Page 118 - ACCCN's Critical Care Nursing

Ethical Issues in Critical Care 95

● Australia’s attractiveness as a place for international Data: Use and Disclosure
investment in commercial sponsored clinical trials is As noted earlier, ‘use’ of data refers to use internally
enhanced. within an organisation, whereas ‘disclosure’ refers to use
● Public confidence in the rigour of Australia’s system of data externally to the institution or place of collection.
of ethical review of human research is increased due It is usual for hospitals and health organisations to have
to the standardisation of ethical review processes. strict requirements regarding access to a person’s health/
● The roles and responsibilities of the researcher, the medical record for research purposes.
institution, the HREC and other key stakeholders in
the conduct of multi-centre research are transparent Use of codes in data collection sheets or computer records
and consistent. 93 should not contain patient/subject identifiers. Data
should not be used so as to cause material, emotional or
In New Zealand:
other disadvantage to any participant, nor should it be
● Single-region applications go to one of six regional used for any purpose(s) other than those specified in the
committees, and proposals involving more than one HREC-approved protocol. No more information than
region are assessed by a national multi-region ethics that specifically needed to accomplish the study must be
committee. recorded. 8,94 Attention to this is important, because a data
● ECs in NZ may request a second opinion from the collector will usually be privy to the entire health record.
Health Research Council Ethics Committee. It is therefore imperative that anyone extracting data
● Applicants may appeal decisions to the National understand that only approved data are removed used
Ethics Advisory Committee. and/or disclosed. It is usual for the examination of the
health records to occur on-site, with no record removed
See Online resources for further information.
19
from the hospital/organisation. The revised Joint
NHMRC and AVCC Statement and Guidelines on Research
RESEARCH INVOLVING Practice (1997) is now the Australian Code for the Respon-
UNCONSCIOUS PERSONS sible Conduct of Research (2007). It recommends that data
The question of whether it is justified to include an be securely stored for a minimum of 5 years from publi-
cation date, with a minimum of 15 years for data derived
unconscious patient in a research project without his or from clinical research. 95
her consent is the most difficult one facing critical care
researchers and ECs. 8,92 Paramount in these consider-
ations is the careful weighing of potential risks and ben- ETHICS IN PUBLICATION
efits by a competent individual. However, analysis of Journal editors are increasingly requiring that researchers
these risks and benefits by a surrogate on behalf of an demonstrate evidence of their ethics review process before
incompetent individual poses a range of ethical difficul- a manuscript/study is considered for publication (see
ties. Most national and international guidelines concur http://www.icmje.org). The Australian Code for the Respon-
that such research is justified as long as certain safeguards sible Conduct of Research (2007) provides guidance on the
are in place. minimum requirements for authorship of research.
Authorship is defined as substantial participation, where
8
Both the National Statement and the Operational Stan- all the following conditions are met: 95
12
dards outline categories of vulnerable persons and the
relevant ethical considerations that apply to these groups. ● conception and design, or data collection or analysis/
The governing bodies recommend careful consideration interpretation of data
of these highly vulnerable groups. Of note, the New ● drafting the article, or revising it critically for impor-
12
Zealand Operational Standards recognise that research tant intellectual content
on unconscious patients is appropriate, but emphasise ● final approval of the version to be published.
the need for communication with the family or other Authors must also ensure that all those who have con-
legal representatives wherever possible. These Standards tributed to the work are recognised and acknowledged.
do note that in emergency situations consultation with Acquisition of research funding or general supervision of
the family/legal representatives may not be possible, but a research group is not considered sufficient for author-
that the ‘health care practitioner must always act in the ship. Intellectual honesty should be paramount and
best interests of the consumer’. 12
used to inform publication ethics and to prevent
misconduct. 95
RESPONSIBLE RESEARCH PRACTICES
Ethical integrity must be maintained throughout all CLINICAL TRIALS
phases of clinical research, including research design, The Therapeutic Goods Administration (TGA) in Australia
conduct, monitoring, data management and dissemina- has adopted the Note for Guidance on Good Clinical Practice
tion. This ethical integrity is reflected in the demonstrated (CPMP/ICH/135/95) to replace the Guidelines for Good
rigour throughout any given study. An understanding Clinical Research Practice (GCRP), but at the same time
of the relevant ‘responsible research practices’ is needed notes there is some overlap with The National Statement
to be able to ensure fulfilment of ethical integrity which prevails. The TGA has published an annotated
requirements. Some key primary examples are discussed version for the Australian regulatory context. The Note for
here. Guidance on Good Clinical Practice (CPMP/ICH/135/95) is