Pauline McCormack

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The increased international sharing of data in research consortia and the introduction of new technologies for sequencing challenge the informed consent (IC) process, adding complexities that require coordination between research centres worldwide. Rare disease consortia present special challenges since available data and samples may be very limited. Thus,(More)
Hip implants have provided life-changing treatment, reducing pain and improving the mobility and independence of patients. Success has encouraged manufacturers to innovate and amend designs, engendering patient hopes in these devices. However, failures of medical implants do occur. The failure rate of the Articular Surface Replacement metal-on-metal hip(More)
Although the therapeutic misconception (TM) has been well described over a period of approximately 20 years, there has been disagreement about its implications for informed consent to research. In this paper we review some of the history and debate over the ethical implications of TM but also bring a new perspective to those debates. Drawing upon our(More)
There is a growing international agreement on the need to provide greater access to research data and bio-specimen collections to optimize their long-term value and exploit their potential for health discovery and validation. This is especially evident for rare disease research. Currently, the rising value of data and bio-specimen collections does not(More)
In this paper we argue that the consensus around normative standards for the ethics of research in clinical trials, strongly influenced by the Declaration of Helsinki, is perceived from various quarters as too conservative and potentially restrictive of research that is seen as urgent and necessary. We examine this problem from the perspective of various(More)
Within the myriad articles about participants’ opinions of genomics research, the views of a distinct group – people with a rare disease (RD) – are unknown. It is important to understand if their opinions differ from the general public by dint of having a rare disease and vulnerabilities inherent in this. Here we document RD patients’ attitudes to(More)
Rare disease patient organisations have a tendency to be deeply involved in research development and infrastructures, and are practiced at founding strategic alliances with clinical and research networks [1]. In building an integrated platform for rare disease databases, registries, biobanks and bioinformatics through the RD Connect project, we wanted to(More)
Duchenne muscular dystrophy (DMD) is a chronic, complex, genetic childhood disease affecting boys, where sufferers typically die in their 20s. DMD is caused by mutations in the dystrophin gene and trials are currently underway with exon skipping, a therapy which works by patching the mutation thereby allowing production of a functional gene. The dystrophin(More)
The new 'Recommendation of the Committee of Ministers to member States on research on biological materials of human origin', adopted in Europe in May 2016 is confusing and lacks specificity on the research use of biomaterials taken from persons not able to consent. It is possible to interpret the relevant clauses in a restrictive manner and doing so would(More)