Application Guide to assist completion of the ACC Research Ethics Committee Application Template

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1 Application Guide to assist completion of the ACC Research Ethics Committee Application Template A number of guiding principles govern the review of research proposals. The following provide guidance but are by no means exhaustive. 1. Methodology: Proposals for research must be methodologically valid to ensure that research participants are not needlessly exposed to risks or inconvenience. Therefore a proposal should demonstrate that: The proposed research has the potential to address a significant issue or to advance knowledge and that it may contribute to improved outcomes for people. The proposed research has scientific validity - the research design, methods and analyses chosen should be described and the choice of method justified. Risks and limitations of the research should be identified. In order to provide a reliable basis for ACC decision making, the methodology of the research project should be described in enough detail so that the Committee will be assured that the results of the research will be robust. The risk/benefit ratio has been addressed - will any potential adverse impacts of a study be outweighed by the benefit to individuals and to society, or will there be a risk of harm for little gain? The use of ACC data, or surveying of ACC clients, will be aimed at improving client outcomes through informing ACC decision making around treatments, rehabilitation, service delivery or injury prevention work. Merit will be balanced against other considerations such as respondent burden, for example, the Research Ethics Committee may decide to allow a practice in one project that is deemed not acceptable in another, because of the greater value to ACC or worthiness of the former project. The research team collectively have the academic qualifications, time and facilities, topic-based knowledge and research experience to undertake the proposed research. The research project has chosen the least invasive method of obtaining the information from the research participants.

2 2. Conflict of interest Research, in which the researcher has a conflict of interest, or the appearance of conflict of interest, is not ethically acceptable and is often methodologically suspect. The funding or sponsorship of a project must not compromise its research adequacy or ethical acceptability. Any conflict of interest must be declared. 3. Recruitment of participants to take part in research The research proposal should describe in detail how potential participants will be identified and the method by which they will be invited to take part in the research. The following should be specified: the population from which participants will be drawn inclusion and exclusion criteria estimated number of participants demographic criteria (age, gender, ethnicity, etc) method of recruitment any payment or reward for participation The contact information (name and address) for the intended sample of participants must be obtained, so that they can be sent information about the research on which to base whether to give informed consent or to decline to take part. Informed consent is needed from a potential participant, whether it is for agreement to be contacted for the research, or simply agreement for specified parts of their claims or treatment files to be used for research purposes. ACC Research process for approaching potential participants to participate in research Researchers seeking participant contact information in order to carry out research will need to clearly show why it is necessary to contact people (as opposed to utilising information already on file), whether the methods and questions are the least invasive possible, and whether the researcher s letter seeking consent from potential participants, and material informing them about the project, are clear and explicit. The following are processes are undertaken by ACC Research to obtain informed consent from clients to participate in research. Researchers external to ACC may not contact clients directly to ask them to participate in research.

3 When the research proposal is approved by the Ethics Committee, a request is sent to Business Information for the data requested. ACC Research will receive a spreadsheet of client details for the purposes of obtaining informed consent for the research. ACC Research will set up a spread-sheet for the purposes of carrying out a mail merge and documentation of the responses to the mail-out. Pre-notification letters which include a personalised ID number and accompanying information sheet are sent out in plain sealed envelopes to the research sample notifying them about the research and giving them the opportunity to opt out of the research. When an external research supplier is being used by ACC the following wording should be used: ACC has appointed [Research Company] to manage the collection of the survey data on our behalf. [Research Company] is an independent research company that we have asked t conduct this survey as an agent of ACC. This means that, under the Privacy Act, [Research Company] processes the information it collects as if it were ACC. Potential participants are usually given 10 working days to opt out. In some cases an opt in is required where the potential participant is required to actively phone in to confirm their wish to take part in the research. An opt in is required if the research is deemed by the Committee to be of a particularly sensitive nature and where discussion prior to contact by a researcher is deemed advisable. Clients who would like to opt out call (ACC Research s 0800 number) and leave their name and personalised identification number which is provided in the pre-notification letter. The 0800 number is checked by ACC Research on a regular basis and those who have opted out are noted. Letters that are returned undelivered are noted and removed from the sample The names of those who have opted out are removed from the research sample and after the deadline has passed the cleaned research sample is password protected and securely sent to the Researcher. When the researcher contacts the intended participants, there is further opportunity, even after the research has started for them to withdraw at any stage. ACC would not be informed of who withdraws, nor would any refusal to take part in the research. 4. Privacy and confidentiality The protection of privacy is a legal requirement as well as an issue of ethical consideration. The principles of the Privacy Act 1993 and the Health Information Privacy Code 1994 should be observed. See Confidentiality of information means that the information is held between the parties sharing the confidence. It may be misleading to say that information collected during research is confidential if it will be reported or published. It is more appropriate to say, if the information you provide is reported or published, this will be done in a way that does not identify you.

