Flinders University and Southern Adelaide Local Health Network SOCIAL AND BEHAVIOURAL RESEARCH ETHICS COMMITTEE Research Services Office, Union Building, Flinders University GPO Box 2100, ADELAIDE SA 5001 Phone: (08) 8201 3116 Email: human.researchethics @flinders.edu.au APPROVAL NOTICEPrincipal Researcher: Mr Jamie RanseEmail: email@example.comAddress: School of Nursing and MidwiferyProject Title: The lived experience of Australian civilian nurses working in the out-of-hospital disaster environment Approval ApprovalProject No.: 5423 10 October 2011 31 December 2015 Date: Expiry Date:The above proposed project has been approved on the basis of the information contained in theapplication and its attachments.Please ensure that any permission letters (item D8) that are required by the Committee areforwarded as soon as possible. Additionally, for projects where approval has also been soughtfrom another Human Research Ethics Committee (item G1), please be reminded that a copy of theethics approval notice will need to be sent to the Committee on receipt.In accordance with the undertaking you provided in your application for ethics approval for theproject, please inform the Social and Behavioural Research Ethics Committee, giving reasons, ifthe research project is discontinued before the expected date of completion.You are also required to report anything which might warrant review of ethical approval of theprotocol. Such matters include: serious or unexpected adverse effects on participants; proposed changes in the protocol (modifications); any changes to the research team; and unforeseen events that might affect continued ethical acceptability of the project.To modify/amend a previously approved project please either mail or email a completed copy ofthe Modification Request Form to the Executive Officer, which is available for download fromhttp://www.flinders.edu.au/research/info-for-researchers/ethics/committees/social-and-behavioural-research-ethics-committee/notification-of-committee-decision.cfm. Please ensure that any new oramended participant documents are attached to the modification request.In order to comply with monitoring requirements of the National Statement on Ethical Conduct inHuman Research (March 2007) an annual progress and/or final report must be submitted. A copyof the pro forma is available from http://www.flinders.edu.au/research/info-for-researchers/ethics/committees/social-behavioural.cfm.
Your first report is due on 10 October 2012 or on completion of the project, whichever is theearliest. Please retain this notice for reference when completing annual progress or final reports. Ifan extension of time is required, please email a request for an extension of time, to a date youspecify, to firstname.lastname@example.org before the expiry date.Andrea MatherExecutive OfficerSocial and Behavioural Research Ethics Committee18 October 2011Cc: Prof Paul Arbon, email@example.com Dr Lynette Cusack, firstname.lastname@example.org
Administrative Section1. TITLE AND SUMMARY OF PROJECT 1.1. Title 1.1.1 What is the formal title of this research proposal? The lived experience of Australian civilian nurses working in the out-of-hospital disaster environment 1.2. Description of the project in plain language 1.2.1 Give a concise and simple description (not more than 400 words), in plain language, of the aims of this project, the proposal research design and the methods to be used to achieve those aims. The literature pertaining to disaster health is growing. Similarly, the literature specifically pertaining to nurses in the disaster health environment is growing; however, this is primarily focused on  descriptive accounts of disasters,  the development and implementation of disaster competencies to guide education and training programs, and  psychological topics, such as post-traumatic stress disorder and post-traumatic growth. Historically, Australian nurses have been active participants in the response and recovery to health care disasters, both nationally and internationally. Initially, the response to disasters was organized in a haphazard manner, as clinicians with little out-of-hospital experience were recruited as responders to these events. With this in-mind, the process for deploying Australian nurses to disaster has become more rigorous. This is primarily due to the increasing impact of disasters in the oceanic region. However, the experience of Australian nurses who participate in disasters remains poorly understood. Having a better understanding of the experience of Australian nurses in disasters, may assist in the further development of curriculum, policy and resources to support nurses. Using a hermeneutic phenomenological methodology, this project will explore the lived experience of Australian civilian general registered nurses (division 1) working in the out-of-hospital disaster environment. In particular, this project will explore the transferability of nurses experience between the in-hospital and out-of-hospital disaster environment. Participants will be recruited by using a snowballing purposive sampling technique. Data will be collected in individual in-depth interviews and thematically analyzed. Commercial-in-Confidence Page 2 of 23
3. RESOURCES 3.1. Project Funding / Support 3.1.1. Indicate how the project will be funded 3.1.1... Type of funding. [Please note that all fields in any selected funding detail column (with the exception of the code) will need to be completed.] External Competitive Sponsor By Researchers Grant Department or Organisation Name of Grant / Sponsor Royal College of Flinders University University of Canberra Nursing, Australia Amount of funding $10,000 $4,500 In-kind Confirmed / Sought Sought Confirmed Confirmed Detail in kind support If successful, funding These funds are Primarily in relation to will provide an provided by Flinders time release and opportunity to attend University as a stipend. administrative face-to-face interviews These funds will infrastructure. See in the research provide assistance in below (220.127.116.11) for participants city of attending regular more details residence, and for the supervisory meetings, transcription of these attendance at interviews. conferences to present outcomes from this research, and to purchase a Flinders University laptop computer. Indicate the extent to which the scope of this This funding is alinged This funding is alinged This funding is alinged HREC application and grant are aligned with the scope of this with the scope of this with the scope of this project. project. project. 3.1.1... How will you manage a funding shortfall (if any)? The funding shortfall will primarily be in the area of research time and administrative infrastructure. Partial time to conduct and complete this research will be provided by the University of Canberra. As an academic staff member of the University of Canberra, research time is considered a part of the researcher work. As such, the researcher will undertake this work during this research time. Additionally, the researcher will utilise personal time to complete this project. Similarly, administrative infrastructure, such as printing, stationary and computer access will be provided by the University of Canberra. 3.1.2 Will the project be supported in other ways eg. in-kind support/equipment by an No external party eg. sponsor 3.2. Duality of Interest 3.2.1 Describe any commercialisation or intellectual property implications of the funding/support arrangement. Nil 3.2.2 Does the funding/support provider(s) have a financial interest in the outcome of No the research? 3.2.3 Does any member of the research team have any affiliation with the provider(s) of Yes funding/support, or a financial interest in the outcome of the research? 3.2.3... Describe affiliation(s) and/or interest(s). Jamie is a Fellow of the Royal College of Nursing, Australia. Additionally, Jamie is the Chair of the Disaster Faculty of the Royal College of Nursing, Australia. 3.2.3... Do you consider the relationship between the research team and the funding/support provider constitutes: Commercial-in-Confidence Page 6 of 23
