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Research Ethics & Governance
Mr Bill Karanatsios Manager, Office for Research (Western Health)
Interim Manager, Clinical and Translational Science Platform The University of Melbourne
WH Research Training Workshop 26 Feb 2015
2
Research at Western Health
Office for Research: what we do
Governance of Human Research Ethics
Why Research Ethics Matters?
Research Misconduct
Risks in Human Research
Research Ethics Requirements
OVERVIEW
3
Research at Western Health
Office for Research: what we do
Governance of Human Research Ethics
Why Research Ethics Matters?
Research Misconduct
Risks in Human Research
Research Ethics Requirements
OVERVIEW
5
Research at Western Health
Office for Research: what we do
Governance of Human Research Ethics
Why Research Ethics Matters?
Research Misconduct
Risks in Human Research
Research Ethics Requirements
OVERVIEW
6
What we do
The Western Health Office for Research oversees and co-ordinates
research activities within Western Health.
Provides guidance to investigators and staff in the conduct of
research.
Seeks to enhance the excellence, scope and efficiency of research
efforts.
Facilitates and integrates all required regulatory steps in the
conduct of research.
7
WH Low Risk Ethics Panel Chair: Prof Edward Janus
OFFICE FOR RESEARCH Director: Prof Edward Janus
Manager: Bill Karanatsios
Research Coordinators Group Chair: Mr Bill Karanatsios
Ethics Admin Assistant Kerrie Russell
Biostatistician Dr Emily Karahalios
Admin Assistant Volunteers Research Ethics Intern Event Management Team
Research Governance Officer Virginia Ma
RESPONSIBILITIES:
Low Risk Projects Quality Assurance /
Improvement Single Site /Multisite
Amendments
RESPONSIBILITIES:
Research Ethics / Governance: Single Site Ethics (CT & non-CT) Multisite Ethics (CT & non-CT)
Low Risk Projects Quality Assurance/Improvement
RESPONSIBILITIES:
Study design Database development
Analysis of data Biostatistics Training
8
Research at Western Health
Office for Research: what we do
Governance of Human Research Ethics
Why Research Ethics Matters?
Research Misconduct
Risks in Human Research
Research Ethics Requirements
OVERVIEW
9
What is Human Research?
Human research is conducted with or about people, or their
data or their tissue.
Examples of human research:
Trials of clinical interventions
Interviews
Surveys
Focus Groups
Observations
Medical records
Clinical Audits
10
Australian Research Ethics National
Framework
NHMRC Statement on Human Experimentation and
Supplementary Notes (First published 1966, multiple
revisions, last revised 1992)
National Statement on Ethical Conduct in Research
Involving Humans (1999)
National Statement on Ethical Conduct in Human
Research (2007)
http://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/e72.pdf
Australian Code for the Responsible Conduct of
Research (2007) – Research Integrity not research
ethics, but an important document for your research
http://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/r39.pdf
In the National Statement (2007)
• Different research methods and disciplines:
– Qualitative research
– Human tissues
– Clinical trials
– Databanks
• Different types of participants – Children
– Overseas
– Aboriginal and Torres Strait Island people
• Ethical review – Membership and role of HRECs
– Low risk and negligible risk
– Duplication of review
• Researcher responsibilities
• Institutional responsibilities
http://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/e72.pdf
12
Research at Western Health
Office for Research: what we do
Governance of Human Research Ethics
Why Research Ethics Matters?
Research Misconduct
Risks in Human Research
Research Ethics Requirements
OVERVIEW
13
Principles of Ethics
Six of the values that commonly apply :
Autonomy - the right to refuse or choose their treatment.
Beneficence - act in the best interest of the patient.
Non-maleficence - "first, do no harm”
Justice - distribution of scarce health resources, and the decision of who gets what treatment
Dignity - the patient (and the person treating the patient) have the right to be treated with dignity.
Truthfulness & honesty - the concept of informed consent
14
Responsibility to participants
Professional obligations
Use of public funds carries with it obligations to the
community
Requirements of research funding bodies, state, federal
and international
Requirements of the Hospital insurer – indemnification of
researchers
Requirements of many journals
Reputation of the Hospital
Why research ethics matters?
15
Historical Cases of Unethical Research
• 1932-1972 Tuskegee Syphillis Study
• Denying standard care to a particular population by deception
• 1963-1966 Willowbrook Study
• Exploitation of a vulnerable population
• Children with mental retardation being infected with HepA
16
Responses to Ethical Violations
The Nuremberg Code (1949)
Produced in response to the Nuremburg trials, this
international guideline specifies responsibilities of
medical researchers.
The Declaration of Helsinki (1964):
Another important international document
specifying rules for medical research.