4 If participants cannot be guaranteed confidentiality, for example, focus groups or where the number of participants is small, they should be informed. Where third parties (that is, people other than the named researchers) are given access to data that is not anonymous, for example, for transcription services, the third party must sign a confidentiality agreement. 5. Storage and security of information Confidential information must be protected and the research proposal should carefully describe your data storage and security procedures. ACC client information will be delivered to a researcher in encrypted form and must be securely stored. Researchers should use secure computer networks. Data should only be accessed by named researchers directly involved in the research Data should be stored for the correct period after the research is completed and securely destroyed. 6. Informed consent At the time of injury ACC claimants sign an injury form in which they authorise: The collection and disclosure of information for the purposes of research into injury prevention and effective assessment and rehabilitation. and, The collection and disclosure of any information about me to the extent necessary to and/or to assist the evaluation of services and the performance of the ACC scheme and/or to support the administration of the health and safety in Employment Act ACC does not consider that this constitutes informed consent for the release of health information, participation in research, or for personal or health data, to be used for research. ACC requires ethical safeguards as provided by the ACC Research Ethics Committee. Informed consent consists of three components: The provision of adequate information to enable an informed judgement to be made. The information provided should include: the purpose and intended use of the research; an explanation of the procedures to be followed; what will be required of the participant in terms of time and the extent of their participation; all foreseeable risks and how they will be mitigated; the right to withdraw from the research at any time; how long the data will be kept and how it will be stored; the participant s access to research findings; names and contact details of those leading the research; mechanisms of confidentiality; and the responsibilities of the researchers.

5 The information provided in a form that can be understood by each individual, and Consent is voluntary in nature, that is, participation is free from coercion, manipulation or any undue influence. The right to decline to participate at any stage should be made transparent All respondents should be fully informed of why they have been selected and about the purpose and intended use, outcomes or benefits to the individual or community from the research. Researchers must identify themselves and provide a means of subsequent contact. This is particularly important for vulnerable respondents. Appropriate measures need to be taken to ensure that respondents understand and can exercise their rights: not to participate in a research project; to withdraw from the research interview at any time; to require that their personal data are not made available to others; and to delete or to rectify incorrect personal data which are held about them. 7. Vulnerable participants, those with a disability or cognitive impairment Respect for persons requires that greater protection be provided to those persons with diminished autonomy to ensure that they are not subjected to harm, exploitation or discrimination. In any population at any given time there may be intended research participants who are feeling unwell or upset, in addition to those who have obvious or known disabilities. Surveys in the health sector, including ACC claimants, are likely to have even higher levels of vulnerable participants than a general population. Groups with specific known injuries or impairment may be the target of the research. It is important that research among specific groups is not skewed toward those who are easier to survey, and leave out the more seriously impacted, as in order to be valid, research on the target group must be representative of the whole spectrum of affected people. A research proposal must therefore demonstrate how the research will be inclusive of people with incapacity or impairments. Respect for respondents means that the design and methodology provide for the diversity of participants by respecting ethnicity, age, intellectual ability, emotional state and health needs. Researchers should be mindful that any random sample of the population may include respondents who are vulnerable. Such respondents, whether through events immediately prior to the research or through longer standing physical or mental

6 health issues, may need supportive handling to be included in the research, for it to be fully representative of the population under study. People whose first language is not English may need language support in order to fully comprehend and give effect to the informed consent process, and to participate meaningfully in the research. A protocol should be developed for situations where the researcher witnesses, or a participant or another person discloses, something that is of concern or would put themselves or anyone else at risk. 8. Children Informed consent and the presence of the parent or legal guardian must be obtained before carrying out research involving children under 16. It is advisable to inform a parent or guardian for children under 19 particularly if they are living in the care of an adult. Research should consider the necessity of involving children and young people with regard to their well-being. The study method should be appropriate and the circumstances in which the research is conducted must provide for the physical, emotional and psychological safety of the child. It is essential that the child has full information about the research in order to give their informed consent to take part and that consent is freely volunteered. The child should also know that they can withdraw at any time. Information presented to the child and parent should explain what will happen; what is being asked of the child so that the child can agree or disagree to take part without adverse consequences and may withdraw at any time; and be given clear language at a level that the child can understand, using visual aids if necessary. Young people aged with sufficient understanding are able to give their full consent to participate in research independently of their parents and guardians. Children under 16 are able to give their full consent providing they have been counselled and do not wish to involve their parents and they have sufficient maturity to understand the nature, purpose and likely outcome of the proposed research. Parental consent is required where it is viewed that a child is incapable of understanding the implications of taking part in a study or where the child is regarded as incompetent to consent. Although the child s assent/agreement is advisable, the power to consent, in law, is that of his/her parents or legal guardian. 9. Ethnic diversity The increasingly ethnically diverse population in New Zealand will be reflected in an increased number and variety of ethnicities among potential research participants. Researchers carrying out research, or simply seeking informed consent to use client data should be prepared to provide language support, in order to be inclusive and representative of the population.

