Search PubMed⌕ Search

SEARCH · Search PubMed

Results for “First Amendment”

Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 1,009 records · Page 56Linked to original sources
PubMed1982

Prognostic features of early renal transplant rejections.

In an analysis of 632 cadaver transplants, the early renal transplant course gave important prognostic information depending on temporal and/or renofunctional characteristics of rejection episodes. Two transplant rejections occurring within the first 2 mo posttransplant were associated with either 37%, 27%, or 6% 1-yr graft survivals depending on whether these episodes were separate, temporally back-to-back, or were without interrejection renofunctional recovery, respectively. This compares to 1-yr graft survivals of 89% or 73% in those patients who had no rejection or one with recovery early posttransplant. Patient survival in groups with multiple early rejections was also associated with a poor prognosis. Ninety to 93% 1-yr patient survival was noted when there was no or one rejection. There was only a 74%-83% 1-yr patient survival with two early treated rejections. Transplant rejection therapy must be individualized or even withheld in order to ensure optimum graft and patient survival.

Blood Transfusion↗
PubMed2006

Fate of arsenic compounds in poultry litter upon land application.

The use of the organic As compound, roxarsone, as an antibiotic additive to poultry feed continues to raise concern over potential negative environmental impacts. Total As concentration in poultry litter can reach >40 mg kg(-1) and both roxarsone and its mineralization product As(V) have been identified in poultry litters (PL). To investigate the fate of these As species upon land application of PL we conducted two studies. In the first, an Orangeburg soil (Ultisol from the Atlantic Coastal Plain) was spiked with either 20 mg kg(-1) As(V) or roxarsone and incubated at 10% moisture content for 4 months. Exchangeable As was determined periodically by extraction with 0.1M PO(4). Both As(V) and roxarsone displayed similar desorption; initially, approximately 70% of added As was ligand exchangeable and this decreased to 35% after 4 months incubation, presumably due to either slow sorption reactions or a change in solid phase speciation of As to less exchangeable forms. In the second study, various manipulations of two PL samples were applied to the Orangeburg soil at realistic field application rates. The treatments were wet to 10% moisture content and water soluble As, Cu and organic carbon (DOC) was measured over 30 days. Arsenic and Cu solubility were highest from the dried litter samples. Ashing of the PLs decreased soluble As and Cu, presumably because of the loss of organic matter from the ashed litter and subsequent decrease in DOC. Application of leachates from either PL resulted in higher concentrations of soluble As and Cu than when the soil was amended with equivalent concentrations of soluble As and Cu dissolved in DI H(2)O. We hypothesize that the increased levels of DOC from the PL treatments enhance As and Cu solubility through competitive sorption and complexation, respectively. In fact, As and Cu solubility was correlated to DOC levels in the amended soil extracts. Even though land application of PL introduced relatively low concentrations of As and Cu to soil it appeared that other soluble constituents of PL significantly enhanced As and Cu solubility.

Animals↗
PubMed1979

Do blood transfusions enhance the possibility of a compatible transplant?

Blood transfusions prior to first cadaver kidney transplants have a significant beneficial effect on graft survival and, in this sense, appear to enhance the possibility of a compatible transplant. This desirable effect, however, occurs concomitantly with an increased degree of sensitization, which in turn reduces the likelihood of identifying a compatible kidney by direct crossmatch testing. This report illustrates that the beneficial effect is achieved with one to five transfusions prior to transplantation, but that more transfusions afford no additional benefits. In addition, the presence of cytotoxic antibodies per se does not have an adverse influence on graft survival. Liberal transfusion policies are therefore indicated in cadaver transplant candidates, but more than five transfusions prior to transplantation should probably be avoided unless clinically necessary.

Antibodies↗
PubMed2002

A population at risk: civil commitment of substance abusers after Kansas v. Hendricks.

In its 1997 decision, Kansas v. Hendricks, the U.S. Supreme Court radically changed the face of civil commitment. In finding the Kansas Sexually Violent Predators Act constitutional, the Court liberalized the first constitutional requirement for involuntary commitment from "mental illness" to a much broader "mental abnormality" standard, without correspondingly restricting the second requirement of dangerousness. The decision essentially authorizes states to civilly commit a broad range of individuals without sufficient due process protections. This Comment explores the possibilities for expansion of civil commitment in the wake of Hendricks. It argues that the holding was unjustifiably broad, focusing in particular on the potential danger facing substance abusers. In conclusion, it offers several suggestions for mitigating the potential misuse of this dangerous precedent.

