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The New Zealand Medical Journal

 Journal of the New Zealand Medical Association, 20-January-2012, Vol 125 No 1348

Proposed changes to the New Zealand Ethics Committees
Frank A Frizelle
The New Zealand House of Representatives’ “Inquiry into improving New Zealand’s environment to support innovation through clinical trials” was stimulated because of concerns that New Zealand has lost its advantage as a “good place” to carry out clinical trials.
This Inquiry made 54 recommendations and concluded that “the main elements of the system can be put right at almost no cost, and we believe the returns for New Zealand patients, the health service, and the economy will be significant.”
Their main recommendations were:
  • Simplify and streamline ethical review processes.
  • Promote collaboration between Government departments to coordinate the system.
  • Develop a national health research action plan to foster innovation and commercialisation.
  • Develop a framework for clinical trial research throughout district health boards (DHBs), to be facilitated by a hub.
The full report is available at:
http://www.parliament.nz/NR/rdonlyres/5AFC2393-05CF-44DB-8BF1-DD501A057408/193163/DBSCH_SCR_5154_InquiryintoimprovingNewZealandsenvi.pdf
The Government's response to this document was mostly supportive and progressed most of the recommendations.
The Government's full response is available at:
http://www.parliament.nz/NR/rdonlyres/5AFA2E8E-F8A3-486F-9F51-1C0FE455D4A8/200866/DBHOH_PAP_21990_GovernmentResponsetoReportoftheHea.pdf
As a result, the Ministry of Health is currently seeking feedback on draft procedural rules for health and disability ethics committees (HDECs), particularly:
  • Rules clarifying that HDECs will be expected to check that proposed research has been appropriately peer reviewed, rather than conducting peer review themselves (see section 2 of the draft SOPs).
  • Clarifying and reduce the scope of HDEC review (section 3).
  • Imposing a 35-day timeline for full review (section 5), and a 15-day timeline for expedited review (section 6).
  • Allowing some clinical trials to be reviewed through the expedited review pathway, on the basis of risk (section 6).
  • Clarifying that localities (such as DHBs), rather than HDECs, are responsible for ensuring that local research governance issues are addressed (section 10).
  • Clarifying when amendments to approved studies themselves require HDEC review (section 11).
The Ministry of Health is currently seeking your feedback on:
  • Draft standard operating procedures for HDECs, and
  • A draft HDEC application form.
Submissions close at 5pm, Friday 10 February 2012. Full details are available at:
http://www.ethicscommittees.health.govt.nz/moh.nsf/indexcm/ethics-upcomingchanges
The Ministry of Health’s website also comments that it expects to announce further details of the online HDEC application system in early 2012, and that the number of HDECs will be reduced from 7 to 4, and their size from 12 to 8 members, as of 1 July 2012. The 7 current HDECs will continue to operate normally until this date.
These changes are important for researchers to understand and have input into. Although most researchers will be supportive of these changes, it is important for those involved to spend some time to appreciate what is being suggested.
Competing interests: None declared.
Author information: Frank A Frizelle, Editor, New Zealand Medical Journal.
Correspondence: Professor Frank A Frizelle, Department of Surgery, Christchurch Hospital, Private Bag 4710, Christchurch, New Zealand. Fax: +64 (0)3 3640352; email: frank.frizelle@cdhb.govt.nz
     
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