The Research Register will provide a mechanism for ongoing collection and monitoring of all research conducted on the Mater campus.
The second phase of development of the Mater Research Register is now finalised.
The Register now includes a publication module and the ability to update the initial research project registration details with information on progress of the project.
The users manual is available on the research register home page and includes detailed instructions regarding these enhancements.
We would like to bring to the attention of researchers one key point regarding the recent enhancements to the register.
1. Publications Register
With the assistance of Jacki Chamberlain (Mater Library) we have identified all "Mater" journal publications between 1995 and January 2005. These have been imported into the Register and assigned to the appropriate researchers.
To ensure that the details are accurate, we would ask that researchers check that all publications have been correctly assigned and that all records are up to date. This includes ensuring that there are no missing publications. Only publications from peer reviewed journals have been registered at present, therefore if you have any publications in conference proceedings or other scholarly books please update the Register to include these using the on-line register function.
2. Progress reports module:
This new module allows progress on the researhc project to be collected and reported including an automated Mater HREC progress report where applicable. As a part of this functionality initial registration of research projects are required to be closed by the researcher once the required information is completed.
Projects which have been registered for longer then 30 days and not closed by the researcher will be closed automatically.
However, researchers will still be able to update the information through the update module.
Your assistance with this task is greatly appreciated.
For further information on the register or how to register a new publication please do not hesitate to contact myself or Hannah White Ext. 1583, hannah.white@mater.org.au, or Yan Lin Liu Ext 1582, yanlin.liu@mater.org.au
Research Publication Module and HREC Submission Now Available
Mater Health Services recognises the value of research and encourages high quality research activity. As there is a considerable amount of research being undertaken across “The Mater” campus, in May 2005 the Research Register was established to enable access to comprehensive information on research studies. The Mater Research Support Centre provides the Research Register Secretariat.
The Research Register is on the Mater Intranet in Applications, Research Register or at: http://intranet.mater.org.au/rsc/home Phase 1 of the Research Register development, which enabled on-line registration of ongoing and planned research and researchers details and reporting, was completed at the time of the official launch in May 2005. Since then, 139 research studies and 100 researchers have registered on the Research Register. Phase 2 has seen the incorporation of a Publications Register and the ability for the Research Register to generate the Mater Human Research Ethics submission form. In the development of the Publications Register, the Research Register Secretariat worked closely with the Mater Librarians, (Jackie Chamberlain and Kelly Dann). In order to measure the quality and quantity of research outputs at the Mater, the development of the Publications Register drew upon the methods used by the University of Queensland (UQ)1.
For the purposes of external funding (ie according to Department of Education, Science and Training DEST)2, UQ includes the following research publication types in its official quality and quantity analysis of research publications: research books; chapters in a research book; refereed journal articles; and refereed conference papers. Other types of research publications are also included in the UQ publications database for the purposes of reporting overall activity. Journal impact factors and article citations are commonly used to grade the quality of research publications. Both measures are maintained (updated annually) and made available by the ISI Web of Knowledge3 and are now incorporated into the Research Register.
Identifying Mater Publications for the Research RegisterJournals
A search of electronic databases was undertaken
to identify Mater journal publications. The search found a total of
1249 articles in 424 Journals over the period January 1995 to June
2005. For the 10 full years 1995 to 2004 there were 1173 articles –
a rate of 117/year. There has been a steady increase in
the numbers of Mater journal article publications over the past 10
years. The publication rate over recent years (2001-2004) is
142/year, compared with 100/year for the preceding 6-year period
(1995-2000) (Figure 1).
IMPACT Factors and Citation Index
Of the 144 journals identified in the year 2004 which published Mater research 20 journals (representing 34 publications) did not have an IMPACT factor or citation index on ISI3*. Although IMPACT factors and citation index has been included in the register, analysis by these variables awaits verification of publications by the individual researchers.
All journal publications have now been imported into the Research Register and Researchers are asked to check the publications listed under their name for accuracy.Other publications
Publications such as books and conference proceedings were not included in the search strategy as these are more difficult to identify electronically. However, these types of publications (particularly conference papers) could make up a substantial proportion of Mater research output, and therefore a mechanism for manual data entry or importing from researchers publication lists has been incorporated in the Research Register.
Next stage of development
Implementation of an automated audit function
The next major stage of development is to implement an automated audit function to enable monitoring of research performance. The key purpose of the function is to provide easily generated information to researchers and management on individual and overall research activity. A further purpose is to assist in identifying areas for improvements in the conduct of research at the Mater.
