What+is+required

Ethics application This section should include an ethics application (waiting on reply from Laila to know if this is the right one) for the data collection and validation stages of developing your measure. This will involve completing a revised ethics application form.

I have emailed Laila about the "revised ethics application form"

email to Laila

> associated with your target group/measure, e.g. working with children, obtaining > a large clinical sample, testing procedure involving risk.
 * Ethics/Resources –mention only any unusual or higher-than-normal risk issues

The measure we are developing does not expose the participant or researchers to "unusual or higher-than-normal" risk. The biggest issue I can see is gathering data about existing hearing loss which means we are collecting sensitive medical information

All research that involves people requires ethics approval from the ethics department.

Human research requiring ethics approval

The ethics department web page with contact details and other forms

[|Contact Ethics department at Swinburne]

[|How to apply for Ethics approvel (downloadable forms)]

[|Policies and forms]

This is a good guide for us to use when filling out the application form.

[|Guidelines and common mistakes]

=Main issues for Ethics approval=

This research __does__ require ethics approval as it involves people but is very low risk while being of potentially great benefit to society and the individual.

This test is to identify at risk groups for future hearing loss and possible current hearing loss but so does not test for actual hearing loss.

The only source of concern is the participant's risk of distress if finding out about unknown hearing loss. (i.e. Low compared to a brain tumour )

**These are issue that needs to be discussed as it is about balancing risks -** > >> This can be avoided by giving all participants an information pack containing warnings about potentially dangerous activities. This way no-one is singled out. >
 * Does our duty of care mean we need to give instructions to participants to seek a hearing test if we suspect they have existing loss? Are we obliged to advise those taking part in risky behaviours about their potential future hearing loss? This means we need to have identifying data to contact them.
 * Does our lack of qualifications in the area of diagnosing hearing loss mean we shouldn't say anything so as not to cause undue distress? "We are not qualified to offer an opinion on hearing loss so those that are concerned about their hearing should seek the advice of an Audiologist. We encourage everyone to use hearing protection and have regular hearing tests."
 * The results of the test are not reliable until the scale is validated but individuals likely to sustain future hearing loss due to risky behaviours should be warned? Could cause unnecessary distress.

The main area for ethical consideration is protecting the identity of the individual. Even though we are not asking for identifying information There is no reason to collect identifying information unless we need to contact them about getting tested for hearing loss. Demographic data is potentially identifying and should be handled with due care. We are asking for information about previous medical conditions, these answers are sensitive and the participant should be protected for

"Counselling services are available to anyone suffering distress due to unforeseen outcomes of taking the test."