Towards a data transfer agreement for the South African research community: The empowerment approach.

The idea of a data transfer agreement (DTA) template for the South African (SA) research community is receiving increasing attention. While developing such a DTA template is certainly a worthwhile project, questions regarding the project's practical execution should be addressed, including how to best operationalise the envisioned DTA template, and the content of the envisioned DTA template. It is proposed that an empowerment approach be followed in operationalising the envisioned DTA template, which is contrasted with the regulatory approach followed with the material transfer agreement that the Minister of Health promulgated in 2018. While the regulatory approach would entail government making the use of the envisioned DTA template compulsory regardless of the quality of such a template, the empowerment approach, by contrast, entails a focus on developing a high-quality, professionally drafted DTA template for the SA research community and making the use thereof a matter of own choice. Regarding the content of the envisioned DTA template, four hot-button content provisions are analysed, and it is argued that SA research institutions and researchers should be empowered to: (i) have clarity and legal certainty regarding their ownership of data, where relevant; (ii) be able to commercialise their research findings without unnecessary contractual constraints; (iii) avoid falling into the trap of unlawful benefit sharing with research participants; and (iv) be aware that their legal role as responsible parties, where relevant, cannot be contracted out via a DTA.

Privacy rights of human research participants in South Africa must be taken seriously.

Letter by Thaldar and Townsend, following an article by the same authors (Thaldar D, Townsend B. Genomic research and privacy: A response to Staunton et al. S Afr Med J 2020;110(3):172-174. https://doi.org/10.7196/SAMJ.2020.v110i3.14431) and both commenting on an article by Staunton et al. (Staunton C, Adams R, Botes M, et al. Safeguarding the future of genomic research in South Africa: Broad consent and the Protection of Personal Information Act No. 4 of 2013. S Afr Med J 2019;109(7):468-470. https://doi.org/10.7196/SAMJ.2019.v109i7.14148); and response to article and letter by Staunton et al.

An investigation into specialist practice nurses' knowledge of cardiopulmonary resuscitation guidelines in a tertiary hospital in Gauteng Province, South Africa.

Background: Cardiac arrest is among the major causes of sudden deaths globally. Although out-of-hospital cardiac arrest occurs more commonly, in-hospital cardiac arrest is still a major health problem. Critical care areas provide care to critically ill patients who are at risk of cardiac arrest. It is important that nurses are knowledgeable and competent in cardiopulmonary resuscitation (CPR) in order to optimise the patient's chances of survival and quality of life after cardiac arrest. Objectives: To investigate specialist practice nurses' knowledge of evidence-based guidelines for CPR. Methods: A descriptive cross-sectional survey was utilised. We sampled all critical care registered nurses (n=96) currently working in the adult emergency departments and intensive care units at Charlotte Maxeke Johannesburg Academic Hospital in Johannesburg, South Africa. A self-administered instrument, the 'evaluation questionnaire on CPR knowledge for health personnel from emergency services' was used. Data were analysed using descriptive and comparative statistics. Results: The mean CPR knowledge score was 46%. A score of 84% was considered adequate for a pass, and no respondents achieved this score. The majority of the respondents (80.85%; n=76) were specialists in the field of intensive care nursing. Conclusion: The CPR knowledge of specialist practice nurses was suboptimal for the care required in high-risk settings. Further training is indicated. Contributions of the study: We showed that specialist nurses working in critical care environments at a public hospital in Johannesburg scored poorly in a CPR knowledge test.

Contact tracing during the COVID-19 pandemic: Protection of personal information in South Africa

Containing the COVID-19 pandemic necessitates the use of personal information without the consent of the person. The protection of personal information is fundamental to the rights that ensure an open and democratic society. When regulations that limit the right to privacy are issued outside of the democratic process, every effort must be made to protect personal information and privacy. The limitation of human rights must be treated as an exception to the norm, and any regulations should be drafted to ensure minimum limitation of rights, rather than to the minimum acceptable standard. The contact tracing regulations included in the COVID-19 disaster regulations include some basic principles to ensure privacy; however, other important principles are not addressed. These include principles of transparency and data security. The envisaged future use of human data for research purposes, albeit de-identified, needs to be addressed by the COVID-19 designated judge appointed under the regulations

Safeguarding the future of genomic research in South Africa: Broad consent and the Protection of Personal Information Act No. 4 of 2013.

