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Ethics Training
Dr Nik Zeps
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What is Ethics?What is Ethics?
Moral philosophy–Right and wrong–Good and bad–Justice and virtue
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Codes of ethicsCodes of ethics
Applied ethics– Not always dichotomous
Bioethics– Coined in 1927 by Fritz Jahr– Field emerged in last 90 years
Prompted by unethical behaviour
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““getting” ethicsgetting” ethics
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The Ethics FrameworkThe Ethics Framework
Australian Context – Guidelines– Legislation– Policies
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• Research merit and integrity
• Justice
• Beneficence
• Respect for human beings
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Code of Responsible Code of Responsible Conduct Conduct
Is mandatory to implement by Australian Research Institutes– But who does?
Training? Written policies on data
collection, retention, distribution?
Key to public trust is transparent and accountable researcher behaviour
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HRECs or other?HRECs or other?
Who is required to do the review? 5.1 Institutional responsibilities
– 5.1.3 Institutions may establish their own processes for ethical review of research, or use those of another institution.
– 5.1.7 (low risk-5.1.18-5.1.21) and 5.1.8 (negligible risk 5.1.22-5.1.23)
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NS: Ethical ConsiderationsNS: Ethical Considerations
Guided by the National Statement on ethical conduct in human research 2007– Not simply a matter of regulatory compliance
1.1 Research Merit and Integrity– Is the study worth doing?– Are those doing the work competent and
trustworthy? 2 Risk and benefit
– Consent 3 Specific types of research 4 Specific populations 5 Governance and ethical review
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Important DistinctionsImportant Distinctions
…between substantive ethics and regulatory ethics
…between ethics and governance
…between ethics/governance and bureaucracy
J Kenner 2010
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Substantive Ethics vs Regulatory Substantive Ethics vs Regulatory EthicsEthics
“Substantive (research) ethics” relates to the evaluation of proposed research with a view toward ensuring proper respect for and protection of participants in that research as well as the promotion and facilitation of good research design and practice.
“Regulatory ethics” involves the quasi-regulatory, administrative systems used to review and approve proposed research.
J Kenner 2010
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Components of Research Components of Research GovernanceGovernance
Site-related assessments prior to project start-up– Fit with organisational priorities– Clarification of roles and responsibilities– Identification of potential/actual conflicts of interest– Supervisory relationships– Credentialing– Assessment of resources– Completion of grants processes– Budgetary matters– Contractual relationships/documentation (including IP and
publication)– Establishment of proper indemnity/insurance coverage– Compliance with relevant
laws/regulations/codes/guidelines/policies– Ethics approval, including scientific/technical assessments– Other risk management considerations
J Kenner 2010
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Components of Research Components of Research GovernanceGovernance
Responsibilities during research and after project completion– Monitoring by HREC of conditions of approval– Safety of participants– Data management and storage/confidentiality of research data– Financial management– Training/supervision/mentoring within project team– Exposure and management of research misconduct– Compliance with progress reporting obligations– Auditing (self, internal and external)– Managing complaints/concerns of (a) research team and (b)
participants– Ensuring proper project closure processes– Final reporting– Ensuring promised feedback to participants is provided– Monitoring security of data/tissue sample storage (including
destruction, if intended)– Consideration of secondary use of data/tissue samples
J Kenner 2010
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The Governance – Ethics The Governance – Ethics HierarchyHierarchy
Old model = Research projects are reviewed by a local HREC. (Many) governance matters devolved to site ethics administration.
Current model = Ethical review and research governance sit side by side as related and complementary processes. Promotes introduction of streamlined review programs.
Future model = Recognition that ethical review is but one component (amongst many) of research governance within an organisation.
Note: The last model more readily liberates an organisation to devolve ethical review to off-site HRECs if it wishes to – for single-site research as well as multi-centre research.
