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

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Specific Questions
1. Please comment on the following definition of ‘opt-out’:: 
Suggested amended definition: A method used in the recruitment of participants into research where information has been provided to the potential participant "and, where appropriate, parents/guardians of potential participants" regarding the activity and their involvement in which their participation is presumed unless they "or, where appropriate, their parents/guardians" take action to decline to participate. We propose the above highlighted changes to the definition to allow for this form of obtaining consent from the parents/guardians of young people of developing and developed maturity.
2. Please comment on the rationale provided for an opt-out approach (i.e. Section 3).: 
The evidence on parental consent procedures is in concurrence with that of Section 3 and the concerns raised are supported by our and other research findings. In studies conducted in the last 10 years, participation rates under explicit or active (opt-in) parental consent conditions ranged between 15% - 76% (Courser et al., 2009; Cross, Brown, Epstein, & Read, 2009; Ellwood et al., 2010; Frissell et al., 2004; Hall et al., 2011; Mellor et al., 2008; Unger et al., 2004). However, participation rates in health-related studies under opt-out parental consent conditions are often above 90% (Ellwood et al., 2010; Frissell et al., 2004; Mellor, Rapoport, & Maliniak, 2008; Tigges, 2003). In Australia, participation rates dropped from over 90% to below 40% when consent procedures were switched from opt-out to explicit consent in the International Study of Asthma and Allergies in Childhood (ISAAC) (Ellwood et al., 2010). In the Australian Covert Bullying Prevalence Study (ACBPS) the mean consent rates were 36% when explicit consent was required and 96% when using a mixed (explicit followed by opt-out) procedure (Cross, Shaw, Hearn, et al., 2009). Samples constituting only students with explicit parental consent have been shown to be biased and differ systematically from the larger student population (Courser et al., 2009; Dent et al., 1993; Henry et al., 2002; Secor-Turner et al., 2010; Shaw et al., 2013; Tigges, 2003; Unger et al., 2004). Importantly, the samples under-represent students who are more involved in and more at risk of involvement in problem behaviours such as aggression, tobacco use and alcohol and other drug use (Courser et al., 2009; Dent et al., 1993; Tigges, 2003; Unger et al., 2004; White et al., 2004), and more likely to be overweight or at risk of being overweight (Mellor et al., 2008). Thus, young people at higher risk who are most able to inform and benefit from the research, who may or may not have chosen to participate, are more likely to be excluded. It is important to note that biased samples can produce biased estimates of associations (Shaw et al., 2013). For example, when assessing the effects of health programs, if students engaged in the higher risk behaviours targeted by the program, i.e. those with the most potential to shift their behaviours as a result of the program, are under-represented in the sample, it is likely that the impact of effective programs will be underestimated. Rather than providing valid evidence, inferences drawn from such research may lead to mistargeted policies and interventions and missed opportunities to improve the health and well-being of young people.
3. Please comment on the proposed limited application of an opt-out approach (i.e. Section 4).: 
The content of this section is endorsed, in particular Section 4.1. Section 4.2 which recognises there may be a need for a combination of consent approaches in a single research project is of practical importance.
4: Please comment on the flow chart (i.e. Section 4).: 
The flowchart is helpful and clear.
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.: 
Please see the response to Question 9. Also, some consideration of the time frame involved may be appropriate for the case of data already collected, for example the feasibility and cost of contacting participants from whom data were collected some years previously, may be a consideration.
6. Please comment on the proposed amendments to the National Statement (see Attachment A underlined and in red text).: 
We endorse the amendments, however if the opt-out approach is extended to include parental consent, rigorous procedures as described briefly in the response to Question 9 need to be followed.
7. Are there situations where an opt-out approach might be appropriate that have not been considered in the proposed amendments?: 
As described, we suggest the opt-out approach is also appropriate when seeking parental consent for the participation of young people (of maturity as defined in categories (c) and (d) in Chapter 4.2 of the National Statement) in low-risk research (which meets guidelines 4.2.1-4.2.6, 4.2.13-4.2.14 of the National Statement) and where the specific consent of the young person is obtained.
