This sample application for HREC approval (NURBN3022) provides details about the project, researchers, lay description, research aims and significance, research methodology, recruitment of participants, and risk management procedures.
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Sample Application for HREC Approval (NURBN3022) Total word limit for this assessment item is 2000 words 1.PROJECT DETAILS Project title: What type of project is this? (Tick as many as apply) Masters projectClinical TrialPostgraduate Diploma UndergraduateStudent Research ProjectHonours PhDStaff Research ProjectOther Through which School/Section is the research to be conducted? 2.RESEARCHERS Principal Researcher (STAFF MEMBER ONLY) Title & Name:Dr Joanne Porter Position:Senior Lecturer School/Section:School of Nursing, Midwifery and Healthcare Phone number:51 236996 Email address:joanne.porter@federation.edu.au Please list academic qualifications:PhD, MN, GradDipCC, GradDipHSM, GradCertHeD, BN, RN Describe what this researcher will do in the context of this project: The lead researcher will be an expert guide though all aspects of the project. Include a brief summary of relevant experience for this project: Supervisionofhigherdegreestudents,multiple publications to peer reviewed journals and successful competitive grants applications. Student/Other Researcher/s Title & Name: Position: School/Section: Phone number: Email address: Student ID number: Please list academic qualifications: Describe what this researcher will do in the context of this project: Include a brief summary of relevant experience for this project: 1
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Sample Application for HREC Approval (NURBN3022) 3.LAY DESCRIPTION Provide a brief outline of the project describing in everyday, jargon-free language the key aspects of the research (e.g., who will be participating, what information will be collected and by what means, what participants will be required to do, etc.) and the key research aims. (300 words max.) 4.RESEARCH AIMS & SIGNIFICANCE State the aims, key research questions, and significance of the project. Also provide a brief description of the relevance of your proposed project to current research, supported by the literature. (500 words max.) 2 Accidental needle stick injuries or NSIs is a common problem in Australia where NHS employers estimated that approximately 40000 needle stick injuries are recognised in every year (Rha et al., 2013). The unrecorded number of this issue can be twice of this projected quantity. Many authorized policies have been already made to promote the safety procedures and training to prevent NSIs. Utilisation of NSDs or Needle Safety Devices is one of these initiations, which lacks its implementation in practical cases significantly (Bhattarai et al., 2014). In this situation the identification the loopholes in the implementation phase of all these essential measures is chiefly essential. The purpose of this research is to explore the real picture of utilisation of the safety measures and examine the feasibility of the existing training procedures. To achieve the evidence-based healthcare approach the research collected authentic data and information from the real time sample resources and from the Government and NSW reports of the Australia as well as the WHO studies and international reports on PICO frameworks (Amini et al., 2015). The participants of the research are ranged from the internal student of the university to the actual patients and regular healthcare service receivers. The focus of this research will be on the situational discrepancies in the implications of NSD’s utilisation and training procedure that is causing the negative outcomes of inappropriate needling practice in healthcare industry across the Australia. This research proposal presents the scopes of the research with research aims and significance. Apart from that, the detailed description of research methods and approach will be explained considering the data collection and analysis process. The recruitment of participants is also described in this paper. The ethical considerations including the data protection, privacy and security regulations are abided by the planning or the research and included in this proposal. Needle stick injuries are referred to wounds that are caused by the needles that accidentally puncture the skin of an individual. According to researchers, needlestick injuries majorly occur to individual who works with hypodermic syringes along with other needle equipments. These injuries can take place any time while the healthcare service providers use, dissemble and dispose the already used needles. In majority of cases, it has been seen that needle stick injuries are caused due to inappropriate disposal of the needles like needles can hide in garbage or linen and thus can injure other healthcare service providers while they work near the spots. Health care workers who use or may be exposed to needles are at increased risk of needle stick injury (Loveday et al., 2014). According to a survey conducted in the year 2016, it has been found that severe needle stick injuries posses the potential to lead to serious or fatal infection with blood borne pathogens such as hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV) (Hoffmann, Buchholz & Schnitzler, 2013). In several settings other infects apart from the mentioned ones for instance, Treponema Pallidum and human T-cell lymphoma virus (HTLV-1) are endemic in some populations in remote Australia. Accidental needle stick injuries (NSIs) are considered to be one of the predominant sharp-associated issues in several industrialized countries. According to a survey there prevails approximately 430000 case of NSIs per year. However, the true figure may be twice the , since a good number of NSI cases goes unreported. In spite of the fact that the risk of contracting blood borne pathogen is low, the psychological trauma that follows the injury can be disabling (Mbaisi, Wanzala & Omolo, 2013). In order to deal with the issue several measures have been taken by the directive of Australian Health care industry. For instance, modification of work practices in organizations that pose risk to sharp injures by the mean of training in order to make them a safer place has been taken. It promoted a range of initiatives to prevent NSIs, such as training, use of needle-safety devices (NSDs), using sharps containers and improved treatment and care after an NSI has occurred. The aim of the research is to find out analyze and evaluate whether training and needle safely devices posses the potential to prevent needle stick injuries in the current healthcare setting. The objectives of the research are as follows: To find out the severity of injuries that takes place to the healthcare service providers as well as users due to needle sticks (Kebede, Molla & Sharma, 2012). To analysis the potential of the current training processes as well as innovative device that are being used by the healthcare service providers to prevent the needle stick injuries. Finally, to provide effective recommendation to the healthcare service providers as well as the government so that the needle stick injuries can be eradicated from Australia.
