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

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

Lessons from the removal of lead from gasoline for controlling other environmental pollutants: A case study from New Zealand

<p>Abstract</p> <p>Background</p> <p>It took over two decades to achieve the removal of leaded gasoline in this country. This was despite international evidence and original research conducted in New Zealand on the harm to child cognitive function and behaviour from lead exposure.</p> <p>Objective</p> <p>To identify lessons from the New Zealand experience of removing leaded gasoline that are potentially relevant to the control of other environmental pollutants.</p> <p>Discussion</p> <p>From the available documentation, we suggest a number of reasons for the slow policy response to the leaded gasoline hazard. These include: (1) industry power in the form of successful lobbying by the lead additive supplier, Associated Octel; (2) the absence of the precautionary principle as part of risk management policy; and (3) weak policymaking machinery that included: (a) the poor use of health research evidence (from both NZ and internationally), as well as limited use of expertise in academic and non-governmental organisations; (b) lack of personnel competent in addressing technically complex issues; and (c) diffusion of responsibility among government agencies.</p> <p>Conclusion</p> <p>There is a need for a stronger precautionary approach by policymakers when considering environmental pollutants. Politicians, officials and health workers need to strengthen policymaking processes and effectively counter the industry tactics used to delay regulatory responses.</p

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