Note: if you are conducting a clinical trial, please use the Clinical Trial Protocol Template.

If
you are conducting a Research project, please use the General Research Protocol Template

Please fill out all sections that are relevant to your project. If not relevant, delete the section. Review
the National Statement on Ethical Conduct in Human Research 2007 (updated 2018) before
completing the Research Protocol. If you require assistance with any aspect of planning your project
don’t hesitate to contact the Research Office ([email protected]) or the AWH Library
([email protected]). Delete all explanatory blue text in the final draft.

QUALITY IMPROVEMENT PROJECT

PROTOCOL

Insert project title

Version: #
Date: DD/MM/YYY

Author/s:
list authors

Confidentiality Statement
This document is confidential and the property of Albury Wodonga Health. No part of it may be
transmitted, reproduced, published, or used without prior written authorization from the institution.

Statement of Compliance
This study will be conducted in compliance with all stipulation of this protocol, Albury Wodonga Health
research governance documents, the conditions of the ethics committee approval, the NHMRC
National Statement on Ethical Conduct in Human Research (2007) and the Good Clinical Practice
Framework.
Project Name: insert short title

Table of Contents
1 Project summary..........................................................................................................................................2
2 Project team roles and responsibilities.....................................................................................................2
3 Study sites....................................................................................................................................................3
4 Resources.....................................................................................................................................................3
5 Background information..............................................................................................................................3
6 Project objectives and outcomes...............................................................................................................3
6.1 Project aims..........................................................................................................................................3
6.2 Outcomes and benefits.......................................................................................................................3
7 Project design...............................................................................................................................................3
7.1 Methodology.........................................................................................................................................3
7.2 Participants...........................................................................................................................................4
7.3 Data collection......................................................................................................................................4
7.4 Data analysis........................................................................................................................................5
7.5 Data management...............................................................................................................................5
8 Schedule.......................................................................................................................................................5
9 Contingency plans.......................................................................................................................................5
10 Results, outcomes and future plans......................................................................................................5
11 References................................................................................................................................................6
12 Review Pathway Checklist......................................................................................................................7

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1 Project summary
Provide brief information

Title: Full title

Short title: Acronym or abbreviated title

Project topic: A brief description of the topic of your quality improvement project

Project aim: A brief description of the main aims and objectives for the project

Number of planned
If participants are involved, estimate the number included in your project
participants:

Methodology: Brief description: e.g. descriptive, qualitative, quantitative or mixed methods

2 Project team roles and responsibilities

Copy this table and repeat for each person

Title First Name Surname

Mailing
Address
Suburb/City Postcode
Organisation Department
Appointment Qualification
s
Phone (BH) Mobile
Email
Is this person the project lead? Yes No
Is this person the contact for the Yes No
application?
Is this person a student? Yes No
Does this person require training in order Yes No (if yes, specify training required below)
to complete this project?

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Who will provide the training?

3 Study sites
At which AWH sites will your project take place?

Site Address Contact person Phone Email

4 Resources
List the resources necessary for the project to be conducted and any funding being sought or secured.
Is the project part of a collaboration?

 Staff time
 Access to AWH RedCap
 Staff time to recruit patients/transcribe interviews/code data/analyse data
 UNSW Stats Central for statistical support (UNSW-related projects only)
 Funding for stationary/printing if necessary
 Source of any external funding

5 Background information
What is the problem, procedure or practice that will be assessed? This section should provide details
on the need for the project and where it fills a gap in clinical knowledge, procedures, or the current
literature. You may need to conduct a literature review to see if there are similar projects in the
literature. Contact the AWH Library ([email protected]) if you need help.

6 Project objectives and outcomes

6.1 Project aims
What are the aims of the project? Be clear and concise and make sure aims are able to be addressed
with the proposed methodology.

6.2 Outcomes and benefits

What are the likely outcomes of the project? What are the likely benefits?

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7 Project design
7.1 Methodology
Provide a summary of the methodological approach, including the type of study (e.g. quantitative,
qualitative, mixed methods, prospective, retrospective). For guidance on Quality Improvement
methodologies see:

 A guide to quality improvement tools – HQIP.

 Quality Improvement Tools - Clinical Excellence Commission (nsw.gov.au)

7.2 Data collection

7.2.1 How will data be collected?
How will you collect the required information to meet the aims of the project? Include details of who
will collect the data. What is the data source? (ie health records, electronic database). Include name
and owner of any database to be used and ensure you have permission to access.

7.2.2 What information/data will be collected?

Provide details of all data fields/variables you will be collecting. This includes personal information
(e.g. name or Medical Record Number) and demographic data. Include details of data collection tools
such as surveys.
You can address issues relating to consent and data management in later sections.

