Top Takeaways from the Common Rule Amendments
In: Hodge, JG, Arnold S, Wetter S. Top take-aways from the Common Rule amendments. Jurist; Feb. 19, 2017
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In: Hodge, JG, Arnold S, Wetter S. Top take-aways from the Common Rule amendments. Jurist; Feb. 19, 2017
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In: U of Houston Law Center No. 2012-W-4
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In: Ethics & human research: E&HR : a publication of the Hastings Center, Band 41, Heft 3, S. 36-38
ISSN: 2578-2363
In: The independent review: journal of political economy, Band 11, Heft 4, S. 547-564
ISSN: 1086-1653
Though it is agreed that some biomedical scientific research on human subjects must be externally monitored, the degree to which the government should be involved in this process is an open question. Evaluated here is the monitoring of such research by Institutional Review Boards (IRBs), arguing that the protection afforded research subjects by IRB regulation is far outweighed by the costs of implementing the program. The devolutionary process by which public institutions co-opt & "mindlessly expand" successful programs such that they can no longer perform their original functions -- mission drift -- is expanded here to include a deliberate, "nefarious" motive in co-opting such programs -- "mission creep." The history of mission creep over the past 30 years of government-sponsored IRB programs is chronicled & conceptual problems with IRBs are identified. The concepts of biomedical & behavior risk are explicated, & IRB interpretations of such risks are critiqued. Alternatives to the bureaucratic control exercised by IRBs that could truly protect research subjects -- particularly those in vulnerable populations -- are explored. References. K. Hyatt Stewart
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Working paper
The Common Rule is a set of ethical principles that provide guidance on the management of human subjects taking part in biomedical and behavioral research in the United States. The elements of the Common Rule were initially developed in 1981 following a revision of the Declaration of Helsinki in 1975. Most academic facilities follow the Common Rule in the regulation of clinical trials research. Recently, the government has suggested a revision of the Common Rule to include more contemporary and streamlined oversight of clinical research. In this commentary, the leadership of the Society for Immunotherapy of Cancer (SITC) provides their opinion on this plan. While the Society recognizes the considerable contribution of clinical research in supporting progress in tumor immunotherapy and supports the need for revisions to the Common Rule, there is also some concern over certain elements which may restrict access to biospecimens and clinical data at a time when high throughput technologies, computational biology and assay standardization is allowing major advances in understanding cancer biology and providing potential predictive biomarkers of immunotherapy response. The Society values its professional commitment to patients for improving clinical outcomes with tumor immunotherapy and supports continued discussion with all stakeholders before implementing changes to the Common Rule in order to ensure maximal patient protections while promoting continued clinical research at this historic time in cancer research.
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Working paper
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In: Journal of mechanism and institution design: JMID, Band 8, Heft 1, S. 57-74
ISSN: 2399-8458
This paper considers common use of natural, renewable resources. It identifies good prospects for efficiency and welfare. To be precise, a core outcome -- hence cooperation -- can be secured over time by principal planning of total quotas, and in time by agents who share these in short-term markets. Information flows in two directions: to the principal as market prices and from him as total quantities. Of particular interest is eventual convergence to a golden-rule, steady state.
This chapter tells the story of how the UCD Common Rules were changed in the late 1980s to allow all UCD staff members to join, regardless of their occupation. As membership had been confined to academics and senior administrative staff, this was a significant achievement. After much debate and many meetings from 1985-87, the decision to democratise the Common Room was made at an AGM on March 12th 1987. The meeting was attended by 100 members of whom 77 voted to make to open up the Common Room.
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In: http://hdl.handle.net/2027/uc1.aa0005632435
Cover title: Rules, orders, and forms of proceeding of the House of Commons, Canada, 1906. ; Mode of access: Internet.
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In: Parliamentary journal, Band 43, Heft 4, S. 141-144
ISSN: 0048-2994
Despite the great importance and final success of the convergence process that led to the establishment of the European Monetary Union, there is no clear agreement regarding the monetary policy pursued in the member countries during the convergence process. This paper contributes to the literature with an empirical analysis of the period from 1993 to 1998 that encompasses eleven EMU countries. In particular, Taylor type interest rate rules are estimated with monthly national data to find that, despite certain similarities and exceptions, the rule followed by each country is distinct and differs substantially from the standard Taylor rule. However, for most countries, the parameter estimates reflect the principles proclaimed by the monetary policy authorities and, in addition, it is shown that in most cases the estimated rules reproduce the policy setting quite closely.
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In: ECB Working Paper No. 659
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