One step forward, two steps back – requiring ministerial approval for all ‘non-therapeutic\' health research involving minors

The new National Health Act has clarified that children may take part in ‘non-therapeutic\' research (NTR) and the age at which they may provide independent consent to such research, viz. at legal majority. However, the Act will require consent from the Minister of Health for all research classed as NTR and involving minors regardless of the level of risk. This requirement is overly broad. It will require that low-risk research without direct benefits, which might be adequately reviewed by an accredited research ethics committee (REC), must also be reviewed by the Minister. As it currently stands this requirement serves no plausible ethical purpose, will cause delays and discourage essential research on the needs of children, and may inspire researchers and RECs alike to ‘foil the system\'. We argue that in the long term there should be comprehensive law reform for child research. However, in the short term, amendments should be made to the Act to narrow the scope of this provision. The amendment should require ministerial consent for research that is currently not approvable by an REC in terms of national ethical guidelines, namely, research that does not hold out direct benefit but presents more than a minor increase over minimal risk. If our law reform recommendations are rejected, we favour the delegation of this task to RECs because, if they receive appropriate training, they should be competent to conduct it. We accept the disadvantages, namely that the same body will review protocols twice from slightly different perspectives and that certain categories of research will remain unapprovable.South African Medical Journal Vol. 97 (2) 2007: pp.200-202

Protection of human participants in health research - a comparison of some US Federal Regulations and South African Research Ethics guidelines

In response to criticism of ethical review of a South African clinical trial, we contrast aspects of the United States Common Rule with South African research ethics requirements. In the USA the Common Rule does not apply to all health research and allows many exemptions from ethics review and waivers of informed consent. At a structural level research ethics review in South Africa is in many cases equivalent to the US institutional review board (IRB) and Office for Human Research Protections (OHRP) oversight system, is wider reaching, and has no exclusions

Growing Information System: New Vision in Integration of Information System Into Organization

Since organization change from stable to emergent condition, information system (IS) as part oforganization should have capability to follow the changes of requirement from the functional purposes andinteractivities with the users. Need of new strategy in IS development methodology is urgent. Integration of ISand organization could be seen as new vision and growing IS could be the new paradigm in IS developmentmethodology. The research conducted concludes that growing IS could be developed using role and task asorganic constructor. This paper presents theoretical approach leads to requirement of growing IS model (GiSM)

The FAOSTAT database of greenhouse gas emissions from agriculture

Peer reviewedPublisher PD

Research ethics committees in a tight spot: Approving consent strategies for child research that are prima facie illegal but are ethical in terms of national guidelines

It is an internationally accepted principle that ethics norms should be applied and enforced in research with humans through ethics review by research ethics committees (RECs). This places RECs at the very heart of the system for protecting participants and enforcing their rights. In the South African ethical-legal framework for child research, there are divergent approaches to consent. That is, section 71 of the National Health Act (No. 61 of 2003) (NHA) requires mandatory parental consent for child research, and limits the authority for proxy consent to parents and legal guardians. However, national ethics guidelines authorised by section 72 of the NHA and issued by the National Health Research Ethics Council (NHREC) acting in terms of its mandate (National Department of Health, 2015) allow a more nuanced approach – i.e. self-consent by older adolescents, provided certain conditions are met, and consent by a range of parental substitutes where there are no available parents or legal guardians. We have argued elsewhere that the consent approach in section 71 is inappropriately restrictive and are of the view that the consent approach endorsed in national ethics guidelines is more defensible. An REC that elects to approve a consent strategy allowable in ethics guidelines is effectively electing to not follow section 71, which raises the question of what the consequences might be for that REC. This article examines the legal liability of RECs through three ‘threads’ of accountability: the NHREC, the institutions hosting RECs, and the courts. We conclude that: (i) if an REC approves a child protocol with consent strategies allowable in terms of national ethics guidelinesbut not in terms of section 71, it is unlikely that the NHREC would discipline the REC in the face of a complaint – provided the REC acted within national ethics guidelines issued by the NHREC in terms of the latter’s section 72 mandate to set national norms and standards; (ii) if an REC approves a consent approach allowed for in ethics guidance, it is also unlikely that the host institution would discipline the REC in the face of a complaint – especially if the institution is aware of the REC’s explicit decision to follow national ethics guidelines that are authorised by section 72 of the NHA; and (iii) an REC could only be sued by a participant in terms of the law of delict (and be liable for damages) if several demanding components are proven, such as that the harm suffered by the participant resulted directly from the REC’s actions in approving a particular consent strategy for that research. Furthermore, the court may well look to national ethics guidelines in making determinations about whether an REC’s conduct was wrongful for the purposes of liability in civil law. RECs are protected from being collectively liable by insurance taken out by their host institutions. We make a series of recommendations to address this issue.Â

Migratory Connectivity of the Monarch Butterfly (Danaus plexippus): Patterns of Spring Re-Colonization in Eastern North America

Each year, millions of monarch butterflies (Danaus plexippus) migrate up to 3000 km from their overwintering grounds in central Mexico to breed in eastern North America. Malcolm et al. (1993) articulated two non-mutually exclusive hypotheses to explain how Monarchs re-colonize North America each spring. The ‘successive brood’ hypothesis proposes that monarchs migrate from Mexico to the Gulf Coast, lay eggs and die, leaving northern re-colonization of the breeding range to subsequent generations. The ‘single sweep’ hypothesis proposes that overwintering monarchs continue to migrate northward after arriving on the Gulf coast and may reach the northern portion of the breeding range, laying eggs along the way. To examine these hypotheses, we sampled monarchs throughout the northern breeding range and combined stable-hydrogen isotopes (δD) to estimate natal origin with wing wear scores to differentiate between individuals born in the current vs. previous year. Similar to Malcolm et al. (1993), we found that the majority of the northern breeding range was re-colonized by the first generation of monarchs (90%). We also estimated that a small number of individuals (10%) originated directly from Mexico and, therefore adopted a sweep strategy. Contrary to Malcolm et al. (1993), we found that 62% of monarchs sampled in the Great Lakes originated from the Central U.S., suggesting that this region is important for sustaining production in the northern breeding areas. Our results provide new evidence of re-colonization patterns in monarchs and contribute important information towards identifying productive breeding regions of this unique migratory insect

Structure calculation, refinement and validation using CcpNmr Analysis

CcpNmr Analysis provides a streamlined pipeline for both NMR chemical shift assignment and structure determination of biological macromolecules. In addition, it encompasses tools to analyse the many additional experiments that make NMR such a pivotal technique for research into complex biological questions. This report describes how CcpNmr Analysis can seamlessly link together all of the tasks in the NMR structure-determination process. It details each of the stages from generating NMR restraints [distance, dihedral,hydrogen bonds and residual dipolar couplings (RDCs)],exporting these to and subsequently re-importing them from structure-calculation software (such as the programs CYANA or ARIA) and analysing and validating the results obtained from the structure calculation to, ultimately, the streamlined deposition of the completed assignments and the refined ensemble of structures into the PDBe repository. Until recently, such solution-structure determination by NMR has been quite a laborious task, requiring multiple stages and programs. However, with the new enhancements to CcpNmr Analysis described here, this process is now much more intuitive and efficient and less error-prone