Sample Application for HREC Approval (NURBN3022) 5.RESEARCH METHODOLOGY Provide an outline of the proposed method, including details of data collection techniques, tasks participants will be asked to do, the estimated time commitment involved, and how data will be analysed. (500 words max). 6.RECRUITMENT OF PARTICIPANTS Participant Details Describe your proposed recruitment strategy to source target participants. Provide the number and age range, giving a justification of your proposed sample size.(100 words) Target participants Who are the target participants?(Tick as many as applicable) Students or staff of this University Adults (over the age of 18 years and competent to give consent) Children/legal minors (under the age of 18 years, with parental consent)* Elderly individuals Individuals from non–English-speaking backgrounds Pensioners or welfare recipients 3 Considering the fact the research will be conducted in order to explore the feasibility of the current training procure as well as the effectiveness of the needle safety devices, the research design of this study will be exploratory. Along with that the research does not contain any hypothesis to prove or any theory to deduce, the approach followed in this research will be inductive approach. In order to obtain an in-depth knowledge of the research issue, both primary as well as secondary data collection will be performed (Frels & Onwuegbuzie, 2013). In order to obtain primary data, in depth interview will be conducted. Along with that survey will also be conducted in order to enhance the authenticity of this research. When it comes to secondary data, review of per review literature that are relevant to the topic of research will be conducted in order to gather information. A research for literature from the year 2012 to 2017 will be performed stipulating those studies that were available in English. Considering the fact that both descriptive data collection as well as survey will be conducted, It can be understood that mixed data analysis method will be followed. The mixed data analysis method comprises of both qualitative as well as quantitative data analysis (Palinkas et al., 2015). The quantitative data includes close ended information that ill be collected by the researchers to measure attitude, behavior as well as performance instruments. The analysis of this type of data comprises of statistically analyzing scores collected on instruments as well as checklists to answer research questions. On the other hand, qualitative data consists of open ended information which will be gathered by the researchers through literature review or in depth interview. This data collection method helps the research to gain in depth knowledge about the research issue along with the thoughts of other researcher about the research issue. Mixed method research is referred to a research methodology for conducting research that includes collecting, analyzing and integrating quantitative a well as qualitative research. This research approach is used by the researchers when this integration is found to be providing a better understanding of the research issue that either of each alone. In order to identify the articles for inclusion into the review and to confirm that the relevancies of these articles are high, the following criteriaes will be maintained: Studies will range between the year 2012 to 2018 English language studies Australian literatures (Mertens, 2014) Studies including healthcare service providers, hospitals Studies that demonstrate education, training and NSDs prevented NSIs Studies that demonstrate a numerical reduction in NSIs Studies that demonstrate a statistical significant reduction in NSIs. The interview will be conducted offline. Before the initiation of the interview, an acknowledgement paper will be provided to the ample so that they can clearly understand the purpose of the interview and provide their consent as interviewees. Individual and semi structure interview will be conducted. To achieve the evidence-based healthcare approach the research collected authentic data and information from the real time sample resources. The participants of the research are ranged from the internal student of the university to the actual patients and regular healthcare service receivers. The university students are considered as a source of information because the can shade light on the current educational system regarding the NSDs and safety measures. The patients will be considered as the participants because their response can give the in depth details about existing healthcare practice and implemented measures for the Needling based discrepancies (Green & Griffiths, 2013). To consider the parameters of PICO in the research outcomes the elderly people are also included, which will allow the research the pain threshold and effectiveness of disputed needling practice on the older people. The age of the participants will be ranged from 18 to 80 years old. ■ ■ ■
Sample Application for HREC Approval (NURBN3022) Intellectually or mentally impaired individuals unable/with compromised capacity to provide consent Physically disabled individuals Patients or clients Prisoners, parolees, or wards of the state Individuals highly dependent on medical care with a compromised capacity to give consent Aboriginal and/or Torres Strait Island communities Women who are pregnant and the human foetus People who may be involved in illegal activities *Parental consent may not be required in some instances -refer National Statement, 4.2.8 & 4.2.9 7.RISK MANAGEMENT This section raises the issue of your duty of care toward research participants. To what risks are participants subjected? What will you do should an emergency occur, or should a participant become upset or distressed? What is your risk management strategy? Refer National Statement: Section 2.1 Risk and Benefit Research Activities Which of the following activities will the research involve? (Tick as many as apply) Use of a questionnaire (attach copy) Interviews (attach interview questions) Observation of participants without their knowledge Participant observation Audio- or video-taping of interviewees or events Access to personal and/or confidential data (including student, patient or client data) without participants’ specific consent Administration of any stimuli, tasks, investigations or procedures which may be experienced by participants as physically or mentally painful, stressful or unpleasant during or after the research process Performance of any acts which may diminish the self-esteem of participants or cause them to experience embarrassment, regret or depression Use of non-treatment of placebo control conditions Collection of body tissues or fluid samples 4 ■ ■ ■ ■
