Biobank literature update week 37 (2015)
[1] Research participants' perceptions and views on consent for biobank research: a review of empirical data and
ethical analysis. D'Abramo F, Schildmann J, Vollmann J. BMC medical ethics 2015; 16:60. BACKGROUND: Appropriate
information and consent has been one of the most intensely discussed topics within the context of biobank research.
In parallel to the normative debate, many socio-empirical studies have been conducted to gather experiences,
preferences and views of patients, healthy research participants and further stakeholders. However, there is scarcity
of literature which connects the normative debate about justifications for different consent models with findings
gained in empirical research. In this paper we discuss findings of a limited review of socio-empirical research on
patients' and healthy research participants' experiences and views regarding consent to biobank research in light of
ethical principles for appropriate information and consent. METHODS: Review question: Which empirical data are
available on research participants' perceptions and views regarding information and elicitation of consent for
biobank research? Search of articles published till March 1st 2014 in Pubmed. Review of abstracts and potentially
relevant full text articles by two authors independently. As categories for content analysis we defined (i)
understanding or recall of information, (ii) preferences regarding information or consent, and (iii) research
participants' concerns. RESULTS: The search in Pubmed yielded 337 abstracts of which 10 articles were included in
this study. Approaches to information and consent varied considerably across the selected studies. The majority of
research participants opted for some version of limited consent when being informed about such possibility. Among
the factors influencing the type of preferred consent were information about sponsoring of biobank research by
pharmaceutical industry and participants' trade-off between privacy and perceived utility. Studies investigating
research participants' understanding and recall regarding the consent procedure indicated considerable lack of both
aspects. Research participants' perceptions of benefits and harms differ across those studies. CONCLUSION: The
knowledge, perceptions and views of research participants who have undergone a consent procedure within the
context of biobank research raise several questions on the issue of how to inform and elicit consent in an ethically
acceptable way. In our empirical-ethical analysis we develop suggestions on how the practice of eliciting consent in
the biobank context should be improved.
[2] Effects of biobanking conditions on six antibiotic substances in human serum assessed by a novel evaluation
protocol. Zander J, Maier B, Zoller M et al. Clinical chemistry and laboratory medicine : CCLM / FESCC 2015.
BACKGROUND: Although therapeutic drug monitoring (TDM) for antibiotics in critically ill patients is recommended
by expert panels, no commercial tests are available for most antibiotics. Therefore, we previously developed a multianalyte method for the quantification of piperacillin, tazobactam, cefepime, meropenem, ciprofloxacin and linezolid
in serum. However, limited stability data were available, and the relevant studies did not address the coefficients of
variation of the methods applied, which may be important for verifying the storage dependency of the observed
effects. Here we aimed to evaluate the storage effects of antibiotics by applying a novel evaluation protocol.
METHODS: Serum-based test samples were aliquoted and stored at room temperature, 4 degrees C, -20 degrees C or
-80 degrees C for up to 180 days. Using an innovative evaluation protocol (considering the coefficient of variation, pvalue, and criterion of monotony of observed changes), we assessed whether relevant changes (defined as >/=15% in
comparison with baseline) were storage dependent (defined as substantial changes). RESULTS: Storage at -80
degrees C for up to 180 days did not lead to substantial changes for any analyte. In contrast, storage at -20 degrees C
induced substantial decreases after >/=7 days for piperacillin, tazobactam, cefepime and meropenem; after 90 days
at -20 degrees C, only </=23% of the initial concentrations were found for these parameters. No substantial changes
were observed for linezolid and ciprofloxacin at any storage condition. All of the observed substantial changes were
monotonic decreases. CONCLUSIONS: We recommend a storage temperature of -80 degrees C for beta-lactam
antibiotics. The applied evaluation protocol yielded conclusive results and may be generally useful for stability
studies.
[3] Risks of phase I research with healthy participants: A systematic review. Johnson RA, Rid A, Emanuel E, Wendler D.
