How to complete an Expedited Ethical Review Submission.ppt by pptfiles


									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
 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.   Read the National Statement, ALL of Chapter 2.1
2.   Complete the checkbox for the LNRR guidelines available for
     download at http://hub/REU/LNRR
3.   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
•   Don’t have to complete NEAF
•   Shorten Application Form
 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
 If your project doesn’t qualify as ‘low risk’, then you have already completed all forms required for
    the Non-Drug Submission Process..
•   You have to complete the NEAF & the Victorian Specific Module
Submission Process cont’d
 One electronic copy sent to
     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!
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
 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 re-
identify 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

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