Federation University: NURBN3022 HREC Approval Sample Project

This assignment presents a sample Human Research Ethics Committee (HREC) approval application for a research project titled "Use of therapeutic interventions used by elderly people to improve cognitive outcomes: A qualitative interview based study." The project, overseen by Dr. Joanne Porter from the School of Nursing and Healthcare Professions at Federation University, aims to explore the impact of therapeutic interventions on the cognitive abilities and quality of life of elderly individuals, particularly those experiencing cognitive decline or dementia. The research employs a qualitative approach, using semi-structured interviews with healthcare professionals in nursing homes to gather data on the types of interventions used, their outcomes, and any associated facilitators or barriers. The study's significance lies in addressing the increasing prevalence of cognitive decline in the aging population and the need for effective interventions to maintain cognitive function and improve the quality of life for older adults. The methodology involves thematic analysis of interview transcripts to identify patterns and themes related to effective interventions. The recruitment strategy targets 20 healthcare professionals from two nursing homes in Adelaide, Australia, who have experience implementing therapeutic interventions for elderly patients. The application provides detailed information on the research aims, questions, significance, methodology, and participant recruitment, demonstrating the comprehensive planning required for ethical research involving human subjects.

Sample Application for
HREC Approval
(NURBN3022)
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1. PROJECT DETAILS
2. RESEARCHERS
Total word limit for this assessment item is 2000 words
Project title:
What type of project is this? (Tick as many as apply)
Masters project Clinical Trial Postgraduate Diploma
Undergraduate  Student Research
Project
Honours
PhD Staff Research Project Other
Through which School/Section is the research to be conducted?
Principal Researcher (STAFF MEMBER ONLY)
Title & Name: Dr Joanne Porter
Position: Senior Lecturer
School/Section: School of Nursing and Healthcare Professions
Phone number: 51 236996
Email address: [e-mail]
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:
Supervision of higher degree students, 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:
Use of therapeutic interventions used by elderly people to improve cognitive outcomes: A
qualitative interview based study

Sample Application for
HREC Approval
(NURBN3022)
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Include a brief summary of relevant
experience for this project:

4. RESEARCH AIMS & SIGNIFICANCE
Sample Application for
HREC Approval
(NURBN3022)
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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.)
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.)
Aim: The main aim of this research is to find out interventions to improve cognitive abilities of elderly
people and evaluates its effect on overall quality of life of elderly.
Research question: The research questing that will guide the research process includes the following:
‘What is the impact of therapeutic interventions in improving cognition in older adults compared to other
interventions?’
This projects aims to address the problem of high prevalence of cognitive decline and
diagnosis of dementia in elderly by exploring therapeutic interventions implemented to
address the issue and assessing the impact of these intervention on cognitive capability
and skills of elderly. Past research shows poor cognitive function as a major problem in
older adults and high risk of dementia in elderly. As cognitive impairment lead to
functional dependence and poor quality of life, targeting intervention that promote
neuroplasticity and combat cognitive decline is important (Macpherson et al., 2019).
Various multi-component cognitive and lifestyle interventions exist to develop cognitive
skills of elderly people. However, there is lack of exploration of the impact of such
interventions from the perspective of care givers. Hence, this research uses qualitative
approach to explore about the experience of delivering therapeutic intervention to elderly
people with cognitive impairment issues and analyze the effect of the intervention on
improving quality of life.
As the research aims to analyze experience as well as outcomes related to the research
topic, qualitative research approach will be used to conduct the research. The research
method selected is relevant with the research objectives. The research will be done in
two nursing homes in Adelaide and the health care staffs who have implemented
therapeutic interventions for improvement of cognitive capability in elderly will be
included as research participants. Data will be collected using interview methods and the
duration of the interview will be 30 minutes. All ethical responsibilities such as informed
consent and confidentiality will be fulfilled. The interview questionnaire will collect data
on type of intervention implemented, facilitators and barriers associated with the
intervention, impact on elderly and quality of life of elderly. The interview data will be
transcribed verbatim and analyzed thematically. The arrangement of findings according
to theme will give idea about effective interventions that improve cognitive health and
give recommendation to improve skills to accurately implement these interventions for
elderly.

