Use is
approved by the Director of Research Operations in consultation with the CNC
for Research & Trials.
If
teams would like to use MCRU for non-research purposes, contact the CNC for
Research and Trials directly.
Researchers
requiring use of MCRU for a study, need to seek ‘supporting department
declaration’ as part of their governance application to RCH HREC. Prior to
approval, detailed information about the planned use in the unit will need to
be provided to determine whether it is appropriate for the study be done in
MCRU. The key considerations are whether:
- there is sufficient capacity to fit the proposed study visits.
- there is laboratory capacity to allow the sample processing.
- the type samples to be processed fit within the limitations of any
restrictions in place (e.g. COVID restrictions)
- MCRU is the most appropriate place for the proposed study visits to
occur from a clinical risk point of view
Many
RCH departments frequently support research, most of these departments are part
of a single platform for getting supporting department declarations (SDD)
called the Department Ethics and Research Platform (DERP). On DEPR researchers
can fill in their basic study information (title, summary, type of study,
sponsor name etc) once, and then select all the departments who they require
support from to start the request process.
To
start filling out your study’s record on DERP and submit your request to use
MCRU,
click here. If
your study team already has a platform, you will get an error when you try to
put in your HREC number and instructions on who to contact to get access to
your study’s platform.
After
the researchers submits the form on DERP, the CNC for Research & Trials
reviews the space requirements and the appropriateness of MCRU use in relation
to availability of space and clinical risk. If the CNC is uncertain or the risk
profile of a study, they will seek further advice from the study team and/or
Associate Director of the MCTC and others as required.
If
there are more requests for use than there is space, the following will be
taken into consideration when determining the greatest need:
- Research has priority for the space.
- Within research, study visits that involve the
following are prioritised:
a. Study drug administration
b. High risk procedures
c. Frequent blood collection where the samples need to be
processed in a time critical manner and cannot be transferred to another
laboratory.
It is
the responsibility of the CNC to manage this process on behalf of the
Department of Research Operations. The CNC is responsible for ensuring the
speedy response to researchers and providing an initial assessment and their
professional opinion for the Director. Researchers are encouraged to engage the
CNC early in feasibility assessments. This can be done by contacting them
directly or submitting their request through DERP). The CNC is generally
responsible for managing the MCRU SDD database and liaising with researchers
during the application process.