STUDY POPULATION: Stanford University School of Medicine’s Senior Associate Dean for Research and PI of Stanford’s CTSA applied a 3-part strategy to address unacceptable rates of results reporting. The strategy included (1) regular compliance reports to department chairs, (2) establishment of a central office, Clinical Research Quality (CRQ), to provide consistent training and support, and (3) interdepartmental cooperation across the school and university. Compliance reports, identifying all studies late for results reporting were sent monthly to all department chairs, with heightened focus on departments that conduct the most clinical trials. Senior leadership described the process in executive meetings and set improvement goals. Reports included multiple data points to help departments mobilize resources and identify trends; half-way through the period, soon-to-be late study records were included. CRQ hired 2 fulltime employees tasked with all aspects of managing the CTgov process and designed a portfolio of activities including: (1) a master list of all Stanford studies in the CTgov system; (2) a process for generating and distributing monthly reports; (3) an education program; and (4) support services, including an administrator working group. RESULTS/ANTICIPATED RESULTS: Since December 2015, Stanford has had the second-highest compliance rate improvement out of the 20 schools of medicine that receive the most NIH funding (+ 62%). DISCUSSION/SIGNIFICANCE OF IMPACT: Managing ClinicalTrials.gov compliance requires a high degree of technical knowledge of regulations, NIH policy, and the CTgov system. But without an equally high degree of engagement from senior leadership, results would not have been achieved. Central resources are critical to set policy and establish consistent processes, but without regular and repeated interactions between faculty, a multitude of administrators and staff, more central resources would have been required. By working simultaneously “down from the top” and “up from the bottom,” communication and education expanded rapidly, ineffective efforts were quickly transformed, and what began as an irritating and cumbersome problem became an occasion for collaboration and celebration of increased transparency.

Leading the way: The National Cancer Institute’s (NCI) single IRB for multi-site research.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e18259-e18259
Author(s):  
Holly A. Massett ◽  
Jacqueline Goldberg ◽  
Sharon Hampp ◽  
Margaret M. Mooney ◽  
Brian Campbell ◽  
...  
Keyword(s):  
Late Phase ◽  
National Level ◽  
Lessons Learned ◽  
Successful Implementation ◽  
Noticeable Effect ◽  
Help Desk ◽  
New Model ◽  
Nih Policy ◽  
Time Required ◽  
Total Accrual

e18259 Background: NCI instituted a Central IRB (CIRB) with voluntary participation in 2001 for its late-phase trials and demonstrated that efficiency could be improved and costs reduced (Wagner et al JCO, 2010; 28). As a forerunner to the new NIH policy for single IRBs for all NIH multi-site trials (Hudson et al. JAMA Oct 4, 2010), NCI implemented a new CIRB model in 2014 where the CIRB was the IRB of record. We report adoption data of the new model within NCI’s National Clinical Trials Network (NCTN) and lessons learned from the rollout. Methods: We reviewed: Annual CIRB participant data from 2013-2016; site/accrual data for late phase trials activated between 2013-2016 (N = 64) via CIRB or local IRBs; and data from CIRB reports to identify acceptance and lessons learned. We compared time required for CIRB protocol reviews via the new model to baseline measures in the literature. Results: Of the 2,300 U.S. NCTN sites, the percentage of participation went from 47% in 2013, to 74% (2014), 79% (2015), and 81% (2016). For activated trials, a median of 43% of sites used their local IRB in 2013, dropping to 18% in 2014, 5% in 2015, and only 1% in 2016; i.e., 99% of sites opening trials in 2016 did so using the CIRB. Annual accrual to NCTN trials remained steady through the CIRB adoption; CIRB sites represented a median of 56% of total accrual in 2013 increasing to 87% in 2016. Help-desk and survey data indicate increased acceptance and a reduction of concerns over the 3 years. Previous analyses prior to 2013 reported a median of 70-123 days required from protocol application receipt to final CIRB approval; the new model reports a median of 41 days in 2016. Conclusions: NCI has demonstrated that a single IRB for multi-site trials is not only viable but valuable. Its new CIRB model rollout over 3 years has resulted in a doubling of site adoption, high utilization rates, further efficiencies, and overall acceptance, with no noticeable effect on overall NCTN accrual. Our experiences provide important lessons learned and insights into the successful implementation of a single IRB at a national level, and support the feasibility of NIH’s recently finalized policy requiring all sites to use a single IRB for multi-site research.