8. Are there any situations you can think of where the draft amendments would allow an opt-out approach that may be inappropriate?: 
Opt-out consent procedures, more so than those where explicit consent is sought, rely on the person receiving and understanding the information. Research in which an opt-out approach is used, must employ procedures of obtaining consent which are rigorous i.e. are appropriately designed and implemented to meet the ethical research requirements of voluntary participation based on sufficient information and provide multiple opportunities for the person to indicate their non-consent. Thus, there may be circumstances, e.g. where the person from whom the consent is sought is not approached in person (face-to-face or by telephone), where multiple approaches or rounds of seeking consent are necessary and the methods of returning forms indicating non-consent are as infallible as possible. As an example, in school-based research it would be important to use multiple communication channels to maximise the likelihood parents have received / are aware of the research and the schools’ support for the research eg: via newsletters; the school portal; letter from the school endorsing the research; consent forms mailed to parents’ home addresses and distributed through teaching staff etc.
9. Can you provide examples where an opt-out approach may be useful?: 
An example of research where opt-out parental consent would be useful is surveying young people in schools on low-risk health-related topics, where specific consent is obtained from the young person. The potential risk of harm to young people and violation of the autonomy and rights of parents need to be weighed against the consequences and costs of requiring explicit parental consent prior to student participation in low-risk research. Considerations related to this form of research are: • Our experience in the conduct of ten large-scale projects in schools within the last 12 years and the findings of others (e.g. Langhinrichsen-Rohling et al., 2006; Leakey et al., 2004) is that such data collection carry little risk of adverse outcomes to young people. • A minority of parents, typically less than 10%, actively refuse permission for their child to participate. Available research shows that 87% of non-responders to an opt-out consent process had received and understood the materials, and had consciously decided to allow participation (Ellickson & Hawes, 1989). Thus, non-response was more likely to indicate consent than refusal (Ellickson & Hawes, 1989). Additionally, non-responding parents were more alike in their attitudes to research to consenting parents, than those who refused consent (Baker, Yardley, & McCaul, 2001). As far as we have been able to determine, in the course of our research projects no parents who did not return consent forms and for whom consent was assumed, have indicated their dissatisfaction with their child’s participation, either to us, the University Ethics Committee or the school. • Such research undergoes a thorough external review, with approval from the researcher’s institutional HREC, the school principal or equivalent and the relevant educational sector, prior to the conduct of data collection. • In most school-based evaluations of health programs, such as those addressing bullying or tobacco and drug use, consent from parents is only required for data collection as schools have the authority to implement programs deemed to be beneficial to students. • Achieving high parental response rates under explicit consent requires expenditure of considerable resources (e.g. US$7 - US$32 per completed survey; Esbensen et al., 2008; Secor-Turner et al., 2010; Tigges, 2003), and some of the strategies employed in these studies may not be considered ethical in the Australian context. This increased expenditure on recruitment reduces funding available for activities such as program development and support to schools for program implementation. References Baker, J. R., Yardley, J. K., & McCaul, K. (2001). Characteristics of responding-, nonresponding- and refusing-parents in an adolescent lifestyle choice study. Evaluation Review, 25(6), 605-618. Courser, M. W., Shamblen, S. R., Lavrakas, P. J., Collins, D., & Ditterline, P. (2009). The impact of active consent procedures on