The Belmont Report (1978)
Legislation in 1974 created the National
Commission for the Protection of Human Subjects
of Biomedical and Behavioral Research
17
The role of an HREC
1. risk to subjects are minimized;
2. risk to subjects are reasonable in relation to anticipated benefits;
3. selection of subjects is equitable, i.e. fair;
4. informed consent is sought form each subject or his/her legally
authorized representative;
5. informed consent is appropriately documented;
6. when appropriate, the research plan makes provisions for monitoring
data collection;
7. privacy and confidentiality of research subjects is appropriately
protected; and
8. when some or all of the subjects are likely to be vulnerable to coercion
or undue influence, additional safeguards have been included.
A common mistake researchers make is to describe a project as
involving no risks
When what they actually mean is that there are strategies in place
to negate or minimise the risks
Risks in human research: Types
• What are some of the risks of Human Research.
– Physical (Injury, illness, harm)
– Psychological (significant distress)
– Social (impact on social networks, access to services and support)
– Economic (loss of income, earnings and cost to participants)
– Legal (exposure to civil or criminal proceedings)
– Humiliation (devaluation of worth)
– Environment (see Code not NS)
• Recognition of burden on participants.
Any research also holds reputational risks for both the researcher and the institution.
Risks in human research: Types
Assessing Risks • To whom do the risks apply?
– Participants, potential participants, third parties, environment, and / or researchers.
• Addressing risks
– Are there alternatives?
– Can risks be negated or minimised?
– Can risks be managed?
• Can the risks be justified?
• Disclosure to potential participants
Yet another common mistake is to focus only on the risks to the participants.
Risks in human research: Assessing
A failure to comply with the Code of Conduct for Research and includes conduct in, or in connection with, research that is
(a) dishonest, reckless or negligent and
(b) seriously deviates from accepted standards within the scientific and scholarly community for proposing, conducting or reporting research:
• the fabrication or falsification of data or results,
• the use of another person's ideas, work or data without appropriate acknowledgement (plagiarism),
• misleading ascription of authorship to a publication
• failure to disclose conflicts of interest
• failure to obtain the required prior ethical or regulatory approval for the research project to proceed;
• or failure to conduct the research project in accord with the approved ethical or regulatory protocol.
Research Misconduct
Procedures for dealing with allegations of misconduct in research are set out in:
•Staff: WH’s disciplinary policy; University’s Responsible Conduct of Staff Policy
•Students: University’s Student Discipline Policy
Research Misconduct: Disciplinary
Action
23
Research at Western Health
Office for Research: what we do
Governance of Human Research Ethics
Why Research Ethics Matters?
Research Misconduct
Risks in Human Research
Research Ethics Requirements
OVERVIEW
25
http://www.wh.org.au/Office_for_Research/index.aspx
26
Research at Western Health
Office for Research
Governance of Human Research Ethics
Why Research Ethics Matters?
Research Ethics Requirements
OVERVIEW
27
Research Governance vs. Research Ethics
ETHICS GOVERNANCE
The Ethics Submission is created to facilitate the scientific and ethical review of a research project by an Human Research Ethics Committee (HREC).
The Research Governance Submission is created to facilitate assessment of overall feasibility and compliance with institutional requirements of a research project by a governance or ethics officer.
Any accredited HREC can perform this function
Performed at individual institutions
28
QA, Low Risk & High Risk Research
QA Low Risk Research High Risk Research
STUDY DESIGN: Retrospective medical audit of current practice
Impact on patients? If review will identify issues that will require pts to be contacted/ treatment amended
Prospective study comparing "standard of care" vs. intervention
QUESTIONNAIRE BASED RESEARCH Questionnaires/survey of treatment group
Patients group – survey of patients outside “usual care”
DATA STORAGE: 12 months 5 years 5 years/ CT 15 years (For Children more)
CONSENT: Consent or waiver of consent
Consent or waiver of consent (data use related to purpose of collection)
Pts unable to consent for themself or waiver of consent (data use not related to purpose of collection)
DATA IDENTIFIABILITY: Data re-identifiable or non-identifiable
Collect and use identifiable data Collect, use and release of identifiable data
INTERVENTION & IMPACT RISK TO PARTICIPANTS – minimal or none
Participants – minimal impact and able to consent for themselves
Participants – high impact, unable to consent and/or “vulnerable” e.g. Children, pregnant women, mentally impaired
*Please note this table is a guide only and may not be applicable for all studies, please contact
the Office for Research for guidance if unsure.
29
Case Study
QA/QI
Low Risk
High Risk
Clinical Trials
GMOs
Others
Case Study:
DESCRIPTION
The clinical review of a single case report does not require
review by the WH Low Risk Ethics Panel or notification to the
Office for Research.