J Kenner 2010
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Beyond Ethics and Beyond Ethics and GovernanceGovernance
Bureaucracy …
Refers to administrative aspects of review and governance of research that do not appear to have a rational purpose in promoting or protecting the interests of participants, researchers or research sites
Usually emanates from misinterpretation or overzealous application of regulatory requirements or requirements developed by lawyers or wanna-be-lawyers that have not previously been considered necessary
J Kenner 2010
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Beyond Ethics and Governance Beyond Ethics and Governance (2)(2)
UFO = Unnecessary Formalistic Obstruction
Consequence of blind adherence to (apparent) regulatory requirements
The problem of “Ethics Creep”
Forces re-consideration of what we who are responsible for review, approval and monitoring of research are doing
J Kenner 2010
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E vs G vs B – Which is Which?E vs G vs B – Which is Which? Proper insurance coverage Proposed consent processes for eligible participants lacking
decisionmaking capacity Review of collaborative research agreements Review of budget Statistical rigour Amendment to a protocol Correspondence announcing an upcoming amendment to a protocol Reporting of expected adverse events from Sweden Sign off from the hospital IT department or outpatient clinic Sign off from Associate Investigators Typographical errors in the PICF form Typographical errors on the application form Repetition of participant information sheet information on the consent form Sponsor requirement for inclusion of US law references in an Australian
PICF Disclosure of potential conflict of interest of the Principal Investigator Disclosure of potential conflict of interest of a study coordinator Sponsor requirement for responsive correspondence from the HREC
regarding submission of a file note Review of request for patient input on layout of reception area
J Kenner 2010
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HoMER and 5.3.1HoMER and 5.3.1
Wherever more than one institution has a responsibility to ensure that a human research project is subject to ethical review (see paragraph 5.1.1, page 77), each institution has the further responsibility to adopt a review process that eliminates any unnecessary duplication of ethical review.
HoMER provides a framework to deliver on 5.3.1
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Benefits and risks: risks and Benefits and risks: risks and reviewreview
NS identifies three risk levels and relates these to proportionate levels of ethical review
More than low risk = risk is more than discomfort:HREC review requiredLow risk = risk is no more than discomfort:Low risk review mechanism permitted
Negligible risk = risk is no more than inconvenience:ONLY WHERE research uses EXISTING collections of non-
identifiable data about human beings, institutions MAY exempt research from review
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Low risk research 5.1.7Low risk research 5.1.7
For research that carries only low risk (see paragraph 2.1.6, page 18) and does not fall under any of the chapters listed in paragraph 5.1.6, institutions may choose to establish other levels of ethical review.
These levels are described in paragraphs 5.1.18 to 5.1.21.
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Low risk researchLow risk research 5.1.20 The levels of ethical review referred to in
paragraph 5.1.18 may include, but need not be limited to:
(a) review or assessment at departmental level by the head of
department; (b) review or assessment by a departmental
committee of peers (with or without external or independent
members); (c) delegated review with reporting to an HREC; or (d) review by a subcommittee of an HREC.
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Quality Improvement vs Quality Improvement vs ResearchResearch
Means to avoid review Not defined by whether intend to
publish Ethics review should be determined
by consideration of ethical issues– Some don’t believe researchers capable
of this But doesn’t have to be an HREC
Currently a project for AHEC
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Elements of a Good Ethics Elements of a Good Ethics ApplicationApplication
Communication– Application form– Supporting documents– Interview
National Ethics Application Form (NEAF) is a means to communicate that researchers have recognised and addressed the ethical issues
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NEAF - aimsNEAF - aimsDesigned to collect
– in one application all information about a human research proposal that an HREC reviewing that proposal would need, so as to be satisfied that
– the proposal met the relevant requirements of the National Statement and was ethically acceptable .
Hence, use of helps: Information buttons – explain what terms meant Guidance buttons – help in answering questions National Statement links – to relevant paragraphs
of NS Help phone line
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NEAF NEAF Demonstrate that ethical issues have been considered NEAF sections 1 Title and Summary 2 Researchers and investigators 3 Resources 4 Prior Reviews 5 Project 6 Participants 7 Participants specific 8 Confidentiality/ Privacy 9 Project Specific
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NEAF DemoNEAF Demo
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Why do we ask for Why do we ask for consent?consent?
Respect (NS 1.10)
Expression of Autonomy– empowerment
Altruism Compliance with
guidelines/legal requirements
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Demonstrating TrustDemonstrating Trust
Consent is the material demonstration of a process that indicates a patient ‘trusts’ the person/system they give it to.
