(Adapted from the Victorian SpecificModule)
EthicsID:ProjectTitle:
1.PRIVACYPRINCIPLES
Type of Information / Type of Organisation(s)Involved / Privacy PrincipleCodesDataCollection / Data Use &Disclosure
Health information1 / Victorian publicsector / HPP1 / HPP2
Victorian privatesector / HPP 1, APP 2, APP3,
APP 5 / HPP 2, APP6
Where disclosure iscross- border: APP 8, HPP9,
IPP 9
Commonwealth publicsector / APP 2, APP 3, APP5 / APP 6
Other / APP 3, APP 5 / APP 6
Personal information2(otherthan health information) / Victorian publicsector / IPP 1 / IPP 2
Victorian privatesector / APP 2, APP 3, APP5 / APP 3, APP 5
Commonwealth publicsector / APP 2, APP 3, APP5 / APP 6
Other / APP 3, APP 5 / APP 6
Sensitive information3 / Victorian publicsector / IPP 10 / IPP 2
Victorian privatesector / APP 3 / APP 3, APP 6
Commonwealth publicsector / APP 3 / APP 3, APP 6
Other / APP 3 / APP 3, APP 6
APPAustralian Privacy Principles[Privacy Act 1988(Cth)]
HPPHealth Privacy Principles[HealthRecordsAct2001(Vic)]
IPPThe Information Privacy Principles[Privacy and Data Protection Act 2014]
Short guide to the Information Privacy Principles ;
1 “Health information” means: A) Information or an opinion (that is also personal information) about: the health or a disability(at anytime)of anindividual; oranindividual’s expressedwishesaboutthefutureprovisionofhealthservicestohimorher; ora health service provided, or to be provided, to an individual; or B) Other personal information collected to provide, orin providing, ahealthservice; orC)otherpersonalinformationaboutanindividualcollectedinconnectionwiththedonation,orintendeddonation,bytheindividualof hisorherbodyparts,organsorbodysubstances;orD)geneticinformationabout anindividualinaformthatis,orcouldbe, predictiveofthehealthoftheindividualoragenetic relativeoftheindividual.
2 “Personal information” means information or an opinion about an identified individual, or an individual who isreasonably identifiable, whethertheinformationoropinionistrueornot; andwhethertheinformationoropinionisrecordedinamaterial form ornot.
3 “Sensitive information” means information or an opinion about an individual’s racial or ethnic origin; or political opinions;or membershipofapoliticalassociation;orreligiousbeliefsoraffiliations;orphilosophicalbeliefs;ormembershipofatradeunion;or sexual preferences or practices; or criminalrecord.
2.COLLECTION OF PARTICIPANTS’INFORMATION
A.Does the project involve collection of information about individuals without their knowledge orconsent?/ No (Proceed to Section3)
/ Yes
B. What type of information will be collected? (Tick all thatapply)
/ Personalinformation
/ Sensitiveinformation
/ Healthinformation
C. A waiver of consent is sought to use the collected informationfor:
/ This research project (specificconsent)
/ Future research related to this project (extendedconsent)
/ Any future research (unspecifiedconsent)
D. Does the project involve the establishment of adatabank?
/ No
/ Yes
E.Does the Participant Information and Consent Form explainthefollowing:
YES / NO / N/A
What information is beingcollected? / /
The purposes for which the information is beingcollected? / /
The extent of future use of data (if you are seeking extended orunspecified consent)? / / /
Thewide-rangingimplicationsofunspecifiedconsent(ifyouareseekingunspecified consent)? / / /
A description of the terms of the unspecified consent (if you are seekingunspecified consent)? / / /
If permission is being sought to enter the information into adatabank? / / /
The period for which the records relating to the participant will bekept? / /
The form in which the data will be stored (i.e. whether identifiable ornot)? / /
The steps taken to ensure confidentiality and secure storage ofdata? / /
The types of individuals or organisations to which your organization usually discloses information of thiskind? / /
E. DoestheParticipantInformationandConsentFormexplainthefollowing:
YES / NO / N/A
Howprivacyand confidentialitywillbeprotectedinanypublicationofthe
information? / /
Thefact that theindividualmayaccessthatinformation? / /
Anylawthat requirestheparticularinformationtobecollected? / / /
The consequences(if any) fortheindividualif allorpartof theinformationisnot provided? / /
Theidentityof theorganisation collectingtheinformationandhowto contact it? / /
If youansweredNotoanyofthequestionsabove, givethereasonswhythisinformationhasnot been includedintheParticipant InformationandConsent Form.