Civil Rights↗
PubMed2004

Photocopier exposure and risk of sarcoidosis in African-American sibs.

BACKGROUND: In a family study of sarcoidosis in African-Americans, we detected a positive association between sarcoidosis and ever working in a sales or clerical occupation. This finding, and case reports of granulomatous lung disease in patients with photocopier toner dust exposure, led us to hypothesize that sarcoidosis risk may increase as a result of photocopier exposure. METHODS: Retrospective data on photocopier use and maintenance were collected from African-American sarcoidosis cases and their first degree relatives. The study sample consisted of 181 African-American sibships where one or more members had a history of sarcoidosis (n = 540). RESULTS: Sarcoidosis was statistically significantly associated with ever using a photocopier (Odds Ratio [OR] = 1.74, 95% confidence interval [CI]: 1.23-2.46), and ever changing photocopier toner or carrying out photocopier maintenance (OR = 2.88, 95% CI 1.83-4.54). In a conditional logistic regression model that adjusted for age and sex, the OR associated with a sarcoidosis history and being in the highest tertile of photocopier exposure ranged from 1.83 to 2.19 depending on the exposure measure used. CONCLUSIONS: These results suggest that photocopier toner dust may be a previously unrecognized antigen in the pathophysiology of some patients diagnosed with sarcoidosis.

Adult↗
PubMed2003

Treatment history and treatment dose are important determinants of sulfadoxine-pyrimethamine efficacy in children with uncomplicated malaria in Western Kenya.

This study retrospectively studied amendable determinants of sulfadoxine-pyrimethamine (SP) efficacy involving 2869 treatments among 1072 Kenyan children <5 years old who had uncomplicated malaria. The dose was based on age: one-quarter tablet was given to infants <1 year old, one-half tablet was given to 1-3-year-old children, and a full tablet was given to 4-year-old children. Only 23.5% received the internationally recommended target dose of 25/1.25 mg of SP per kg of body weight. SP intake in the previous 15-35 days (adjusted relative risk, 1.67; 95% confidence interval, 1.35-2.07) and low SP dose (<27.5/1.375 mg/kg) (adjusted relative risk, 1.58; 95% confidence interval, 1.17-2.13) explained 38% of parasitological treatment failures by day 7. Patients with recent SP intake are likely to have recrudescent infections and may need close follow-up if treated with SP or alternative treatment. Applying our weight-for-age data to 31 existing age-based SP dose recommendations predicted that 22 of them would result in underdosing of >25% of children <5 years. Many age-based dose recommendations need urgent revision, because SP is increasingly used as first-line treatment in sub-Saharan Africa.

Age Factors↗
PubMed2006

Importance of algal biomass to growth and development of Anopheles gambiae larvae.

We conducted experiments to investigate the importance of algal food resources for larval growth and adult emergence of Anopheles gambiae Giles s.s. in simulated larval habitats in Kenya, and in greenhouse and laboratory microcosms in the United States. In the first experiment, we used shading to reduce algal biomass, and because algal production and larval development might be a function of underlying soil nutrients, we crossed sun-shade treatments with soils of two distinct types collected near larval habitats. Shading reduced pupation rates and total adult biomass of An. gambiae by approximately 50%. Soil type had no significant effect on mosquito production, but it did significantly affect concentrations of phosphorus and chlorophyll a in the surface microlayer. In a subsequent experiment conducted in the greenhouse to reduce temperature differences found between the shaded and sunlit treatments, <1% of larvae in the shaded treatments reached the pupal stage. There was a marked reduction of chlorophyll a levels as a function of shading and larval density. In a third experiment, larvae receiving material harvested from sunlit surface microlayers performed as well as those receiving liver powder, whereas those receiving surface microlayer from shaded habitats suffered >90% mortality and failed to pupate. In a fourth experiment, glucose was added to shaded microcosms to stimulate bacterial activity in the absence of algae. Bacterial growth rates were 2 to 3 times higher, and larval development was enhanced in glucose-amended treatments. However, pupation rates and adult weights in glucose-amended shaded microcosms were still poor compared with those in nonamended sunlit microcosms. Overall, these results demonstrate the importance of algal biomass in the surface microlayers of larval habitats to development and adult production of An. gambiae.

Animal Feed↗
PubMed1997

Formation and disappearance of mycophenolic acid, patulin, penicillic acid and PR toxin in maize silage inoculated with Penicillium roqueforti.

