INFORMED CONSENT FOR CLINICAL TRIALS: A REVIEW

Objective: To identify and highlight challenges related to informed consent processfor clinical trials in sub-Saharan Africa.Data sources: Published original research findings and reviews in the English literature,together with anecdotal information from our current professional experiences withclinical trials.Design: Review of peer-reviewed articles.Data extraction: Online searches were done and requests for reprints from correspondingauthors and institutional subscription.Data synthesis: Information categorised accordingly.Results: Informed consent for clinical trials conducted in sub-Saharan Africa (SSA) isnot always “truly informed” or “truly voluntary”. Guidelines for obtaining informedconsent are often difficult to implement because of low literacy levels, socio-economicand cultural factors. The local ethics committees, whose role is critical in informedconsent, are weak, ill-equipped or non-existent in some countries. Many participantsmay have incomplete understanding of the various aspects of the clinical trials due tolanguage barriers, the way information is disclosed or terms used for informed consentdocuments. In some settings, clinical trials are the only access to health care servicesfor the local population. Further, participants may enroll with perceived notion ofcure of their conditions, for monetary or material benefits.Conclusions: There is need for national guidelines on clinical research including ethicsreview, compensation of subjects, requirements for research investigators, facilitiesand ethics committees as well as budgetary allocation. These guidelines must not onlyaddress specific and unique local circumstances but also meet minimum internationalclinical research standards. Local bioethics and research capacity should be developedand strengthened with research sponsors contributing towards this. Local research isneeded on the validity and reliability of informed consent for clinical trials and factorsinfluencing that in different socio-cultural settings in SSA

Evaluating the impact of social franchising on family planning use in Kenya

Background: In Kenya, as in many low-income countries, the private sector is an important component of health service delivery and of providing access to preventive and curative health services. The Tunza Social Franchise Network, operated by Population Services Kenya, is Kenya\u2019s largest network of private providers, comprising 329 clinics. Franchised clinics are only one source of family planning (FP), and this study seeks to understand whether access to a franchise increases the overall use or provides another alternative for women who would have found FP services in the public sector. Methods: A quasi-experimental study compared 50 catchment areas where there is a Tunza franchise and no other franchised provider with 50 purposively matched control areas within 20 km of each selected Tunza area, with a health facility, but no franchised facility. Data from 5609 women of reproductive age were collected on demographic and socioeconomic status, FP use, and care-seeking behavior. Multivariate logistic regression, with intervention and control respondents matched using coarsened exact matching, was conducted. Results: Overall modern contraceptive use in this population was 53 %, with 24.8 % of women using a long-acting or permanent method (LAPM). There was no significant difference in odds of current or new FP use by group, adjusted for age. However, respondents in Tunza catchment areas are significantly more likely to be LAPM users (adj. OR = 1.49, p = 0.015). Further, women aged 18\u201324 and 41\u201349 in Tunza catchment areas have a significantly higher marginal probability of LAPM use than those in control areas. Conclusions: This study indicates that access to a franchise is correlated with access to and increased use of LAPMs, which are more effective, and cost-effective, methods of FP. While franchised facilities may provide additional points of access for FP and other services, the presence of the franchise does not, in and of itself, increase the use of FP in Kenya

Transport Properties and Ionic Association in Pure Imidazolium-Based Ionic Liquids as a Function of Temperature

In this work, three transport properties (viscosity, diffusion coefficient, and electrical conductivity) were experimentally determined from 298 K to 343 K in four pure imidazolium-based ionic liquids with two anions and different alkyl chain lengths on the cation: 1-ethyl-3-methylimidazolium methylsulfate, [C₁C₂Im]­[CH₃SO₄], 1-butyl-3-methylimidazolium methylsulfate, [C₁C₄Im]­[CH₃SO₄], 1-ethyl-3-methylimidazolium triflate, [C₁C₂Im]­[CF₃SO₃] and 1-butyl-3-methylimidazolium triflate, [C₁C₄Im]­[CF₃SO₃]. Higher viscosities, lower diffusion coefficients, and electrical conductivities were measured when the alkyl chain length was increased or a sulfate anion was present. From these experimental data, the ionic association was discussed using the qualitative approach of the Walden plots and the quantitative ionicity concept. An increased ionic association was observed when the alkyl chain length on the cation was increased, while comparable ionicities were measured for both anions. Finally, the applicability of the Stokes–Einstein equation (relation between the diffusion coefficient and the viscosity) was also discussed in these systems

Transport properties and ionic association in pure imidazolium-based ionic liquids as a function of temperature.

