Western Health Low Risk Human Research Ethics Panel

Western Health Low Risk Human Research Ethics Panel

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Western Health Low Risk Human Research Ethics Panel
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Participant Information and Consent Form
Participant Information and Consent Form
Version 1 Dated 23/05/2018
Site: Sunshine Hospital
Full Project Title: Feasibility of introducing specialized vestibular
physiotherapy in the Emergency Department: A pilot evaluation
Principal Researchers: Melanie Lloyd and Anne-Maree Kelly
Associate Researcher(s): Allison Luscombe, Catherine Grant, Tissa
Wijeratne, Harin Karunajeewa, Koen Simons
This Participant Information and Consent Form is 7 pages long. Please
make sure you have all the pages.
1. Your Consent
You are invited to take part in this research project at Western
Health. You have been invited because you have attended our Emergency
Department (ED) with dizziness or vertigo.
This Participant Information contains detailed information about the
research project. Its purpose is to explain to you as openly and
clearly as possible all the procedures involved in this project before
you decide whether or not to take part in it.
Please read this Participant Information carefully. Feel free to ask
questions about any information in the document. You may also wish to
discuss the project with a relative or friend or your local health
worker. Feel free to do this.
Once you understand what the project is about and if you agree to take
part in it, you will be asked to sign the Consent Form. By signing the
Consent Form, you indicate that you understand the information and
that you give your consent to participate in the research project.
You will be given a copy of the Participant Information and Consent
Form to keep as a record.
2. Purpose and Background
Many patients attend emergency departments with dizziness and vertigo.
One common cause of sudden onset dizziness is a mechanical problem in
the inner ear called BPPV (Benign Paroxysmal Positional Vertigo). BPPV
is common disorder and is estimated to be an underlying cause in up to
a third of patients presenting with dizziness. Specialised
Physiotherapists, who have been trained in this area, can safely
perform tests to determine if the cause is due to an inner ear problem
such as BPPV. They can also perform simple exercise-based treatment to
address the problem. Currently, there is no specialised physiotherapy
service to assess and treat dizziness in the ED at Western Health, and
it is unclear whether such a service would be of benefit to patients.
We estimate that a total of around 100 people will participate in this
project.
There are published guidelines which outline the optimal management of
patients with dizziness or vertigo that is suspected to be the result
of an inner ear issue. Several studies, including one at Western
Health, suggest that these best practice guidelines are not always
applied in the ED. This may be due to a number of reasons including
time constraints, lack of availability of staff with specialised
training, or simply that patients in the Emergency Department are
feeling too unwell to participate in the recommended assessment.
Therefore, we would like to investigate whether providing a
specialised physiotherapy service in the ED is feasible, can address
some of these barriers and provide better patient outcomes. To do
this, we need to understand more about how many people are coming to
the ED with these symptoms, what sort of treatment they are currently
receiving, and how they are recovering.
You are invited to participate in this research project because it
will assist in our investigation which aims to provide high quality
clinical care for patients.
3. Procedures
Participation in this project will involve assessment with a
physiotherapist whilst you are attending the ED in addition to the
standard care you would normally receive.
The physiotherapist will explain the assessment process and may
provide treatment for the dizziness if it is required. It is expected
that this time with the physiotherapist would not exceed 30 minutes.
This assessment will include the physiotherapist asking questions to
find out more information about your dizziness, testing of your eye
movements, as well as physical assessment of your walking and balance.
The assessment can be stopped at any time if you request to stop, or
if you experience any unexpected discomfort. The physiotherapist will
answer any questions you have as you go along.
If it is likely that you would benefit from further physiotherapy
intervention for your dizziness you will be offered a referral to
physiotherapy at Western Health Community Based Rehabilitation or a
similar service in your area. The Western Health service is free of
charge.
Five days after you are discharged from the ED we will contact you via
phone to find out how you are feeling and if you are having any
ongoing problems related to your dizziness. This contact will include
asking you questions from a validated questionnaire, related to how
the dizziness is impacting on your quality of life. This phone call
will take a maximum of 15 minutes of your time and can be stopped at
any time if you request it to stop.
There are no costs associated in participating with this research
project, nor will you be paid.
4. Possible Benefits
We cannot guarantee or promise that you will receive any benefits from
this research; however possible benefits may include resolution or
improvement of your dizziness symptoms, and therefore improvement in
daily function and quality of life. The follow up phone call will also
allow experienced research nurses to check on your progress after you
go home, and enable them to suggest further treatment options if you
are still feeling unwell.
5. Possible Risks
Possible risks, side effects and discomforts include the possibility
of an increase in dizziness during physiotherapy assessment, although
this is likely to be short term. Assessment will be ceased if you
request or when symptoms or signs are present. Where required, close
standby supervision will be provided to prevent loss of balance.
You may suspend or end your participation in the project if any
distress occurs. ED medical and nursing staff not involved in the
study will also be available during physiotherapy assessment and
treatment should their input be required.
There may be additional unforeseen or unknown risks.
6. Alternatives to Participation
You do not have to participate in this research project to receive any
medical care you may require. The physiotherapy service provided as
part of this study will be in addition to any assessment and
treatments you would usually receive in the ED.
Alternative procedures/alternative treatments include referral to a
specialist physiotherapist in the community.
7. Privacy, Confidentiality and Disclosure of Information
Any information obtained in connection with this project and that can
identify you will remain confidential. It will only be disclosed with
your permission, except as required by law. If you give us your
permission by signing the Consent Form, we plan to publish and/or
present the results in a variety of forums.
All results will be coded and data will be non-identifiable for
analysis. Results will be analysed by members of the Project Team who
do not have a direct professional relationship with participants. Data
will be stored in a password protected electronic file or locked
cabinet only accessible to the project team.
In any publication, information will be provided in such a way that
you cannot be identified.
In accordance with relevant Australian and/or Victorian privacy and
other relevant laws you have the right to access the information
collected and stored by the researchers about you. You also have the
right to request that any information with which you disagree be
corrected. Please contact one of the researchers named below if you
would like to access your information.
8. New Information Arising During the Project
During the research project, new information about the risks and
benefits of the project may become known to the researchers. If this
occurs, you will be told about this new information. This new
information may mean that you can no longer participate in this
research. If this occurs, the person(s) supervising the research will
stop your participation. In all cases, you will be offered all
available care to suit your needs and medical condition.
9. Results of Project
We intend to publish the results of this study in an academic journal,
as well as sharing the results with colleagues at organisational
forums such as Western Health Research Week. Results may also be
shared with the general public through the Western Health website
and/or local media as appropriate.
10. Test Samples
This project does not involve any test samples.
11. Further Information or Any Problems
If you require further information or if you have any problems
concerning this project (for example, any side effects), you can
contact the principal investigators: Melanie Lloyd (Physiotherapy) or
Dr Anne-Maree Kelly (Medical); or the treating Physiotherapist:
Allison Luscombe; through the Western Health switchboard (03) 9345
6666.
12. Other Issues
If you have any complaints about any aspect of the project, the way it
is being conducted or any questions about your rights as a research
participant, then you may contact:
Position:
Manager, Western Health Office for Research
Telephone:
(03) 8395 8073
Email:
[email protected]
(You will need to tell the Manager the name of one of the researchers
given in section 11 above.)
13. Participation is Voluntary
Participation in any research project is voluntary. If you do not wish
to take part you are not obliged to. If you decide to take part and
later change your mind, you are free to withdraw from the project at
any stage.
Your decision whether to take part or not to take part, or to take
part and then withdraw, will not affect your routine treatment, your
relationship with those treating you or your relationship with Western
Health.
Before you make your decision, a member of the research team will be
available to answer any questions you have about the research project.
You can ask for any information you want. Sign the Consent Form only
after you have had a chance to ask your questions and have received
satisfactory answers.
If you decide to withdraw from this project, please notify a member of
the research team before you withdraw. This notice will allow that
person or the research supervisor to inform you if there are any
health risks or special requirements linked to withdrawing. Please
note that once your data has been deidentified for analysis it will no
longer be possible to withdraw data that has already been collected.
14. Ethical Guidelines
This project will be carried out according to the National Statement
on Ethical Conduct in Human Research (2007) produced by the National
Health and Medical Research Council of Australia. This statement has
been developed to protect the interests of people who agree to
participate in human research studies.
The ethical aspects of this research project have been approved by the
Western Health Low Risk Human Research Ethics Panel.
15. Reimbursement for your costs
You will not be paid for your participation in this project.