[X] no ethical issue3.2.3... Provide an explanation. The competitive grant at the Royal College of Nursing, Australia is assessed and ranked by nursing academics and clinicians blinded from the applicant. Additionally, staff at Royal College of Nursing, Australia have no input into the outcome of the grant.3.2.4 Does any other individual or organisation have an interest in the outcome of this Yesresearch3.2.4... Indicate the interested party and describe the interest. It is possible that a number of parties would be interested in the conduct and outcome of this work. These parties may include, but are not limited to: • Commonwealth Department of Health and Aging (Health Emergency Preparedness and Response), • Individual State or Territory government departments with a responsibility for disaster preparedness, response and/or recovery, • Organisations involved in disaster health, such as Red Cross and St John Ambulance, • Associations, such as the College of Emergency Nursing, Australasia, • Individual clinical institutions and clinicians with an interest or experience in disaster health.3.2.5 Are there any restrictions on the publication of results from this research? No Commercial-in-Confidence Page 7 of 23
4. PRIOR REVIEWS 4.1. Ethical review 4.1.0. Duration and location 4.1.0... In how many Australian sites, or site types, will the research be conducted? 1 4.1.0... In how many overseas sites, or site types, will the research be conducted? 0 Provide the following information for each site or site type (Australian and overseas, if applicable) at which the research is to be conducted 4.1.0...Site / Site Type 1 4.1.0... Site / Site Type Name Australia 4.1.0... Site / Site Type Location Potential participants for this research will include Australian nurses who have worked in the out-of-hospital disaster environment. As such, potential participants for this research may be located in any State or Territory in Australia. The researcher will use face-to-face interviews to collect data relating to this project, and will travel to the participants city of residence to conduct these. 4.1.0...Provide the start and finish dates for the whole of the study including data analysis Anticipated start date 01/10/2011 Anticipated finish date 31/12/2015 4.1.0... Are there any time-critical aspects of the research project of which an HREC No should be aware? 4.1.1 To how many Australian HRECs (representing site organisations or the 1 researcher’s / investigators organisation) is it intended that this research proposal be submitted? 4.1.1...HREC 1 4.1.1... Name of HREC Social and Behavioural Research Ethics Committee (EC00194) 4.1.1...Provide the start and finish dates for the research for which this HREC is providing ethical review. Anticipated start date or date range 01/10/2011 Anticipated finish date or date range 31/12/2015 4.1.1... For how many sites at which the research is to be conducted will this HREC 1 provide ethical review? 4.1.1...Site 1 4.1.1... Name of site Australia 4.1.1... Which of the researchers / investigators involved in this project will conduct the research at this site? Principal Researcher(s) Associate Researcher(s) Mr Jamie Ranse 4.1.2 Have you previously submitted an application, whether in NEAF of otherwise, for No ethical review of this research project to any other HRECs? 4.3. Peer review 4.3.1 Has the research proposal, including design, methodology and evaluation Yes undergone, or will it undergo, a peer review process? NS 1.2 4.3.1... Provide details of the review and the outcome. A copy of the letter / notification, where available, should be attached to this application. In undertaking this PhD program, the researcher has presented his research proposal at a two research residential schools. The participants of these schools (both PhD candidates and PhD prepared academics) have provided feedback regarding the rigorous nature and appropriateness of the proposed project. The researcher will be presenting his proposal again at a scheduled HDR student presentation forum at Flinders University in December this year. Commercial-in-Confidence Page 8 of 23
Additionally, regular meetings between the supervision team and researcher provide ongoing feedback regarding the progress and appropriateness of the research project.Commercial-in-Confidence Page 9 of 23
Ethical Review SectionSummaryApplicant / Principal Researcher(s) Mr Jamie Ranse Qualifications: BNurs; GCClinicalEd; GCClinicalEpi; MCritCareNurs Expertise: Disaster and mass gathering health; pre-ambulance care. Experience: I have successfully completed various research activities in the area of disaster and emergency health which, in the past five years has resulted in 12 peer-reviewed publications, 8 non-peer-reviewed publications, and 31 presentations at national and internationals conferences (2 as a keynote). Additionally, my in the last five years has been supported by 11 competitive research grants. A list of my publications is available at: http://www.jamieranse.com/p/publications_30.html A list of my presentations is available at: http://www.jamieranse.com/p/presentations.html Potential conflicts of interest NilOther Relevant Personnel Prof Paul Arbon Qualifications: BSc, DipEd, GradDipHlthEd, MEd(Studies), PhD. Relevant expertise: PhD supervision, phenomenology, disaster and mass gathering health. Paul is the current President of the World Association for Disaster and Emergency Medicine (WADEM), Director of the Torrens Resilience Institute, Professor of Nursing and Director of the Flinders University Research Centre for Disaster Resilience and Health. Dr Lynette Cusack Qualifications: RN, PhD, MHA, BN. Relevant expertise: Currently hold a Post Doctoral Research Fellow (Population Health), Flinders University, Faculty of Health Sciences, School of Nursing and Midwifery. Dr Cusack has experience in research related to disaster preparedness and response as well as professional nursing issues such as scope of practice and regulation. Commercial-in-Confidence Page 10 of 23
