Abstract
In 2007 the National Medical Health and Research Council (NHMRC) released a revised National Statement on Ethical Conduct in Human Research. This was the result of two rounds of public consultation by a working committee of the Australian Health and Ethics Committee (AHEC), a principal committee of the NHMRC. Drawing on the public consultation documentation and publicly available submissions to the review, this chapter assesses the consultation process which accompanied the review and revision of the 1999 National Statement on Ethical Conduct in Research Involving Humans to determine whether the consultation process was effective as a mechanism for encouraging consultation, deliberation and accountability by AHEC, through the working committee responsible for redrafting this National Statement. Drawing on recent literature in deliberative democracy we identify three aspects of the review process for critical evaluation: inclusive participation in policy development, discursive deliberation about policy arguments, and public accountability for policy decision-making.
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Notes
- 1.
Other functions listed include: any other functions conferred to the Committee in writing by the Minister after consulting the CEO; and any other functions conferred on the Committee by this Act, the regulations or any other law.
- 2.
Thomson et al, this volume, Chap. 9, note that whilst previously two rounds of consultation had been a statutory requirement, this had been amended in 2000 to requiring only one round of consultation. Despite this, the review of the 1999 National Statement went through two rounds of public consultation.
- 3.
Correspondence with NHMRC Secretariat, email August 2009.
- 4.
Following the release of the 2007 National Statement, AHEC introduced a process of “rolling review” for revising guidelines contained in the National Statement. This involves updating parts of the National Statement as needed, in contrast to the practice of reviewing the entire document every five years. This process allows for updates and revisions as needed, so as to address changes in research practice or specific sections of the Statement in a timely fashion. In 2013, AHEC established a sub-group, including representatives from the ARC and UA, to make an appraisal of the National Statement and to develop a strategy for its ongoing review. We note that no amendments have been made to the chapter ‘Research involving children and young people’ since the release of the 2007 National Statement and the production of this chapter.
- 5.
For a full list of members of the working committee, see National Statement on Ethical Conduct in Human Research (NHMRC 2007a: 97).
- 6.
Meeting with NHMRC Secretariat, August 2009.
- 7.
The NHMRC made available to our research team the non-confidential submissions to the first and second consultation drafts of the National Statement.
- 8.
An analysis of the 74 publicly available submissions from organisations by stakeholder shows that: 22 were received from universities/university faculties; 17 from professional bodies (professional bodies includes peak bodies and learned bodies); 9 from research centres/institutes (often within universities); 8 from hospitals/health services; 7 from NGO’s (which includes consumer groups, advocacy groups, not for profits and community groups); 6 from government departments and agencies; and, 3 from churches/religious organisations (2 were unknown). Of the 30 publicly available submissions received from private individuals: 25 were received from persons with institutional – university, hospital or research centre – affiliations; 3 listed no affiliation; and 2 were anonymous.
- 9.
Submissions made to the second consultation draft that were not confidential were made available on the NHMRC website. This website is no longer available.
- 10.
An analysis of the 106 publicly available submissions from organisations by stakeholder shows that: 21 were received from universities/university faculties; 20 from professional bodies; 18 from government departments and agencies; 17 from NGO’s (which includes consumer groups, advocacy groups, not for profits and community groups); 13 from research centres/institutes; 12 from hospitals/health services; and, 5 from churches/religious organisations. Of the 41 publicly available submissions received from private individuals: 27 were received from persons with institutional – university, hospital or research centre – affiliations; and, 14 listed no affiliation.
- 11.
The increased number of submissions from groups concerned with fertility and motherhood issues may have been in light of legislative review of reproductive cloning and embryo research (Australian Government 2005).
- 12.
The 2007 National Statement on Ethical Conduct in Human Research is 107 pages long and consists of a Preamble, 5 sections (each with a number of sub-sections/chapters), and an Appendix, Glossary and Index. The 1999 National Statement on Ethical Conduct in Research Involving Humans is 68 pages long and consists of a Preamble, 19 chapters and 3 Appendices.
- 13.
And meets the requirements as listed in 5.1.22 and 5.1.23 (NHMRC 2007a).
