by M Spriggs · Cited by 54 — Opt-out consent and the role of parental consent in a study in a child The cases could be used for training Human Research Ethics Committees (HRECs).
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Missing: na sa cybersecurity

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Case Studies i Lead Investigator: Dr Merle Spriggs Children’s Bioethics Centre Murdoch Childrens Research Institute PO BOX 911 Parkville, Vic. 3052, Australia. Phone: +61 3 9090 5237 Email: Website: Co-investigators: Associate Professor Lynn Gillam; Professor Colin Thomson; Associate Professor Justin Oakley Steering Committee: Dr Helen Liley; Professor W endy Rogers; Assoc. Prof. Jane Halliday; Assoc. Prof. Sylvia Metcalfe; Dr Craig Olsson; Dr Catherine Lees; Dr Arnold Smith; Dr Lyndal Bond; Ms Malar Thiagarajan. Thanks for the valuable input from: Associate Professor Lynn Gillam Professor Colin Thomson Professor Wendy Rogers Dr Judith Munro Ms Alexandra Robertson Dr Catherine Lees Ms Georgina Hall This project is funded by a grant from the Alfred Felton Bequest which is managed by the ANZ Trustees Version 2 © Merle Spriggs 2009 Research Team Acknowledgments

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Case Studies 1 Table of Contents Research Team i Acknowledgments i Purpose of this Resource 2 CASE 1 3 Adolescent invited to take part in research without parental consent: C onsent to research versus consent for other activities. CASE 2 5 Consent issues in research involving MySpace CASE 3 10 Unobtrusive observation: Research involving an on -line support group CASE 4 13 Opt -out consent and the role of parental consent in a study in a child care centre. CASE 5 16 Research involving infants: Risky research and the framing of risk.

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Case Studies 2 This resource provides guidance on thinking through ethical issues in research involving children and young people and presents some models for best practice. Some cases will be easy and some will be hard. It is intended that there will be some contr asts. The cases could be used for training Human Research Ethics Committees (HRECs) and in research ethics education for researchers who are going to conduct research with children. Some cases are real, some are based on real life cases and some are f ictitious. They are labelled accordingly. Cases are designed to raise issues for deliberation by Human Research Ethics Committees and researchers in situations in which they have not found sufficiently clear guidance in the National Statement . Any guida nce provided in this resource is meant to build on the National Statement. We welcome new case studies to add to this resource. To add a case, email Note ŒThe term fiassentfl i s not used in the National Statement, but it is widely referred to in the research community and it is established in the literature. We use the term here to signify the role for children that lies between no involvement in discussions and full decisional authority. 1 1 M. Spriggs & L. Gillam. (2008). Consent in paediatric research: An evaluation of the guidance provided in the 2007 NHMRC National Statement on Ethical Conduc t in Human Research. Medical Journal of Australia. 188(6): 360 -362 . Purpose of this Resourc e

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Case Studies 3 [Fictitious case] Adolescent invited to take part in research without parental consent: Consent to research versus consent for other activities. A 14 -year -old youth suffering depression does not want to discuss his problems with his parents. He seeks help from a community health centre. On his first visit he is provided with counselling and asked to return for a second visit where the possibility of medication will be discussed. He is reassured that his parents do not have to be involved if he does not want them to be. Researchers from the centre are looking for people to take part in a study that will find out if a new investigational drug can help in the treatment of depression. They invite the fourteen year old to particip ate in the randomised controlled trial. The researchers say that parental consent is not needed for the 14 -year -old to access treatment so they do not need to obtain parental consent for him to participate in the research. Questions: 1. Is the researchers™ view correct? Comments: The researchers view is not correct here. Allowing independent access to treatment by the 14 -year -old is not in itself an indication of his competence. It does not mean that his consent is sufficient to authorise participation in a randomised controlled trial of an experimental drug. There are three reasons why the researchers™ reasoning is not right: i. Research and treatment are ethically different . They have different objectives, procedures and justifications. The goal of t reatment is always the benefit of the patient. Any risks involved in treatment can be expected to be monitored carefully and individually and there will be no ethical interest that will compete with changing treatment whenever that is seen to be for the p atient™s best interests. The goal of research is the discovery of knowledge. Although researchers do have ethical responsibilities for the welfare of participants, that welfare is not the researcher™s primary responsibility. There will always be a compe ting ethical interest (namely the completion of the research) that can compete with the care of participants. Therefore, it cannot be assumed that consent in the research setting is ethically equivalent to consent in the clinical setting. ii. A decision to p articipate in research can be more complex and require a greater level of competence and understanding . Risks can be greater in research or more uncertain because of the experimental context. The fact that the effectiveness and safety of the drug is not kn own, means that the risks are, CASE 1