5. PROJECT 5.1. Type of Research 5.1.1 Tick as many of the following types of research as apply to this project. Your answers will assist HRECs in considering your proposal. A tick in some of these boxes will generate additional questions relevant to your proposal (mainly because the National Statement requires additional ethical matters to be considered), which will appear in Section 9 of NEAF. This project involves: [X] Research using qualitative methods NS 3.1 5.1.2 Does the research involve limited disclosure to participants? NS 2.3 No 5.1.3 Are the applicants asking the HREC / review body to waive the requirement of No consent? NS 2.3.5 5.2. Research plan 5.2.1 Describe the theoretical, empirical and/or conceptual basis, and background evidence, for the research proposal, eg. previous studies, anecdotal evidence, review of literature, prior observation, laboratory or animal studies (4000 character limit). NS 1.1 Historically, Australian nurses have been active participants in the response and recovery to health care disasters, both nationally (Cameron, et al., 2009; Ranse, et al., 2010a) and internationally (Robertson, et al., 2005). Initially, the response to disasters was organized in a haphazard manner, as clinicians with little out-of-hospital experience were recruited as responders to these events. With this in-mind, the process for deploying Australian nurses to disaster has become more rigorous. This is primarily due to the increasing impact of disasters in the oceanic region For the purpose of this research, a disaster is defined as an event that interrupts the normal functioning of a community, resulting in the need for external human and/or physical resources to assist in a response beyond that of the normal day-to-day operational capacity for that community (TFQCDM/WADEM, 2002). The literature pertaining to disaster health is growing. Similarly, the literature specifically pertaining to nurses in the disaster health environment is growing; however, this is primarily focused on  descriptive accounts of disasters,  the development and implementation of disaster competencies to guide education and training programs, and  psychological topics, such as post-traumatic stress disorder and post-traumatic growth. Descriptive accounts of disasters are important to report, as they provide some insight into the event and possible lessons learnt for future responses. Since the Bali Bombings  and Sumatra-Andaman earthquake and tsunami  the literature is saturated with such accounts. Commonly, these descriptions relate to the individual accounts, disaster medical assistance teams experiences (Anderson, 2007; Kwak, et al., 2006; Robertson, et al., 2005) or the experiences of field hospital teams (Kreiss, et al., 2010), of which nurses were a part of the broader health response. In the United States, core competencies for nurses in emergencies and disasters have been suggested (Gebbie & Qureshi, 2002). Similarly, the World Health Organization and International Council of Nurses have developed a set of ‘disaster nursing competencies’ (WHO & ICN, 2009). Whilst the development of competencies to underpin disaster education and training is important, it seems that the current disaster education for nurses is somewhat haphazard and fragmented requiring the further development of a national disaster education and training framework for the Australian context (FitzGerald, et al., 2010). This possibly exists due to the mismatch or gap between our understanding of the nursing role in disasters and the education nurses receive (Ranse, et al., 2010a; Ranse, et al., 2010b). There is an abundance of literature pertaining to the health and wellbeing of first responders to disasters, highlighting that post traumatic stress disorder is commonly diagnosed after responding to traumatic events (Alexander & Klein, 2009; Palm et al, 2004). Additionally, there is an increasing body of literature suggesting that there are positive outcomes resulting from disasters, such as personal growth and resilience (Tedeschi & Kilmer, 2005). However, this literature doesn’t necessarily relate to nurses. More recently, there has been a move from descriptive and commentary style literature as described above, to research papers with an aim at better understanding the clinical background, roles, resources and training of nurses who participate in disasters (Arbon, et al., 2006; Ranse, et al., 2010a). However, the experience of Australian nurses who participate in disasters remains poorly understood. 5.2.2 State the aims of the research and the research question and/or hypotheses, where appropriate. Commercial-in-Confidence Page 11 of 23
Research question: What is the lived experience of Australian civilian registered general nurses (division 1), working in the unfamiliar out-of-hospital disaster environment? Objectives: This research has three broad objectives nested within the overarching research question. These objectives are, to: 1) Explore the transferability of nurses experience between the in-hospital and out-of-hospital disaster environment, and 2) Explore the role of nurses in the out-of-hospital disaster environment.5.2.3 Has this project been undertaken previously? No5.3. Benefits/Risks5.3.0 Does the research involve a practice or intervention which is an alternative to a Nostandard practice or intervention?5.3.2 What expected benefits (if any) will this research have for the wider community? This research will provide insight into the disaster experience of civilian nurses, with a particular focus on nurses who normally work in an in-hospital environment, and were working out-side these institutions (for example, in a temporary field hospital) in the disaster environment. Such information may inform policy, curriculum design or practice pertaining to nurses who participate in a disaster. Subsequently, this may result in the benefit to the community by enhancing the preparation of nurses to participate in disaster response and recovery activities.5.3.3 What expected benefits (if any) will this research have for participants? NS 2.1 The research will provide an opportunity for the participant to reflect on their participation in disasters.5.3.4 Are there any risks to participants as a result of participation in this research Yesproject? NS 18.104.22.168 Explain how the likely benefit of the research justifies the risks of harm or discomfort to participants.NS 1.6 Potentially, participants from this research may have a negative emotional response associated with their disaster participation. Participants who participate in this research may evoke or highlight this response. From the researchers experience in facilitating research regarding the nurses experience and role in during the Black Saturday and Victorian Bushfire of 2009, this is unlikely to occur. However, if this does occur during an interview. That interview will be ceased, and the participant will be strongly encouraged to seek the support of their General Practitioner or their hospital / health service employee assistance program. A statement similar to this is included in the potential participants invitation and information sheet [see attached]. If the researcher believes that the emotional response requires a more rapid intervention from a health professional, the researcher, having a clinical, management and educator background in a metropolitan emergency department has the necessary skills to determine the appropriate level of care and referral for a research participant (for example, to a case manager, emergency department or mental health crisis assessment team).5.3.8 Are there any other risks involved in this research? eg. to the research team, the Noorganisation, others5.3.9 Is it anticipated that the research will lead to commercial benefit for the Noinvestigator(s) and or the research sponsor(s)?5.3.11 Is there a risk that the dissemination of results could cause harm of any kind to Noindividual participants - whether their physical, psychological, spiritual, emotional,social or financial well-being, or to their employability or professional relationships - orto their communities?5.4. MonitoringRefer to NS 3.3.19 - 22.214.171.124.1 What mechanisms do the researchers / investigators intend to implement to monitor the conduct andprogress of the research project? NS 5.5 The researcher will meet monthly with the supervisory team. The purpose of these meetings are to monitoring the progress and conduct of the researchers work and to provide guidance. Commercial-in-Confidence Page 12 of 23