Genomic research has been identified in South Africa (SA) as important in developing a strong bio-economy that has the potential to improve human health, drive job creation and offer potential solutions to the disease burden harboured by low- and middle-income countries. Central to the success of genomic research is the wide sharing of biological samples and data, but the true value of data can only be unlocked if there are laws and policies in place that foster the legal and ethical sharing of genomic data. The introduction and entry into force of SA's Protection of Personal Information Act (POPIA) No. 4 of 2013 is to be welcomed, but the wording of POPIA as it pertains to consent for the processing of personal information for research purposes has sparked a debate about the legal status of broad consent. We argue that a purposive interpretation of the legislation would permit broad consent for the processing of personal information for research. Although there are ongoing debates surrounding the ethical use of broad consent in Africa, the objective of this article is not to engage with the ethics of broad consent itself, but rather to focus on the legal status of broad consent for genomic data sharing under POPIA.

The microbial community of a biofilm contact reactor for the treatment of winery wastewater.

AIMS: To utilize a three-tiered approach to provide insight into the microbial community structure, the spatial distribution and the metabolic capabilities of organisms of a biofilm in the two towers of a high-rate biological contact reactor treating winery wastewater. METHODS AND RESULTS: Next-generation sequencing indicated that bacteria primarily responsible for the removal of carbohydrates, sugars and alcohol were more abundant in tower 1 than tower 2 while nitrifying and denitrifying bacteria were more abundant in tower 2. Yeast populations differed in each tower. Fluorescent in situ hybridization coupled with confocal microscopy showed distribution of organisms confirming an oxygen gradient across the biofilm depth. The Biolog system (ECO plates) specified the different carbon-metabolizing profiles of the two biofilms. CONCLUSIONS: The three-tiered approach confirmed that the addition of a second subunit to the bioreactor, expanded the treatment capacity by augmenting the microbial and metabolic diversity of the system, improving the treatment scope of the system. SIGNIFICANCE AND IMPACT OF THE STUDY: A three-tiered biofilm analysis provided data required to optimize the design of a bioreactor to provide favourable conditions for the development of a microbial consortium, which has optimal waste removal properties for the treatment requirements at hand.

Safety and exposure of once-daily ritonavir-boosted atazanavir in HIV-infected pregnant women.

OBJECTIVE: There are limited antiretroviral options for use in the treatment of HIV infection during pregnancy. The purpose of this study was to assess the safety, efficacy and appropriate dosing regimen for ritonavir (RTV)-boosted atazanavir in HIV-1-infected pregnant women. METHODS: In this nonrandomized, open-label study, HIV-infected pregnant women were dosed with either 300/100 mg (n=20) or 400/100 mg (n=21) atazanavir/RTV once-daily (qd) in combination with zidovudine (300 mg) and lamivudine (150 mg) twice daily in the third trimester. Pharmacokinetic parameters [maximum observed plasma concentration (C(max) ), trough observed plasma concentration 24 hour post dose (C(min) ) and area under concentration-time curve in one dosing interval (AUC(τ) )] were determined and compared with historical values (300/100 mg atazanavir/RTV) for HIV-infected nonpregnant adults (n=23). RESULTS: At or before delivery, all mothers achieved HIV RNA <50 HIV-1 RNA copies/mL and all infants were HIV DNA negative at 6 months of age. The third trimester AUC(τ) for atazanavir/RTV 300/100 mg was 21% lower than historical data, but the C(min) values were comparable. The C(min) value for atazanavir/RTV 400/100 mg was 39% higher than the C(min) for atazanavir/RTV 300/100 mg in historical controls, but the AUC(τ) values were comparable. Twice as many patients in the 400/100 mg group (62%) had an increase in total bilirubin (>2.5 times the upper limit of normal) as in the 300/100 mg group (30%). Atazanavir (ATV) was well tolerated with no unanticipated adverse events. CONCLUSIONS: In this study, use of atazanavir/RTV 300/100 mg qd produced C(min) comparable to historical data in nonpregnant HIV-infected adults. When used in combination with zidovudine/lamivudine, it suppressed HIV RNA in all mothers and prevented mother-to-child transmission of HIV-1 infection. During pregnancy, the pharmacokinetics, safety and efficacy demonstrated that a dose adjustment is not required for ATV.

Probiotic lactic acid bacteria in the gastro-intestinal tract: health benefits, safety and mode of action.