Sample Application for
HREC Approval
(NURBN3022)
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Significance of the project:
The main rationale for research on this topic is understood from the decline in cognitive outcomes of
elderly people due to ageing. There are numerous research evidence which points to the risk of cognitive
decline in older adults and its overall impact on health and well-being. Li et al. (2017) affirms the high
diagnosis of Alzheimer’s disease with increase in aging. As the prevalence of dementia is likely to
increase, the paper suggested the need to increase the detection of elderly people who have high risk for
cognitive decline. This form of assessment is important because age associated cognitive decline can
reduce normal functioning of elderly people and it can interfere with health related quality of life. For this
reason, cognitive decline associated with ageing is regarded as an immediate health and social problem
for elderly people. Cognitive impairment can lead to loss of independence and autonomy which can have
major impact on quality of life of elderly people (Foroughan, Nejati & Shati, 2018). Hence, finding common
therapeutic interventions to improve cognitive ability of older adults and assessing its impact on overall
cognitive function is critical.
The research question is focused on identifying therapeutic interventions to improve cognitive
functions in elderly people and assess the effectiveness of these interventions. The contribution of this
research to current research is that it provides a solution to reduce challenges for people who
experience cognitive decline. Harada et al. (2013) explains that cognitive declines affects many
function such as visual attention, executive function and memory. For this reason, older adults are at
high risk of cognitive problems. Fogg et al. (2018) argues that cognitive impairment and dementia
diagnosis increase with age and this leads to long hospital stays because of falls, delirium, poor
nutritional status, risk of infection and deterioration in physical and cognitive functions. Hence, in such
circumstances, implementation of therapeutic interventions like physical activities and social
engagement can be associated with improves in cognitive functions.
The literature review on interventions implemented to improve cognitive health in older adults
revealed use of physical exercise, computerized training, music therapy and nutrition therapy and
diverse range of benefits were obtained for different interventions (Liang et al., 2018). Carrion et al.
(2018) also evaluated the efficacy of skills training in reversing cognitive abilities of older adults.
However, the main gap identified through literature review was that no intervention directly collected
data from health care professionals to know about common interventions implemented for elderly and
the impact of those interventions on overall health outcomes and care experience. By conducting
qualitative exploration regarding the research topic, this research project is likely to give more details
about the efficacy of the intervention and its impact on improving quality of life of older adults. The
exploration of data related to prevalence of cognitive decline and its impact on functional outcome of
elder adults gives idea about the significance and relevance of this research project.

Sample Application for
HREC Approval
(NURBN3022)
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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).
Research method: This research will use qualitative research approach to get answer to the
research question. The main rationale for using qualitative approach is that the research not only
aims to identify the impact of therapeutic interventions to improve cognitive health, but also
analyze the impact of those interventions on overall functioning and quality of life of elderly people.
Hence, qualitative research method is appropriate to get better understanding about the research
topic (Taylor, Bogdan & DeVault, 2015). It can help in interpretation of perception of people related
to a social perspective using data collection tools like surveys, interview and polls. As this research
focuses on evaluating therapeutic interventions implemented in clinical setting, the qualitative
research method will help to explore about the intervention by collecting data from health care
professionals.
According to Hammarberg, Kirkman and de Lacey (2016), use of qualitative research is
appropriate when there is need to answer questions about experience or perspective. Hence,
semi-structured interview method or small group discussions can help to understand a experience.
Focusing on qualitative exploration of the topic can help to understand potential problems in
implementing therapeutic interventions too.
Data collection: Interview method has been chosen to collect data related to the research
question. Interview is an important tool for data collection in qualitative research and it can help to
gather information about the experience of implementing interventions to develop cognitive skills in
elderly people with dementia or age related cognitive impairment. The interview question will
collect data related to type of interventions used to treat cognitive impairment in elderly people,
outcome of those interventions, facilitators and barriers during implementation process and the
overall effect of the intervention on quality of life of elderly people. The duration of the interview will
be 30 minutes and the process will be completed in hospital setting. Face to face interview will be
done. The interviews will be audio recorded and transcribed verbatim.
Data analysis:
Two research staffs with knowledge and experience in Aged care will engage in data analysis
process. The interview transcripts will be analyzed using thematic approach. It is a process of
identifying patterns or themes within a research data and it is a common method for analysis of
qualitative data. The advantage of this data analysis method is that it is theoretically flexible
method and it helps to make sense of a research (Nowell et al., 2017). To ensure rigour and
transparency during the thematic analysis process, the two reviewers appointed will first read and
reread transcripts and then relevant codes will be framed. The main reason for reading the data is
that it helps reviewers to get familiar with the research data. Following discussion, emergent
themes will be created and analyzed. Theme will be developed by examining codes from
transcripts and then organizing these codes into broader themes. This will be followed by review of
the themes to ensure that the themes make sense and they do not overlap with each other. This
process will help in final refinement of themes and engage in effective reporting of research
findings (Maguire & Delahunt, 2017).
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)

