Do National and International Ethics Documents Accord With the Consent Substitute Model for Emergency Research?

In 2010 Largent, Wendler and Emanuel proposed the ‘consent substitute model’ for emergency research with incapacitated participants. The model provides a means to enroll participants in emergency research without consent, if five conditions are met: (1) the research addresses the patients’ urgent medical needs (2) the risk‐benefit ratio is favorable (3) there are no known conflicts with patients’ values or interests (4) cumulative net risk is minimal and (5) consent is given as soon as possible. We review national and international ethics laws, regulations and guidelines to determine (a) whether they accord with the consent substitute model’s five conditions and (b) the level of congruence across these documents. We find that only one document meets all five conditions and that there is significant disparity among the documents, particularly between national and international ones. These differences may have stymied international collaboration in emergency research. We recommend that the two international documents used most, the International Council for Harmonisation’s Guideline for Good Clinical Practice and the World Medical Association’s Declaration of Helsinki, are revised to include more specific provisions on emergency medical research

Re‐conceptualization of scientific literacy in South Korea for the 21st century

As the context of human life expands from personal to global, a new vision of scientific literacy is needed. Based on a synthesis of the literature and the findings of an online survey of South Korean and US secondary science teachers, we developed a framework for scientific literacy for South Korea that includes five dimensions: content knowledge, habits of mind, character and values, science as a human endeavor, and metacognition, and self‐direction. The framework was validated by international science educators. Although the names of these dimensions sound familiar, the framework puts a new perspective on scientific literacy by expanding and refining each dimension, stressing integrated understanding of big idea and the importance of character and values, adding metacognition, and emphasizing global citizenship. Twenty‐first century citizens need integrated understanding of the big ideas of science and habits of mind such as systematic thinking and communications. They also need to realize that science is a human endeavor that changes, as new evidence is uncovered. However, these aspects of scientific literacy provide only a partial picture. Scientific literacy should also emphasize character and values that can lead learners to make appropriate choices and decisions to ensure a sustainable planet and provide all people with basic human rights. Individuals will also need to develop metacognitive skills in order interpret new complex scientific information and know when they need additional information. Although this framework was developed primarily for South Korea, a new vision of scientific literacy that is applicable for K‐12 has the potential to spur the development of new standards, curriculum materials, instructional practices, professional development and assessments, and dialog across nations. © 2011 Wiley Periodicals, Inc., Inc. J Res Sci Teach 48: 670–697, 2011Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/87123/1/20424_ftp.pd

Scientific and Legal Perspectives on Science Generated for Regulatory Activities

This article originated from a conference that asked “Should scientific work conducted for purposes of advocacy before regulatory agencies or courts be judged by the same standards as science conducted for other purposes?” In the article, which focuses on the regulatory advocacy context, we argue that it can be and should be. First, we describe a set of standards and practices currently being used to judge the quality of scientific research and testing and explain how these standards and practices assist in judging the quality of research and testing regardless of why the work was conducted. These standards and practices include the federal Information Quality Act, federal Good Laboratory Practice standards, peer review, disclosure of funding sources, and transparency in research policies. The more that scientific information meets these standards and practices, the more likely it is to be of high quality, reliable, reproducible, and credible. We then explore legal issues that may be implicated in any effort to create special rules for science conducted specifically for a regulatory proceeding. Federal administrative law does not provide a basis for treating information in a given proceeding differently depending on its source or the reason for which it was generated. To the contrary, this law positively assures that interested persons have the right to offer their technical expertise toward the solution of regulatory problems. Any proposal to subject scientific information generated for the purpose of a regulatory proceeding to more demanding standards than other scientific information considered in that proceeding would clash with this law and would face significant administrative complexities. In a closely related example, the U.S. Environmental Protection Agency considered but abandoned a program to implement standards aimed at “external” information

The decreased molar ratio of phytate:zinc improved zinc nutriture in South Koreans for the past 30 years (1969-1998)

For the assessment of representative and longitudinal Zn nutriture in South Koreans, Zn, phytate and Ca intakes were determined using four consecutive years of food consumption data taken from Korean National Nutrition Survey Report (KNNSR) every 10 years during 1969-1998. The nutrient intake data are presented for large city and rural areas. Zn intake of South Koreans in both large city and rural areas was low during 1969-1988 having values between 4.5-5.6 mg/d, after then increased to 7.4 (91% Estimated Average Requirements for Koreans, EAR = 8.1 mg/d) and 6.7 mg/d (74% EAR) in 1998 in large city and rural areas, respectively. In 1968, Zn intake was unexpectedly higher in rural areas due to higher grain consumption, but since then until 1988 Zn intake was decreased and increased back in 1998. Food sources for Zn have shifted from plants to a variety of animal products. Phytate intake of South Koreans during 1969-1978 was high mainly due to the consumption of grains and soy products which are major phytate sources, but decreased in 1998. The molar ratios of phytate:Zn and millimmolar ratio of phytate×Ca:Zn were decreased due to the decreased phytate intake in South Koreans, which implies higher zinc bioavailability. The study results suggest that Zn nutriture has improved by increased dietary Zn intakes and the decreased molar ratio of phytate:Zn in South Koreans in both large city and rural areas

Nanotechnology, governance, and public deliberation: What role for the Social Sciences?