Lactic acid bacteria (LAB) have received considerable attention as probiotics over the past few years. This concept has grown from traditional dairy products to a profitable market of probiotic health supplements and functional foods. Extensive research is done on novel potential probiotic strains, with specific emphasis on their health benefits and mode of action. Criteria for the selection of probiotic strains have only recently been formulated by the Food and Agriculture Organization of the United Nations and the World Health Organization (FAO/WHO). Several in vitro techniques have been developed to evaluate the probiotic properties of strains. In many cases, this is followed by in vivo tests. Safety studies are also obligatory, as a few cases of bacteremia caused by LAB have been reported. This review focuses on the health benefits and safety of LAB probiotics, the criteria used to select a probiotic, mode of action and the impact these organisms have on natural microbiota in the gastro-intestinal tract.

Encapsulation of Lactobacillus plantarum 423 and its Bacteriocin in Nanofibers.

Plantaricin 423, produced by Lactobacillus plantarum 423, was encapsulated in nanofibers that were produced by the electrospinning of 18% (w/v) polyethylene oxide (200 000 Da). The average diameter of the nanofibers was 288 nm. Plantaricin 423 activity decreased from 51 200 AU/ml to 25 600 AU/ml and from 204 800 AU/ml to 51 200 AU/ml after electrospinning, as determined against Lactobacillus sakei DSM 20017 and Enterococcus faecium HKLHS, respectively. Cells of L. plantarum 423 encapsulated in nanofibers decreased from 2.3 × 10(10) cfu/ml before electrospinning to 4.7 × 10(8) cfu/ml thereafter. Cells entrapped in the nanofibers continued to produce plantaricin 423. This is the first report on the encapsulation of a bacteriocin and cells of L. plantarum in nanofibers. The method may be used to design a drug delivery system for bacteriocins and the encapsulation of probiotic lactic acid bacteria. The technology is currently being optimized.

Boza, a natural source of probiotic lactic acid bacteria.

AIMS: To evaluate the probiotic properties of strains isolated from boza, a traditional beverage produced from cereals. METHODS AND RESULTS: The strains survived low pH conditions (pH 3.0), grew well at pH 9.0 and were not inhibited by the presence of 0.3% (w/v) oxbile. Cytotoxicity levels of the bacteriocins, expressed as CC(50), ranged from 38 to 3776 microg ml(-1). Bacteriocin bacST284BZ revealed high activity (EC(50) = 735 microg ml(-1)) against herpes simplex virus type 1. Growth of Mycobacterium tuberculosis was 69% repressed after 5 days in the presence of bacST194BZ. Various levels of auto-cell aggregation and co-aggregation with Listeria innocua LMG 13568 were observed. Adhesion of the probiotic strains to HT-29 cells ranged from 18 to 22%. CONCLUSIONS: Boza is a rich source of probiotic lactic acid bacteria. All strains survived conditions simulating the gastrointestinal tract and produced bacteriocins active against a number of pathogens. Adherence to HT-29 and Caco-2 cells was within the range reported for Lactobacillus rhamnosus GG, a well-known probiotic. In addition, the high hydrophobicity readings recorded define the strains as good probiotics. SIGNIFICANCE AND IMPACT OF THE STUDY: Boza contains a number of different probiotic lactic acid bacteria and could be marketed as a functional food product.

Probiotic properties of Lactococcus lactis ssp. lactis HV219, isolated from human vaginal secretions.

AIMS: To determine the resistance of Lactococcus lactis ssp. lactis HV219 to acids, bile, antibiotics, inflammatory drugs and spermicides, compare adsorption of the strain to bacteria and Caco-2 cells under stress, and evaluate the antimicrobial activity of bacteriocin HV219. METHODS AND RESULTS: Bacteriocin HV219 activity against Gram-positive and Gram-negative bacteria was confirmed by leakage of DNA and beta-galactosidase, and atomic force microscopy. Adsorption of bacteriocin HV219 to bacteria is influenced by pH, temperature, surfactants and salts. Initially, only 3% of HV219 cells adhered to Caco-2 cells. However, after 2 h, adherence increased to 7%. Strain HV219 and Listeria monocytogenes ScottA did not compete for colonization. Strain HV219 is sensitive to most antibiotics tested, but resistant to amikacin, ceftazidime, nalidixic acid, metronidazole, neomycin, oxacillin, streptomycin, sulphafurazole, sulphamethoxazole, sulphonamides, tetracycline and tobramycin. Ibuprofen, ciprofloxacin, diklofenak and nonoxylol-9 inhibited the growth of strain HV219. CONCLUSION: Strain HV219 is resistant to hostile conditions in the intestinal tract, including therapeutic levels of specific antibiotics and binds to Caco-2 cells, but not in competition with L. monocytogenes. SIGNIFICANCE AND IMPACT OF THE STUDY: Strain HV219 will only be effective as probiotic if taken with specific antibiotics and not with anti-inflammatory drugs and spermicides.

