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Review of Chapter 2.3 of the National Statement: Qualifying or waiving conditions for consent submission

This submission reflects the views of
Organisation Name: 
Collaboration of interested researchers
Please identify the best term to describe the Organisation: 
Personal Details
Specific Questions
1. Please comment on the following definition of ‘opt-out’:: 
No comment
2. Please comment on the rationale provided for an opt-out approach (i.e. Section 3).: 
No comment
3. Please comment on the proposed limited application of an opt-out approach (i.e. Section 4).: 
No comment
4: Please comment on the flow chart (i.e. Section 4).: 
No comment
5. Please comment on the appropriate mechanism for providing information to participants for the opt-out approach represented at box 6d of the flow chart.: 
No comment
6. Please comment on the proposed amendments to the National Statement (see Attachment A underlined and in red text).: 
Comment: One suggestion is for the addition of guidance around consent for participation in longitudinal data collection. For example, if data are to be collected annually, then it is reasonable to require that the participants be notified of data collection each year prior to the start of data collection and that they be reminded of the opportunity to opt out of data collection at this time. This is done with ‘standing parental consent’ (section 4.2.10 of the National Statement). Another suggestion is for the addition of guidance around what should be done if English is not the primary language of all of the prospective participants. This could relate to sections 2.3.10(d) and 2.3.10(e). Section 2.3.10(e) should not include ‘(where appropriate and practicable)’. It is necessary to provide prospective participants with a mechanism for obtaining further information and to register their intention for non-participation. Section 2.3.10(d) should include more specific guidance around the amount of time that prospective participants must be given to opt out of data collection prior to data collection commencing. Section 2.3.10(h) is unclear. What is meant by ‘relevant technical standards’? Section 2.3.10(i) is unclear. Shouldn’t all ethical data collection have a governance process in place with the responsibility of appropriate management of the data?
7. Are there situations where an opt-out approach might be appropriate that have not been considered in the proposed amendments?: 
No comment
8. Are there any situations you can think of where the draft amendments would allow an opt-out approach that may be inappropriate?: 
No comment
9. Can you provide examples where an opt-out approach may be useful?: 
Comment: An important example of where an opt-out approach would be useful is in monitoring childhood obesity in Australia (Stubbs & Achat 2009, Lacy et al. 2012). International childhood obesity monitoring programs rely on opt-out consent (Crowther et al. 2006, Raczynski et al. 2009). Typically, an opt-out approach yields high participation rates, which provide more representative data and more accurate obesity prevalence estimates (Nellist et al. 2009, The NHS Information Centre 2009). Childhood obesity monitoring appears to fit the criteria for low-risk research described in the National Statement (Stubbs & Achat 2009). The childhood obesity monitoring program in the state of Arkansas in the United States has existed since 2003. Evaluations of the program showed no significant increases in teasing, weight concerns, embarrassment or unhealthy dieting among adolescents involved in the first three years of the program (Raczynksi et al. 2009). Additionally, over the course of the nine years of the program, parent and child refusals to participate have remained at 6-7% of eligible children (Arkansas Center for Health Improvement 2007, Arkansas Center for Health Improvement 2012), suggesting that concern about the weight assessments has not increased over time. References Arkansas Center for Health Improvement. Year Four Assessment of Childhood and Adolescent Obesity in Arkansas (Fall 2006–Spring 2007) [Internet]. Arkansas Center for Health Improvement: Little Rock (US), 2007 September. 30 p. URL http://www.achi.net/ChildObDocs/ACHI_2007_BMI_ Online_State_Report.pdf. Arkansas Center for Health Improvement. Year Nine Assessment of Childhood and Adolescent Obesity in Arkansas (Fall 2011–Spring 2012) [Internet]. Arkansas Center for Health Improvement: Little Rock (US), 2012 November. 42 p. URL http://www.achi.net/ChildObDocs/ 121207%20State%20Report%20FINAL%202.pdf. Crowther R, Dinsdale H, Rutter H, Kyfinn R. (South East Public Health Observatory on behalf of the Association of Public Health Observatories). Analysis of The National Childhood Obesity Database 2005–06 [Internet]. Department of Health: London (UK), 2006 December. 23 p. Gateway Reference No.:7573. [WWW document]. URL http://www.dh.gov.uk/prod_consum_dh/groups/dh_ digitalassets/@dh/@en/documents/digitalasset/dh_063783.pdf. Lacy K, Kremer P, de Silva-Sanigorski A, et al. The appropriateness of opt-out consent for an Australian childhood obesity monitoring program. Pediatric Obesity, 2012;7:e62-e67. Nellist K, Coats K, Friedrichs M. Using a representative sample of elementary school students to determine the statewide prevalence of childhood overweight and obesity in Utah. Prev Chronic Dis 2009; 6: (4). The NHS Information Centre, Lifestyle Statistics. National Child Measurement Programme: England, 2008/09 school year [Internet]. The NHS Information Centre for Health and Social Care: London (UK), 2009 December 10. 49 p. [WWW document]. URL http://www.ic.nhs.uk/webfiles/ publications/ncmp/ncmp0809/NCMP_England_2008_09_school_year_report_2.pdf. Raczynski JM, Thompson JW, Phillips MM, et al. Arkansas Act 1220 of 2003 to reduce childhood obesity: its implementation and impact on child and adolescent body mass index. J Public Health Policy 2009; 30 (Suppl. 1): S124–S140. Stubbs JM, Achat HM. Individual rights over public good? The future of anthropometric monitoring of school children in the fight against obesity. Med J Aust 2009; 190:140–142.
General Comments

This submission was prepared by:

Dr Katie Lacy, [ONHMRC has removed third party information]

Dr Peter Kremer, [ONHMRC has removed third party information]

Ms Lynne Millar, [ONHMRC has removed third party information]

Professor Liz Waters, [ONHMRC has removed third party information]

Dr Evie Leslie, [ONHMRC has removed third party information]

Dr Lisa Gibbs, [ONHMRC has removed third party information]

Ms Claudia Strugnell, [ONHMRC has removed third party information]

Professor Steve Allender, [ONHMRC has removed third party information]

Page reviewed: 28 March, 2014