FDA abandons the Declaration of Helsinki: The effect on the ethics of clinical trial conduct in South Africa and other developing countries

Four years ago, the US Food and Drug Administration (FDA) ceased compliance with the Declaration of Helsinki (DoH) (2000 revision andall subsequent revisions) for conduct of clinical trials outside its borders. It instead ruled that compliance with the Good Clinical Practices (GCP) of the International Conference of Harmonization (ICH) is sufficient. However, the ICH-GCP guidelines do not address certain ethical requirements stipulated in the DoH, such as the use of placebos v. standard therapy, post-trial access to treatment and other benefits for participants; public disclosure of trial design; publication of trial results; and disclosure of conflicts of interest. The FDA’s adoption of less morally stringent guidelines could encourage pharmaceutical companies to take ethical short cuts. It could also have practical consequences for trial ethics in developing countries, especially where research ethics committees may not be promotinghigh standards of protection for participants in clinical trials, due to lack of financial and human resources. Pharmaceutical companies may also pressurise research ethics committees to relax guidelines and legislation, in order to facilitate future clinical trials in developing and emerging countries that lack the resources to conduct their own clinical research on epidemics such as HIV/AIDS, which have devastating effects on their populations

The South African clinical trial industry: Implications of problems with the issuing of human tissue export permits

The National Health Act requires a valid permit before human biological tissue samples are exported from South Africa. However, delays in issuing export permits make it difficult for many researchers and pharmaceutical companies to comply. There are misconceptions about who is responsible for obtaining such a permit. Delays have caused many new trials to start without a permit, and biological samples from ongoing trials have been exported using expired permits. This could have detrimental consequences for the South African trial industry, especially with the country’s history of vulnerable populations in developing areas. Medicine Control Council inspections have listed findings related to export permits for several trial sites. Researchers must be aware that it remains their responsibility to apply for such a permit. The most important steps to ensure a smoother approval process are for applicants to (i) familiarise themselves with the permit issue process and (ii) recognise the importance of correctly completing and signing application forms

Measurement & verification of a utility sponsored residential demand side management programme involving multiple technologies

Due to the low reserve margin on the electrical grid in South Africa many energy initiatives were introduced by the utility over the last decade. One such initiative was to roll out identified energy efficiency technologies at residential homes. The utility aimed to achieve a 90MW evening peak (18h00 to 20h00) demand reduction by distributing free CFLs, LEDs, geyser timers, pool timers and low flow shower roses to residential electricity customers throughout the country. This paper presents an overview of the process and methodology used to measure and verify (M&V) the energy and demand impact of the programme. The verified saving achieved was 87.2MW. This includes both an energy efficiency and a load shifting component. The project was M&V’d using the International Performance Measurement & Verification Protocol (IPMVP) and SANS 50010 standard for determining energy savings

Black Hole Mergers and Unstable Circular Orbits

We describe recent numerical simulations of the merger of a class of equal mass, non-spinning, eccentric binary black hole systems in general relativity. We show that with appropriate fine-tuning of the initial conditions to a region of parameter space we denote the threshold of immediate merger, the binary enters a phase of close interaction in a near-circular orbit, stays there for an amount of time proportional to logarithmic distance from the threshold in parameter space, then either separates or merges to form a single Kerr black hole. To gain a better understanding of this phenomena we study an analogous problem in the evolution of equatorial geodesics about a central Kerr black hole. A similar threshold of capture exists for appropriate classes of initial conditions, and tuning to threshold the geodesics approach one of the unstable circular geodesics of the Kerr spacetime. Remarkably, with a natural mapping of the parameters of the geodesic to that of the equal mass system, the scaling exponent describing the whirl phase of each system turns out to be quite similar. Armed with this lone piece of evidence that an approximate correspondence might exist between near-threshold evolution of geodesics and generic binary mergers, we illustrate how this information can be used to estimate the cross section and energy emitted in the ultra relativistic black hole scattering problem. This could eventually be of use in providing estimates for the related problem of parton collisions at the Large Hadron Collider in extra dimension scenarios where black holes are produced.Comment: 16 pages, 12 figures; updated to coincide with journal versio