International audienceIn this work, three transport properties (viscosity, diffusion coefficient, and electrical conductivity) were experimentally determined from 298 K to 343 K in four pure imidazolium-based ionic liquids with two anions and different alkyl chain lengths on the cation: 1-ethyl-3-methylimidazolium methylsulfate, [C1C2Im][CH3SO4], 1-butyl-3-methylimidazolium methylsulfate, [C1C4Im][CH3SO4], 1-ethyl-3-methylimidazolium triflate, [C1C2Im][CF3SO3] and 1-butyl-3-methylimidazolium triflate, [C1C4Im][CF3SO3]. Higher viscosities, lower diffusion coefficients, and electrical conductivities were measured when the alkyl chain length was increased or a sulfate anion was present. From these experimental data, the ionic association was discussed using the qualitative approach of the Walden plots and the quantitative ionicity concept. An increased ionic association was observed when the alkyl chain length on the cation was increased, while comparable ionicities were measured for both anions. Finally, the applicability of the Stokes–Einstein equation (relation between the diffusion coefficient and the viscosity) was also discussed in these systems

Effect of Nitrile-Functionalization of Imidazolium-Based Ionic Liquids on Their Transport Properties, Both Pure and Mixed with Lithium Salts.

CAPLUS AN 2014:2146289(Journal; Online Computer File)International audienceThe influence of the presence of a nitrile group in the cation of imidazolium-based ionic liquids on their transport properties was investigated. As these liquids can be used as electrolytes in lithium ion batteries, their mixtures with lithium salts were also considered. 1-Butyl-3-methylimidazolium bis(trifluoromethylsulphonyl)imide, [C1C4Im][NTf2], 1-butylnitril-3-methylimidazolium bis(trifluoromethylsulphonyl)imide, [C1C3CNIm][NTf2], and their mixtures with bis(trifluoromethylsulphonyl)imide lithium, Li[NTf2], were studied. Their mass transport properties (viscosity, ionic conductivity, self-diffusion) were experimentally determined. NMR spectroscopy was also used to explore molecular organization and interactions in these systems. The addition of a cyano group increases the viscosity and the ionicity of the liquid. The effect of lithium ion is more pronounced on [C1C3CNIm][NTf2], with interactions between Li+ and the nitrile group

Playing with ionic liquids to uncover novel solid polymer electrolytes

Solid polymer electrolytes (SPEs) based on chitosan and fourteen ionic liquids (ILs) were synthesized by solvent casting method. All ILs had in common a 1-ethyl-3-methylimidazolium cation ([C2mim]+). Therefore, this study focuses on the influence of the anion on the thermal, morphological, and electrochemical properties of the SPEs. The samples were analyzed by thermogravimetric analysis (TGA), differential scanning calorimetry (DSC), X-ray diffraction (XRD), scanning electron microscopy (SEM), atomic force microscopy (AFM), complex impedance spectroscopy (ionic conductivity) and cyclic voltammetry. The SPEs displayed an amorphous morphology, a thermal stability higher than the one obtained for the pure chitosan matrix (>140 ºC), a maximum room temperature (T = 25 ºC) ionic conductivity of 1.61 x 10-3 S cm-1 and a wide electrochemical window of ~ 4.0 V.FEDER through the COMPETE Program and by the Portuguese Foundation for Science and Technology (FCT) in the framework of the Strategic Project PEST-C/QUI/UI0686/2013, research units GREEN-it “Bioresources for Sustainability” (UID/Multi/04551/2013) and Associated Laboratory for Green Chemistry - Clean Technologies and Processes (UID/QUI/50006/2013)