Public interest or public meddling? Towards an objective framework for the regulation of assisted reproduction technologies

BACKGROUND: Assisted reproductive technologies (ART) bear a heavy regulatory burden in some jurisdictions. This burden constrains patient autonomy and the professional autonomy of doctors and scientists. METHODS: We question why this should be by analyzing the possible public interests in ART regulation under the headings: health, financial, ethico-legal and socio-political. Throughout, we try to identify whether comparable public interest claims are made for other areas of medicine, but accommodated without the requirement for specialized statutory frameworks such as those exemplified in the UK and Victoria (Australia). RESULTS: We identify a small core of public interest concerns that seem to justify some sort of special regulatory structure, but not one as elaborate as those currently in place. We then develop a five-step quality control model, familiar to biomedical practice but novel in the context of legal thinking, to aid development and review of regulatory policy and practice. This model is applied both prospectively to the proposal to record 'by donation' on birth certificates, and retrospectively to the regulation of parental choice about the genetic make-up of offspring in UK and Victorian jurisdictions. CONCLUSIONS: The model provides a useful and robust framework for pin-pointing problems with regulatory regimes, to stimulate empirical research, and to facilitate both the review and development of regulatory policy.     

Do the public share practitioners’ views about the best evidence?

Objective

To investigate whether general practitioners (GPs) and patients agree on what constitutes the best evidence for the effectiveness of treatments.

Methods

GPs and members of the public aged 18–83 read five scenarios describing comparisons between hypothetical treatments for common ailments. Each scenario reported that one treatment was the more effective, as determined by randomised controlled trial (RCT), audit of treatment outcomes from many doctors’ patients, a single doctor's clinical experience, a friend's experience, or a web-based sales site. Participants rated how confident they would be that the treatment reported to be more effective would work for them.

Results

All participants had least confidence in the web-based sales site, more confidence in a friend's experience and more still in one doctor's experience. For doctor's experience, audit and RCT, amongst the public there were some differences by age but, importantly, only GPs had most confidence in evidence from an RCT.

Conclusion

GPs may treat evidence from RCTs as the gold standard while members of the public (their patients) may not afford it that same respect.

Practice implications

GPs engaged in shared decision-making should be alert to possible differences from their patients in the weight given to different types of evidence.     

Addressing conflicts of interest in the research paper: a societal demand in contemporary science?

In the last decade, dialogue between science and society has found a forum in an increasing number of publications on topics such as public engagement with science and public trust in science. Concerning the latter, issues that include cases of research misconduct, accountability in research, and conflicts of interest (COIs) have shaped global discussions on the communication of science. In the publication setting, the perception that hiding COIs and/or not managing them well may affect public trust in the research record has grown among editors. We conducted a search for editorials addressing COIs between 1989 and 2011, using four major databases: Medline/PubMed, Embase, Scopus, and Web of Knowledge. We explored the content of these editorials and the relationship they established between COIs and the public trust in science. Our results demonstrate that the relationship between disclosure of COIs and public trust in science has become a major concern among editors. We, thus, argue that COIs should be discussed more openly and frequently in graduate courses in the sciences, around the globe, not only in biomedical but also in non-biomedical areas. This is a critical issue in contemporary science, as graduate students are the future voices and decision-makers of the research community. Therefore, COIs, especially in the broader context of science and society, merit closer attention from policymakers, researchers, and educators. At times of great expectations for public engagement with science, mishandling of COIs may have undesirable consequences for public engagement with science and confidence in the scientific endeavor.     

Extending the reach of public health genomics: What should be the agenda for public health in an era of genome-based and “personalized” medicine?

The decade following the completion of the Human Genome Project has been marked by divergent claims about the utility of genomics for improving population health. On the one hand, genomics is viewed as the harbinger of a brave new world in which novel treatments rectify known causes of disease. On the other hand, genomics may have little practical relevance to the principal causes or remedies of diseases which are predominantly social or environmental in origin, particularly in low- and middle-income countries. Those supportive of a role for public health genomics argue that increasing knowledge of genomics and molecular pathology could unlock effective diagnostic techniques and treatments, and better target public health interventions. To resolve some of these tensions, an international multidisciplinary meeting was held in May 2010 in Ickworth, United Kingdom, with the aim of setting an agenda for the development of public health in an era of genome-based and “personalized” medicine. A number of key themes emerged, suggesting a need to reconfigure both the focus for existing genomic research and the stage at which funding is targeted, so that priority is given to areas of greatest potential health impact and that translation from basic science to implementation is given greater emphasis. To support these developments, there should be an immediate, sustained and systematic effort to provide an evidence base. These deliberations formed the basis for six key recommendations, which could guide the practice of public health in an era of genomics and personalized medicine.     

Saying the ‘S’ word in public

The mechanism by which self-reactive, peripheral lymphocytes are prevented from causing overt autoimmune disease is the subject of much debate. A recent meeting¹ examined the evidence to support a role for T-cell mediated suppression in maintenance of peripheral tolerance.