Biobank literature update week 38 (2015)
[1] Use of altered informed consent in pragmatic clinical research. McKinney RE, Jr., Beskow LM, Ford DE et al. Clinical
trials (London, England) 2015. There are situations in which the requirement to obtain conventional written informed
consent can impose significant or even insurmountable barriers to conducting pragmatic clinical research, including
some comparative effectiveness studies and cluster-randomized trials. Although certain federal regulations governing
research in the United States (45 CFR 46) define circumstances in which any of the required elements may be waived,
the same standards apply regardless of whether any single element is to be waived or whether consent is to be waived
in its entirety. Using the same threshold for a partial or complete waiver limits the options available to institutional
review boards as they seek to optimize a consent process. In this article, we argue that new standards are necessary in
order to enable important pragmatic clinical research while at the same time protecting patients' rights and interests.
[2] All in the Blood: A Review of Aboriginal Australians' Cultural Beliefs About Blood and Implications for Biospecimen
Research. Kowal E, Greenwood A, McWhirter RE. Journal of empirical research on human research ethics : JERHRE 2015;
10:347-359. Public participation in medical research and biobanking is considered key to advances in scientific discovery
and translation to improved health care. Cultural concerns relating to blood have been found to affect the participation
of indigenous peoples and minorities in research, but such concerns are rarely specified in the literature. This article
presents a review of the role of blood in Australian Aboriginal cultures. We discuss the range of meanings and uses of
blood in traditional culture, including their use in ceremonies, healing, and sorcery. We draw on more recent literature
on Aboriginal Australians and biomedicine to consider how traditional beliefs may be changing over time. These findings
provide an empirical basis for researchers and bioethicists to develop culturally grounded strategies to boost the
participation of Aboriginal Australians in biomedical research. They also serve as a model for integrating anthropological
literature with bioethical concerns that could be applied to other indigenous and minority groups.
[3] Participant Satisfaction With a Preference-Setting Tool for the Return of Individual Research Results in Pediatric
Genomic Research. Holm IA, Iles BR, Ziniel SI et al. Journal of empirical research on human research ethics : JERHRE
2015; 10:414-426. The perceived benefit of return of individual research results (IRRs) in accordance to participants'
preferences in genomic biobank research is unclear. We developed an online preference-setting tool for return of IRRs
based on the preventability and severity of a condition, which included an opt-out option for IRRs for mental illness,
developmental disorders, childhood-onset degenerative conditions, and adult-onset conditions. Parents of patients <18
years of age at Boston Children's Hospital were randomized to the hypothetical scenario that their child was enrolled in
one of four biobanks with different policies for IRRs to receive (a) "None," (b) "All," (c) "Binary"-choice to receive all or
none, and (d) "Granular"-use the preference-setting tool to choose categories of IRRs. Parents were given a hypothetical
IRRs report for their child. The survey was sent to 11,391 parents and completed by 2,718. The Granular group was the
most satisfied with the process, biobank, and hypothetical IRRs received. The None group was least satisfied and least
likely to agree that the biobank was beneficial (p < .001). The response to the statement that the biobank was harmful
was not different between groups. Our data suggest that the ability to designate preferences leads to greater
satisfaction and may increase biobank participation.
[4] Whole Genome Amplification from Blood Spot Samples. Sorensen KM. Methods in molecular biology (Clifton, N.J.)
2015; 1347:163-178. Whole genome amplification is an invaluable technique when working with DNA extracted from
blood spots, as the DNA obtained from this source often is too limited for extensive genetic analysis. Two techniques
that amplify the entire genome are common. Here, both are described with focus on the benefits and drawbacks of each
system. However, in order to obtain the best possible WGA result the quality of input DNA extracted from the blood
spot is essential, but also time consumption, flexibility in format and elution volume and price of the technology are
factors influencing system choice. Here, three DNA extraction techniques are described and the above aspects are
compared between the systems.
[5] Pre-Analytical Determination of the Effect of Extended Warm or Cold Ischaemia on RNA Stability in the Human
Ileum Mucosa. Lee SM, Schelcher C, Thasler R et al. PLoS One 2015; 10:e0138214. The use of banked human tissue,
obtained with informed consent after elective surgical procedures, represents a powerful model for understanding
Biobank literature update week 38 (2015)
underlying mechanisms of diseases or therapeutic interventions and for establishing prognostic markers. However,
donated tissues typically have varying times of warm ischaemia in situ due to blood arrest or cold ischaemia due to
procurement and transportation. Hence, before using these tissues, it is important to carry out pre-analytical studies to
ensure that they are representative of the in vivo state. In particular, tissues of the gastrointestinal tract have been
thought to have low RNA stability. Therefore, this study aimed to determine if extended warm or cold ischaemia times
and snap-freezing or banking in RNA stabilization solution affects RNA integrity or gene expression in human ileum
mucosa. In short, ileum mucosa was collected for up to 1.5 h and 6 h of simulated warm or cold ischaemia respectively.
Subsequently, RNA integrity and gene expressions were determined. It was found that RNA integrity remained high over
the course of warm and cold ischaemia examined and there were in general no significant differences between snapfreezing and banking in RNA stabilization solution. Following the same trend, there were in general no significant
changes in gene expressions measured (MYC, HIF1alpha, CDX, HMOX1 and IL1beta). In conclusion, RNA in the ileum
mucosa is maintained at a high integrity and has stable gene expression over the examined time course of warm or cold
ischaemia when banked in RNA stabilization solution or snap-frozen in liquid nitrogen. As the average warm and cold
ischaemia times imposed by surgery and the process of tissue banking are shorter than the time period examined in this
study, human ileum mucosa samples collected after surgeries could be used for gene expression studies.