Apply for a new study

So you want to do an APSU study ?

The APSU has conducted surveillance on over >65 different conditions including infectious or vaccine preventable diseases, genetic conditions, mental health disorders, and rare injuries.

How are conditions chosen?

An independent Scientific Review Panel considers applications for inclusion of new studies. The applicants must demonstrate the need for surveillance through a sound rationale, clear achievable aims and the likely impacts that will result from the study in terms of generating new scientific evidence to affect change in policy, clinical practice, community awareness, or leading to further research. As reporting is predominantly by paediatricians and paediatric specialists, the condition must be one that is likely to be seen by this group of clinicians, but it must be sufficiently rare so as not to overburden them.

Who can apply?

Groups of researchers or clinicians regardless of seniority may apply. Representation within the research group from most Australian states is important - state investigators raise awareness and act as points of contact for their local colleagues. Groups may also consider international collaboration as the APSU is a part of the International Network of Paediatric Surveillance Units - surveillance for Vitamin K deficiency bleeding and Haemolytic Uraemic Syndrome are excellent examples of studies that allowed international comparisons.

What about ethics?

Ethics committee approval is required before the commencement of the study and all data collected is de-identified.

How do i get started?

In the first instance its best to contact APSU staff (SCHN-APSU@health.nsw.gov.au) to discuss the new study proposal and to determine whether the APSU is indeed a suitable vehicle for your study. APSU staff can provide guidance and advice on the application process, questionnaires and database development.

Guidelines:

1. APPLICATION PROCESS

Applications for the inclusion of a study in the Australian Paediatric Surveillance Unit (APSU) reporting scheme are considered by the APSU Scientific Review Panel (SRP). The SRP will give fair and impartial consideration to all applications.  Where appropriate, the advice of independent referees will be sought.  The panel may also make inquiries to help avoid duplication or possible conflict with the work of other researchers in the same field.  Principal investigators may be invited to a meeting of the SRP to discuss their proposal.

1.1 Planning 

Researchers interested in applying for the inclusion of their study are encouraged to first make informal enquiries to the APSU Executive, who will be prepared to discuss protocols at the design stage. 

Once preliminary suitability has been established applicants will be asked to submit an Expression of Interest form. This is a one-page form reviewed by the SRP for feasibility and appropriateness to the APSU mechanism.

Formal application should be made on the APSU study application form.

When planning their study, investigators are asked to take into account the following:

  • The process from first discussion to acceptance may take several months.
  • Timing of inclusion of new studies on the APSU card depends on the number and the nature of other studies being conducted.
  • The APSU office must receive applications which are ready for submission one month prior to the SRP meeting, to allow time to circulate documents for review.
  • The SRP meets twice yearly and information on meeting dates is available from the APSU office.  For conditions of public health importance which require immediate evaluation this process will be accelerated.

2. ELIGIBILITY

A study is eligible for participation in the scheme if:

  • The condition of interest is a relatively rare childhood condition or a rare complication of a more common disease of such a low incidence or prevalence as to require ascertainment of cases on a national scale in order to generate sufficient numbers for study.  The SRP may also consider inclusion of short-term or geographically limited studies of comparatively more common conditions.
  • It is important for the success of the scheme that the workload of mailing list is kept to a minimum.  Accordingly, the SRP must be certain that studies conducted through the APSU are well designed and worthwhile.  The SRP will take into consideration the scientific merit and public health importance of the proposed study, its methodology and the suitability of the condition for ascertainment through the APSU scheme.  Studies depending on immediate reporting and/or sample collection, or requiring the participation of other specialties, are less likely to be suitable.

Condition means in this context, any definable problem or event normally leading to a child coming under the care of a paediatrician.  The condition of interest need not be infectious or a disease.
(For a list of past and present conditions please see Studies)

Child normally implies an upper age limit of 15 years. The SRP wishes to maintain consistency in this respect.

Mailing list refers to all clinicians who are sent the monthly APSU report card.  This group is comprised of paediatricians, paediatric sub-specialists, paediatric general surgeons and other clinicians working predominantly with children.

3. ETHICS APPROVAL

  • The Chief Investigator must have the approval of the human research ethics committee within his/her own institution.
  • All Co-Investigators should inform their local ethics committee that they are participating in an APSU study that has already been approved by another ehtics committee. Seperate approvals from multiple ethics committees are not required (NHMRC Human Research Ethics Handbook, 2001).
  • All data collected is de-identifed. All the usual considerations of confidentiality in medical research apply to information collected through the APSU scheme. Any approach to the patient or their family may be made only by the reporting paediatrician.

4. FUNDING

Adequate funding or organisational arrangements must have been obtained for the completion of the research.

4.1 APSU Fee Structure

  • An investigator's fee of $25,000 per year of study has been instituted to cover the costs associated with running the study through the APSU mechanism plus a one off study establishment fee of $10,000. This includes the monthly mailing or e-mailing of the report card to approximately 1500 clinicians, maintenance of the APSU clinician database, data collection via questionnaire, database development, data entry and reporting to the investigator of any case notifications received. 

4.2 Fee Payment Schedule

All fees must be paid prior to the inclusion of the study on the APSU monthly report card.

The APSU are happy to negotiate the fee amount dependent on the nature of the study, the organisation through which it is run and the investigator's funding circumstances.

5. REPORTS & PUBLICATIONS

5.1 Investigators are asked to declare that they will acknowledge both the assistance of the APSU and the contributors to the APSU in any manscripts submiited for publication.

5.2 The APSU does not exercise any control whatsoever over when or where research workers publish their results, nor does it require being included in authorship.

5.3 APSU is part funded by the following: Australian Government Department of Health and Ageing, Royal Australasian College of Physicians, Division of Paediatrics and Child Health and the NHMRC. These funding bodies and any other sources of funding received by the Investigators for their study must be acknowledged in any publications or presentations. Suggested acknowledgement:

"The activities of  the APSU are funded in part by the Australian Government Department of Health and Ageing and NHMRC Enabling Grant 402784, Faculty of Medicine, The University of Sydney, and the Royal Australasian College of Physicians, Division of Paediatrics and Child Health."

5.4 The APSU also requires a copy of published articles and abstracts presented at meetings and information about any other relevant presentations, publications or media interviews.

5.5 Regular feedback to reporting clinicians is important to encourage their full co-operation with the scheme. Accordingly, participating investigators are asked to contribute short reports each year and on completion of their project for the APSU Annual Research Report. They may also be invited to participate in any APSU Annual Scientific meetings or workshops and to occasionally supply periodic reports and review articles, as requested.

5.6 The SRP would like to remind investigators who are not themselves paediatricians, that the success of the scheme depends on the goodwill of the RACP members. Submission of articles to the Journal of Paediatrics and Child Health as an alternative to a journal apropriate to the investigator's speciality ,such as genetics or microbiology, should at least be considered.

5.7 Once your study has been approved by the Scientific Review Panel (SRP) you will be required to sign an Investigator Agreement.

FORMS AND GUIDES