Sample Application for
HREC Approval
(NURBN3022)
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The main target population for this research is health care professionals or caregivers who provide
therapeutic interventions to elderly people with cognitive decline. The health care professionals will
be selected from two nursing homes in Adelaide, Australia. Only those professionals will be taken
who had implemented therapeutic interventions for elderly people with dementia. The eligibility of
the participants will be considered by developing inclusion criteria. The inclusion criteria is that all
staffs must be older than 18 years old and they must have implemented at least one therapeutic
intervention for improvement of cognition in elderly people. The sample size will be 20 and the
main rational for this is that the research is based on qualitative research approach. Qualitative
research inquiry uses small sample size as the data collection process is intensive requiring lot of
time (Boddy, 2016).
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

Sample Application for
HREC Approval
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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

8. CONSENT
9. INFORMATION PROTECTION (DATA STORAGE & SECURITY)
Sample Application for
HREC Approval
(NURBN3022)
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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)
Risk management in scientific research is critical to reduce risk for research participants and avoid any
conflict during the research process. This research aims to conduct a qualitative interview with health care
staffs working in two nursing homes. To ensure that the research is implemented without any risk for
patient, possible risk will be identified and strategies will be implemented to mitigate it. The possible types
of risks that the research participants can be exposed to during research process includes physical,
psychological, legal, social and economic risk. In this research, as the research participants will have to
just give interview and not get exposed to any intervention, there is little physical, psychological, economic
and social risk for participants. However, as nursing staffs have other work priorities, they may be exposed
to legal risk if they leave their clinical duty and spend time in interviews. To avoid any legal or professional
consequences for the participants, the permission for research will be taken from clinical managers of the
two nursing homes. They will be explained regarding the research method, purpose and the time required
for the interview. Participants will be recruited and contacted only after permission from hospital authorities
are obtained. This will help to minimize legal risk and reduce concerns related to timing of the interviews.
There is also a possibility that some staffs may be overstressed with work and may panic during the
interview process. To promote psychological well-being of this staff, they will be referred to Australian
Medical Association that emphasize on improving access to mental health for vulnerable groups in
Australia (Australian Medical Association, 2018).
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):
Confidentiality
Tick which method will be used to guarantee confidentiality/anonymity?
  Non-identifiable (anonymous) data, which have never been labelled with

Sample Application for
HREC Approval
(NURBN3022)
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individual
identifiers or from which identifiers have been permanently removed, and by means of
which no 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?

Y
Who will have access to data?
 Access by named researchers only Access by other(s) than named researcher(s)