16. Consent Form
Version 1 Dated 23/05/2018
Site: Sunshine Hospital
Project title: Feasibility of introducing specialized vestibular
physiotherapy in the Emergency Department: A pilot evaluation
I have read, or have had read to me in my first language, and I
understand the Participant Information version 1 dated 23/05/2018.
I freely agree to participate in this project according to the
conditions in the Participant Information.
I will be given a copy of the Participant Information and Consent Form
to keep
The researcher has agreed not to reveal my identity and personal
details if information about this project is published or presented in
any public form.
Participant’s Name (printed) ……………………………………………………
Signature………………………………… Date
Name of Witness to Participant’s Signature (printed) …………………………………
Signature………………………………… Date
Declaration by researcher*: I have given a verbal explanation of the
research project, its procedures and risks and I believe that the
participant has understood that explanation.
Researcher’s Name (printed) ……………………………………………………
Signature………………………………… Date
* A senior member of the research team must provide the explanation
and provision of information concerning the research project.
Note: All parties signing the Consent Form must date their own
signature.

REVOCATION OF CONSENT FORM
Revocation of Consent Form
Full Project Title: Feasibility of introducing specialized vestibular
physiotherapy in the Emergency Department: A pilot evaluation
I hereby wish to WITHDRAW my consent to participate in the research
proposal described above and understand that such withdrawal WILL NOT
jeopardise any treatment or my relationship with Western Health.
Participant’s Name (printed) ……………………………………………………
Signature………………………………… Date
Page 7 of 7
Participant Information and Consent Form 2, Sunshine Hospital, version
1 dated 23/05/2018