The treatment of oral candidiasis in a cohort of South African HIV/AIDS patients.

The purpose of this study was to determine the extent and outcome of antifungal treatment in HIV/AIDS patients. Data obtained from patients attending a hospital-based, semi-urban comprehensive care HIV clinic, were retrospectively analysed. The clinic serves patients from urban, semi-urban and rural communities. A total of 751 confirmed black heterosexual HIV/AIDS patients received routine oral examinations and surveillance swabbing for oral yeast culture. Patients received nystatin solution as prophylaxis, miconazole for clinically detectable oral candidiasis and only in severe cases or cases of chronic candidiasis were they treated with either fluconazole or itraconazole. Treatment was regarded as successful when there was an absence or resolution of clinical lesions of oral candidiasis. Nystatin prophylaxis was prescribed to 7.9% of patients, miconazole treatment to 9.7% and 3.5% received fluconazole. Of the 60 patients who received nystatin prophylaxis, 40 (66.6%) had clinically detectable candidiasis. A negative statistical correlation was found between nystatin prophylaxis and clinically detectable candidiasis. Of 72 patients who received miconazole treatment, only 3 failed to respond. Eleven of the 27 patients who received fluconazole treatment did not return for follow-up visits. In the remaining 16 patients there was no recurrence of clinical symptoms during the following 3 - 24 months after treatment with fluconazole. It is concluded that nystatin prophylaxis proved not to be effective under these particular clinical circumstances. Resistance to azole antifungal medication is not yet a problem in this black heterosexual group of South African HIV/AIDS patients.

The parameters of septic abortion.

PIP: A retrospective analysis of 50 cases of septic incomplete abortion is made. In order to evaluate the spread of infection, septic abortions were grouped into 3 types. In Group 1 were cases with infection limited to the uterus alone. Group 2 included cases with extrauterine spread of infection to parametrium and/or adnexa, and Group 3 cases had pelvic or generalized peritonitis. The purpose of the study was 1) to correlate bacterial cultures with the clinical classification and with special reference to the offensive vaginal discharge; 2) to determine whether there is a dominant clinical parameter; and 3) to evaluate, after consideration of 1 and 2, whether endotoxic shock can be prevented by prophylactic treatment. The clinical picture, vaginal discharge, bacteriologic cultures of the cervix and uterine cavity and the histopathological picture of the uterine curettements were correlated. The mean temperature on admission was 98.9 degrees F in Group 1, 101 degrees F in Group 2, and 102.4 degrees F in Group 3. Of the cases with a history of criminal intervention 9 percent were in Group 1; 57 percent in group 2, and 86 percent in Group 3. In Group 1, 14 percent had offensive discharge, although 23 percent yielded positive cervical cultures and 9 percent positive uterine cultures. In Group 2, the discharge occurred in 57 percent, and positive cervical and uterine cultures were 43 percent and 33 percent respectively. The cases with peritonitis (Group 3) showed a very strong correlation: 71 percent offensive discharge with 86 percent cervical cultures and 71 percent positive uterine cultures. Analysis of the positive neutrophil responses showed that in Group 1 there was a 75 percent positive and a 25 percent negative response, in Group 2 there was a 40 percent positive and a 60 percent negative response, and in Group 3 there was a 30 percent positive and a 70 percent negative. It appeared that the more overwhelming the infection, the less was the response of the body against the infection. It is suggested that suspicion of criminal intervention might still be the only dominant clinical parameter to justify aggressive prophylactic treatment, if the patient would only give this information more freely. It is concluded that a septic abortion is any abortion where tenderness (indicating infection) can be elicited on bimanual examination. A classification of cases into the 3 groups is suggested. Group 2 and 3 cases should be evacuated vaginally without delay.^ieng