Alternatives to consent are community trust in a system that demonstrates responsibility and accountability
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Consent (Chapter 2.2)Consent (Chapter 2.2)
Respect for a person = consent– Voluntary– Informed
Considerations– Communication
Mutual understanding– No coercion or pressure– Payment for participation
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CompetenceCompetence
Functional approach not status based
Competence to make particular decision at particular time
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Incompetence Competence
Simple Complex
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InformationInformation
Providing information is not merely satisfying a formal requirement (2.2.4)– Material information - participant
centred concept– Information that a reasonable person
would think was significant for making the decision to participate
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Skills for obtaining Skills for obtaining consentconsent
NS 3.1.13 Predicting what topics are likely to lead to distress will not always be easy. Researchers should have sufficient training to help them in making such predictions.
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FlexibilityFlexibility NS 3.1.16 The method of providing
consent in qualitative research depends on various factors, including the type of research, its level of sensitivity, its cultural context, and the potential vulnerability of the participants. In some contexts, the protection of vulnerable participants may favour a formal, written process of consent; in other contexts, an oral process.
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Implied consentImplied consent
NS 3.1.17 In some circumstances, consent may be implied by participation, for example the return of a survey, or the answering of a verbal question
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Renegotiating consentRenegotiating consent
2.2.8 In some research, consent may need to be renegotiated or confirmed from time to time, especially where projects are complex or long-running, or participants are vulnerable. Research participants should be told if there are changes to the terms to which they originally agreed, and given the opportunity to continue their participation or withdraw (see paragraphs 5.2.16 and 5.2.17, page 84).
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Research participants – impaired Research participants – impaired consentconsent
Coercion NS 2.2.9 } limited disclosureDeception NS 2.3.1-2.3.4} NEAF 5.1.2
Dependent relationships = example of coercionNEAF always asks about this – 6.4.1 – 6.4.5NEAF 6.1.1 assumes knowledge of examples in NS 4.3See also other NS references, e.g. NS 3.1.3-3, 3.3.13-18Leads to NEAF 7.4
Inducement NS 2.2.10/11* NEAF 6.6.1..*NHMRC Using the NS: payment
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Waiver of ConsentWaiver of Consent Section 2.3.6 of the NS
– A) low risk– B) benefits outweigh harms– C) Impracticable to get consent– D) No reason why a person would say no– E) Privacy protected– F) Adequate plan to protect confidentiality– G) A plan to feedback results (or not)– H) Commercial outcomes will not cause
disadvantage– I) Waiver is not unlawful
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Privacy and ConfidentialityPrivacy and Confidentiality
Privacy Laws– Commonwealth– State– Private sector
Confidentiality– Requirement of employment contract– Guarantee to patients (participants)
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Potential HarmsPotential Harms Invasion of privacy
– A sense of violation Concerns regarding
– inappropriate use– who has access– What use the information is put to
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A Good PICF – The Basic A Good PICF – The Basic ElementsElements
Invitation Nature and purpose of research Procedures/requirements of participation Risks and potential benefits Alternatives to participation Voluntary participation/right to withdraw Privacy and confidentiality Sponsorship/financial support Reimbursement (if any) End of project
– Reasons for termination– Consequences for participant
Availability of results Who to contact re concerns or complaints Approval by HREC Consent Form
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Breakout into table Breakout into table discussiondiscussion
Issues related to recruitment of specific groups
Consent processes– how much to rely upon PICF or are
there other considerations more important?
Feedback/discussion
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Alternative processesAlternative processes Standard information and process
for recruitment in departments that do research– Only provide information about
non-standard therapies and procedures Additional burdens and risks
– No PICF should be longer than 2 pages– Current system ignores usual practice
and leads to the conclusion that the only item of importance is the PICF
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Break for LunchBreak for Lunch
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Research Involving Human Research Involving Human biospecimensbiospecimens
Translational Research?‘ Bench to bedside and back again’ Requires a multidisciplinary team
approach– Laboratory– Clinical– Health Services– Primary care
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Developing new treatmentsDeveloping new treatments
Phase 1:Right dose?
Preclinical testing
Phase 2:Can it work?
Phase 3:What is best?