Prosecuting the main perpetrators of international crimes in Eritrea: Possibilities under international law

A growing international consensus has emerged in the last few decades on the need to prosecute egregious violations of international law. In this regard, the establishment of the International Criminal Court (ICC) is seen as a landmark development in the global protection of international human rights and humanitarian law standards. Since its independence in 1991, Eritrea has experienced heinous violations of international law. The violations amount to international core crimes, as defined by the ICC Statute and customary international law. These include crimes against humanity, war crimes and the crime of aggression. There are consistent reports, as well as documentary and testimonial evidence from reliable sources on this. Accordingly, a number of high-ranking government officials may be reasonably suspected of involvement in the perpetration of international crimes in Eritrea. However, Eritrea is not a state party to the ICC Statute and this means that many of the international crimes perpetrated in the country may not fall under the jurisdiction of the ICC. On the other hand, violations are continuing with impunity, as there are no effective domestic remedies to rectify the problem, giving rise to the need for immediate intervention by the international community. The article discusses the legal implications of the ICC Statute with regard to international crimes committed in Eritrea before and after the coming into effect of the Statute. Drawing on the latest developments of international criminal law, it explores possible options for the prosecution of the main perpetrators of international crimes pursuant to Security Council referral as stipulated under article 13(b) of the ICC Statute

The Surface Chemical Properties of Novel High Surface Area Solids Synthesized from Coal Fly Ash

The zeolite, Na-P1, was synthesized from fly ash samples originating from coal-fired power stations in South Africa by hydrothermal treatment of the raw ash with concentrated aqueous NaOH solutions. The zeolite was then further modified by acid leaching at elevated temperatures. This resulted in the formation of a novel high surface-area solid. Spectroscopic and potentiometric investigations into the surface properties of both solids indicate that acid-base properties are most likely due to the presence of =AlOH- and =SiOH-type surface groups. Surface protonation constants for the various solids (unmodified ash, base-modified ash, acid-etched zeolitic product) are reported. Metal sorption studies were performed for cadmium and copper. It is suggested that the zeolitic product sorbs copper and cadmium by an ion exchange mechanism instead of a surface complexation mechanism, whereas the high surface-area solid, formed after acid etching, sorbs these metals via a surface complexation mechanism. Metal adsorption constants for the formation of =XOMOH species on the surface of the last mentioned solid for use in speciation models are reported. (South African Journal of Chemistry: 2003 56: 34-39

Personality profile and coping resources of family medicine vocational trainees at the University of Limpopo, South Africa

Background: Doctors are exposed to various stress factors in their personal and family lives, as well as in the workplace. Stress inherent to the responsibilities and challenges of the medical field may become a health hazard and threaten the well-being of the medical practitioner.Methods: The aim of this study was to investigate the personality traits and coping resources that contribute to the wellbeing of medical practitioners. A cross-sectional study of 44 out of 45 (98% response rate) family medicine vocational trainees at the Medical University of Southern Africa (now known as the University of Limpopo) was conducted. A biographic questionnaire was utilised to obtain specific information regarding the participants. The principal researcher used the CopingResources Inventory (CRI) questionnaire to assess coping resources, and the 16PF personality analysis (16PF) to establish a personality profile of the participants.Results: The majority of participants (81.8%) indicated that they mainly experienced work-related stress. Thirty-two participants (72.72%) self-medicated. Fourteen participants (31.81%) claimed to experience burn-out and twenty (45.45%) reported fatigue. In terms of their coping resources, 24 male participants (54.54%) did not cope socially (p ≤ 0.008) and eight (18.18%) also did not cope physically (p ≤ 0.024).Conclusions: The medical practitioners had a universal personality profile. They lacked insight regarding the symptoms they were experiencing that warranted management, e.g. depression and anxiety. The medical practitioners in this study did not utilise their social and physical coping resources optimally and reported poor help-seeking behaviour.Keywords: personality; coping resources; family medicine; stress; vocational trainee