UCD TOPMed10
Risk assessment template
A risk assessment for a research project is a valuable tool for both researcher and PI as it
enables risks to be identified and managed.
Risks can include issues with the research methodology, problems getting samples, technical
failures as well as not meeting project deadlines. If you are actively considering the potential
for such issues to come up it is possible to put in place measures to mitigate the risks;
evaluators will be looking for evidence that what you propose can be actually be delivered
and a thorough and realistic risk assessment is a good place to start.
The following table gives risks from an example research project that aims to assess the
potential impact of next generation sequencing and bioinformatics analysis platform on
clinical practices in oncology.
Table 1: Risks and mitigating measures
Risk
Description of risk
number
Mitigating measures
Work packages
involved
WP3, WP5
R1
Whole Exome Sequencing
results on gene signatures
not clearly different for
the subgroups of interest.
This is unlikely as Whole Exome
Sequencing already has been shown to be
able to derive such signatures for
response to immunotherapies in example
clinical centre 1 and chemotherapy in
example clinical centre 2. In order to
enhance discriminatory power, we can
increase sample numbers, switch to
whole genome sequencing, and include
miRNA analysis.
R2
Results of the gene
signature are not
transferable to a gene
panel
Decision algorithm having
too little discriminatory
power.
Limited material for
analysis
Increase the size of the gene panels. Gene WP2, WP3, WP4
panels including 800 amplicons still give
good results with DNA from formalinfixed paraffin embedded tissues.
Include more orthogonal data, e.g. from WP2, WP4, WP5
whole genome sequencing, and more
histological and immune markers.
The first studies utilise retrospective,
WP2
clinically annotated cohorts which are
R3
R4
This project has received funding from the European Union’s Horizon 2020
research and innovation programme under the Marie Skłodowska-Curie
grant agreement No. 666010.
R5
R6
R7
already available. Consistency in
assessment will allow direct comparison
between centres giving optimal
conditions for decision tree analysis on
which approaches are suitable for
personalised medicine
Next Generation
All centres have demonstrated successful WP2, WP3, WP4
Sequencing fails to work
Next Generation Sequencing panel testing
adequately on formalinusing formalin-fixed paraffin embedded
fixed paraffin embedded
samples in their own laboratories. WES
samples
will use validated fresh frozen material.
Technology platforms not Logistic planning in preparatory phase in WP2, WP3, WP4
ready in time for sample order to harmonise sample delivery with
analysis
analysis capacities.
Schedule slippage, late
Regular meetings with Prinicipal
WP1
deliveries and slow
Investigator and Secondment Host will
progress in general
identify problems early on. Relevant
indicators will be defined to identify
trends in progress achievement, showing
the average actual schedule slippage of
each task with respect to the original
planning;
This project has received funding from the European Union’s Horizon 2020
research and innovation programme under the Marie Skłodowska-Curie
grant agreement No. 666010.