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Kelley A.,Review-Board | Kelley A.,University of North Carolina at Greensboro | Belcourt-Dittloff A.,Review-Board | Belcourt-Dittloff A.,University of Montana | And 2 more authors.
American Journal of Public Health | Year: 2013

Institutional review boards (IRBs) function to regulate research for the protection of human participants. We share lessons learned from the development of an intertribal IRB in the Rocky Mountain/Great Plains Tribal region of the United States. We describe the process through which a consortium of Tribes collaboratively developed an intertribal board to promote community-level protection and participation in the research process. In addition, we examine the challenges of research regulation from a Tribal perspective and explore the future of Tribally regulated research that honors indigenous knowledge and promotes community accountability and transparency. We offer recommendations for researchers, funding agencies, and Tribal communities to consider in the review and regulation of research.


Unguru Y.,Herman and Walter Samuelson Childrens Hospital at Sinai | Unguru Y.,Johns Hopkins University | Sill A.M.,Center for Biostatistics and Informatics | Kamani N.,Review-Board | Kamani N.,Center for Cancer and Blood Disorders
Pediatrics | Year: 2010

BACKGROUND: Most children with cancer enroll in clinical research trials. Whenever possible, children must provide their assent before enrolling in research studies. We studied what children aged 7 to 18 with cancer understand about research, their research-related treatment, and their preferences for inclusion in decision-making. PROCEDURE; Thirty-seven face-to-face, audiorecorded interviews using a novel, semi-structured tool, the quality-of-assent instrument, were conducted. Exploratory univariate and bivariate analyses of the quantitative data elucidated patterns and trends of understanding and preferences. RESULTS: Nineteen of the 37 children (51%) did not know or recall that their treatment was considered research, and 19 of 22 (86%) did not understand their doctor when he or she discussed the trial. More children enrolled in trials to help future children with cancer (27 of 37 [73%]), than to get better personally (22 of 37 [60%]). Irrespective of age, children with Hodgkin's disease, germ-cell tumors, and leukemia had significantly greater research awareness and appreciation than children with other cancers (P = 019 and P < 001, respectively). Although all children wanted to be involved in decision-making, 18 of 37 (49%) did not have or recall having a role in deciding to enroll in their trial, and 14 of 37 (38%) did not feel free to dissent to trial enrollment. Only 4 of 37 children (11%) discussed increased decision-making roles with parents, and only 7 of 37 (19%) discussed them with their doctors. CONCLUSIONS: Most children have limited understanding of research despite physicians' explanations. Many children reported that they feel minimally involved in the decision to enroll in clinical trials. Tools to assist investigators ascertain that children understand what they are agreeing to when they assent to research and to determine their preferences for inclusion in research may help make assent more meaningful.


Kowalski C.J.,Review-Board
Perspectives in Biology and Medicine | Year: 2010

It is widely accepted that if one is to follow the ethical tenets of clinical equipoise, phase III controlled clinical trials must be designed pragmatically, to measure effectiveness rather than efficacy. This choice of a pragmatic rather than an explanatory approach to phase III clinical trial design has a number of consequences, some of which may be considered problematic. These include changes in what the trial is expected to accomplish, the way treatments are defined, the selection of subjects, the ways in which treatments are compared, and the assessment of the results. One also may end up challenging the real-world expectation that scientific results will be replicated before they are considered valid. This article discusses the connection between clinical equipoise and pragmatic trials, contrasts explanatory with pragmatic trials, points to the differences in the ways in which trial data are analyzed and interpreted, and discusses the power of replication, one of the defining hallmarks of the scientific method. Viewing clinical equipoise through a consequentialist lens reveals a number of problems many of which are attributable to equipoise's insistence on a pragmatic approach to trial architecture. © 2010 by The Johns Hopkins University Press.


Grimmsmann T.,Review-Board | Himmel W.,University of Gottingen
European Journal of Clinical Pharmacology | Year: 2011

Purpose: Defined daily doses (DDD) are used for the measurement of drug utilisation. The aim of the study was to analyse whether differences between DDD and prescribed daily doses (PDD) exist for relevant drug classes such as antihypertensive drugs and, if so, whether they primarily depend on drug classes or patient-related factors. Methods: Using the data of a large German statutory health insurance scheme, we analysed continuous prescriptions for the following antihypertensive drug classes: thiazide diuretics, beta-blockers, dihydropyridine calcium channel blockers (CCBs), angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin-II receptor blockers (ARBs). We summed the doses of all dispensed drugs per person during a defined time frame. We calculated the PDD (= total dose divided by the number of days) and expressed them as the PDD:DDD ratio (= amount of DDD per day and person). Results: During the study period, 149,704 patients continuously received an antihypertensive medication. The average PDD:DDD ratio ranged from 0.84 (beta-blockers) to 1.88 (ARBs) and 2.17 (ACEIs). The average prescribed dosage of each drug class remained unchanged, even if the patients had previously received another antihypertensive drug with another PDD:DDD ratio. For example, if patients were switched from a beta-blocker to an ACEI, the PDD:DDD ratio increased, on average, from 0.79 to 2.17. Vice versa, the ratio decreased for patients with a drug change from an ACEI to a beta-blocker from 2.06 to 0.75. Conclusions: Even large differences between DDD and PDD seem to be a matter of drug classes and not primarily of patient characteristics. © 2011 The Author(s).