Maize silage was inoculated with Penicillium roqueforti strains which are able to form the mycotoxins mycophenolic acid (MPA), patulin (PAT), penicillic acid (PA), or PR toxin (PRT). The silage was incubated for 160 d without agitation under aerobic conditions at 15 degrees C in the dark. The mycotoxins were quantified by HPLC and identified by HPLC combined with diode array detection and by two-dimensional thin layer chromatography. MPA, PAT, PA, and PRT above the detection limit were measured for the first time at 36, 22-27, 13, and 49 days of incubation, maximum toxin contents (mg/kg) were 3.56 MPA, 15.10 PAT, 3.06 PA, and 2.17 PRT. With increasing storage time toxin contents decreased to a low or non detectable level. The production of MPA, PAT and PRT was preceded by an increase in pH from 4 to 8-9. Along with the initial pH increase the content of ergosterol as well as of P. roqueforti and yeast propagules increased whereas the levels of total soluble sugar and of water extractable NH3 decreased. It is concluded that the probability to detect MPA, PAT, PA, and PRT in maize silage moulded by P. roqueforti under practical conditions of agriculture is low during the growth of this fungus and again after prolonged storage.

Animals↗
PubMed1994

Sensitization to early life stress and response to chemical odors in older adults.

This study examined the hypothesis that older persons who currently report illness from environmental chemical odors (cacosmia) may have experienced higher levels of stress early in life than did noncacosmic controls. The hypothesis derives from a time-dependent sensitization (TDS) model for cacosmia (Bell et al 1992) that predicts a relative interchangeability of stress and chemicals in inducing and eliciting sensitized responses in vulnerable individuals. Subjects were selected from those in the top 24% (cacosmic) and bottom 27% (noncacosmic) of a sample of 192 older adults (mean age 73.8 years) for self-reported frequency of illness form the odors of pesticide, car exhaust, paint, perfume, and new carpet. As in previous investigations, cacosmics were younger, more depressed, and more shy; cacosmics also included a higher proportion of women (83% versus 61%). As predicted, cacosmics rated themselves higher in stress for the first four decades of their lives, but not the recent past or present, even after controlling for depression, anxiety, hostility, shyness, age, and gender. Cacosmics reported increased prevalence of physician-diagnosed nasal allergies, breast cysts, hypothyroidism, sinusitis, food sensitivities, irritable bowel, and migraine headache. Only 4% of the overall sample (including 9% of the cacosmics) acknowledged the controversial physician diagnosis of "chemical sensitivity." The replicated observation of greater shyness in cacosmics is consistent with the ability of hyperreactivity to novelty to predict enhanced susceptibility to TDS from low levels of pharmacological agents in animals. The findings support a TDS model for cacosmia and suggest that cacosmia as a symptom identifies a large subset of the nonindustrial population with significant psychophysiological health problems that merit further objective examination.

Aged↗
PubMed1999

Use of a sentinel system for field measurements of Cryptosporidium parvum oocyst inactivation in soil and animal waste.

A small-volume sentinel chamber was developed to assess the effects of environmental stresses on survival of sucrose-Percoll-purified Cryptosporidium parvum oocysts in soil and animal wastes. Chambers were tested for their ability to equilibrate with external chemical and moisture conditions. Sentinel oocysts were then exposed to stresses of the external environment that affected their viability (potential infectivity), as indicated by results of a dye permeability assay. Preliminary laboratory experiments indicated that temperatures between 35 and 50 degrees C and decreases in soil water potential (-0.003 to -3.20 MPa) increased oocyst inactivation rates. The effects of two common animal waste management practices on oocyst survival were investigated on three dairy farms in Delaware County, N.Y., within the New York City watershed: (i) piling wastes from dairy youngstock (including neonatal calves) and (ii) spreading wastes as a soil amendment on an agricultural field. Sentinel containers filled with air-dried and sieved (2-mm mesh) youngstock waste or field soil were wetted and inoculated with 2 million oocysts in an aqueous suspension and then placed in waste piles on two different farms and in soil within a cropped field on one farm. Controls consisted of purified oocysts in either phosphate-buffered saline or distilled water contained in sealed microcentrifuge tubes. Two microdata loggers recorded the ambient temperature at each field site. Sentinel experiments were conducted during the fall and winter (1996 to 1997) and winter (1998). Sentinel containers and controls were removed at 2- to 4-week intervals, and oocysts were extracted and tested by the dye permeability assay. The proportions of potentially infective oocysts exposed to the soil and waste pile material decreased more rapidly than their counterpart controls exposed to buffer or water, indicating that factors other than temperature affected oocyst inactivation in the waste piles and soil. The effect of soil freeze-thaw cycles was evident in the large proportion of empty sentinel oocysts. The potentially infective sentinel oocysts were reduced to <1% while the proportions in controls did not decrease below 50% potentially infective during the first field experiment. Microscopic observations of empty oocyst fragments indicated that abrasive effects of soil particles were a factor in oocyst inactivation. A similar pattern was observed in a second field experiment at the same site.