3.IDENTIFIABLEDATA
A.Does the project involve the collection, use or disclosure of individually identifiable orre-identifiableinformationfromsourcesotherthantheindividualtowhomtheinformationrelates?Notethataccesstoidentifiablerecordsforthepurposeofextractingnon-identifiabledataconstitutes‘use’and ‘disclosure’ofidentifiabledataevenifsuchdatawillnotbe‘collected’.
/ No (Proceed to Section7)
/ Yes
B.Does the project involve the collection, use or disclosure of information without the consent ofthe individual to whom the information relates (or their legalguardian)?
/ No (Proceed to Section7)
/ Yes
C. Are you seeking approval for collection of information from a third party?
/ No
/ Yes
D. Are you seeking approval for use of information?
/ No
/ Yes
E. Are you seeking approval for disclosure ofinformation?
/ No
/ Yes
4.COLLECTION OF INFORMATION FROM A THIRDPARTY
A. Are you collecting individually identifiableinformation from a third party without consent?Only answer “Yes” to this question if the project involves the collection of individually identifiable orre- identifiableinformationfromasourceotherthantheindividual(ortheirlegalguardian)withouttheconsentof the individual or their legalguardian.
/ No (Proceed to Section 7)
/ Yes
B. From which of the following sources will information be collected? (Tick all thatapply)
/ A Victorian public health serviceprovider
/ A Victorian private health serviceprovider
/ An organisation other than a health serviceprovider
/ AdatasetundertheauspicesoftheVictorianDepartmentofHealthandHumanServices
/ A data set under the auspices of another Victorian governmentdepartment
/ A data set from another Victoriansource
/ A Commonwealthagency
/ An agency from anotherstate
/ An “organisation” as defined in the Privacy Act1988
/ An individual (such as acarer)
/ Other
C. List the categories of individuals or organisations from which individually identifiable orre-identifiable information will becollected.
Ifinformationwillbecollectedfrommorethanonecategory,indicateclearlywhatinformationorrecordswillbe collected from eachcategory.
Category / Type of information or records to becollected
e.g. carers;hospitals / e.g. contact information; complete medicalhistory
D. Have all organisations from which the information is to be collected agreed to providetheinformation or to allow access to theinformation?
/ No(IfNo,explainhowandwhentheagreementofthedisclosingorganisationwillbeobtained.)
/ Yes(IfYes,provideevidenceofthisagreement.Providedetailsofanyconditionsimposedbythe organisation(s) concerning the release of theinformation.)
E.Is any organisation from which the information will be collected seeking separateHRECapproval for disclosure of theinformation?
/ No (If No, a copy of any approval from this HREC will have to be forwarded to thedisclosing organisation.)
/ Yes (If Yes, supply a copy of the decision from the other HREC (whenavailable).)