Has Inflation Persistence Changed under EMU?

2012 ◽  
Vol 13 (1) ◽  
pp. 86-102 ◽  
Author(s):  
Peter Tillmann
Keyword(s):  
European Monetary Union ◽  
New Keynesian ◽  
European Monetary ◽  
Price Inflation ◽  
Inflation Persistence ◽  
European Central ◽  
Persistence Properties ◽  
Keynesian Model ◽  
Rolling Window ◽  
Policy Mandate

Abstract This paper analyzes the persistence of inflation in the euro area and, in particular, whether the persistence properties have changed since the start of European Monetary Union(EMU). For that purpose, we compare pre- and post-EMU inflation persistence, use rolling-window estimates of persistence, and apply tests specifically designed to detect break dates near the end of the sample period. In contrast to previous research, we find that inflation persistence has fallen significantly since the start of EMU. Persistence of consumer price inflation, which is central to the European Central Bank’s policy mandate, has fallen more than the persistence of deflator inflation. The drop in inflation persistence is consistent with the results from a simulated small New Keynesian model with a shift toward a more aggressive monetary policy stance.

Revisiting (or Sharpening) Our Policy Mandate

Fisheries ◽  
2017 ◽  
Vol 42 (5) ◽  
pp. 248-248 ◽  
Author(s):  
Thomas E. Bigford
Keyword(s):  
Policy Mandate

Environmental and Energy Policy

2020 ◽  
pp. 425-444
Author(s):  
Brian Black
Keyword(s):  
Climate Change ◽  
United States ◽  
Energy Management ◽  
New Technologies ◽  
Environmental Policies ◽  
The United States ◽  
First Century ◽  
Environmental Concerns ◽  
New Paradigm ◽  
Policy Mandate

This chapter explores the interrelated nature of the environmental and energy policies in the United States, particularly since 1900. As new technologies made new sources of energy viable, formal and informal political arrangements and laws were used to prioritize the United States’ ability to acquire necessary supplies. During the twentieth century, the essential need for energy has defined the concept of geopolitics and even served as a rationale for war. By the 1970s and 1980s, a separate policy mandate moved environmental concerns into formal local and federal politics. Although these applications of policy developed distinct from one another, a general chronology of their development from 1900 to the present demonstrates the growing interplay between environmental policy and energy management. In the twenty-first century, a new paradigm of economic development has moved energy and environmental policies together to wrestle with complex issues, including the sustainability of energy supplies and climate change.

Through growth to achievement: Examining edtech as a solution to Australia’s declining educational achievement

2020 ◽  
Vol 18 (8) ◽  
pp. 1026-1043 ◽  
Author(s):  
Rachel Buchanan
Keyword(s):  
Continuous Improvement ◽  
Educational Achievement ◽  
Personalized Learning ◽  
Growth Mindset ◽  
Continuous Assessment ◽  
Educational Disadvantage ◽  
Government Report ◽  
Key Aspects ◽  
Constant Improvement ◽  
Policy Mandate

In many educational jurisdictions, school systems are striving to demonstrate constant improvement. In Australia, the latest iteration of this concern is represented by the recent federal government report, Through growth to achievement. The report offers a number of recommendations to address declining achievement in Australian schooling. Pulling together scholarship on policy and educational technology I provide an analysis of key aspects of this report. This analysis draws attention to three salient features of the report: continuous assessment for continuous improvement; education as personalized learning; and growth mindset as a policy mandate. I explore the implications for schooling in Australia if these features were to be taken up. Analysis indicates that Australia could undergo significant change: teaching would be reconstituted as a process of continuous assessment; processes of personalized learning would lead to algorithmically tethered educative opportunities based upon students’ previous achievement and choices; and learners would be reshaped by technologies of persuasion. Given that educational jurisdictions globally are increasingly advocating for these types of educational solutions, this research is valuable as it provides a basis for further critique of such technologies being proffered as a panacea for educational disadvantage.

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