However journal editors may require evidence of project
approval prior to publication; if required, please email the Office
for Research to request formal acknowledgement.
REVIEW
Not required by the WH Low Risk Ethics Panel however;
Please provide a copy of the case study report/abstract being
published/presented for acknowledgement.
30
Case Study
QA/QI
Low Risk
High Risk
Clinical Trials
GMOs
Others
QA/QI:
DESCRIPTION
Evaluation or monitoring of a current service or practice, with
the aim of improving that service or practice.
Audits to identify and/or quantify the extent of a problem,
practice or behaviour to gain knowledge that may then be used
to improve a service or practice
Projects that seek to gain knowledge from monitoring and
evaluating the introduction of a new practice/procedure may
also fit the criteria of quality assurance.
REVIEW
QAs/QIs are reviewed out of session by one reviewer
31
Case Study
QA/QI
Low Risk
High Risk
Clinical Trials
GMOs
Others
Low Risk Projects:
Description
Research in which the only foreseeable risk is one of discomfort or
involving a vulnerable population group. Research, in which the risk
for participants is more serious than discomfort, is not low risk. (NS
Chapter 2.1).
REVIEW
At monthly LREP meeting, 3rd Thursday of every month.
32
Case Study
QA/QI
Low Risk
High Risk
Clinical Trials
GMOs
Others
High Risk Projects
DESCRIPTION
Examples of projects considered higher risk would include the
use of identifiable data in databanks, interventions or
therapies, use of human genetic samples, participants unable
to consent for themselves and research that may breach a
National Privacy Principle.
REVIEW
Full review via Melbourne Health HREC
http://research.mh.org.au
For paediatrics projects via RCH HREC www.rch.org.au
33
Case Study
QA/QI
Low Risk
High Risk
Clinical Trials
GMOs
Others
Clinical Trials
DESCRIPTION
Western Health is an accepting site under the Streamlined
Ethical Review Process (SERP) coordinated by the
Department of Health.
All projects reviewed under the multi-centre research umbrella
are required to submit a Research Governance application
(Site Specific Assessment) to the Office for Research.
REVIEW
Submit an application to Melbourne Health for ethical review
and submit a SSA to Western Health for Research
Governance and site authorisation
SERP - Submit an application to an approved reviewing HREC
for ethical review and submit a SSA to Western Health for
Research Governance and site authorisation.
http://www.health.vic.gov.au/clinicaltrials
34
Case Study
QA/QI
Low Risk
High Risk
Clinical Trials
GMOs
Others
GMOs
DESCRIPTION
Activities involving GMOs fall into four main categories:
Exempt dealings
Non-GMO Biohazard dealings and Risk Group 2/3
Notifiable Low Risk dealings (NLRD)
Licensed dealings (DNIR and DIR)
All dealings involving Genetically Modified Organisms (GMOs)
conducted at Western Health must be reviewed and approved
by either University of Melbourne /Victoria University
Institutional Biosafety Committee (IBC)
REVIEW
University of Melbourne /Victoria University IBC confirmation
letter
Western Health provides a Site Specific Authorisation
35
Case Study
QA/QI
Low Risk
High Risk
Clinical Trials
GMOs
Others
Others: University projects
DESCRIPTION
Projects involving WH’s staff or control subjects (not involving
WH patients)
REVIEW
WH accepts University’s Approval and provide Site Specific
Authorisations
36
Case Study
QA/QI
Low Risk
High Risk
Clinical Trials
GMOs
Others
Review Outcomes: What do they
mean?
APPROVED UNCONDITIONALLY
CONDITIONAL APPROVAL/ APPROVED SUBJECT TO…
ESCALATE TO FULL HREC
REJECTED
NO DECISION MADE
37
Case Study
QA/QI
Low Risk
High Risk
Clinical Trials
GMOs
Others
Review Outcomes: What do they
mean?
APPROVED UNCONDITIONALLY
• The project has met all the principles and guidelines of the
National Statement (2007) and WH Research Governance
requirements.
• Investigators MAY COMMENCE THEIR PROJECT once
they have received acknowledgment/approval
correspondence from the Office for Research.
• Investigators are required to notify the Office for Research
of the date when their project commences.
38
Case Study
QA/QI
Low Risk
High Risk
Clinical Trials
GMOs
Others
Review Outcomes: What do they
mean?
CONDITIONAL APPROVAL/ APPROVED SUBJECT TO…
• The project meets most of the principles and guidelines in
the National Statement (2007) and/or requires further
documentation for Research Governance.
• Investigators SHOULD NOT COMMENCE their study.