7.3 Participants
For retrospective studies, the recruitment, withdrawal and complaints sections will not be relevant. You
will still need to complete the other sections.
For prospective studies, ensure that the information in this section is conveyed to participants through
a Participant Information and Consent Form or Participant Information Statement (see the Research
Office website for a template).

7.3.1 Participant details

Describe the participants involved in the project.
Example: Current consumers/patients/staff/carers. Refer to the National Statement on Ethical Conduct
in Human Research when writing this section.

7.3.2 Risks and Benefits

Describe the benefits to participants. Even if the project is retrospective, you need to consider risks to
participants.
Do these benefits outweigh the risks you describe below?
Referring to Chapter 2.1. of the National Statement on Ethical Conduct in Human Research (2007),
consider the foreseeable risks to participants.
A risk is a potential for harm, discomfort or inconvenience (discussed below). It involves:
- the likelihood that a harm (or discomfort or inconvenience) will occur
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- the severity of the harm, including its consequences.

The three levels of risk referred to in the National Statement are:

 Negligible risk or inconvenience

o “negligible risk research describes research in which there is no foreseeable risk of
harm or discomfort; and any foreseeable risk is no more than inconvenience.”
 Risk of discomfort
o Discomfort can involve body and/or mind. Discomforts include, for example, minor
side-effects of medication, the discomforts related to measuring blood pressure, and
anxiety induced by an interview. Where a person's reactions exceed discomfort and
become distress, they should be viewed as harms.
 Risk of distress/harm
o physical harms: including injury, illness, pain
o psychological harms: including feelings of worthlessness, distress, guilt, anger or fear
related, for example, to disclosure of sensitive or embarrassing information, or learning
about a genetic possibility of developing an untreatable disease
o devaluation of personal worth: including being humiliated, manipulated or in other ways
treated disrespectfully or unjustly
o social harms: including damage to social networks or relationships with others;
discrimination in access to benefits, services, employment or insurance; social
stigmatisation
o findings of previously unknown paternity status
o economic harms: including the imposition of direct or indirect costs on participants
o legal harms: including discovery and prosecution of criminal conduct.

 Likelihood definitions
o Very likely: Expected to occur in several cases/participants
o Likely: Expected to occur in some cases/participants
o Unlikely: Possibility of occurring in some cases/participants

- Even if the risk is low (unlikely to occur), it needs to be included.

- Please complete the below risk table, deleting the examples.
- This risk table will help the Research Office determine the level of ethical review required.
- Please ensure the information here is consistent with Section 12 (Review checklist).

Risk description Is the risk is associated How likely is this risk How will this risk be
with to occur? 1. Unlikely; minimised or
1. Inconvenience; 2. 2. Likely; or 3. Very mitigated?
Discomfort; or 3. likely
Distress/Harm
Survey asking Distress Likely Participants will be
women about the informed of the
result of previous sensitive nature of the
pregnancies, questions before they
including decide whether or not
miscarriage. to participate. A
detailed and clear
referral pathway will be
provided to any
participants that
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become distressed.
Collection of Discomfort/Distress Unlikely Sensitive and personal
personal or information will remain
sensitive on the AWH network in
information (e.g. a password protected
name or medical folder or file. Data will
record number). be de-identified as
Risk that soon as practical. Only
personal or de-identified data will
sensitive data is be shared.
accidentally PI Line Manager, AWH
shared. Health Information and
AWH Research Office
will be made aware of
a data breach as soon
as possible.

7.3.3 Recruitment strategies and provision of information

Explain how participants will be recruited and how the study will be explained to them. Consider the
collection, use, reuse, storage and publication of participant data when providing information to
participants. Consider clear inclusion/exclusion criteria.

7.3.4 Consent
Describe if individual consent will be obtained or if a waiver of consent is required.
Example:
- A waiver of consent is requested because the study uses existing data and consent is not
practical given the retrospective nature of the study.
- Consent is sought from participants through a Patient Information and Consent Form (see
Research Office page for templates)
- Consent is implied though completion of the survey, as outlined in the Participant Information
Statement.
Note: Please refer to the Review Pathway Checklist at the end of the document for further information
regarding waiver of consent.

7.3.5 Participant withdrawal

There are two options for this section depending on the type of study you are conducting:
- Data collected anonymously: Because personal information will not be collected, participants
will not be able to withdraw from the study.
- Personal data collected: participants will need to request to withdraw from the study. This
information is included in the Participant Information and Consent Form (see Template on
Research Office Page).

7.3.6 Participant complaints

Contact Research Office

Telephone 0428 056 672

Email [email protected]

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7.4 Data analysis

Outline a plan for data analysis, including any statistical analyses. Contact the Research Office if you
need statistical support.