6. PARTICIPANTS 6.1. Research participants 6.1.1 The National Statement identifies the need to pay additional attention to ethical issues associated with research involving certain specific populations. This question aims to assist you and the HREC to identify and address ethical issues that are likely to arise in your research, if its design will include one or more of these populations. Further, the National Statement recognizes the cultural diversity of Australia’s population and the importance of respect for that diversity in the recruitment and involvement of participants. Your answer to this question will guide you to additional questions (if any) relevant to the participants in your study. 6.1.1 Tick as many of the following types of research participants’ who will be included because of the project design, or their inclusion is probable, given the diversity of Australia’s population. If none apply, please indicate this below. a) Primary intent of research None apply [X] 6.1.2 Please detail why none of these categories apply to the proposed research Potential participants will include Australian civilian registered general nurses (division 1) who have worked in the out-of-hospital disaster environment. As such, this research does not aim to specifically recruit and include participants from the above mentioned groups. However, nurses may coincidentally fit into one of the above mentioned groups, such as: • People whose primary language is other than English (LOTE), or • Aboriginal and/or Torres Strait Islander people. 6.2. Participant description 6.2.1 How many participant groups are involved in this research project? 1 6.2.2 What is the expected total number of participants in this project at all sites? 10-15 6.2.3. Group 1 6.2.3... Group name for participants in this group Australian civilian nurses who have worked in the out-of-hospital disaster environment 6.2.3... Expected number of participants in this group 10-15 6.2.3... Age range Adults 6.2.3... Other relevant characteristics of this participant group The characteristics of this group include Australian registered general nurses who: • Normally work in an in-hospital clinical capacity, • Have worked in the out-of-hospital disaster environment, • Were deployed in a civilian (non-defence) capacity, and • Where this deployment was in the previous five years. 6.2.3... Why are these characteristics relevant to the aims of the project? These characteristics are of relevance to the project, as this project aims to explore, describe and interpret the experience of people within this group. 6.3. Participation experience 6.3.1 Provide a concise detailed description, in not more than 200 words, in terms which are easily understood by the lay reader of what the participation will involve. Participation in this research will involve two face-to-face interviews with the researcher at a mutually agreeable time, at a mutually agreeable location. Each interview will: • Take place in the participants city of residence, • Last approximately 60 – 90 minutes per interview, and • Be digitally recorded. It is anticipated that the two interviews will take place within the same week. The first interview will focus on exploring information about the participants broad experience in disaster health, and aim to build rapport Commercial-in-Confidence Page 13 of 23
with the participants. The second interview will explore in more detail the personal experiences of the participant in disaster health.6.4. Relationship of researchers / investigators to participants6.4.1 Specify the nature of any existing relationship or one likely to rise during the research, between thepotential participants and any member of the research team or an organisation involved in the research. It is unlikely that the researcher will have an existing relationship with any of the potential participants. Similarly, it is unlikely that a relationship will arise during this research. Additionally, the researcher is currently employed by an academic institution (University of Canberra) which does not have a foreseeable dependent relationship with any potential participants.6.4.2 Describe what steps, if any, will be taken to ensure that the relationship does not impair participantsfree and voluntary consent and participation in the project. It is perceived that a decision to, or not to participate in this research will not result in an impairment of any foreseeable relationships between potential or real participants and the researcher. It will be emphasised throughout the research and consent process that participation is voluntary, and the participant may withdraw at any time with no consequence.6.4.3 Describe what steps, if any, will be taken to ensure that decisions about participation in the researchdo not impair any existing or foreseeable future relationship between participants and researcher /investigator or organisations. Potential research participants who do not wish to participate in the research will not be known to the researcher. Therefore, a decision to participate or not, will not impact on any forseeable relationship with the researcher, the researchers organisation and the potential participants.6.4.4 Will the research impact upon, or change, an existing relationship between Noparticipants and researcher / investigator or organisations.?6.4.5 Is it intended that the interview transcript will be shown or made available to Noparticipants? 126.96.36.199. Recruitment6.5.1 What processes will be used to identify potential participants? It could be argued that potential participants for this research may be difficult to locate. This is due to a number of factors such as: • Transient nursing population within Australia, • Lack of record keeping by organisations of persons deployed in disasters, and • Nurses responding as individuals not associated or affiliated with a registered organisation / relief agency, and are therefore not recorded in anyway. As such, potential participants for this research will be identified using a purposive sampling technique. Snowballing, a subtype of purposive sampling will be used to identify, locate and recruit potential participants.6.5.2 Is it proposed to screen or assess the suitability of the potential participants for Yesthe study?6.5.2... How will this be done? Participants will be assessed on their suitability for participation in this research. Such screening will give consideration to the aim of this research, ensuring the potential participant is: • A nurse who primarily works as a clinician in the in-hospital environment, • Has participated in the health response and/or recovery to a disaster in the last five years (2007 – 2011), • Responded with a civilian (non-military) organisation / association / group, and • The response involved working in the out-of-hospital environment.6.5.3 Describe how initial contact will be made with potential participants. It is anticipated that a traditional snowballing technique of participant recruitment will commence within the researchers existing professional networks. As such, initial contact with a potential participant is likely to be made from the researcher, or from a colleague or associate of the researcher who forwards a copy of the researcher ‘invitation and information’ sheet. Once a potential participant receives an ‘invitation and information’ from a colleague or associate of the researcher, and they wish to participate in this research, they will contact the researcher using the contact details provided on the ‘invitation and information’ sheet.6.5.3... Do you intend to include both males and females in this study? Yes6.5.3... What is the expected ratio of males to females that will be recruited into this study and does thisratio accurately reflect the distribution of the disease, issue or condition within the general community? This research is inclusive of both males and females. This research does not aim to have a specific ratio of Commercial-in-Confidence Page 14 of 23
