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. Read the National Statement, ALL of Chapter Complete the checkbox for the LNRR guidelines available for download at 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 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 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

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 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

Questions