How to complete an Expedited Ethical Review Submission
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Transcript How to complete an Expedited Ethical Review Submission
How to complete an Expedited Ethical
Review Submission
Introducing a new name
A Change in Name:
As of the 1 March 2012, Expedited Ethical Reviews (EER) will now
be called
Low & Negligible Risk Research (LNRR)
Why the Change?
• Use the same terminology in the National Statement and other
institutes in Australia
• Reduce confusion surrounding the word “Expedited”
What qualifies as Low & Negligible Risk
Research (LNRR)?
“Low & Negligible Risk Research describes research in which the only foreseeable
risk of harm is one of discomfort; and any foreseeable risk is no more than
inconvenience. Research in which the risk for participants is more serious than
discomfort is NOT low risk.”
Quality Assurance projects that do NOT invoke emotional
stress
Observational Studies
Recruitment only projects
Intervention studies where the only foreseeable risks are
those of minimal discomfort and inconvenience
How do I know if my project qualifies?
1.
2.
3.
Read the National Statement, ALL of Chapter 2.1
Complete the checkbox for the LNRR guidelines available for
download at http://hub/REU/LNRR
Once you have completed steps 1 & 2, don’t be afraid to call
The Research Ethics Unit for final assurance. Please note, this
step is best once you have completed your protocol
Submission Process for LNRR
LNRR Application without the NEAF
Advantages:
•
Don’t have to complete NEAF
•
Shorten Application Form
Disadvantages:
If your project doesn’t qualify as ‘low risk’, then you will need to complete a full Non-Drug Study
Application which requires you to fill out the NEAF and the Victorian Specific Module
LNRR Application with the NEAF
Advantages:
If your project doesn’t qualify as ‘low risk’, then you have already completed all forms required for
the Non-Drug Submission Process..
Disadvantages:
•
You have to complete the NEAF & the Victorian Specific Module
Submission Process cont’d
One electronic copy sent to [email protected]
Original signatures are not needed for this copy
One hard copy with ORIGINGAL signatures sent to
Research Ethics Unit
Henry Buck Building
Austin Health
Fee sheet
How to fill out the LNRR Application
form without the NEAF.
PLAN for the time it takes to:
Write your application including a PROTOCOL
Submit your application & pass the gate keeping process
Have your application sent out for review. NOTE:You need to allow
a maximum time of 4-weeks from your submission date for this
process, that is if your application is PERFECT!
Document
The Dreaded Protocol
Most studies don’t get past the gate-keeping
process because of an insufficient protocol
What is a Protocol?
• Describes every step of a study
Identification of the problem
Application of the results
• Answers relevant questions
• Public health problem: Important?
• Study question: relevant to the problem?
• Objectives: consistent with the study question?
• Study design: achieves objectives?
• Power of the study: sufficient?
• Public health impact of the findings?
Why do you need a protocol?
To check if the objectives can be achieved
To check the feasibility of the study
Prevents failure to collect crucial information
Lays down the rules for all investigators
To obtain approval of ethical committee(s)
Allows the reviewers to make a judgment call that the research meets all requirements
of the National Statement and is ethically acceptable according to the National
Statement. Making sure your research project is compliant with Australian law that
governs human research.
How do I start writing a protocol?
Use the protocol template (judgment calls must be made on which
section/s are important. Remember templates can’t be written to cover every
single type of study)
Use a well-written protocol as a good example
Get ideas from published articles
Get ideas from your colleagues
Basic outline of what needs to be
in a protocol
Background & justifications
Objectives and research questions
Methods
Ethical Considers (e.g., recruitment, consent, data
collection, storage, security & handling)
Timetable
Resources
References
Appendices
Background & justification
Statement of the problem, study justification
Discuss importance of subject area
Describe why the study is necessary
Describe the principal questions to be addressed
Describe how the study results will be used
Review relevant literature & current knowledge
Objectives & research questions
Be Specific about your objectives
Objective is to measure something e.g., prevalence, incidence, risk etc…
Action orientated e.g., “in order to …..”
Relevant
Time specified
Main Objective
Must be achieved
Dictates design & methods
Secondary objectives
Of interest, but not essential
Specific research questions
Methods – Design & Population
Study Design
What design is being used? (e.g., cohort, case-control, cross-
sectional etc..)
Brief justification for the chosen design
Study Population
Selection & definition
Appropriateness for study objectives
Accessibility to population
Criteria for inclusion & exclusion
Description of recruitment strategy
Methods – Design & Sample Size
Sampling design
Method e.g., random, cluster, stratified
Randomisation procedures
Replacement procedures (in case of participant withdrawal)
Sample Size
Sample size & power calculations based on primary objective
Ensure feasibility of the study & statistical merit.
Methods – Data Required
Describe how you will select and define your population
Items to be measured & how
E.g., scales used, questionnaires, incidence rates etc…
Methods – Data collection
Data Collection
How?
Interview, observation, record review
By whom?
Interviewers: selection, training
Level of supervision
Tools?
Questionnaires, recording materials (forms)
Questionnaires – self or interviewer administered face to face
or telephone?
Procedure for taking samples or performing test
What is collected or performed as part of standard care & what
is additional to standard care
Method – Data Handling
Data coding
Duration data collection & afterwards
By whom?
Security & storage arrangements
Data processing
Manually or by computer?
Data entry during or after the study
Methods - Data Analysis
Why do you need a data analysis plan?
Prevents collection of data that will not be used
Prevents failure to collect crucial information
Better estimates sample size for each analysis group.
Data analysis plan
Structured in terms of specific objectives
Data collection forms
General to specific
Ethical considerations
Type of consent
Informed consent (see section 2.2 of National Statement)
Implied consent
Waivers of consent (see section 2.3 of National Statement)
Confidentiality
Data storage and protection
Appendices
Questionnaires
Telephone scripts
Letters of invitation
Common problems with protocols
Inadequate description of research methodology
Inappropriate analysis
Poorly formulated objectives by not being specific
Insufficient attention to previous literature
Poor justification
Why is it important to answer the question?
What impact does it have on public health?
Hints & Tips - Terminology
Describing the type of data you are collecting:
De-identified data
Discouraged from using this term as it is ambiguous.
Identifiable data
Data from which the identity of a specific individual can reasonable be ascertained.
Re-identifiable/Coded data
Data from which identifiers have been removed & replaced by a code, but it remains possible to reidentify a specific individual by linking data sets.
Non-identifiable data
Data that have never been labeled with individual identifiers or from which identifiers have been
permanently removed, and by means of which no specific individual can be identified.
More hints & tips
Recruitment procedures & Study Methodology
Where, what, when, how & who
Describing your study population
Are they subjects, patients or participants?
Participant Information & Consent Forms (PICF)
Where applicable, use the standard template wording
Sentences should be clear & concise
Average reading level should be aimed at a person with a grade 6 education (~12 year old)
Should be upfront about all study procedures, time commitments, reimbursement & handling of
their personal information
Questions