10. RESEARCH TOOLS
Sample Application for
HREC Approval
(NURBN3022)
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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)
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?
Yes No N/A
Questionnaire Draft
Interview Questions  D
r
a
f
t
Other
The interview question for this research will focus on data collection in three areas. The first section will
focus on data collection related to demographic information. The second section will focus on data
collection related to interventions for cognitive ability in older adults and the third section will collect data
on practice recommendation or improvement. The interview question for each part is discussed in detail
below:
SECTION A: DEMOGRAPHIC DETAILS:
Q1. What is your age?
Q2. What is your current position in the nursing home?
Q3. What is your educational qualification?
Q4. How long have you been working as health care staffs?
SECTION B: INTERVENTION FOR COGNITIVE ABILITY
Q1. Have you ever come across elderly people with cognitive impairment due to ageing or dementia?
Q2. What is your perception of the impact of cognitive impairment on elderly patients?
Q3. What interventions have you implemented to develop cognitive capacity of older adults?
Q4. Do you feel the intervention is effective in promoting cognitive function and independence? How?
Q5. What are the facilitating factors to effectively implement this intervention?
Q6. What are the barriers to the implementation of this intervention?
Q7. What changes in cognitive function has been observed in elderly following this intervention?
Q8. Were you satisfied with the intervention provided to promote cognitive skills of elderly? If no, why?
Q9. Do you prefer physical activity or behavioral intervention to improve cognitive ability of older patients?
SECTION C: PRACTIC RECOMMENDATION
Q1. Do you feel burden when an elderly patient with cognitive impairment comes to you?
Q2. Do you feel you have adequate skills to understand the challenges for this people
Q3. Do you need more support to effectively implement the above intervention described?
Q4. Do you want professional development training or organization support to provide the right support to

Sample Application for
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elderly people with dementia or cognitive deficits?

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HREC Approval
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11. DECLARATIONS
Researcher Declarations:
The information contained herein is, to the best of my knowledge and belief, accurate. I have read
the University’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: …..../…...../….....

Sample Application for
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References:
Australian Medical Association (2018). Mental Health – 2018. Retrieved from: https://ama.com.au/position-
statement/mental-health-2018
Boddy, C. R. (2016). Sample size for qualitative research. Qualitative Market Research: An International
Journal, 19(4), 426-432.
Carrion, C., Folkvord, F., Anastasiadou, D., & Aymerich, M. (2018). Cognitive Therapy for
Dementia Patients: A Systematic Review. Dementia and Geriatric Cognitive
Disorders, 46(1-2), 1–26. https://doi.org/10.1159/000490851
Fogg, C., Griffiths, P., Meredith, P., & Bridges, J. (2018). Hospital outcomes of older people with cognitive
impairment: An integrative review. International journal of geriatric psychiatry, 33(9), 1177-1197.
Foroughan, M., Nejati, V., & Shati, M. (2018). Association between age associated cognitive decline and
health related quality of life among iranian older individuals. Electronic physician, 10(4), 6663.
Hammarberg, K., Kirkman, M., & de Lacey, S. (2016). Qualitative research methods: when to use them
and how to judge them. Human reproduction, 31(3), 498-501.
Harada, C. N., Love, M. C. N., & Triebel, K. L. (2013). Normal cognitive aging. Clinics in geriatric
medicine, 29(4), 737-752.
Li, Y., Fang, X., Zhao, W. G., Chen, Y., & Hu, S. L. (2017). A risk factor analysis of cognitive impairment in
elderly patients with chronic diseases in a Chinese population. Medical science monitor:
international medical journal of experimental and clinical research, 23, 4549.
Liang, J.-H., Xu, Y., Lin, L., Jia, R.-X., Zhang, H.-B., & Hang, L. (2018). Comparison of multiple
interventions for older adults with Alzheimer disease or mild cognitive impairment: A
PRISMA-compliant network meta-analysis. Medicine, 97(20), e10744.
https://doi.org/10.1097/MD.0000000000010744
Macpherson, H., Brownell, S., Duckham, R. L., Meyer, B., Mirzaee, S., & Daly, R. M. (2019). Multifaceted
intervention to enhance cognition in older people at risk of cognitive decline: study protocol for the
Protein Omega-3 and Vitamin D Exercise Research (PONDER) study. BMJ open, 9(5), e024145.
Maguire, M., & Delahunt, B. (2017). Doing a thematic analysis: A practical, step-by-step guide for learning
and teaching scholars. AISHE-J: The All Ireland Journal of Teaching and Learning in Higher
Education, 9(3).
Nowell, L. S., Norris, J. M., White, D. E., & Moules, N. J. (2017). Thematic analysis: Striving to meet the
trustworthiness criteria. International Journal of Qualitative Methods, 16(1), 1609406917733847.
Taylor, S. J., Bogdan, R., & DeVault, M. (2015). Introduction to qualitative research methods: A guidebook
and resource. John Wiley & Sons.