Clinical trials (London, England) 2015. BACKGROUND/AIMS: Tragedies suggest that phase I trials in healthy
participants may be highly risky. This possibility raises concern that phase I trials may exploit healthy participants to
develop new therapies, making the translation of scientific discoveries ethically worrisome. Yet, few systematic data
evaluate this concern. This article systematically reviews the risks of published phase I trials in healthy participants
Biobank literature update week 37 (2015)
and evaluates trial features associated with increased risks. METHODS: Data on adverse events and trial
characteristics were extracted from all phase I trials published in PubMed, Embase, Cochrane, Scopus, and PsycINFO
(1 January 2008-1 October 2012). Inclusion criteria were phase I studies that enrolled healthy participants of any age,
provided quantitative adverse event data, and documented the number of participants enrolled. Exclusion criteria
included (1) adverse event data not in English, (2) a "challenge" study in which participants were administered a
pathogen, and (3) no quantitative information about serious adverse events. Data on the incidence of adverse
events, duration of adverse event monitoring, trial agent tested, participant demographics, and trial location were
extracted. RESULTS: In 475 trials enrolling 27,185 participants, there was a median of zero serious adverse events
(interquartile range = 0-0) and a median of zero severe adverse events (interquartile range = 0-0) per 1000 treatment
group participants/day of monitoring. The rate of mild and moderate adverse events was a median of 1147.19 per
1000 participants (interquartile range = 651.52-1730.9) and 46.07 per 1000 participants/adverse event monitoring
day (interquartile range = 17.80-77.19). CONCLUSION: We conclude that phase I trials do cause mild and moderate
harms but pose low risks of severe harm. To ensure that this conclusion also applies to unpublished trials, it is
important to increase trial transparency.
[4] What Role for Law, Human Rights, and Bioethics in an Age of Big Data, Consortia Science, and Consortia Ethics?
The Importance of Trustworthiness. Dove ES, Ozdemir V. Laws 2015; 4:515-540. The global bioeconomy is generating
new paradigm-shifting practices of knowledge co-production, such as collective innovation; large-scale, data-driven
global consortia science (Big Science); and consortia ethics (Big Ethics). These bioeconomic and sociotechnical
practices can be forces for progressive social change, but they can also raise predicaments at the interface of law,
human rights, and bioethics. In this article, we examine one such double-edged practice: the growing, multivariate
exploitation of Big Data in the health sector, particularly by the private sector. Commercial exploitation of health data
for knowledge-based products is a key aspect of the bioeconomy and is also a topic of concern among publics around
the world. It is exacerbated in the current age of globally interconnected consortia science and consortia ethics,
which is characterized by accumulating epistemic proximity, diminished academic independence, "extreme
centrism", and conflicted/competing interests among innovation actors. Extreme centrism is of particular importance
as a new ideology emerging from consortia science and consortia ethics; this relates to invariably taking a middle-ofthe-road populist stance, even in the event of human rights breaches, so as to sustain the populist support needed
for consortia building and collective innovation. What role do law, human rights, and bioethics-separate and
together-have to play in addressing these predicaments and opportunities in early 21st century science and society?
One answer we propose is an intertwined ethico-legal normative construct, namely trustworthiness. By considering
trustworthiness as a central pillar at the intersection of law, human rights, and bioethics, we enable others to trust
us, which in turns allows different actors (both nonprofit and for-profit) to operate more justly in consortia science
and ethics, as well as to access and responsibly use health data for public benefit.
[5] Systems Medicine: The Application of Systems Biology Approaches for Modern Medical Research and Drug
Development. Ayers D, Day PJ. Molecular biology international 2015; 2015:698169. The exponential development of
highly advanced scientific and medical research technologies throughout the past 30 years has arrived to the point
where the high number of characterized molecular agents related to pathogenesis cannot be readily integrated or
processed by conventional analytical approaches. Indeed, the realization that several moieties are signatures of
disease has partly led to the increment of complex diseases being characterized. Scientists and clinicians can now
investigate and analyse any individual dysregulations occurring within the genomic, transcriptomic, miRnomic,
proteomic, and metabolomic levels thanks to currently available advanced technologies. However, there are
drawbacks within this scientific brave new age in that only isolated molecular levels are individually investigated for
their influence in affecting any particular health condition. Since their conception in 1992, systems biology/medicine
focuses mainly on the perturbations of overall pathway kinetics for the consequent onset and/or deterioration of the
investigated condition/s. Systems medicine approaches can therefore be employed for shedding light in multiple
research scenarios, ultimately leading to the practical result of uncovering novel dynamic interaction networks that
are critical for influencing the course of medical conditions. Consequently, systems medicine also serves to identify
clinically important molecular targets for diagnostic and therapeutic measures against such a condition.