males to females. However, given that nursing is a female dominated profession, it would be reasonable to assume that more females would participate when compared to males.6.5.4 Is an advertisement, e-mail, website, letter or telephone call proposed as the form Noof initial contact with potential participants?6.5.5 If it became known that a person was recruited to, participated in, or was Noexcluded from the research, would that knowledge expose the person to anydisadvantage or risk?6.6. Consent process6.6.1 Will consent for participation in this research be sought from all participants? Yes6.6.1... Will there be participants who have capacity to give consent for themselves? Yes6.6.1... What mechanisms/assessments/tools are to be used, if any, to determine each of these participantscapacity to decide whether or not to participate? No tools will be used, as it is anticipated that potential participants will have the capacity to decide whether or not to participate based on the information provided on the invitation and information sheet. Additionally, potential participants will have an opportunity to contact the researcher, to clarify any issues or concerns, prior to agreeing to participate in this research. This will be possible as this researchers contact details will be provided on the invitation and information sheet.6.6.1... Are any of the participants children or young people? No6.6.1... Will there be participants who do not have capacity to give consent for Nothemselves?6.6.1... Describe the consent process, ie how participants or those deciding for them will be informed about,and choose whether or not to participate in, the project. Information about the research project will be provided to potential participants on the invitation and information sheet [see attached]. This information sheet will outline the research project, participant participation requirements and ethics relating to the project. Additionally, a consent form will be provided to each potential participant, after sceening [see attached]. Similar to the invitation and information sheet, the consent form will outline the participant requirements and ethics relating to the project.6.6.1... If a participant or person on behalf of a participant chooses not to participate, are there specificconsequences of which they should be made aware, prior to making this decision? 4.6.6 - 4.6.7 No, there is no perceived consequence / risk as a result of not participating in this research. The researcher will ensure this is clearly communicated during the recruitment process.6.6.1... Might individual participants be identifiable by other members of their group, and if so could thisidentification expose them to risks? It is unlikely that a potential participant would be identifiable by other participants or the wider nursing community, unless the potential participant had previously voluntarily disclosed their information to other potential participants, or the wider community.6.6.1... If a participant or person on behalf of a participant chooses to withdraw from the research, are therespecific consequences of which they should be made aware, prior to giving consent? No, there is no perceived consequence as a result of withdrawing from this research at any point throughout the research process.6.6.1... Specify the nature and value of any proposed incentive/payment (eg. movie tickets, food vouchers)or reimbursement (eg travel expenses) to participants. Nil. There are no incentives or payments associated with participating in this research.6.6.1... Explain why this offer will not impair the voluntary nature of the consent, whether by participants orpersons deciding for their behalf. NS 2.2.10 - 2.2.11 Not applicable, as no incentives or payments will be offered to real or potential participants as part of this research project.6.6.3 Do you propose to obtain consent from individual participants for your use of Notheir stored data/samples for this research project?6.6.3... Give justification Not applicable - this project will not obtain any biological / pathological findings from participants. Commercial-in-Confidence Page 15 of 23
8. CONFIDENTIALITY/PRIVACY 8.1. Do privacy guidelines need to be applied in the ethical review of this proposal? 8.1.1 Indicate whether the source of the information about participants which will be used in this research project will involve: [X] collection directly from the participant 8.1.1... Information which will be collected for this research project directly from the participant 8.1.1... Describe the information that will be collected directly from participants. Be specific where appropriate. Please see the attached interview schedules. 8.1.1... The information collected by the research team about participants will be in the following form(s). Tick more than one box if applicable. [X] individually identifiable 8.1.1... Give reasons why it is necessary to collect information in individually identifiable or re-identifiable form. Due to the nature of interviews, it is likely that the researcher will be able to identify individuals and their associated interview transcripts. However, all information presented in the final publications and/or presentations will only include de-identifiable information. The process of de-identifying the participant narrative will occur once the data analysis stage of this project is completed. The participant narrative will be transcribed verbatim from the recorded conversation. This transcription is likely to be undertaken by a third party. The chosen third party will be a professional transcription company, with experience in research manuscript transcription that adhere to the Australian Commonwealth Privacy Act. Such companies include: www.pasificsolutions.com.au OR www.transcribeonline.com OR www.escribe.com.au 8.1.1... Consent process You have indicated that you will be varying the conditions of or waiving consent. See questions in section 6.6 8.1.1... Will consent be specific or extended or unspecified? NS 2.2.14 - 2.2.18 Specific 8.1.1... Provide reasons why this form of consent has been chosen. You may need to revise your answer at 188.8.131.52.3 to provide details on the consent process Consent provided by participants of this research project will be considered valid and appropriate for this project only. Any additional projects will require a new ethics application, recruit process and consent from participants. 8.2. Using information from participants 8.2.1 Describe how information collected about participants will be used in this project. Information collected during this project will only be used for the purpose stated in the aims. 8.2.2 Will any of the information used by the research team be in identified or Yes re-identifiable (coded) form? 8.2.2... Indicate whichever of the following applies to this project: [X] Information collected for, used in, or generated by, this project will not be used for any other purpose. 