Animal Husbandry↗
PubMed1988

The importance of eosinophil cells in kidney allograft rejection.

The composition of the intragraft cellular infiltrate was studied in 83 renal allograft recipients with the technique of fine-needle aspiration cytology in the first four weeks following kidney transplantation. We found a significantly (P less than 0.05) higher mean tissue eosinophil percentage in patients who had irreversible rejections with transplant loss than in those who had reversible rejections (12.54 +/- 2.31 versus 3.79 +/- 1.14, mean +/- SEM). Patients who had serious, dialysis-requiring rejections also showed a significantly (P less than 0.05) higher mean tissue eosinophil percentage than those who had reversible rejections (21.40 +/- 5.98 versus 3.79 +/- 1.14, mean +/- SEM). The frequency of the HLA B8 antigen was 46.2% in patients who had excessive tissue eosinophilia, whereas its frequency in all the studied patients was 18.3%. Based on our observations, the presence of more than 4% eosinophils in the tissue inflammatory exudate is a specific (91%) and fairly sensitive (78%) indicator of irreversible and severe acute rejections.

Eosinophilia↗
PubMed1981

Graft survival with high levels of cytotoxic antibodies.

In this study, pretransplant transfusions significantly improved the survival of first cadaver kidney transplants. Large numbers of transfusions had the same influence on graft survival as small number of transfusions. Graft survival was not influenced by pretransplant antibody levels, and the beneficial effect of transfusions was also independent of highest pretransplant antibody levels. The positive relationship between transfusions and cytotoxic antibodies was shown to be highly significant. B-warm and T-warm antibodies were both increased by transfusions and tended to occur together. B-cold antibodies occurred independent of transfusions, B-warm and T-warm antibodies. The results of this study suggest, but do not confirm, that B-cold antibodies benefit graft survival, while T-warm antibodies adversely influence graft survival. Transfusions and B-cold antibodies appear to influence graft survival by different mechanisms.

Antibody Formation↗
PubMed1995

Extraction and purification of microbial DNA from petroleum-contaminated soils and detection of low numbers of toluene, octane and pesticide degraders by multiplex polymerase chain reaction and Southern analysis.

We investigated the use of multiplex polymerase chain reaction (PCR) techniques coupled with Southern analysis to detect xenobiotic-degrading organisms that had been added to three soils. Two soils highly contaminated with petroleum hydrocarbons and a less contaminated control soil were amended with tenfold dilutions of Pseudomonas putida mt-2 (pWW0), P. oleovorans (OCT), and Alcaligenes eutrophus JMP134 (pJP4), or, for controls, phosphate buffer alone. Total DNA was then isolated from the soils and purified using a sequential precipitation and dissolution purification procedure. This DNA was subjected to multiplex polymerase chain reaction (PCR) using primers that amplify regions of xylM (PCR product = 631 bp), alkB (546 bp) and tfdA (710 bp), which are found on pWW0, OCT and pJP4, respectively. The sizes of the amplified DNA fragments were designed to permit simultaneous amplification and detection of the target genes. Ethidium bromide-stained gels of the initial PCR reaction indicated detectable amplification of between 10(0) to 10(6) cells per gram soil, depending on the soil and the target gene. Southern analysis of the PCR amplified DNA improved detection limits to between 1 and 10 cells of each target species per gram of soil, and confirmed the identity of the PCR products. For some samples that were initially resistant to PCR, dilution of the environmental DNA resulted in positive PCR results. This treatment presumably overcame the inhibition of the PCR by diluting coextracted contaminants in the environmental DNA. A second PCR on an aliquot (1 microL) of the first reaction increased the ethidium bromide-based detection limits for one of the soils to six cells per gram of soil; it did not increase the detection limits for the other soils. Therefore, the DNA extraction procedure and multiplex PCR permitted the simultaneous detection of three types of biodegradative cells, at a lower detection limit of approximately 10 cells per gram of highly contaminated, organic soil. However, due to kinetic limitations of multiplex PCR, the amplified signals did not follow a close dose response to the numbers of added target cells.

