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Ethical Issues in research into alcohol and other drugs submission

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Specific Questions
Those making a submission are encouraged to comment on the need for an ethical guidance framework, on whether the values and principles in the National Statement are adequate to address the ethical issues in AOD research, on whether the specific issues identified in this paper are sufficiently distinctive of AOD research to merit specific consideration in the proposed ethical guidance framework, and on whether there are additional issues that should be specifically considered in that framework.
Section Two – 2.1.3: 

These are issues but when writing guidelines needs to make distinction clear between AOD research where use is made of non-identifiable routinely collected data  and the other end of the spectrum where there will be face-to-face interviews or survey. What might be considered LNR research, especially the difference between rural perceptions and knowledge of rural issues and urban ethics committees needs more consultation. 

Also the following should be considered from the NSW Health and Medical Research Strategic Review – Discussion Paper: Review stakeholders reported that research ethics and site authorisation processes in NSW are onerous and slow and in the case of site authorisation, inconsistent between LHDs.

Researchers often raise delays in ethics and governance approval as a major frustration and wanted improvements in the the efficiency of research ethics and governance processes

Section Five - 5.1: 

I have had to complete an ethics application and demonstrate the principles so I don't think there needs to be more done unless the application specifically has a section to demonstrate the values and principles, without making the process more onerous than currently ( see section 2 comments).

Section Five – 5.4: 

AOD research should address the below comments and realise that non health people will undertake and are necessary for AOD research and may not have the same understanding of the ethics process/ requirements which is not surprising given the frustration felt by those more closely involved (see comments in Section 2)

From the NSW Health and Medical Research Strategic Review – Discussion Paper: Respondents also suggested the need for a stronger focus on community and consumer involvement in the decision-making and conduct of research; a whole of government approach; and stronger involvement of non health agencies that have relevance for health


Section Six : 

 As AOD research lends itself to research in hospitals and community settings, consideration to community settings (see below) and minors and methods of recruitment and ata collection especially by non health agencies, NGOs, etc in a range of possible settings is probably needed.

From the NSW Health and Medical Research Strategic Review – Discussion Paper: Strong feedback was received to broaden the scope and to include more emphasis and actions related to Research conducted in hospitals and community settings

Section Six – 6.1: 

My only experience is from a project asking those in ED to complete an extra survey about alcohol consumption while waiting in ED. ED data was also collected including nurse notes. Those who were obviously intoxicated may not have completed survey but had alcohol noted by nurse. there were some who did complete survey and did not have alcohol consumption recorded elsewhere. Completion of survey voluntary and while there was patient information sheet there were no reserach staff present to either encourage or possibly be seen as coercing people to complete.

Section Six – 6.2.2: 

Surveys of youth/ students at Drug and alcohol forums may be acceptable especially as, at least in NSW, consent from parents is required to attend eg ones organised by local Community Drug Action Teams. Often there will be a survey of youth alcohol patterns and beliefs and information about where and how the alcohol is supplied which can be of use for local community interventions. The surveys are voluntary and non identifiable to improve honesty in answers and compleyion, and completion of the survey is taken as consent by the minor. 

There may be a case when conducting community surveys, eg at a community AOD free event or at youth AOD free events eg iFest or similar, where you want to gauge has the event worked, what did they like etc and how did the event feel without consuming alcohol where they may normally have done (and how much). These can easily be made non identifiable with just age and sex for valid reporting.

Section Six – 6.2.3: 

With the several funding rounds from the federal government for the National Binge Drinking Strategy, Community Level Initiative which focuses on youth 12-25 there is likely to be quite a few projects and programs happening where one would hope the evaluation of these programs is conducted in an accepted way to measure alcohol-related harm.

While ethics focus on research, money for CLI programs stipulates not research but does require evaluation and perhaps the values and principles should be applied here as well and by linking ethics National Statement to grant application web pages and links to other sites eg Community Builders would be a way of disseminating awareness of ethical values. This is especially so as good OD work could cover a variety of non health settings. Appropriate wording for those who have little experience in  completion of forms that can frustrate those in research is needed.

While in the past where I live and work these have been conducted and analysed without ethics approval being sought this has changed as I became involved in evaluation once the local CDAT received National Binge Drinking Strategy, Community Level Initiative funds. Other data used included non identifiable retrospective ED presentations and police alcohol-related crime, both with data custodian and ethics approval. Neither parental or minors consent was possible but using routine data means long term trends can be followed.

Section Six – 6.3: 

A distinction between non identifiable, retrospective research eg hospital, GP data and  prosepective, interviews/ surveys. One would hope that in the former any mandatory reporting required by staff would have been followed at the time.

Section Six - 6.4: 

There is a need for guidance in general, both for those recruited and also for the researchers as a particpant could use access for (unethical) ends as well as completely faking who they are and responses. AOD have extra issues in revealing illegal activities and presenting a vulnerablilities potentially misued by researchers and someone who could hack into site (especially for minors/ youth).  Ensuring safety and confidentiality is a key factor.

Section Six – 6.6: 

Given the wide range of settings that AOD could be conducted in and through various health and non health agencies there should be at least wider awareness of possible ethical issues, as suggested before links to grant application sites, NGOs, other agencies would be beneficial and highlight possible risks in research and evaluation. But also should be clear that rigorous, evidence based evaluation of programs is required and what might be permissible in clear, easily understood wording. Wider dissemination and better awareness, of NHMRC ethical guidelines, as suggested previously is probably called for as a minimum.


Section Six - 6.7: 

I would say that the same issues apply here as in section 6.6, especially given the possible multiple community settings and agencies/ organisations that may be involved in AOD research.

Page reviewed: 26 October, 2012