Lab tests
Clinical trialsAdvances in Technology
Clinical practice
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Patients
Clinical Phenotyping
Medical notes• Diagnostic Tests
•Pathology•Imaging•Genetics
•Medical History
Treatment •Standard•Trial
Follow Up
Clin
ical
Reg
istr
ies
Clinical Practice
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Patients
Biospecimens •Clinical Phenotype
Genomics-Proteomics •Genotyping
Follow Up •Prognosis•Prediction
Clinical Research
Res
earc
h D
atab
ases
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Types of ‘biobank’Types of ‘biobank’
Population based– Dedicated collections eg Busselton
Pathology services– Surgical resections– Biopsies– ‘Waste’ blood– Mortuary
Outpatient (biopsy/blood)– Direct to researcher
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Public trust: The result of good ethical Public trust: The result of good ethical researchresearch
But….
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Guidelines for Guidelines for Biobanks/databanksBiobanks/databanks
Privacy Act NATA/NPAAC ISBER Best Practices Manual NHMRC-HGAC Biobanks Information Paper
– http://www.nhmrc.gov.au/your_health/egenetics/practitioners/practitioners.htm
OECD Biobanks paper– Guidelines for Human Biobanks, Genetic
Research Databases & Associated Data
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ConsentConsent
How much should the participant understand?
What do we mean by ‘informed’ consent?– Poly-omic research?– Gene lists?
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Consent formConsent form F O R M 7 3 0 .8 U R N :
W A R E S E A R C H T I S S U E N E T W O R K C O N S E N T F O R M
S U R N A M E : F O R E N A M E : S E X :
D O B :
C o n s e n t fo r t is s u e / b l o o d ta k in g a n d t is s u e /b lo o d b a n k in g fo r c l i n ic a l r e s e a r c h I , _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ o f_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
h a v e re a d th e In fo rm a t io n B ro c h u re e n t i t le d “ W A R E S E A R C H T IS S U E N E T W O R K ” . ( D o c to r o r h e a lth p ro fe s s io n a l ) … … … … … … … … … … … … .. h a s e x p la in e d to m e a n d I u n d e rs ta n d th e c o n s e q u e n c e s in v o lv e d in m y v o lu n ta ry d o n a t io n o f t i s s u e a n d /o r b lo o d fo r th e W A R e s e a r c h T is s u e N e tw o rk . I h a v e h a d a n o p p o r t u n ity to a s k q u e s t io n s a n d a m s a t i s f ie d w ith th e a n s w e r s g iv e n
In m a k in g m y d o n a t io n , I u n d e r s ta n d a n d a g r e e th a t :
1 ) th e t i s s u e /b lo o d (w h ic h in th is c o n s e n t fo rm , in c lu d e s i t s c o n s t i tu e n ts a n d a n y c e l l l in e s d e riv e d f ro m
th e t i s s u e /b lo o d ) w il l b e u s e d in r e la t io n to (W R I T E I N P R O J E C T N A M E ) , 2 ) s a m p le s o f a n y t i s s u e /b lo o d o r d e r iv e d c e l l l in e /s h e ld in a b a n k w i l l b e d is c a rd e d u p o n m y w r i t te n
re q u e s t to th e W A R e s e a rc h T is s u e N e tw o r k P ro je c t M a n a g e r , 3 ) th e r e s u l t s o f r e s e a rc h s tu d ie s a re d e e m e d e x p e r im e n ta l a n d n o t fo r d ia g n o s t ic p u rp o s e s a n d th e r e fo re
n o t in te n d e d to b e p a s s e d b a c k to m e o r m y im m e d ia te f a m i ly , 4 ) I w is h / d o n o t w is h to b e in fo rm e d o f im p o r ta n t g e n e ra l r e s u l t s a n d th e p r o g re s s o f a n y s tu d y
th r o u g h a n e w s le t te r w h ic h w i l l c o n ta in in fo r m a t io n a b o u t th e s e s tu d ie s in a fo rm th a t w i l l n o t a l lo w in d iv id u a ls to b e id e n t i fie d ,
5 ) I c a n re q u e s t to k n o w m o re s p e c i fic d e ta i l s o f a n y s tu d ie s th a t u s e d m y s a m p le s a t a n y t im e b y c o n ta c t in g th e W A R T N ,
6 ) R e s e a rc h re s u l t s , a n d th e f a c t th a t I h a v e m a d e th is d o n a t io n , w i ll n o t b e r e v e a le d to a n y 3 rd p a r ty n o t d i r e c t ly p a r t o f m e d ic a l r e s e a r c h w i th o u t m y w r i t te n c o n s e n t , e x c e p t u n d e r s u b p o e n a ,