Alcaligenes↗
PubMed1997

First production-level bioremediation of explosives-contaminated soil in the United States.

Umatilla Army Depot Activity (UMDA) near Hermiston, Oregon was the location of the first production-level bioremediation of explosives-contaminated soil in the U.S. Soil from munitions washout lagoons contained high concentrations of TNT (2,4,6-Trinitrotoluene) and RDX (Hexahydro-1,3,5-trinitro-1,3,5- triazine) as well as HMX (Octahydro-1,3,5,7-tetranitro-1,3,5,7-tetrazocine). In addition to these primary contaminants, laboratory tests were performed for Tetryl (Methyl-2,4,6-trinitrophenylnitramine), 4-Am-DNT (4-Amino-2,6-dinitrotoluene), 2-Am-DNT (2-Amino-4,6-dinitrotoluene), 2,4 DNT (2,4-Dinitrotoluene), 2,6 DNT (2,6-Dinitrotoluene), 1,3,5-TNB (1,3,5-Trinitrobenzene), 1,3,-DNB (1,3-Dinitrobenzene) and NB (Nitrobenzene) during the pilot-scale treatability tests. The clean-up goal established by the Record of Decision (ROD) was 30 mg/kg each for TNT and RDX. Degradation progress was monitored using immunoassay field screening Methods SW 846,4050 and 4051. Confirmational analysis consisted of EPA Method 8330. Treatment time on a 2,700 cubic yard batch (810 cubic yards of soil) was 10-12 days. A composting technique developed by the Army Environmental Center and implemented by Bioremediation Service, Inc., Portland, Oregon was used at the site. Agricultural waste products (or amendments including cow manure, chicken manure, potato waste, sawdust and alfalfa) were blended with the contaminated soil during treatment. Specialized soil turning equipment mixed the compost for optimum biological action and homogeneity. Homogeneity of the compost mix ensured rapid degradation of all contaminants. Physical and chemical properties were closely monitored to ensure that thermophilic bacteria played a dominant role in the degradation process. Nearly 5,000 cubic yards of soil have been successfully treated, and more than 70% of all analyses indicate non-detectable levels of both TNT and RDX. The U.S. Army Corps of Engineers estimates that over $2.6 million is being saved using bioremediation at Umatilla.

Azocines↗
PubMed1999

Private patients in NHS hospitals: comparison of two sources of information.

BACKGROUND: The use of National Health Service (NHS) hospitals to treat private patients is debatable on the grounds of equity of access. Hospital Episodes Statistics (HES) annual reports are the only routine source of information on the scale of this activity. The accuracy of the information is doubted. This enquiry tested the completeness of HES data against information obtained directly from private patient unit managers. METHOD: Managers of the 71 pay bed units in NHS hospitals in England were asked to supply from local registers and accounts the numbers of in-patients and day cases admitted in 1995-1996. Their reports were matched with the numbers of first consultant episodes for private in-patients and day cases shown for those hospitals in the HES data file for that year. RESULTS: Of the 71 units 62 responded; 53 of these gave usable data. The 53 included, and 18 excluded from the comparison, matched on median and range of bed numbers. Managers identified 16 per cent more total admissions than did HES, 62,572 against 54,131; 13 per cent more in-patient admissions, 39,776 against 35,319; and 21 per cent more day cases, 22,796 against 18,812. More total admissions were reported by managers of 38 pay bed units than were recorded in HES, fewer by 12, and equal numbers by three. Similar sized discrepancies were noted for in-patient admissions and day cases. Reasons for the under-reporting of private patients in HES included the use of separate patient administration systems for private patients with a failure to feed data to HES, and the omission of some provider units altogether by a minority of trusts from the returns made to the Department of Health. CONCLUSION: Overall, HES underestimates the amount of private patient activity reported directly by NHS hospitals. No method of validating private patient data is currently available. An amendment to an existing statistical return would provide a check on numbers. Central guidance on the inclusion of private patient activity in data transmitted by providers to the HES processing agency should be reinforced.

England↗
PubMed1980

[Testing of medical devices (author's transl)].