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Case Studies 4 to an important extent, unknown and so may be greater than in treatment with an established drug. iii. Giving young people independent access to treatment does not in itself indicate a particular level of competence. It is oft en assumed that independent access necessarily means that the young person is competent. This might be the reason for giving access, but it could also be to protect from harm. Independent access could be a public health response fidesigned to encourage ad olescents to seek health care for problems which they might deny, ignore, or delay if they had to inform their parents and/or get parental permissionfl. 2 It is a common mistake to assume that parental consent is not needed because young people can consent to other activities. For instance, Kelly and Halford (2007) argue that 16 -year -olds in Australia have the fimaturity and capacityfl to make an fiinformed decisionfl because they can legally consent to sexual intercourse (and deal with risks such as unwanted pregnancy and/or sexually transmitted disease). Based on this, they conclude that the same 16 -year -old™s consent should be adequate fito fill in a form reporting anonymously on their sexual behavior.fl 3 Their view that parental consent is not needed is appr opriate but the reasons are wrong. Consenting to sexual intercourse is not the same as consenting to involvement in research. Reasons matter. Mistaken reasons can lead to an ethically inappropriate conclusion. 2. Does it depend on the nature of the re search? Comments: Yes, it depends on the nature and complexity of the research [4.2 Intro] The 14 -year -old™s consent alone may be adequate to allow participation in a different study in which the decision to take part requires understanding of less complex information, and/or consideration of less significant consequences Œ for example, an anonymous questionnaire about the user friendliness of the clinic where there is no medical or privacy risk. 2 Friedman Ross, Lanie. (2006). Children in medical research. , Oxford: Clarendon Press. Pp.92 -3 3 Kelly A. B. and Halford W. K. (2007). Responses to ethical challenges in conducting res earch with Australian adolescents. Australian Journal of Psychology . 59(1):24 -33. p. 26

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Case Studies 6 fikeep an auditable record of any researchfl they are fiundertaking that is exempted from ethical review in accordance with paragraphs 5.1.22 and 5.1.23fl [5.1.8]. And, instit utions are to fimake publicly accessible summary descriptions of all research projects for which consent was waived e.g. in its annual reportfl [2.3.8] While not conclusive, this implies a need for HREC review. The definition of what constitutes human s ubject research may be different in other countries e.g. Canadian regulations 5 and U.S. regulations. 6 Some have argued that under U.S. and Canadian regulations, internet -based research is exempt from Institutional Review Board (IRB) or ethics committee rev iew. For example, under Canadian regulations, r esearch fibased exclusively on publicly available information, documents, records, works, performances, archival materials or third -party interviews, is not required to undergo ethics review.fl 7 Another view is that internet -based research moves into a human subject paradigm fiwhen engaging active analyses, where researchers participate in communications; or when researchers identify themselves and gather information through online communications.fl 8 A lack of ap plicability and clarity in the various guidelines suggests a need to update the various guidelines or develop universal guidelines for internet -based research, especially the combination of internet -based research and young people. 2. Can the researche r use content from Sophie™s MySpace prof ile without Sophie™s consent? Comments: This is contentious. There are different views: Consent is needed Consent is not needed Researchers generally do not need consent to use information that is in the publi c domain – but what is public and what is private on the internet is not so clear and the immature judgment of some young people may mean that a distinction between public and private is not meaningful. Some young people may not seem to be concerned about their privacy but this may be due to a lack of maturity, understanding and imagination. Recent research findings show that young people 5 Canadian Institutes of He alth Research, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada, Tri -Council Policy Statement: Ethical Conduct for Research Involving Humans. 1998 (with 2000, 2002 and 2005 amendments). Research requiring ethics review Article 1.1.c (Accessed 23 April 2009) 6 Code of Federal Regulations. TITLE 45 Š PUBLIC WELFARE. Department of Health and Human Services PART 46. PROTECTION OF HUMAN SUBJECTS, Revised June 23, 2005. Effective June 23, 2005 Available at hrp/documents/OHRPRegulations.pdf (Accessed 23 April 2009) 7 Tri -Council Policy Statement Article 1.1.c 8 Kitchin Heather A. (2003). The Tri -Council policy statement and research in cyberspace: Research ethics, the internet, and revising a ‘living docum ent’, Journal of Academic Ethics . 1:397 -418

