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O = 6Legal Framework for e-Research e-RESEARCH and PRIVACY776 )12 July 2007 David Ruschena Health Legal ** * zThe political environment  There will always be someone who opposes you Easily understood concepts are more powerful Perception is more important than reality Normalisation is essential All research exists at the public s sufferance(@(0  / What privacy means to e-Research ! TFrom the Researcher s perspective Higher research costs Lost opportunity costs Barriers to innovation Less effective cooperation and education Sub-optimal quality of data2"@(@" ("  (How (medical) researchers see themselves)) )  0@(@(  0)How the public sees (medical) researchers** * .Nature of the dilemma  Many people will not seek the health care they need if they believe that their information will not remain private. A single decision finding that there has been a intrusion on the privacy of the subject will have a chilling effect on e-Research generally.@(  *Relevant Legislation   !Privacy Act 1988 (Cth) Health Records and Information Privacy Act 2002 (Cth) Health Records Act 2001 (Cth) Personal Information Protection Act 2004 (Tas) Health Records (Privacy and Access) Act 1997 (ACT) Information Act 2002 (NT) Privacy and Personal Information 1998 (NSW) Information Privacy Act 2000 (Vic) Information Standard 42 on Information Privacy (SA) Section 135 AA National Health Act 1953 (Cth) Jurisdiction occurs where Information that reasonably identifies an individual Information is of a sensitive nature (health information)0PoPot  3    *   2What duties are owed?   Collection with consent (or exceptions) Use and Disclosure with consent (or exceptions) Accuracy Security Transborder Data Flows :&k   -How can e-Research proceed? Use non-identifiable / de-identified information Obtaining consent Use for a secondary purpose that is directly related and reasonably expected Relevant to public health plus hoops Relevant to health service management plus hoops@(  +De-identified Information  Can the individual s identity  is apparent, or can reasonably be ascertained ? By whom? With what additional data? <PP(yPu z 8Secondary purposeWhat types of secondary activities are reasonably expected? What scope of secondary activities is reasonably expected? Guidelines: reasonable expectations are  what a reasonable individual with no special knowledge of the health sector would expect to happen to their health information in the given circumstances. Everything the public knows, it learnt on television.4<PZ(9Zw u 6Obtaining consent * Voluntarily provided Based upon adequate information (sufficient detail and specificity) Given by a person with sufficient capacity and in appropriate circumstances Obtaining consent in advance Consent to different aspects of the project Allocation of appropriate resources Opt out v opt in NPP()PPP() + 4 The hoops   Inappropriate to use de-identified information Impracticable to seek consent of all individuals involved Collected in accordance with competent professional body Complies with Privacy Commissioner s Guidelines Additional security if disclosed to another party@(  5 The traps   Impracticability is not determined by HREC NRHMC:  impracticable means it is impossible in practice to obtain consent; obtaining consent is likely to cause unnecessary anxiety obtaining consent would prejudice the scientific value of the research; and public interest in the research substantially outweighs the public interest in privacy..IPZ(P-Z(X X  What are your long term goals?  Successful completion of individual research projects Successful publication of results of the research project Normalisation of eResearch Increased infrastructure to leverage existing results and expertise$P  7What are the best solutions? kUnderstand which legislation applies to you and your project Understand the privacy concerns that people raise If consent can be obtained, it must be obtained Split up the matters to which the subject is consenting Publicise your results to the community and to the subjects Sell eResearch as far and as wide as possible Be modest when developing databases lPl l /)>BEJLMNQTUVWXZ   0` 33` Sf3f` 33g` f` www3PP` ZXdbmo` \ғq>9y`Ӣ` 3f3ff` 3f3FKf` hk]wwwfܹ` ff>>\`Y{ff` R>&- {p_/̴>?" dd@ |?" dd@  " @ ` n?" dd@   @@``PR    @ ` ` p>>  F(  P  C A"Z  6.3  I 3  T Click to edit Master title style! !  0l13  v 3  RClick to edit Master text styles Second level Third level Fourth level Fifth level!     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