nonresponse and nonresponse error in youth survey data. Evidence from a new experiment. Evaluation Review, 33(4), 370-395. Cross, D., Brown, D., Epstein, M., & Read, M. (2009). Strengthening school and families’ capacity to reduce the academic, social, and emotional harms secondary students’ experience from cyber bullying. Perth, Western Australia: Child Health Promotion Research Centre, Edith Cowan University. Cross, D., Shaw, T., Hearn, L., Epstein, M., Monks, H., Lester, L., & Thomas, L. (2009). Australian Covert Bullying Prevalence Study (ACBPS) Retrieved from http://www.deewr.gov.au/Schooling/NationalSafeSchools/Pages/research.aspx Dent, C. W., Galaif, J., Sussman, S., Stacy, A., Burtun, D., & Flay, B. R. (1993). Demographic, psychosocial and behavioral differences in samples of actively and passively consented adolescents. Addictive Behaviors, 18(1), 51-56. Ellickson, P. L., & Hawes, J. A. (1989). An assessment of active versus passive methods for obtaining parental consent. Evaluation Review, 13(1), 45-55. Ellwood, P., Asher, M. I., Stewart, A. W., & ISAAC Phase III Study Group. (2010). The impact of the method of consent on response rates in the ISAAC time trends study. The International Journal of Tuberculosis and Lung Disease, 14(8), 1059-1065. Esbensen, F. A., Melde, C., Taylor, T. J., & Peterson, D. (2008). Active parental consent in school-based research. How much is enough and how do we get it? Evaluation Review, 32(4), 335-362. Frissell, K. C., McCarthy, D. M., D'Amico, E. J., Metrik, J., Ellingstad, T. P., & Brown, S. A. (2004). Impact of consent procedures on reported levels of adolescent alcohol use. Psychology of Addictive Behaviors, 18(4), 307-315. Hall, M., Cordin, T., Bruce, K., & Paki, D. (2011). Strengthening pastoral care to reduce secondary students’ harm from tobacco. Final report to Healthway. Perth, Western Australia: Child Health Promotion Research Centre, Edith Cowan University. Henry, K. L., Smith, E. A., & Hopkins, A. M. (2002). The effect of active parental consent on the ability to generalize the results of an alcohol, tobacco, and other drug prevention trial to rural adolescents. Evaluation Review, 26(6), 645-655. Langhinrichsen-Rohling, J., Arata, C., O'Brien, N., Bowers, D., & Klibert, J. (2006). Sensitive research with adolescents: Just how upsetting are self-report surveys anyway? Violence and Victims, 21(4), 425-444. Leakey, T., Lunde, K. B., Koga, K., & Glanz, K. (2004). Written parental consent and the use of incentives in a youth smoking prevention trial: A case study from project SPLASH. American Journal of Evaluation, 25(4), 509-523. Mellor, J. M., Rapoport, R. B., & Maliniak, D. (2008). The impact of child obesity on active parental consent in school-based survey research on healthy eating and physical activity. Evaluation Review, 32(3), 298-312. Secor-Turner, M., Sieving, R., Widome, R., Plowman, S., & Vanden Berk, E. (2010). Active parent consent for health surveys with urban middle school students: Processes and outcomes. Journal of School Health, 80(2), 73-79. Shaw, T., Cross, D., Thomas, L.T., Zubrick, S.R. (under review). Bias in student survey findings from active parental consent procedures. British Educational Research Journal. Tigges, B. B. (2003). Parental consent and adolescent risk behavior research. Journal of Nursing Scholarship, 35(3), 283-289. Unger, J. B., Gallaher, P., Palmer, P. H., Baezconde-Garbanati, L., Trinidad, D. R., Cen, S., & Anderson Johnson, C. (2004). No News is Bad News. Characteristics of adolescents who provide neither parental consent nor refusal for participation in school-based survey research. Evaluation Review, 28(1), 52-63. White, V. M., Hill, D. J., & Effendi, Y. (2004). How does active parental consent influence the findings of drug-use surveys in schools? Evaluation Review, 28(3), 246-260.
General Comments

This submission addresses the need to consider the option of an opt-out approach to parental consent when seeking the participation of young people of developing and developed maturity, as defined in categories (c) and (d) in Chapter 4.2 of the National Statement, in low-risk research which meets guidelines 4.2.1-4.2.6, 4.2.13-4.2.14 and where the specific consent of the young person is obtained.

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Page reviewed: 28 March, 2014