In this article we argue that nanotechnology represents an extraordinary opportunity to build in a robust role for the social sciences in a technology that remains at an early, and hence undetermined, stage of development. We examine policy dynamics in both the United States and United Kingdom aimed at both opening up, and closing down, the role of the social sciences in nanotechnologies. We then set out a prospective agenda for the social sciences and its potential in the future shaping of nanotechnology research and innovation processes. The emergent, undetermined nature of nanotechnologies calls for an open, experimental, and interdisciplinary model of social science research

Linguistic challenges faced by rural Tshivenda-speaking teachers when Grade 4 learners transition to English

The general complaint of teachers in rural monolingual communities is that teaching becomes problematic after learners are promoted to Grade 4. While the transition to a next academic phase places new cognitive demands on the learners, they must also adjust to being taught in English after 3 years of mother tongue education. This qualitative case study was underpinned by Krashen’s theory of second-language acquisition which emphasises the importance of exposure to and interaction in the target language. Six Grade 4 teachers who are mother tongue speakers of Tshivenda and two curriculum advisors participated in the study. Data were collected through individual interviews and classroom observations. Initially, it was assumed that the transition was problematic, because learners’ English proficiency was inadequate, but teachers too struggled to impart academic content to Grade 4 learners and relied heavily on code switching. This strategy contributed to learners’ understanding of content, but militated against any improvement in their English. The remoteness of this rural monolingual community implies a limited exposure to the target language, but ought not to be reckoned an excuse. Means to build teachers’ linguistic confidence and improve their oral proficiency during initial teacher preparation as well as greater in-service support should ameliorate the transition for learners. A revision of the mother tongue Foundation Phase curriculum and monitored implementation is advisable

Systematic Review of Potential Health Risks Posed by Pharmaceutical, Occupational and Consumer Exposures to Metallic and Nanoscale Aluminum, Aluminum Oxides, Aluminum Hydroxide and Its Soluble Salts

Aluminum (Al) is a ubiquitous substance encountered both naturally (as the third most abundant element) and intentionally (used in water, foods, pharmaceuticals, and vaccines); it is also present in ambient and occupational airborne particulates. Existing data underscore the importance of Al physical and chemical forms in relation to its uptake, accumulation, and systemic bioavailability. The present review represents a systematic examination of the peer-reviewed literature on the adverse health effects of Al materials published since a previous critical evaluation compiled by Krewski et al. (2007). Challenges encountered in carrying out the present review reflected the experimental use of different physical and chemical Al forms, different routes of administration, and different target organs in relation to the magnitude, frequency, and duration of exposure. Wide variations in diet can result in Al intakes that are often higher than the World Health Organization provisional tolerable weekly intake (PTWI), which is based on studies with Al citrate. Comparing daily dietary Al exposures on the basis of “total Al”assumes that gastrointestinal bioavailability for all dietary Al forms is equivalent to that for Al citrate, an approach that requires validation. Current occupational exposure limits (OELs) for identical Al substances vary as much as 15-fold. The toxicity of different Al forms depends in large measure on their physical behavior and relative solubility in water. The toxicity of soluble Al forms depends upon the delivered dose of Al+ 3 to target tissues. Trivalent Al reacts with water to produce bidentate superoxide coordination spheres [Al(O2)(H2O4)+ 2 and Al(H2O)6 + 3] that after complexation with O2•−, generate Al superoxides [Al(O2•)](H2O5)]+ 2. Semireduced AlO2• radicals deplete mitochondrial Fe and promote generation of H2O2, O2 • − and OH•. Thus, it is the Al+ 3-induced formation of oxygen radicals that accounts for the oxidative damage that leads to intrinsic apoptosis. In contrast, the toxicity of the insoluble Al oxides depends primarily on their behavior as particulates. Aluminum has been held responsible for human morbidity and mortality, but there is no consistent and convincing evidence to associate the Al found in food and drinking water at the doses and chemical forms presently consumed by people living in North America and Western Europe with increased risk for Alzheimer\u27s disease (AD). Neither is there clear evidence to show use of Al-containing underarm antiperspirants or cosmetics increases the risk of AD or breast cancer. Metallic Al, its oxides, and common Al salts have not been shown to be either genotoxic or carcinogenic. Aluminum exposures during neonatal and pediatric parenteral nutrition (PN) can impair bone mineralization and delay neurological development. Adverse effects to vaccines with Al adjuvants have occurred; however, recent controlled trials found that the immunologic response to certain vaccines with Al adjuvants was no greater, and in some cases less than, that after identical vaccination without Al adjuvants. The scientific literature on the adverse health effects of Al is extensive. Health risk assessments for Al must take into account individual co-factors (e.g., age, renal function, diet, gastric pH). Conclusions from the current review point to the need for refinement of the PTWI, reduction of Al contamination in PN solutions, justification for routine addition of Al to vaccines, and harmonization of OELs for Al substances