7.5 Data management

Data management can be broken into collecting and using. For instance, you may need to collect
some personal information initially but then de-identify and use de-identified data for analysis and
publications.
If data already exists, explain how with this data be accessed.
For retrospective studies, will you need to collect patient personal data (e.g. name or Medical Record
Number) initially so that you can connect patient records, and check for duplicates and errors?
Guidance for those collecting and/or using sensitive data: Working With Sensitive Data | ARDC
(urlisolation.com). This link includes information on de-identification of data.
For AWH existing data:
- Data will be accessed through Health Information and AWH IT department and through
approved process.
- Data will be stored on AWH network drive in a password protected file and only accessible to
members of the research team until de-identified.
- De-identification of data will occur by relacing personal identifiers (e.g. name or Medical
Record Number) with a unique study number or a code (e.g M1).
- Once deidentified the data can be removed from AWH network and may be made available to
publishers via research databases.
- You may need to hold a key to the de-identification process to assist with participant
withdrawal or data analysis, and this key must remain on AWH networks in a password
protected file.
- Transfer of study files will only occur through secure systems.
- The study data will be kept for a minimum of five years, or longer if requested if requested by
publishers of academic journals (for student projects this minimum is 12 months, unless
seeking publication).
- Prospective studies: The re-use of data for other research will only occur with the consent of
participants (describe this here).

8 Schedule
Provide a schedule for the project, including the start and end date and timing of phases or stages.

Example:

Activity Jan/Feb Mar/Apr May/Jun Jul/Aug Sep/Oct Nov/Dec

Review literature and prepare
draft proposal
Develop detailed project plan
and documentation
Obtain ethics approvals
Collect data

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Data analysis
Write report
Present findings/Final report
submission

9 Contingency plans
Explain the obstacles that may arise and plans for overcoming them.

10 Results, outcomes and future plans

Explain how results will be shared. Explain any plans for publication.

11 References
Include literature cited within the Research Protocol. Please use a published referencing style, i.e.
APA, Harvard, or Vancouver. If you need help, contact the AHW Library ([email protected]).

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12 Review Pathway Checklist

Please note that you must notify the Research Office if any of these answers change throughout the
duration of the project.
This checklist is in line with the National Statement on Ethical Conduct in Human Research 2007
(Updated 2018) and AWH Research Policy and Procedures.

Negligible risk research YES NO

Does the proposed project involve MORE than negligible risk or inconvenience?

Refer to section 8.2.5. Participant risks and benefits for details and definitions

Does your project involve collecting or using personal or health information (e.g. name
or medical record number), either prospectively or retrospectively?

Is the proposed activity to be conducted by a person who does NOT normally have
access to the patient’s records for clinical care or a directly related secondary purpose?

Does the proposed activity seek to gather information about the patient beyond that
collected in routine clinical care?

Does the proposed activity involve any clinically significant departure from the routine
clinical care provided to the patients?

Does the proposed activity involve randomisation or the use of a control group or a
placebo?

Does the proposed activity pose any risks/burden for patients beyond those of their
routine care?

Does the proposed activity potentially infringe the rights, privacy or professional
reputation of carers, healthcare providers or institutions?

Does the proposed activity test non-standard (innovative) protocols or equipment?

Do you intend to publish some or all of the results (e.g., journal, conference
presentation)?

If you answered ‘No’ to all of the above, you are eligible to submit a Negligible Risk application.
If you answered ‘Yes’ to one or more of the above questions, please proceed to the table on the next
page.
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Low and Greater than Low Risk research YES NO

Is the risk to participants more serious than discomfort?

Refer to section 8.2.5. Participant risks and benefits for details and definitions

Are you using personal information, or personal health information, and intend to not
gain consent?

Are you requesting a waiver of consent?*

Are you using personal information, or personal health information, and intend on
using an opt-out approach to consent?
Does the research include interventions and therapies, including clinical and non-
clinical trials and innovations?
Does the research include human genetics or human stem cells, or the use of stored
biospecimens?

Does the research activity target women who are pregnant and the human foetus?

Does the research activity target Children and young people?

Does the research activity target People in dependent or unequal relationships?

Does the research activity target People highly dependent on medical care who may be
unable to give consent?
Does the research activity target People with a cognitive impairment, an intellectual
disability, or a mental illness?

Does the research activity target People who may be involved in illegal activities?

Does the research activity target Aboriginal and Torres Strait Islander Peoples?

Does the research activity target People in other countries?

If you answered ‘No’ to all of the above, your research is classified as Low Risk.

If you answered ‘Yes’ to one or more of the above questions, your research requires a Greater than
Low Risk (Full Ethical Review) application.

*If the project is a research project, a waiver of consent will need to be granted by the AWHHREC. For
quality improvement projects, the Research Governance Officer can grant a waiver of consent.

Next steps:
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Once you have completed a draft protocol and filled out the Review Pathway Checklist, please
submit an AWH Research Request Form to register your project and receive guidance on the
next steps for your project.

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