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Sample Application for HREC Approval (NURBN3022) Identify as far as possible all potential risks to participants (e.g., physical, psychological, social, legal, economic) associated with the proposed research. Explain what risk management procedures will be put in place, along with contact details of an appropriately qualified organisation for participant reference in case of distress, eg: Lifeline(200 words) 8.CONSENT Obtaining and Documenting Consent How will informed consent be obtained/recorded? Signed consent form Recorded verbal consent Implied by return of survey Other (Please specify): 9.INFORMATION PROTECTION (DATA STORAGE & SECURITY) Confidentiality Tick which method will be used to guarantee confidentiality/anonymity? Non-identifiable (anonymous) data, which have never been labelled with individual identifiers or from which identifiers have been permanently removed, and by means of whichno specific individual can be identified. Re-identifiable data, from which identifiers have been removed and replaced by a code, but it remains possible to re-identify a specific individual by, for example, using the code or linking different data sets. Individually identifiable data, where the identity of a specific individual can reasonably be ascertained. Examples of identifiers include the individual’s name, image, and date of birth or address. Security and Storage Does the Principal Researcher accept responsibility for the security of the data collected? Yes Who will have access to data? Access by named researchers onlyAccess by other(s) than named researcher(s) 5 Ethical consideration will be the measure concern of this research procedure. The research questions, interview and survey structure will not be developed considering any sexual, racial and national discrepancy. Before starting the survey and interview process each respondents will be receive the acknowledgement form where they will know the purpose of this research and will show their consent. Apart from that, willingness of the participants is another major concern (LoBiondo-Wood et al., 2013). All participants will be free to quit the survey or interview process or skip any question any time they want. The research procedure will also ensure the compliance of data protection act that will enable the research to store the data securely without bringing out true identity of the participants. The interview process of students will ensure that it will be not hampering the classes or educational practices of them. Apart from that before taking the offline verbal survey of the patients the research will ensure that the participant are physically and mentally supportive to be involved in the survey procedure. Apart from that, the research will also ensure that the survey procedure will not affect the regular health check-up procedure. For this, the patient health records and check-up schedule should be considered before involving the participant in the survey. ■ ■ ■ ■■
Sample Application for HREC Approval (NURBN3022) Which of the following methods will be used to ensure data security? Data will be kept in locked filing cabinets Data and identifiers will be kept in separate, locked filing cabinets Access to computer files will be available by password only Other (please describe) 10. RESEARCH TOOLS Please check that the following documents are included in your application by writing in the box below(300 words) Are the following research tools are included in this application? YesNoN/A QuestionnaireDraft Interview QuestionsDraft Other 6 ■ ■ ■ Survey questioners for patients: Name of the participant Sex/Gender Male Female Age of the participants 18 to 25 25 to 35 35 to 50 50 to 70 More than 70 When you have injected or gone through a needle based healthcare service last Today Yesterday Within last week Within last month The frequency of receiving injection or a needle based healthcare service No specific frequency At least once in a day At least once in a week At least once in a month How you consider your average experience for needling in terms of pain No pain Little pain Moderate pain Highly painful Extremely painful In which frequency you received a painful needling operation Once in a day Once in a weak Once in a month I cannot remember
Sample Application for HREC Approval (NURBN3022) 11. DECLARATIONS Researcher Declarations: The information contained herein is, to the best of my knowledge and belief, accurate. I have read theUniversity’s current human ethics guidelines,and accept responsibility for the conduct of the procedures set out in the attached application in accordance with the guidelines. I and my co- researchers have the appropriate qualifications, experience and facilities to conduct the research set out in the attached application and to deal with any emergencies and contingencies related to the research that may arise. Principal Researcher DR JOANNE PORTER (Print name in block letters) Date: …..../…...../…..... Other Researcher ……………………………………………… (Print name in block letters) Date: …..../…...../…..... Other Researcher ………………………………………………… (Print name in block letters) Date: …..../…...../…..... 7