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Ethical Issues in research into alcohol and other drugs submission

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General Ethical Issues Sub-committee of Alfred Hospital EC
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General comments from the General Ethical issues Sub-committee of the Alfred Hospital Ethics Committee on the NHMRC’s Public Consultation on the Ethical Issues in Research into Alcohol and Other Drugs: An Issues Paper exploring the need for a guidance framework

The Issues Paper was reviewed by the General Ethical Issues Sub-Committee at its December 2011 meeting.  The meeting was also attended by researchers from various disciplines and partner institutions involved in research that raises many of the issues identified in the Paper (although not necessarily specifically focusing on alcohol and other drugs).  This research includes areas such as mental health, sexual health, accident and emergency research, and justice health (research with prison populations).

The Issues Paper raised a number of concerns:

  • It is unclear why the issues and ‘features’ identified in the paper need to be dealt with under the umbrella of alcohol and other drug (AOD) research.  As the Paper points out, each can be found in other research fields, and many of these issues also arise in ordinary practice (i.e. outside the research context).
  • Restricting these issues to AOD users reinforces stigmatizing and discriminatory attitudes to AOD use and users, and fails to acknowledge that the same issues occur – and need to be managed – in other contexts.
  • Clustering the issues around AOD use also implies that such use is per se problematic, and overlooks moderate use of various drugs such as caffeine, alcohol and tobacco.
  • The issues identified in the Paper are already broadly dealt with in the National Statement.  To make the NS more specific would narrow and undermine its utility as a source of non-prescriptive, non-directive guidance.
  • Some separate, more specific, guidance on particular issues (that are found in, but not limited to, AOD research) could be helpful:
    • for HRECs who do not routinely review research where these issues arise and/or do not have access to the expertise of experienced researchers
    • to avoid HRECs having to re-visit their position and/or decisions each time a new project raising the issue/s is reviewed
    • to assist with consistency of decision-making between different HRECs, as these can be quite variable
    • to guide researchers when developing their applications.

Such guidance could be along the lines of the AHEC Alerts previously issued by AHEC/NHMRC on specific issues.

  • Four of the areas identified in the Issues Paper have presented particular challenges for this Ethics Committee and/or researchers:

          i)         legal risks for participants and researchers

          ii)       payments to research participants

          iii)      assessing capacity to provide informed consent when participants might be  intoxicated

          iv)      online recruitment and data collection.

(i & ii) The first two areas (legal risks and payments) have raised issues frequently enough for the Ethics Committee to develop its own guidance for members and researchers.  These are available on the Alfred Health Research and Ethics website:

http://www.alfredresearch.org/ethics/ecguidelines.htm
Research that potentially involves legal risks for participants and researchers” and “Payments to research participants”  (Note that in the latter, it is this Committee’s policy not to put restrictions on the level or method of payments to participants based on value judgments about how the payments might be used.  The Committee does not agree with the stance taken in Section 6.1 of the Issues Paper.)

(iii) The National Statement’s coverage of people with a decision-making impairment (Chapter 4.5) does not extend to impaired capacity due to intoxication; it could be helpful to incorporate this into the chapter.

(iv) There is little guidance available on the ethical issues raised by online research processes; this is an area of need for HRECs and researchers.  As pointed out above, however, the issues are not restricted to AOD research and are just as significant for other kinds of research.

  • The most challenging area is that of legal risks – where the research collects information (including human samples) that could be seen as evidence of illegal activities.  On the one hand, participants need to be informed about, and protected from, potential legal risks of participation; on the other hand, giving undue weight to these risks might make it difficult to recruit participants.  An over-emphasis on possible legal consequences could potentially make it impossible to continue conducting valuable and much-needed research in any field where ‘legally sensitive’ information might be collected.

Professor John McNeil
Chair, General Ethical Issues Sub-committee & theAlfredHospitalEthics Committee
20th December 2011

Page reviewed: 26 October, 2012