Update Report Function
To ensure the audit is timely and helpful, an Update Report function will be implemented to enable update reports to be processed on an annual basis until the research has been completed.
1. The 2004 University of Queensland Publications Data Collection Recording Year 2004 Publication Output. University of Queensland. Office of Research and Postgraduate Studies 10 March 2005.2. The Australian Clinical Trials Registry (CTC) has been established by the Federal Government through NHMRC for this purpose. Trials can be registered on the ACTR by going to www.actr.org.au
3. ISI Web of Knowledge www.isiwebofknowledge.com. Last accessed 12 July 2005
Please note that registering on the Mater Research Register does not currently meet the International Committee of Medical Journal Editors (ICJME) requirements.
Researchers are reminded that the ICJME - which includes, among many others, the Medical Journal of Australia, the Lancet and The New England Journal - have stated that they will consider a trial for publication only if it has been registered before the enrolment of the first patient. This policy applies to "clinically directive" trials ( please see information below) that start recruiting on or after 1 July 2005. The policy also covers ongoing trials which will need to be registered before 13 September 2005 to be considered for publication.
To register for this purpose, please go to the Australian Clinical Trials Registry (the ACTR). The ACTR is an intitaive of the NHMRC in conjunction with the University of Sydney.
For more information about which trials require registration for the ICMJE and about the the Australian Clinical Trials Registry, visit the website at www.actr.org.au
Further information on the ICJME policy on trial registration is available at:
http://www.mja.com.au/public/issues/182_12_200605/van10384_fm.pdf
According to the Australian Clinical Trials Registry (ACTR)
“all clinical trials involving Australian investigators or
participants, in all areas of health and testing all forms of
interventions should be registered” (ACTR, n.d.).
Trials that meet the ICMJE definition (International Committee
of Medical Journal Editors) of a clinical trial should be
registered. Any research that prospectively assigns human
subjects to intervention and comparison groups to study the
cause-and-effect relationship between a medical intervention and
a health outcome should be registered prior to commencement.
Medical interventions include any intervention used to modify a
health outcome and include drugs, surgical procedures, devices,
behavioural treatments, etc.
ICMJE states that among the trials that meet the above
definition, some may be clearly excluded or included.
Exclusion from the registration requirement is accepted if the
primary goal of the clinical trial is to assess major unknown
toxicity or determine pharmokinetics (phase 1 trials).
Inclusion on registry is mandatory for all trials whose primary
purpose is to affect clinical practice (phase 3 trials). Others
are not so clear. ICMJE states that between the “two extremes
are some clinical trials whose prespecified goal is to
investigate the biology of disease or to provide preliminary
data that may lead to larger, clinically directive trials” (De
Angelis, 2005).
Each journal editor will decide on a case by case basis about
reviewing unregistered trials in this category. Authors whose
trial is unregistered will have to convince the editor that they
had a sound rationale when they decided not to register their
trial. This policy will come under review in 2 years time, from
2005. (Please refer to De Angelis, 2005 for further details)
The ACTR is consistent with the WHO requirements set out by
the ICMJE. The ICJME has stated that they do not promote one
registry but its member journals will require authors to
register their trial in a registry that meets several criteria.
WHO require that a register should be electronically searchable
and accessible to the public at no charge. It must be open to
all registrants and not for profit and must have a mechanism to
ensure the validity of the registration data.
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Yes |
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1. |
Is this a phase 2, 3 or 4 clinical trial? |
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2. |
Does the study involve prospectively assigning human subjects to intervention and comparison groups evaluating a cause-and-effect relationship between a medical intervention and a health outcome? |
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3. |
Are you in doubt whether your trial meets the criteria for registration? |
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If you ticked Yes to any of the above, registration of the trial
in the ACTR is recommended.
Please go to the ACTR website
http://actr.org.au or contact Kate Triggs at the MRSC
Kate.Suridge@mater.org.au
or EXT 2119
Please note that registration in the Mater Research Register
does not fulfill the requirement for registration in terms of
the ICMJE criteria.
The MRSC is exploring means by which relevant research
registered in the Mater Research Register can be automatically
registered with the ACTR.
ACTR, n.d. Australian Clinical Trials Registry, viewed 15 July
2007, <http://actr.org.au/faq.aspx>.
De Angelis CD 2005, ‘Is this clinical trial fully registered? A
statement from the International Committee of Medical Journal
Editors’, The Lancet, vol. 365, no. May 28, pp. 1827 - 1829.
De Angelis CD 2004, ‘Clinical trial registration: a statement
from the International Committee of Medical Journal Editors’,
The Lancet, vol. 364, no. September 11, pp. 911 - 912.