8.2.4 List ALL research personnel and others who, for the purposes of this research, will have authority to use or have access to the information and describe the nature of the use or access. Examples of others are: student supervisors, research monitors, pharmaceutical company monitors . Only the researcher will have access to the raw data. The supervisors of this project will be provided with de-identified transcriptions of the participants narrative. 8.3. Storage of information about participants during and after completion of the project 8.3.1 In what formats will the information be stored during and after the research project? (eg. paper copy, computer file on floppy disk or CD, audio tape, videotape, film) The digitally recorded interviews and subsequent transcribed data from this research will be electronically stored. 8.3.2 Specify the measures to be taken to ensure the security of information from misuse, loss, or unauthorised access while stored during and after the research project? (eg. will identifiers be removed and at what stage? Will the information be physically stored in a locked cabinet?) Commercial-in-Confidence Page 16 of 23
The researcher will ensure electronic data will be stored in a password-protected computer in a password-protected file, only accessible to the researcher. Identifying elements of the participants narrative and subsequent transcriptions will be removed at the completion of the data analysis stage.Given the this research involves a proposed waiver of consent and the intent of exposing illegal activity [see NS 4.6.1] the HREC must be satisfiedthat your response to this question has justified that there is sufficient protection of the privacy of the participants.8.3.5 The information which will be stored at the completion of this project is of the following type(s). Tickmore than one box if applicable. [X] non-identifiable8.3.6 For how long will the information be stored after the completion of the project and why has this periodbeen chosen? Seven years following the completion of the research project.8.3.7 What arrangements are in place with regard to the storage of the information collected for, used in, orgenerated by this project in the event that the principal researcher / investigator ceases to be engaged atthe current organisation? This is unlikely to occur, however hypothetically if this did occur, the data and research documents will be made available to the research supervisors.8.4. Ownership of the information collected during the research project and resulting fromthe research project8.4.2 Who is understood to own the information resulting from the research, eg. the final report or publishedform of the results? The researcher and research supervisors, with due acknowledgement to Flinders University, University of Canberra and any funding bodies of this research.8.4.3 Does the owner of the information or any other party have any right to impose Nolimitations or conditions on the publication of the results of this project?8.5. Disposal of the information8.5.1 Will the information collected for, used in, or generated by this project be Nodisposed of at some stage?8.6. Reporting individual results to participants and others8.6.1 Is it intended that results of the research that relate to a specific participant be Yesreported to that participant?8.6.1... Specify in what form the results will be reported to participants. The final results from this research will be disseminated to the participants in the form of the final thesis, subsequent publications and presentations resulting from this project.8.6.1... How will the results be communicated to participants? eg telephone call, individual letter, copy ofpublication, consultation with a medical practitioner or other Participants will be provided with a website link [http://bit.ly/JamiesPhD] that will contain all publications and presentations resulting during and following the completion of this project.8.6.1... Who will be responsible for communicating the project results to participants? The researcher will be responsible for communicating the results of this project to the participants.8.6.2 Is the research likely to produce information of personal significance to Yesindividual participants?8.6.3 Will individual participants results be recorded with their personal records? No8.6.4 Is it intended that results that relate to a specific participant be reported to Noanyone other than that participant?8.6.5 Is the research likely to reveal a significant risk to the health or well being of Nopersons other than the participant, eg family members, colleagues8.6.6 Is there a risk that the dissemination of results could cause harm of any kind to Noindividual participants - whether their physical, psychological, spiritual, emotional,social or financial well-being, or to their employability or professional relationships - orto their communities?8.6.7 How is it intended to disseminate the results of the research? eg report, publication, thesis It is anticipated that the results of this research will be presented at various conferences relating to disaster and emergency health. Additionally, the findings will be submitted for publication in a peer-reviewed journal and written-up in the researchers final thesis. Commercial-in-Confidence Page 17 of 23
8.6.8 Will the confidentiality of participants and their data be protected in the Yesdissemination of research results?8.6.8... Explain how confidentiality of participants and their data will be protected in the dissemination ofresearch results Information pertaining to an individual participant in any presentation and publication will be de-identified. However, if information is likely to identify a particular participant, that particular piece of information will be withheld from the publication and/or presentation. Commercial-in-Confidence Page 18 of 23
9. DECLARATIONS AND SIGNATURES 9.1 Project Title The lived experience of Australian civilian nurses working in the out-of-hospital disaster environment 9.2 Human Research Ethics Committee to which this application is made Social and Behavioural Research Ethics Committee (EC00194) 9.3 Signatures and undertakings Applicant / Principal Researchers (including students where permitted) I/we certify that: - All information is truthful and as complete as possible. - I/we have had access to and read the National Statement on Ethical Conduct in Research Involving Humans. - the research will be conducted in accordance with the National Statement. - the research will be conducted in accordance with the ethical and research arrangements of the organisations involved. - I/we have consulted any relevant legislation and regulations, and the research will be conducted in accordance with these. - I/we will immediately report to the HREC anything which might warrant review of the ethical approval of the proposal NS 5.5.3 including: - serious or unexpected adverse effects on participants; - proposed changes in the protocol; and - unforseen events that might affect continued ethical acceptability of the project. - I/we will inform the HREC, giving reasons, if the research project is discontinued before the expected date of completion NS 5.5.6 see NS 5.5.8(b); - I/we will adhere to the conditions of approval stipulated by the HREC and will cooperate with HREC monitoring