7 Provision of language support will help fulfil the ethical requirements for obtaining informed consent. Informed consent is only effective if the intended participants fully comprehend why they have been selected, what the project is about, and that their participation (or not) is voluntary at all stages and will not affect any ACC handling of their claims or business. These can be difficult concepts to convey to people of non- English-speaking backgrounds, and use of their own language helps convey these concepts. The differences between cultures in their attitudes to health, illness, injury and death, are marked. Such attitudes may impact the willingness or ability of respondents to answer questions or to give answers that could be viewed as meaning the same as within the mainstream New Zealand culture. Ethnicity is only a guide to cultural norms as marked religious, social strata, age and gender differences can exist within ethnic groups. ACC has a Cultural Services Unit (phone ). Researchers may need to check whether the topic of the research raises any particular cultural issues, prior to designing their methodology and questionnaires. Language Line is a free telephone interpreting service provided by the New Zealand government covering 42 languages. A number of government, health, advice and information organisations and local councils use Language Line to assist clients needs to speak in a language other than English. 10. Acknowledgement of the Treaty of Waitangi Obligations and responsibilities toward Māori arise from the Treaty of Waitangi. Inherent in these concepts are: a) Respect shown by the researcher for cultural differences and ways of knowing; b) Regard for participants physical, mental, spiritual and social well-being; c) Reciprocity in terms of sharing of knowledge, outcomes, control and benefits of the research. Minimisation of harm to Māori research participants will be achieved by the inclusion of Māori as partners and participants in the design, implementation, management and analysis of research about Māori. 11. Professionalism The research proposal should be independently reviewed by someone knowledgeable in the topic area but independent of the study. Researchers should be alert to the need to identify potential situations of risk such as carrying out a telephone interview and not realising the respondent is diverted from a landline to a cell phone and is driving a vehicle, or is under the age of 16.

8 Researchers should never allow personal data they collect in a research project to be used for any purpose other than for that research. Respondents may sometimes divulge information of a personal nature as part of being friendly and chatting with the interviewer. Researchers should be clear that only the material collected during the formal interview process is appropriate for research purposes. Respondents should be informed before observation techniques or recording equipment are used for research purposes, except where these are openly used in a public place and no personal data are collected. If respondents so wish, the record or relevant section of it will be destroyed or deleted. In the absence of explicit consent a respondent s personal identity must be protected The researcher should be aware of Codes of Conduct appropriate to their position. The researcher should be appropriately qualified to do the research 12. Dissemination and access to research findings Dissemination of research findings is an important part of the research process, passing on the benefits to other researchers, professional practitioners and the wider community. Research findings should be disseminated appropriately. If the results of completed research are not intended to be publicly released or published, there must be adequate justification for not doing this. The results of research should be made available to research participants. 13. Information sheets An information sheet usually accompanies the letter to a potential participant for research and provides information about the research project. Information sheets should be written in plain language, which can be easily understood by those invited to participate. They should provide information concerning: The identity of the researchers The aim of the project The nature and duration of the participants involvement Steps taken to ensure confidentiality and anonymity Risks and benefits of participation (if any) Use and sharing of information about who will have access and under what conditions including any personal information How questions or concerns will be addressed

9 How study results will be communicated to research participants Contact details of the researcher and avenues for complaint 14. Consent Forms Consent forms accompany the information sheet and must indicate clearly that the subject: Understands the information provided on the Information Sheet Has the opportunity to ask questions and has had these answered to their satisfaction Voluntarily consents to participate in the research Where relevant, consents to interviews/focus groups being audio or videotaped Understands that they may withdraw at any time including withdrawal of information provided, without reason or incurring any penalty of any sort Agrees to publication and dissemination of results, with the understanding that anonymity will be preserved (unless informed otherwise)

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