7 ) T h e W A R e s e a rc h T is s u e N e tw o r k w i l l n o t b e l ia b le fo r a n y lo s s o f o r d a m a g e to , th e t i s s u e /b lo o d u s e d in a c c o rd a n c e w i th th is fo rm ,
8 ) I w i l l n o t b e n e f i t f in a n c ia ll y i f th i s r e s e a rc h le a d s to d e v e lo p m e n t o f a n e w t re a tm e n t o r m e d ic a l te s t , 9 ) s to ra g e o f a n d a c c e s s to m y t i s s u e /b lo o d w i l l b e m a n a g e d b y a n A d v is o r y C o m m it te e a n d o n ly
re le a s e d w h e re th e re s e a rc h p ro p o s a l h a s b e e n a p p ro v e d b y a H u m a n R e s e a rc h E th ic s C o m m itte e , 1 0 ) I u n d e r s ta n d th a t in te rn a t io n a l re s e a rc h c o l la b o ra t io n u s in g m y t i s s u e /b lo o d w i l l o n ly ta k e p la c e
w h e re r e s e a rc h e rs a b id e b y e q u a l o r m o re s t r i n g e n t r e g u la t io n s o f p r iv a c y a n d e th ic s a s th o s e in A u s t r a l ia , a s a s s e s s e d b y a H u m a n R e s e a rc h E th ic s C o m m it te e
1 1 ) I g iv e p e rm is s io n to a c c e s s h e a l th in fo r m a t io n a b o u t m e re la te d to th e r e s e a rc h a re a d e f in e d in p o in t 1 a b o v e , s u c h a s i s k e p t in a m e d ic a l r e c o rd o r b y th e W A D e p a r tm e n t o f H e a l th , to a s s i s t m e d ic a l r e s e a rc h o n ly w h e re th e re s e a rc h p ro p o s a l h a s b e e n a p p r o v e d b y a H u m a n R e s e a r c h E th ic s C o m m it te e .
I D o
D o N o t
c o n s e n t to th e s to ra g e a n d u s e o f m y t i s s u e a n d /o r b lo o d (d e le te a s a p p ro p r ia t e ) fo r b io c h e m ic a l a n d g e n e t ic b a s e d m e d ic a l r e s e a rc h . … … … … … … … … … … … … … … ..… … … … … … … .… … … … N a m e o f P a tie n t S i g n a t u re o f P a ti e n t D a te … … … … … … … … … . … … … … … … … … … … .… .. … … … .… N a m e o f D o c to r S i g n a t u re o f D o c to r D a te
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Medical ResearchI have read the Information Brochure
entitled “WA Colorectal Research Group”, and Give my voluntary consent to the use
of my biological specimens and health information for medical research as
described therein.Agree/Disagree (delete as
appropriate)Signed
________________Name (printed)________________
Date________________
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Genetic InformationGenetic Information
Is it Exceptional?– Different to any other information?– Predictive– Deterministic– Nature versus nurture– Genes versus environment– Redundancy
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Epigenome:Changes in DNA methylationHistone modificationsChromosomal instability
GenomeChromosomal OrganizationCopy Number Variation Gene Fusion EventSingle Nucleotide PolymorphismSmall Insertions/deletions
Molecular Events During Molecular Events During TumourigenesisTumourigenesis
mRNA, miRNA,ncRNA
RNA pol II
DNA
chromosome
heterochromatin
euchromatin
nucleosome
TranscriptomeGene expressionAberrant expressionAltered miR –mRNA networksGene fusionsExpressed SNPs and mutations
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SNP/CNV Chip analysis, gDNA
sequencing
Tumour & normalgDNA
Genome SequencingGenome Sequencing
1) Profile matched DNAs on CNV/SNP array (Illumina 1M) and call ploidy and stromal gDNA contamination
2) Sequence fragment and long-mate pair libraries to a depth of 25 fold (75Gb)
3) Define Copy Number Variations
4) Define Structural Variations
5) Mine Single Nucleotide Variations
6) Mine insertion and deletions
7) Determine which events are somatic Vs germline
8) Benchmark calls against array data & validate leads
9) Collate all variants into the DCC
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ICGC Ethics and Policy ICGC Ethics and Policy CommitteeCommittee
Mandate– The Ethics and Policy Committee (EPC) is
responsible for examining and raising issues of consent, privacy protection, data access, ethical and legal topics relevant to the
International Cancer Genome Consortium (ICGC).