requirements. At a minimum annual progress reports and a final report will be provided to the HREC. Applicant / Chief Researcher(s) / Principal Researcher(s) Mr Jamie Ranse __________________________________ ____/____/______ Flinders University Signature Date Supervisor(s) of student(s) I/we certify that: - I/we will provide appropriate supervision to the student to ensure that the project is undertaken in accordance with the undertakings above; - I/we will ensure that training is provided necessary to enable the project to be undertaken skilfully and ethically. Prof Paul Arbon __________________________________ ____/____/______ Signature Date Dr Lynette Cusack __________________________________ ____/____/______ Signature Date Heads of departments/schools/research organisation I/we certify that: - I/we are familiar with this project and endorse its undertaking; - the resources required to undertake this project are available; - the researchers have the skill and expertise to undertake this project appropriately or will undergo appropriate training as specified in this application. Commercial-in-Confidence Page 19 of 23
_________ __________________ ________________________________ Title First name Surname ________________________________ ________________________________ Position Organisation name ____/____/____ ________________________________ Date SignatureCommercial-in-Confidence Page 20 of 23
10. ATTACHMENTSThis page and all pages that follow dont need to be submitted to your HREC. 10.1 List of Attachments Core Attachments Attachments which may be required/appropriate. Recruitment/invitation Copy of advertisement, letter of invitation etc Participant Information Copy or script for participant Copy or script for parent, legal guardian or person responsible as appropriate Consent Form Copy for participant For parent, legal guardian or person responsible as appropriate For, optional components of the project eg. genetic sub study Peer review Copy of peer review report or grant submission outcome HREC approvals Copy of outcome of other HREC reviews Attachments specific to Attachments which may be project or participant required/appropriate. group Research conducted in the workplace Evidence of support/permission from workplace where research will be or possibly impacting on workplace conducted relationships Commercial-in-Confidence Page 21 of 23
10.2 Participant information elementsCore ElementsProvision of information to participants about the following topics should be considered for all research projects. Core Elements Issues to consider in participant information About the project Full title and / or short title of the project Plain language description of the project Purpose / aim of the project and research methods as appropriate Demands, risks, inconveniences, discomforts of participation in the project Outcomes and benefits of the project Project start, finish, duration About the investigators / organisation Researchers conducting the project (including whether student researchers are involved) Organisations which are involved / responsible Organistions which have given approvals Relationship between researchers and particpants and organisations Participant description How and why participants are chosen How participants are recruited How many participants are to be recruited Participant experience What will happen to the particant, what will they have to do, what will they experience? Benefits to individual, community, and contribution to knowledge Risks to individual, community Consequences of participation Participant options Alternatives to participation Whether participation may be for part of project or only for whole of project Whether any of the following will be provided: counselling, post research follow-up, or post research access to services, equipment or goods Participants rights and responsibilities That participation is voluntary That participants can withdraw, how to withdraw and what consequences may follow Expectations on participants, consequences of non-compliance with the protocol How to seek more information How to raise a concern or make a complaint Handling of information How information will be accessed, collected, used, stored, and to whom data will be disclosed Can participants withdraw their information, how, when Confidentiality of information Ownership of information Subsequent use of information Storage and disposal of information Unlawful conduct Whether researcher has any obligations to report unlawful conduct of participant Financial issues How the project is funded Declaration of any duality of interests Conspensation entitlements Costs to participants Payments, reimbursements to participants Commercial application of results Results What will particpants be told, when and by whom Will individual results be provided What are the consequences of being told or not being told the results of Commercial-in-Confidence Page 22 of 23
Core Elements Issues to consider in participant information research How will results be reported / published Ownership of intellectual property and commercial benefits Cessation Circumstances under which the participation of an individual might cease Circumstances under which the project might be terminatedResearch Specific ElementsProvision of information to participants about the following topics should be considered as may be relevant to theresearch project. Commercial-in-Confidence Page 23 of 23
In vita tio n a n dIn fo rm a tio n THE LIVED EXPERIENCE OF AUSTRALIAN CIVILIAN NURSESWORKING IN THE OUT-OF-HOSPITAL DISASTER ENVIRONMENTINVITATION AND INFORMATION Are you a nurse who primarily works as a clinician in a hospital? Have you participated in the health response and/or recovery to a disaster, in the last five years? Did you respond with a civilian (non-military) organisation, association, group or health service? Did your response involved working in the out-of-hospital environment?If you have answered yes to all of the above, you are invited to participate in this research project that willexplore your experience of working in the out-of-hospital environment during disasters.OverviewHistorically, Australian nurses have been active participants in the response and recovery to healthrelated disasters, both nationally and internationally. However, the experience of Australian nurses whoparticipate in disasters remains poorly understood. Having a better understanding of the experience ofAustralian nurses in disasters, may assist in the further development of curriculum, policy and resourcesto support nurses.AimThis project aims to explore the lived experience of Australian civilian registered general nurses (division1), who have worked in the out-of-hospital disaster environment. In particular, this project will explore thetransferability of nurses’ experience between the in-hospital and out-of-hospital disaster environment.Your participationParticipation in this research will involve two face-to-face interviews with the researcher at a mutuallyagreeable time, at a mutually agreeable location. Each interview will: • Take place in your city of residence, • Last approximately 60 – 90 minutes per interview, and • Be digitally recorded.It is anticipated that the two interviews will take place within the same week. Participation in this research isvoluntary. During the interviews you do not have to answer any question/s that you do not wish to answer,and you may withdraw any comments from the research at any point in time.