F. Does the person who is collecting the information routinely have access to thatinformation?
/ No
/ Yes
G. What information will be collected? (Tick all boxes thatapply)
Type of information / Type of organisation(s)involved / PrivacyPrinciple(s)
/ Health information / / Victorian publicsector / HPP1
/ Victorian privatesector / HPP 1, APP 2, APP 3, APP5
/ Commonwealth publicsector / APP 2, APP 3, APP5
/ Other / APP 3, APP 5
/ Personal information(other thanhealth information) / / Victorian publicsector / IPP 1
/ Victorian privatesector / APP 2, APP 3, APP5
/ Commonwealth publicsector / APP 2, APP 3, APP5
/ Other / APP 3, APP 5
/ Sensitive information / / Victorian publicsector / IPP 10
/ Victorian privatesector / APP 3
/ Commonwealth publicsector / APP 3
/ Other / APP 3
H. Will the information be collected for deposit in adatabank?
/ No
/ Yes
I.Forwhatreason(s)willinformationbecollectedina(potentially)identifiableform?
J.Forwhatreason(s)willconsentnotbeobtainedfrom theindividual(s)whoseinformationwillbecollected?
Ifinformationwillbecollectedfromhealthrecords,refertoStatutoryGuidelinesonResearchoftheHealth Records Act 2001 (Vic) at or ).
K. Give reasons why the proposed collection of information is in the publicinterest.
Notethatthepublicinterestintheproposedresearchmustsubstantiallyoutweighthepublicinterestin respecting individualprivacy.
5.USE OFINFORMATION
A. Are you using individually identifiableinformation withoutconsent?Onlyanswerthisquestioniftheprojectinvolvestheuseofindividuallyidentifiableorre-identifiableinformation withouttheconsentoftheindividualtowhomtheinformationrelates(ortheirlegalguardian).
/ No (Proceed to Section7)
/ Yes
B. What information will be used? (Tick all boxes thatapply)
Type of information / Type of organisation(s)involved / PrivacyPrinciple(s)
/ Healthinformation / / Victorian publicsector / HPP1
/ Victorian privatesector / HPP 1, APP 2, APP 3, APP5
/ Commonwealth publicsector / APP 2, APP 3, APP5
/ Other / APP 3, APP 5
/ Personal / / Victorian publicsector / IPP 1
information(other than health information) / / Victorian privatesector / APP 2, APP 3, APP5
/ Commonwealth publicsector / APP 2, APP 3, APP5
/ Other / APP 3, APP 5
/ Sensitive information / / Victorian publicsector / IPP 10
/ Victorian privatesector / APP 3
/ Commonwealth publicsector / APP 3
/ Other / APP 3
C. Whatarethespecificpurposesforwhichtheinformationwillbeused?
D. Is the purpose for which the information will be used in this research (the secondarypurpose)relatedtothepurposeforwhichtheinformationwasoriginallycollected(theprimarypurpose)?
/ No
/ Yes (Providedetails)
E. Givereasonswhyinformationwillbeusedina(potentially)identifiableform.
F. Forwhatreason(s)willconsentnotbeobtainedfromtheindividual(s)whoseinformationwillbe used?
G. Give reasons why the proposed use of information is in the publicinterest.
Notethatthepublicinterestintheproposedresearchmustsubstantiallyoutweighthepublicinterestin respecting individualprivacy.
6.DISCLOSURE OF INFORMATION
A.Will individually identifiable or re-identifiable information be disclosed by an organisation totheresearcher, without the consent of the individual to whom the information relates (or theirlegalguardian)?/ No (Proceed to questionD.)
/ Yes
B.What information will be disclosed by the organisation(s) to theresearcher?(Tick all boxes thatapply)
Type of information / Type of organisation(s)involved / PrivacyPrinciple(s)
/ Healthinformation / / Victorian publicsector / HPP1
/ Victorian privatesector / HPP 1, APP 2, APP 3, APP5
/ Commonwealth publicsector / APP 2, APP 3, APP5
/ Other / APP 3, APP 5
/ Personal information(other than health information) / / Victorian publicsector / IPP 1
/ Victorian privatesector / APP 2, APP 3, APP5
/ Commonwealth publicsector / APP 2, APP 3, APP5
/ Other / APP 3, APP 5
/ Sensitive information / / Victorian publicsector / IPP 10
/ Victorian privatesector / APP 3
/ Commonwealth publicsector / APP 3
/ Other / APP 3
C. List the organisations that will disclose information to theresearcher.
Ifmorethanoneorganisationisinvolved,indicateclearlywhatinformationorrecordswillbedisclosedbyeach organisation to the researcher. Add more rows asnecessary.