• Investigators are required to ADDRESS OR CLARIFY the
concerns and queries raised by the LREP and RESUBMIT
to the Office for Research.
• Approval is subject to a receipt of a satisfactory response
to the LREP queries.
39
Case Study
QA/QI
Low Risk
High Risk
Clinical Trials
GMOs
Others
Review Outcomes: What do they
mean?
REJECTED
• The project does not meet the principles and guidelines set
out in the National Statement (2007).
• Investigators SHOULD NOT COMMENCE their study.
• Investigators are to revise their application completely and
address the points raised by the LREP, this includes
requesting signatures from Investigators and Head of
Departments.
40
Case Study
QA/QI
Low Risk
High Risk
Clinical Trials
GMOs
Others
Review Outcomes: What do they
mean?
ESCALATE TO FULL HREC
• The project may not fall under the jurisdiction of the
Western Health LREP and require review by a fully
constituted Human Research Ethics Committee (HREC).
• Investigators must submit to Melbourne Health HREC
according to their requirements.
• Once ethical approval has been issued by the HREC,
investigators are required to submit a Governance
application to the Office for Research.
• Investigators SHOULD NOT COMMENCE THEIR STUDY
at Western Health UNTIL THEY HAVE RECEIVED
AUTHORISATION from the Office for Research.
41
Case Study
QA/QI
Low Risk
High Risk
Clinical Trials
GMOs
Others
Review Outcomes: What do they
mean?
NO DECISION
• The project is incomplete where the LREP cannot
adequately review the project.
• Investigators are required to clarify and revise submission
according to the LREP comments.
• Investigators SHOULD NOT COMMENCE their study.
42
Summary
Consider early: discuss with your supervisor/manager
Consult the Office for Research or see the website for
advice. Website: Intranet/Internet
Apply for the right level of review
Know the standards and justify the approach
Consider the perspective of a potential participant
Have someone (who has done it before) help you!
Don’t get disheartened if you have to do revisions
Ethical issues doesn’t mean the research is not permissible
Fully complete the form & include your attachments
43
Contact Us
Director: Prof E Janus | Manager: Mr Bill Karanatsios
RGO: Ms Virginia Ma | Ethics Admin Assistant: Mrs Kerrie Russell
Office for Research, Level 3 Western Centre for Health Research & Education
Sunshine Hospital - Furlong Road, St Albans VIC 3021
Phone: 03 83958074 Email: [email protected]
Web: www.wh.org.au/Office_for_Research
Topic Presenters Department Date Presenting Site
Footscray VC Site
Time
Introduction to Clinical Research
Prof Edward Janus General Medicine 12 Feb 15 Auditorium WCHRE, Sunshine
NONE 10:00AM-11:00AM
Research Ethics & Governance
Mr Bill Karanatsios Office for Research 26 Feb 15 Lecture Theatre WCHRE, Sunshine
Padua 10:30AM-11:30AM
Evaluating the literature TBC TBC 12 Mar 15 Auditorium WCHRE, Sunshine
Padua 10:30AM-11:30AM
Writing a research proposal
Dr Lizzie Skinner Physiotherapy, WH 02 Apr 15 Auditorium WCHRE, Sunshine
Mavis Mitchell 12:30PM-1:30PM
Beginners statistics: Study Design
Dr Emily Karahalios WH/UoM 16 Apr 15 Auditorium WCHRE, Sunshine
Mavis Mitchell 12:30PM-1:30PM
Using Excel for research Dr Lizzie Skinner Physiotherapy, WH 30 Apr 15 Auditorium WCHRE, Sunshine
Mavis Mitchell 12:30PM-1:30PM
Mixed Methods: Quantitative & Qualitative
Prof Paul Bennett Deakin School of Nursing
14 May 15 Auditorium WCHRE, Sunshine
Mavis Mitchell 12:30PM-1:30PM
Referencing and EndNote TBC (Referencing) Lynn Higgins (Endnote)
Office for Research / Library
28 May 15 Lecture Theatre WCHRE, Sunshine
NONE 12:30PM-1:30PM
Making Sense of your results
Dr Emily Karahalios WH/UoM 11 Jun 15 Auditorium WCHRE, Sunshine
NONE 10:30AM-11:30AM
Getting your work published
TBC TBC 02 Jul 15 Auditorium WCHRE, Sunshine
Padua 10:30AM-11:30AM
Writing Abstract for Research Week/ Conferences
TBC TBC 16 Jul 15 Auditorium WCHRE Mavis Mitchell 12:30PM-1:30PM
Western Health Research Training Workshops 2015 Please contact the Office for Research for any queries: Tel:(03) 8395 8073; E: [email protected]