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Case Studies 7 can be fisomewhat naivefl about the appropriateness and the fipotential negative consequencesfl of information they post on social networking sites. 9 Added to this are the difficult issues around consent in research involving children and young people. If information is potentially identifiable, consent is probably needed. If there is no identifiable information, consent ma y not be needed. But, arguably, it is better to err on the side of safety and obtain consent. If the researcher does not want to get consent, he or she could make a case according to the National Statement criteria for waiver of consent [see sections 2.3.5 to 2.3.8] The main criteria relevant in this case are as follows: A waiver of consent must be granted by an HREC (for using personal information in medical research) or other review body (other research) [2.3.5]. Before waiving the requirement for consent, an HREC or review body must be satisfied that: – the research is fino more than low riskfl [2.3.6 (a)] i.e. fithe only foreseeable risk is one of discomfortfl [2.1.6]. – fithe benefits from the research justify any risks of harm associated with not seekin g consentfl [2.3.6. (b)] – fiit is impracticable to obtain consent – [2.3.6 (c)] – fiThere is no known or likely reason for thinking that participants would not have consented if they had been askedfl [2.3.6 (d)] – fiThere is an adequate plan to protect the confide ntiality of datafl [2.3.6 (f)] fiGiven the importance of maintaining public confidence in the research processfl institutions are to make publicly accessible summary descriptions of all research projects for which consent was waived e.g. in its annual report [2.3.8] 3. Can the researcher use the potentially identifiable content on the basis of Sophie™s consent alone without parental con sent? Comments: Parental consent is not needed if the research does not involve the collection of identifiable informati on e.g. content analysis Œ simply counting instances of something. Parental consent might be needed when information is potentially identifiable. Identifiable information makes risks to individuals higher. If risk involves more than discomfort, a dec ision to forgo parental consent should be clearly articulated and justified in terms of the nature of the study which includes level of risk etc. or in terms of other additional protections such as procedures set up to obtain and validate young people™s in formed and voluntary agreement to participate. It may be possible to establish young people™s competence to consent 9 J. Peluchette & K. Karl. Social networking profiles: An examination of student attitudes regarding use and appropriateness of content. CyberPsychology & Behavior 2008; 11(1):95 -97: 96

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Case Studies 8 via the internet e.g. with mandatory questions which show that the young person does or does not understand what participation entails. Th ere is also a need to consider whether seeking parental consent would make things worse e.g. (i) by putting a young person from a dysfunctional home at risk; (ii) result in disclosure to the researcher of additional identifying information about the identi ty and location of the young person. Parental consent may be fiimpracticablefl for reasons other than that suggested in the National Statement . It can be fiimpracticablefl when it offers no protection or makes matters worse. Researchers need a clear plan and HRECs have to be satisfied that the procedures set up to obtain and validate young people™s informed and voluntary agreement to participate are sufficient and appropriate in the circumstances. 4. If parental consent is deemed necessary but logistica lly difficult to obtain, can the researcher wait for 15 months until Sophie turns 18 and then use the data without parental consent but with Sophie™s consent? Comments: Yes. But as a researcher you have to make clear to Sophie that it is old content (da ta from the 1 st stage) that you want to use. It may actually be good practice to wait until Sophie turns 18 because she is then better able to make an informed choice. Second stage of project: 5. For the second stage of the study, is Sophie™s electroni c acceptance of the researcher as a ‚friend™ equivalent to consent? Is it enough consent? What should the researcher disclose? Comments: Acceptance as a fifriendfl is not equivalent to consent if the researcher/friend has not disclosed that they are condu cting research. Sophie needs to know further details such as what the research is about, the data collection methods and how and where the research will be reported and she needs to know that involvement is voluntary, that she does not have to be involved . Normally, a researcher [who is not a cyber researcher] could not use the justification that he or she is a friend to collect and use personal communications without the consent of the friend – but again depending on the nature of the research, the inf ormation and how it is reported etc. The issue is about appropriate conduct for researchers on MySpace, not ordinary users who are not conducting research. The use of information from social network sites and acceptance of a researcher as a fifriendfl were recent topics of discussion on an online discussion forum for

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Case Studies 9 individuals concerned about and involved in human subject™s protection. See to join IRB Forum and access discussion threa ds. 6. Is parental consent needed for the second stage of the study? Comments: While parental consent might not be needed in the first stage of the project (see question 3), that does not mean that it is not needed in the second stage. The question of consent in stage 2 is independent from stage 1. In stage 2 different data is collected via a different method. The researcher interacts with participants e.g. he causes Sophie to say things she otherwise would not have said. The need for parental con sent will depend on the questions asked, the likelihood of harm through identification and whether the HREC is satisfied that the young person understands relevant information. At 16, parental consent is probably not needed for Sophie but researchers shou ld clearly set out the procedures they will use to secure and validate Sophie™s informed and voluntary agreement to participate in the research. (Parental consent may be required for younger children involved in this study. As in question 3, a decision to forgo parental consent should be clearly articulated). Note : Before planning a project using a social networking site such as MySpace, researchers might want to consider the site™s terms and conditions which in the case of MySpace, apply to Members and t o Visitors (who simply browse the MySpace website). 10 MySpace can reject, refuse to post or remove postings, suspend or terminate access to MySpace Services if the agreement is violated or if a User is perceived as a threat to MySpace or its Users. The following terms and conditions may have relevance to researchers: – If you recruit by having your own MySpace profile and MySpace believes that you are incorrectly representing yourself as being under 18, MySpace can delete your profile and terminate your membership without warning. – MySpace may investigate, terminate membership and take legal action against anyone who: fisolicits personal information from anyone under 18fl; posts content that ficontains restricted or password only access pagesfl 10 MySpace Terms & Condi tions. February 28 th, 2008. Available at: (Accessed 7 th May 2009)

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