The French regulation of medical devices is already old. it gradually begins since 1940 firstly for the need of safety in radiology. In 1952, an Interministerial Commission (Health, Welfare, Defense, Interior, etc.) was instituted for the medical devices approval: the anaesthesiological devices were examinated since 1956. But this regulation is weak because there is no effective penalty. Nevertheless it is efficient: it had allowed the collection of important documents especially in the fields of radiology, anaesthesiology and intensive care, and recently in hemodialysis. During the last ten years all medical devices in this fields were examinated by the French essay laboratories and their performances were registraded. If the compliance of a device is not effective the approval is not gived. For anaesthesiological and intensive care devices, the approval is give, after clinical testing, only for five years. This approval is not renewed if there are complaints about the device during this time. But medical devices are not easy to define and to test. The best definition seems the American one: "There is a new definition of "device". In broad terms, a device is a health-care product that does not achieve any of its principal intended purposes by chemical action within or on the body or by being metabolized. There is specific recognition that a device may diagnose "conditions" that are not necessarily "diseases" (Medical device Amendment, 1976)." The french regulation is of course not perfect: we suffer of a lack of a law on medical device thus this regulation is appliable only if the public health is envolved. Nevertheless a rather good protection of the patients is assured and the efficiency is gradually better as the international exchanges give technical and clinical informations.

Anesthesiology↗
PubMed2005

[Tobacco control in South Africa].

The aim of this paper is to briefly describe South Africa's experience in tobacco control, and to highlight some of the lessons that are applicable to other developing countries. South Africa's tobacco control strategy is based on two main pillars: (1) rapidly increasing excise taxes on tobacco, and (2) comprehensive legislation, of which the most important features are banning all tobacco advertising and sponsorship, and prohibition of smoking in public and work places. As a result of the increases in the excise tax, the real (inflation-adjusted) price of cigarettes has increased by 115% between 1993 and 2003. Aggregate cigarette consumption has decreased by about a third and per capita consumption has decreased by about 40% since 1993. Despite the decrease in cigarette consumption, real government revenue from tobacco excise taxes has increased by nearly 150% between 1993 and 2003. Some important lessons can be drawn from South Africa's experience in tobacco control. Firstly, strong and consistent lobbying was required to persuade the government to implement an effective tobacco control strategy. Country-specific research, drawn from a variety of disciplines, was used to back up and give credibility to the lobbyists' appeals. Secondly, rapid increases in the excise tax on cigarettes are particularly effective in reducing tobacco consumption. An increase in the excise tax increases the price of cigarettes, which in turn reduces cigarette consumption. In South Africa a 10% increase in the real price of cigarettes decreases cigarette consumption by between 6 and 8%. Similar results have been found for many other developing countries. Thirdly, while an increase in the excise tax is generally regarded as the most effective tobacco control measure, tobacco control legislation also plays an important role in a comprehensive tobacco control strategy. Bans on tobacco advertising and bans on smoking in public and work places denormalise and deglamorise smoking, and are likely to make other tobacco control interventions more effective. Fourthly, the industry would typically claim that they want to be constructive partners in drafting "reasonable and sensible" tobacco control legislation. In South Africa's experience, when they were involved in the drafting process in 1993, the role of the industry was to delay and water down the legislation. In drafting an amendment to the original legislation in 1998, the industry's views were largely ignored, and the result was a more comprehensive and effective piece of legislation. Fifthly, tobacco control legislation, particularly laws banning smoking in indoor public places, is largely self-enforcing. It does not require heavy-handed police intervention, as is typically claimed by the industry. The legislation clarifies and explains that the rights of non-smokers to clean air supersede the right of smokers to smoke. Smokers typically refrain from smoking where smoking is not allowed.

Humans↗
PubMed2005

How well does South Africa's National Health Act regulate research involving children?

Currently there are no laws in South Africa regulating the rights of research participants. The National Health Act is the first attempt by the legislature to use the law to protect research participants, including children. This article describes the strengths and limitations of the provisions, implications for researchers and research ethics committees, and makes recommendations. Strengths of the Section include that it enables the Minister of Health to issue regulations detailing protections for research participants, it supplements existing law on consent, it introduces the concept of the 'best interests' of the child and it creates procedural safeguards. Limitations of the Section include that it does not set an independent age for consent to research, it focuses on informed consent and not other protections, it is inconsistent with existing or draft legislation and ethical guidelines, and it retains the contested distinction between 'therapeutic' and 'non-therapeutic' research. Poor drafting and inconsistencies also impede interpretation. The implications for researchers are that it facilitates so-called 'non-therapeutic' research on children. However, procedural burdens for obtaining consent are created. Research Ethics Committees (RECs) will have to work with the 'therapeutic' and 'non-therapeutic' distinction as well as new concepts such as 'best interests' of the child, and ensure that consent procedures comply with the Act. We conclude that while the Act is an important development in the law, it is flawed in places. We recommend that amendments be made and that capacity development be provided to stakeholders.

Child↗