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| Journal of the New Zealand Medical Association,
27-August-2010, Vol 123 No 1321
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Getting tangled in red tape: the challenges of doing
clinical research in New Zealand
Sarah Loveday, Ed Mitchell
New Zealand has recently appointed a chief science advisor
to the Prime Minister, with an aim to actively promote science and research in
order to help stimulate economic growth. However, a fundamental threat to
research may impede scientific progress and impact economic growth.
Scientist Dr William Rolleston has spoken out against the
“onerous and unnecessary regulations” that stifle research in New
Zealand.1 For new researchers a major
frustration in establishing a clinical research project is the number of
repetitive forms that require completion.
This over-regulation of clinical research is not a new
phenomenon nor is it specific to New Zealand. A number of recent articles have
been published bemoaning the overregulation of medical research in England and
the United States of America.2–4
While clinical research needs to be of the highest standard
with reasonable checks in place the duplication of information required and lack
of co-ordination between services is a hindrance in conducting clinical
research. This article will highlight the pitfalls in our current system with a
case study.
Case studyIn June 2008 funding was successfully obtained for the
author (SL) to complete a research project as part of a Fellowship in
Developmental Paediatrics. The project was a cross-sectional observational study
of body composition in children with Down syndrome.
All children were seen at Starship Children’s
Hospital, the paediatric service within the Auckland District Health Board
(ADHB). An application for ethical approval from the regional ethics committee
(using the national ethics application form) was sent in October 2008 and
obtained in November 2008 with minimal changes required to the participant
information sheet and consent form.
In addition to the national ethics application form, a
number of forms were required in order to use an examination and interview room
in the hospital. In order to apply to use a room, the project needed to be
registered with the ADHB Research Office. The application form for this
registration (ADHB Research Project Registration Form) required duplicate
information to that in the National Ethics Application Form.
Once the project was registered with the hospital research
office, a further form was required to grant use of a room for research purposes
(Children’s Research Centre Application Form). However, prior to gaining
approval to use a room, the project required approval from the hospital
Māori Research Review Committee (MRRC).
In order to identify children for the study, a search of the
hospital laboratory database of abnormal karyotypes was required. Two separate
forms were required to use this database. A number of minor changes were
requested from the ADHB research office. Full consent from ADHB was gained in
December 2008.
Table 1. Application process for research
approval
Abbreviations: ADHB – Auckland
District Health Board; CMDHB – Counties Manukau District Health Board; DXA
– dual energy X-ray absorbiometry; NRL – National Radiation
Laboratory; WDHB – Waitemata District Health Board.
The study required enrolment of children living in areas of
Auckland outside of the ADHB area, although all children were seen only at
Starship Children’s Hospital. Locality assessment forms were completed for
the other two district health boards in Auckland, Counties Manukau District
Health Board (CMDHB) and Waitemata District Health Board (WDHB). This required
several forms including CMDHB Research Application, CMDHB MRRC Application Form,
CMDHB Budget Form, Knowledge Centre Approval of Research Application Form and
WDHB MRRC Approval Form.
As the author was not an employee of CMDHB or WDHB, a
credentialing form needed to be completed for both sites, even though all that
the study required was to enrol children living in the CMDHB and WDHB areas. At
each stage each research committee required slightly different modifications to
either the participant information sheet or the consent form.
Final ethical approval to enrol children living in the wider
Auckland area was obtained in March 2009 5 months after the initial application
was made. The application process required 16 separate steps, with considerable
duplication of information required on the forms (Table 1).
History of health and disability ethics in New ZealandThe Medical Research Council was established in
1950.5 Applications to conduct research
required applicants to sign an ethical agreement in order to obtain funding.
Over time ethical standards were developed and published and a committee on
ethics in research was established in 1984. The Auckland hospital ethics
committee was established in 1971 with considerable debate at its inception as
to the necessity of ethical
surveillance.6
A turning point in New Zealand’s history of research
ethics was the 1987 Cartwright Inquiry of the treatment of cervical cancer at
National Women’s Hospital. Following this ethical review was seen as not
only important but a necessity and ethical standards “must be applied
rigorously to research and treatment protocols on behalf of
patients”.5
The Health Research Council was established with an ethics
committee under the Health Research Council Act of 1990. Regional health
authorities were required to establish ethics committees or to contract ethics
committees to provide ethical review by 1993. Further health reforms lead to
minor changes in the inter-relationship between the ethics committees and the
HRC.
The New Zealand Public Health and Disability Act of 2000
established a National Ethics Committee. Currently New Zealand has seven Health
and Disability Ethics Committees of which six are regional. Applications to
conduct research are submitted either to a regional committee or to the
multiregional committee as appropriate. District Health Boards (DHBs) retain
Research Review Committees to advise the clinical board of local research
initiatives and contracts.
Principles of ethical reviewThe primary role of ethical review of research in New
Zealand is two-fold: firstly to prevent unacceptable risk of harm to
participants, and secondly to ensure that all participants are aware of what
their participation will involve and have given informed
consent.7 The underlying principles of ethical
review are respect of persons, informed consent, privacy and confidentiality,
validity of research proposal, minimisation of harm, justice, and social and
cultural responsibility.
Respect of persons encompasses the recognition of the
beliefs, autonomy and privacy of individuals while protecting those who have
reduced competence. Informed consent requires adequate information to be given
which is understandable to the participants and that consent is voluntary
without coercion.
Privacy and confidentiality are essential for the protection
and promotion of human dignity and wellbeing. It is important that research is
methodologically valid to ensure it is worthwhile and participants are not
unduly exposed to risks entailed in research.
The ethical principle of justice requires the burdens and
benefits of research to be fairly distributed over a population without
discrimination. In addition ethical review in New Zealand upholds respect for
the social and cultural sensitivity of the study population. The National Ethics
Committee form encompasses all of these principles.
Improving systemsHaving multiple forms to address the same principles has
given rise to considerable red tape in the process of gaining approval to
conduct clinical research. This duplication threatens to overwhelm researchers
with paper work, and may delay the final approval by several months as described
in our case study.
Several improvements could be made in our current ethical
approval process with no threat to appropriate clinical standards or the
principles governing ethical review.
Firstly, the amount of duplication required could be
mitigated by each DHB research committee accepting the national ethics
application form instead of requiring duplication of all the same information in
a DHB-specific form. If additional information is required, then only this
should be included in a DHB-specific form.
Similarly, a national Māori Research Review Committee
form should be developed which would be accepted in all sites. Conducting
research in Auckland is a unique experience within New Zealand as patients are
divided into three DHB areas. However, for the purposes of research Auckland
should be treated as one area.
In addition, a more common sense approach needs to be taken
when looking at ethical consent for new research. A cross-sectional
observational study in which participants simply undergo anthropometric
measurements is very different from a study in which participants are exposed to
a novel medication or intervention.
Our current system makes no allowance for the potential harm
to participants and the same numbers of forms are required for both. If, in New
Zealand, we are serious about stimulating clinical research, then the current
impediments of over-regulation must be addressed.
Competing interests: None.
Author information: Sarah Loveday,
Paediatric Developmental Fellow, Department of Paediatrics, University of
Auckland, Auckland; Edwin Mitchell, Professor, Department of Paediatrics,
University of Auckland, Auckland
Correspondence: Professor Ed Mitchell,
Department of Paediatrics, Faculty of Medical and Health Sciences, University of
Auckland, Grafton, Auckland 1023, New Zealand. Fax +64 (0)9 3754371; email:
E.Mitchell@auckland.ac.nz
References:
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