About the researcherJamie Ranse is a PhD student at the Flinders University Disaster Research Centre. He is a RegisteredNurse with a background in Emergency and Intensive Care nursing. Jamie has an interest in disasterhealth, from a nursing perspective. Jamie’s PhD research is being supervised by Professor Paul Arbon andDr Lynette Cusack.If at any time you have queries about this project, I may contact either: Mr Jamie Ranse (PhD candidate / researcher): email@example.com or +61 2 6201 5380 Professor Paul Arbon (supervisor): firstname.lastname@example.org or +61 8 8201 3558Emotional wellbeingPrior to, during or following your interview with the researcher, you may experience an emotional responserelating to your experience. You are encouraged to seek the support of your General Practitioner or yourhospital / health service employee assistance program if this occurs.ResultsFollowing completion of this research project, the findings will be submitted in thesis format, as part of therequirements of the researchers PhD. Additionally, the results may be published in a journal and presentedat a conference. Any publications and/or presentations will not individually identify you. All publications orpresentations relating to this project can be found at: http://bit.ly/JamiesPhDEthicsApproval to undertake this research has been obtained from the Flinders University Social and BehaviouralResearch Ethics Committee <<PROJECT NUMBER TO BE INSERTED HERE>>. Should you have anyproblems or queries about the way in which the research is being conducted, and you do not feelcomfortable contacting the research staff, you may contact: Executive Officer, Research Services Office E-mail: email@example.com Phone: +61 8 8201 3116 Fax: +61 8 8201 2035Indicate your interest to participation in this researchIf you wish to participate in this research, please contact:Mr Jamie RansePhD CandidateE-mail: firstname.lastname@example.orgPhone: +61 2 6201 5380Please circulate this invitation and information sheet to your colleagues and associates that may beinterested in participating in this research.
Co n s e n t Fo rm THE LIVED EXPERIENCE OF AUSTRALIAN CIVILIAN NURSESWORKING IN THE OUT-OF-HOSPITAL DISASTER ENVIRONMENTI ________________________________________ have read the research project invitation andinformation sheet, and hereby consent to participate in this research. I am aware that:• Participation in this project will involve two face-to-face interviews of approximately 1 ½ hours each, in my home city.• The data will be digitally recorded, de-identified and securely stored throughout and upon completion of the project.• Participation in this project is voluntary, I may withdraw at any stage and I do not have to answer any question I do not wish to answer.• The results of the project will be submitted for publication in a journal, presented at a conference and submitted to Flinders University as part of the requirement for the researcher PhD candidature.• I may not directly benefit from taking part in this research.• If at any time I have queries about this project, I may contact either: Mr Jamie Ranse (PhD student / principal researcher): email@example.com or 02 6201 5380 Professor Paul Arbon (supervisor): firstname.lastname@example.org or 08 8201 3558• Approval to undertake this research project has been obtained from the ‘Flinders University Social and Behavioural Research Ethics Committee’. Should I have any problems or queries about the way in which the research was conducted, and I do not feel comfortable contacting the research staff, I am aware that I may contact: Executive Officer, Research Services Office E-mail: email@example.com Phone: 08 8201 3116By signing this consent form, I agree to participate in this research project. I have read and understoodthe information provided and I have had the opportunity to ask any questions. Signature Participant Print Name Date Researcher Print Name Date
In te rvie w S c h e d u le s THE LIVED EXPERIENCE OF AUSTRALIAN CIVILIAN NURSESWORKING IN THE OUT-OF-HOSPITAL DISASTER ENVIRONMENTInterview one: semi-structuredThis interview will focus on obtaining information about the participant’s broad experience indisaster health, and aim at building rapport with the participant. Time Activity 0 – 10 mins • Introduction of research student and supervisory team • Reiterate information on ‘invitation and information sheet’ and ‘consent form’ • Ensure consent form has been signed 10 – 85 mins Ice breaker questions: • How long have you been nursing? • What is your nursing background? Previous nursing experience questions: • What areas / specialties within nursing have you associated with? • What roles have you undertaken in these areas? Disaster nursing experience questions: • Tell me about your experience of working in a disaster? Prompting questions relating to disaster nursing experience: • How many disaster events have you been involved with? • Can you tell me about the disaster event/s you have been involved in the last five years? • What was your role/s during these disasters? • Who did you work with? • Did your training adequately prepare you for your role/s? • What have you gained from your in-hospital nursing experience, which contributed to making your disaster involvement a success? • What factors could have enhanced your involvement? • Is there anything that you would like to add? 85 – 90 mins Conclusion and thank youKey phrasesExploring – Can you tell me more about … ?Validating – So, is what you are saying … ?
Interview two: unstructuredThe aim of this interview is to explore in more detail the personal experiences of the participant. Time Activity 0 – 5 mins • Introduction to interview two • Reiterate information on ‘invitation and information sheet’ and ‘consent form’ • Discuss any emotional response that the participant may have experienced since the previous interview 5 – 55 mins Unstructured questioning, with an aim to: • Clarifying previous statements from interview one • Exploring and expanding on statements from interview one • Allow participant to provide additional statements that were not previously explored in interview one 55 – 60 mins Conclusion and thank-youKey phrasesExploring – Can you tell me more about … ?Validating – So, is what you are saying … ?