- 14.
In the first consultation draft only three guiding principles are used: research merit and integrity; balancing benefits and risks; and respect for human beings. By the second consultation draft the guiding principle of justice is added as a subheading and “balancing risks and benefits” is now termed “beneficence”.
- 15.
Of these, 30% (22 of 74) were from organisations and 17% (5 of 30) were from private individuals.
- 16.
Clauses 3.2.2 and 3.2.3 received little or no comment.
- 17.
Of these, half (50%, 53 of 106) were from organisations, and just over a third (34%, 14 of 41) were from private individuals.
- 18.
Included in the letter there was an additional request concerning the merit of combining chapters, which included the chapter on children and young people (NHMRC 2006c, 2). About 12 submissions gave limited comment in the respect.
- 19.
In addition, section 4.2.1 received 7 comments, 4.2.7 – 5 comments; 4.2.9 – 4 comments; 4.2.2 – 3 comments and 4.2.3 – 2 comments.
- 20.
The numbering of the submissions are those assigned by the NHMRC on the original website for each of the rounds of public consultation.
- 21.
The terminological shift from “competence to consent” in the 1999 National Statement to “capacity to consent” in the first consultation draft (and retained thereon) was not due to the impact of the public submissions, as it occurred prior to the release of the first consultation draft. This could mean that the National Statement consultation draft was more concerned with children’s decisional capacity (understood as the effective ability to make a specific decision), whereas the National Statement had previously been concerned with children’s mental competence (which may be said to obtain when a person has a relatively intact and robust set of mental abilities that justify a presumption of decisional capacity); however, it may simply reflect a change in word preference for synonyms (Charland 2008). While it is more likely that a child or young person will have (in specific domains) decisional capacity than (global) mental competence, the National Statement does not elaborate what significance should be given to the change in terminology. It is worth noting that around the time of the review of the National Statement, the bioethics literature was shifting in its recognition of relational autonomy and relative competence to consent based on decision-specific capacity (See for example Berghmans et al. 2004; Beauchamp and Childress 2009).
- 22.
Spriggs and Gillam note, however, that the change from “competency” to consent to “capacity” to consent, is confusing because there is no explanation for the shift. They further argue that the inclusion of “vulnerability”, whilst a move in the right direction, “is likely to cause confusion” and also requires further explanation (Spriggs and Gillam 2008, 362).
- 23.
The first consultation draft uses the term “minimal risk”, this is replaced in the second consultation draft with “neglible”, “low” and “more than low” risk. The change in terminology reflects a revision on how risk is understood in the second consultation draft which is further revised in the 2007 National Statement.
- 24.
Submission #127 notes that “[t]here is no consideration of what ‘refusal’ consists of in the case of infants, toddlers and children with severe intellectual impairment. The researcher may need to seek guidance from the parent/guardian and their knowledge of the child’s best interests to determine the child’s wishes to refuse”. The author suggests some examples of a reworded clause, as well as the inclusion of a qualifying statement guiding the researcher to seek guidance from parents about the child’s interests and wishes.
- 25.
NHMRC 2006a, 1.10, 4.2.4 and 4.2.10.
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Acknowledgments
This research was conducted as part of Australian Research Council Discovery Project Grant “Big Picture Bioethics: Policy-making and Liberal Democracy” (DP0556068). We thank Mathew Sammel from NHMRC for his assistance and Christopher Cordner, Chair of the AHEC working committee which reviewed the National Statement, for discussions of the process of the review and its aims, as well as for comments on earlier drafts of this paper.
Competing Interests
Susan Dodds wrote submissions in response to the review of the National Statement (including both consultation drafts) and was a member of the Australian Health Ethics Committee 2012–2015.
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Goddard, E., Dodds, S. (2016). Consultation, Deliberation and the Review of the National Statement . In: Dodds, S., Ankeny, R. (eds) Big Picture Bioethics: Developing Democratic Policy in Contested Domains. The International Library of Ethics, Law and Technology, vol 16. Springer, Cham. https://doi.org/10.1007/978-3-319-32240-7_10
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