Organisation / What information or records will bedisclosed
D. Will individually identifiableor re-identifiable information be disclosed by the researcher tootherorganisations?
/ No (Proceed to Section7.)
/ Yes
E.What information will be disclosed by the researcher to otherorganisations?(Tick all boxes thatapply)
Type of information / Type of organisation(s)involved / PrivacyPrinciple(s)
/ Healthinformation / / Victorian publicsector / HPP1
/ Victorian privatesector / HPP 1, APP 2, APP 3, APP5
/ Commonwealth publicsector / APP 2, APP 3, APP5
/ Other / APP 3, APP 5
/ Personal information(other than health information) / / Victorian publicsector / IPP 1
/ Victorian privatesector / APP 2, APP 3, APP5
/ Commonwealth publicsector / APP 2, APP 3, APP5
/ Other / APP 3, APP 5
/ Sensitive information / / Victorian publicsector / IPP 10
/ Victorian privatesector / APP 3
/ Commonwealth publicsector / APP 3
/ Other / APP 3
F. List the organisations to which the information will bedisclosed.
Ifmorethanoneorganisationisinvolved,indicateclearlywhatinformationorrecordswillbedisclosedbythe researcher to each organisation. Add more rows asnecessary.
Organisation / What information or records will bedisclosed
G. Givereasonswhyinformationwillbedisclosedina(potentially)identifiableform?
H. Forwhatreason(s)willconsentnot beobtainedfromtheindividual(s)whoseinformationwillbe disclosed?
I.Givereasons why theproposed disclosure ofinformationisin the publicinterest.
Notethatthepublicinterestintheproposedresearchmustsubstantiallyoutweighthepublicinterestin respecting individualprivacy.
7.GENERALISSUES
A. How many records will be sourced and what is thesource?Sources(e.g.medicalrecord,participantinperson).Typeofinformation(e.g.dateofbirth,medicalhistory, number of convictions). Repeat for eachsource.
Source:
Number ofrecords:
Type ofinformation:
B.Does the project involve the adoption of unique identifiers assigned to individuals by otheragencies ororganisations?
/ No
/ Yes(IfYes,givedetailsofhowthiswillbecarriedoutinaccordancewithrelevantPrivacyPrinciples [e.g. HPP 7,APP 9,IPP7])
C. Does the project involve trans-border (i.e. interstate or overseas) dataflow?
/ No
/ Yes(IfYes,givedetailsofhowthiswillbecarriedoutinaccordancewithrelevantPrivacyPrinciples [e.g. HPP 9,APP 8,APP9])
D. Forwhatperiodoftimewilltheinformationberetained?Howwilltheinformationbedisposedof attheendofthisperiod?
E. Describethesecurityarrangementsforstorageoftheinformation.Wherewilltheinformationbe stored?Whowillhaveaccesstotheinformation?
F. If data are to be stored in a databank for future research, provide thefollowing:
Refer to NS §3.2.7, §3.2.9(a), §3.2.9(b), §3.2.11 and§3.2.12.
Name ofDatabank
Form in which data will bestored / / Identifiable / / Re-identifiable / / Non-identifiable
Purpose of futureuse
How will restrictions on use of data be recorded to ensure futureadherence?
Data Custodian’sName
Position
Department
Organisation
G. Howwilltheprivacyofindividualsberespectedinanypublicationarisingfromthisproject?
H. Discussanyotherethicalissuesrelevanttothecollection,useordisclosureofinformation proposedinthisproject.Explainhowtheseissueshavebeenaddressed.