– The EPC will draft recommendations and policy statements or guidelines.
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Returning ResultsReturning Results Consideration must be
made regarding return of results (NS section 3.5.1)
Should not be an option for participants to decide yes or no at time of donation– How could they possibly
know whether they do or do not want results?
Researchers must not give results of any testing to individuals– Must be done by specialist
genetic services There is no ‘right’ to
results under Australian law
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First case in AustraliaFirst case in Australia
35 year old male– Pancreatic cancer (has subsequently
dies)– BRCA1/2 and PALB2 mutations– Has sisters
What do we do?– S95/s95a/s95aa
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Proposed ICGC data Proposed ICGC data embargoembargo
A key challenge with such pre-publication release of data is to balance the interests of the ICGC members to carry out and publish the initial global analysis on the data they have generated while accelerating the use of the data by the wider scientific community.
1 year moratorium?– On publication not access– In all cases data shall be free of
any restriction two years after its initial release
Is this ethical?
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DTC geneticsDTC genetics
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Insurance ImplicationsInsurance Implications
Duty to disclose– Should a participant tell their
insurance company they are a part of a study?
– No Australian moratorium Uk has don’t ask don’t tell policy
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Confidentiality: Data Publishing Confidentiality: Data Publishing Risk?Risk?
“Our findings show that such an approach does not completely conceal identity, since it is straightforward to assess the probability that a person or relative participated in a GWA study”
“greater emphasis is needed for providing mechanisms to confidentially share and combine individual genotype data across Studies”
MotiveOpportunityMeans
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Job candidates getting tripped up by Facebook many students learn the hard
way that online image can limit opportunity
By Wei Du msnbc.com updated 1:30 p.m. ET Aug. 14, 2007
Van Allen runs a company that recruits job candidates for hospitals and clinics across the country. With physicians in short supply, he was happy to come across the resume of a well-qualified young female psychiatrist. As part of his due diligence check, Allen looked her up in Facebook, a popular social networking Web site, and found things that made him think twice. “Pictures of her taking off her shirt at parties,” he said. “Not just on one occasion, but on another occasion, then another occasion.”
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CommercialisationCommercialisation
Should anyone be allowed to make $$ out of selling the human body?
Do patients have an interest in trade or discovery?
NHMRC paper on Commercialisation of Human Tissue Products– Release July 2010– Possible guidelines to come
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DTC geneticsDTC genetics
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Revision to 3.4/3.6Revision to 3.4/3.6
Combine the two chapters New title “Biospecimens” Focus is on consent, identifiability
and risk to donor. Targeted consultation finished
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Safety ReportingSafety Reporting
A.The SAE labyrinth
B.The NHMRC Alerts – Rationale and Interpretation
C.(Data) Safety Monitoring Committees
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Safety Reporting (2)Safety Reporting (2)
SAEs/SUSARs Why we have them What we are expected to do with them Why the Australian system doesn’t work What the NHMRC Alerts advise/require Why the problem isn’t solved Options for coping in the short and long
term
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Safety Reporting (3)Safety Reporting (3)Safety Monitoring Committees (SMCs) Purpose is to ensure the safety of participants Reviews the efficacy and safety data from a clinical
trial– analyses the risks and benefits to the subject population– advises on serious safety considerations or lack of efficacy arising
out of the trial– safeguards the integrity of the trial data
Key factors:– expertise– independence
from project from sponsor
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Safety Reporting (4)Safety Reporting (4)Models for SMCs Commercially sponsored Phase I trials
– PIs + company reps + independent experts Commercially-sponsored Phase II/Phase III non-reg trials
– Pharmacovigilance committee (appointed, often internal) Commercially-sponsored Phase III registration trials
– Independent experts only Cooperative group-sponsored trials
– Investigators +/- project-independent experts Investigator-initiated (in-house) trials
– Investigators +/- in-house project-independent researchers_________________________________________________________** HRECs should review and approve a properly constituted
SMC.** A properly constituted/properly functioning SMC can help
resolve the SAE/SUSAR conundrum.
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