Ethical and legal issues regarding consent in research with adult stroke patients: case study in the ethics of mental health research.

This case study describes research into interventions to enhance stroke patients' ability to communicate. Because patients' cognitive abilities are compromised, it is argued that they may lack the capacity to consent and that surrogate consent should be required. In South Africa, this would make conducting the research difficult because only court-appointed curators are "legally appropriate" substitutes for research enrolment. Here, the research ethics committee must balance legal requirements and ethical concerns. It must also balance protection and respect for autonomy, even for cognitively compromised participants. First, incapacity should not simply be assumed but should be individually assessed. However, stroke patients present a further complication for capacity assessment because they may retain the capacity to reason but have lost the ability to communicate effectively. Second, the research ethics committee must decide whether recruitment should be restricted or whether incapacitated participants may be enrolled. Given the low risk of harm, incapacitated persons could be enrolled by proxies.

Ethical and practical issues to consider in the governance of genomic and human research data and data sharing in South Africa: a meeting report.

Genomic research and biobanking has undergone exponential growth in Africa and at the heart of this research is the sharing of biospecimens and associated clinical data amongst researchers in Africa and across the world. While this move towards open science is progressing, there has been a strengthening internationally of data protection regulations that seek to safeguard the rights of data subjects while promoting the movement of data for the benefit of research. In line with this global shift, many jurisdictions in Africa are introducing data protection regulations, but there has been limited consideration of the regulation of data sharing for genomic research and biobanking in Africa. South Africa (SA) is one country that has sought to regulate the international sharing of data and has enacted the Protection of Personal Information Act (POPIA) 2013 that will change the governance and regulation of data in SA, including health research data, once it is in force. To identify and discuss challenges and opportunities in the governance of data sharing for genomic and health research data in SA, a two-day meeting was convened in February 2019 in Cape Town, SA with over 30 participants with expertise in law, ethics, genomics and biobanking science, drawn from academia, industry, and government. This report sets out some of the key challenges identified during the workshop and the opportunities and limitations of the current regulatory framework in SA.

Projection of hazardous air pollutant emissions to future years.

Projecting a hazardous air pollutant (HAP) emission inventory to future years can provide valuable information for air quality management activities such as prediction of program successes and helping to assess future priorities. We have projected the 1999 National Emission Inventory for HAPs to numerous future years up to 2020 using the following tools and data: the Emissions Modeling System for Hazardous Air Pollutants (EMS-HAP), the National Mobile Inventory Model (NMIM), emission reduction information resulting from national standards and economic growth data. This paper discusses these projection tools, the underlying data, limitations and the results. The results presented include total HAP emissions (sum of pollutants) and toxicity-weighted HAP emissions for cancer and respiratory noncancer effects. Weighting emissions by toxicity does not consider fate, transport, or location and behavior of receptor populations and can only be used to estimate relative risks of direct emissions. We show these projections, along with historical emission trends. The data show that stationary source programs under Section 112 of the Clean Air Act Amendments of 1990 and mobile source programs which reduce hydrocarbon and particulate matter emissions, as well as toxic emission performance standards for reformulated gasoline, have contributed to and are expected to continue to contribute to large declines in air toxics emissions, in spite of economic and population growth. We have also analyzed the particular HAPs that dominate the source sectors to better understand the historical and future year trends and the differences across sectors.