How to complete an Expedited Ethical Review Submission

How to complete an Expedited Ethical Review Submission

Introducing a new nameA 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 StudiesRecruitment only projectsIntervention 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 2.12. 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 NEAFAdvantages: • 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 NEAFAdvantages: 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’dOne electronic copy sent to

[email protected] signatures are not needed for this

copy

One hard copy with ORIGINGAL signatures sent toResearch Ethics Unit

Henry Buck BuildingAustin 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 problemApplication 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 achievedTo check the feasibility of the studyPrevents failure to collect crucial

informationLays down the rules for all investigatorsTo 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 exampleGet ideas from published articles Get ideas from your colleagues

Basic outline of what needs to be in a protocolBackground & justificationsObjectives and research questionsMethodsEthical Considers (e.g., recruitment,

consent, data collection, storage, security & handling)

TimetableResourcesReferencesAppendices

Background & justificationStatement of the problem, study

justificationDiscuss importance of subject areaDescribe why the study is necessaryDescribe the principal questions to be

addressedDescribe 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 ObjectiveMust be achievedDictates design & methods

Secondary objectivesOf interest, but not essential

Specific research questions

Methods – Design & PopulationStudy Design

What design is being used? (e.g., cohort, case-control, cross-sectional etc..)

Brief justification for the chosen design

Study PopulationSelection & definitionAppropriateness for study objectivesAccessibility to populationCriteria for inclusion & exclusionDescription of recruitment strategy

Methods – Design & Sample SizeSampling design

Method e.g., random, cluster, stratifiedRandomisation proceduresReplacement procedures (in case of

participant withdrawal)

Sample SizeSample size & power calculations based on

primary objectiveEnsure feasibility of the study & statistical

merit.

Methods – Data Required

Describe how you will select and define your population

Items to be measured & howE.g., scales used, questionnaires, incidence

rates etc…

Methods – Data collectionData Collection

How? Interview, observation, record review

By whom?Interviewers: selection, trainingLevel of supervision

Tools?Questionnaires, recording materials (forms)Questionnaires – self or interviewer administered

face to face or telephone?Procedure for taking samples or performing

testWhat is collected or performed as part of standard

care & what is additional to standard care

Method – Data HandlingData coding

Duration data collection & afterwardsBy whom?Security & storage arrangements

Data processingManually or by computer?Data entry during or after the study

Methods - Data AnalysisWhy do you need a data analysis plan?

Prevents collection of data that will not be usedPrevents failure to collect crucial informationBetter estimates sample size for each analysis

group.

Data analysis planStructured in terms of specific objectivesData collection formsGeneral to specific

Ethical considerationsType of consent

Informed consent (see section 2.2 of National Statement)

Implied consentWaivers of consent (see section 2.3 of

National Statement)ConfidentialityData storage and protection

AppendicesQuestionnairesTelephone scriptsLetters of invitation

Common problems with protocolsInadequate description of research

methodologyInappropriate analysisPoorly formulated objectives by not being

specificInsufficient attention to previous literaturePoor justification

Why is it important to answer the question?What impact does it have on public health?

Hints & Tips - TerminologyDescribing 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 & tipsRecruitment procedures & Study Methodology Where, what, when, how & who

Describing your study populationAre they subjects, patients or participants?

Participant Information & Consent Forms (PICF)Where applicable, use the standard template wordingSentences should be clear & conciseAverage 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