Lenk C.,Review-Board
Current Drug Targets | Year: 2012

Since more than 35 years, the international medical scientific community tries to solve the problem of the offlabel use of paediatric drugs. The aim is simple, but ambitious: to supply children and adolescents with effective drugs, as safe as possible, with known and well-documented side effects, and with accurate and up-to-date information on dosage and administration form. However, despite the significant efforts of paediatricians, researchers and international health politics, a number of severe obstacles for the optimal supply of children and adolescents with safe drugs remain. The detailed analysis of the problem shows not only a still remaining lack of medical knowledge, but also persistent weaknesses in the ethical, legal, medical, pharmacological, and political practices that surround the phenomenon of off-label use in paediatrics. The article gives an overview about the remaining difficulties in the field of paediatric off-label medication with special consideration to ethical and regulatory questions. © 2012 Bentham Science Publishers.


Ehrlich A.,Review-Board
Impact Assessment and Project Appraisal | Year: 2010

Four environmental assessments of small uranium exploration projects in Canada's Northwest Territories resulted in recommendations to reject the projects. This result was based on potential cultural impacts of a cumulative nature, due largely to the spiritual significance of the setting in which the projects were proposed. A broad weighing of evidence with respect to reasonably foreseeable future developments played a role in these rejections. Four lessons of broad applicability to EIA practitioners are offered. One of these is: It is the scale of the issues, not the scale of the project, which may matter most. © IAIA 2010.


Grimmsmann T.,Review-Board | Himmel W.,University of Gottingen
European Journal of Clinical Pharmacology | Year: 2014

Purpose: To study drug persistence for antihypertensive treatment considering typical patient behaviour including extended drug holidays or irregular repeat prescriptions. Methods: We used prescription data from a German statutory health insurance to follow up patients for 4 years. Medication persistence was defined as the continued use of a specific drug class, therapy persistence as the continued use of any antihypertensive drug. We applied 2 different interval criteria within which a repeat prescription had to be issued: 180 and 360 days. Results: A total of 9,513 patients started an antihypertensive therapy between 2006 and 2008. Applying the 180-day (360-day) interval criterion, 28 % (66 %) of the patients starting therapy with a beta-blocker were still medication-persistent after 4 years. The rates were similar for angiotensin-II receptor blockers (ARBs; 30 % and 69 % respectively) or angiotensin-converting enzyme (ACE) inhibitors (28 % and 61 % respectively). Looking at therapy persistence, these rates were 44 % (79 %) when an ACE inhibitor was the initial drug, 46 % (82 %) for ARBs. On average, even of those who were defined as therapeutically persistent with the 360 days criterion, half received a repeat prescription within 96 days, three quarters within 131 days - with a median supply of 1.2 units per day and 1.25 defined daily doses. Conclusion: By applying more patient-orientated criteria, we found that many patients were therapy-persistent and received a prescription at the appropriate time. Therapy persistence was nearly independent of the initial agent; thus, drug persistence may not be an argument in favour of choosing a certain drug as a first-line option. © 2013 Springer-Verlag Berlin Heidelberg.


Niederstadt C.,Review-Board | Droste S.,Institute for Quality and Efficiency in Healthcare IQWiG
International Journal of Technology Assessment in Health Care | Year: 2010

Background: Information retrieval (IR) in health technology assessment (HTA) calls for transparency and reproducibility, but common practice in the documentation and presentation of this process is inadequate in fulfilling this demand. Objectives: Our objective is to promote good IR practice by presenting the conceptualization of retrieval and transcription readable to non-information specialists, and reporting of effectively processed search strategies. Methods: We performed a comprehensive database search (04/2010) to synthesize the current state-of-the-art. We then developed graphical and tabular presentation methods and tested their feasibility on existing research questions and defined recommendations. Results: No generally accepted standard of reporting of IR in HTA exists. We, therefore, developed templates for presenting the retrieval conceptualization, database selection, and additional hand-searching as well as for presenting search histories of complex and lengthy search strategies. No single template fits all conceptualizations, but some can be applied to most processes. Database interface providers report queries as entered, not as they are actually processed. In PubMed, the huge difference between entered and processed query is shown in Details. Quality control and evaluation of search strategies using a validated tool such as the PRESS checklist is suboptimal when only entry-query based search histories are applied. Conclusions: Moving toward an internationally accepted IR reporting standard calls for advances in common reporting practices. Comprehensive, process-based reporting and presentation would make IR more understandable to others than information specialists and facilitate quality control. Copyright © Cambridge University Press 2010.


Every nation that has adopted a strategy for the long-term management of its high-level radioactive waste (HLW) and spent nuclear fuel (SF) has opted for disposal in a deep-mined, geological repository. Identifying a site for such a facility has proven to be a technical and social challenge. Over the last 50 years, both challenges have been met (at least so far) in only three out of the ten countries that have tried. This historical experience makes clear how important it is to gain social acceptability for a site's selection: such acceptability is a prerequisite for policymaking in democratic societies. The inability to gain social acceptability has proven to be the Achilles' heel for most efforts to choose a repository site. © 2016 by the Mineralogical Society of America.


Decuir J.,Review-Board
IEEE Consumer Electronics Magazine | Year: 2014

In 2010, the bluetooth special interest group published their Core Specification 4.0, including Bluetooth Low-Energy (BLE) technology, or Bluetooth Smart. This short-range radio breaks technical ground: it can run for years on batteries or scavenged power. It is a leading candidate to connect the "Internet of Things." This was updated to Core Specification v4.1 in late 2013 [1]. For more details, including reasons for decisions, see Bluetooth Low Energy, The Developers Handbook [2]. © 2014 IEEE.

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