A Primer on the ACT Ethics Protocol for Candidates and Supervisors

advertisement
A Primer on the ACT Ethics Protocol for Candidates and Supervisors
The right hand column of the tables below indicate questions the HREC will ask that you
need to demonstrate you’ve considered and have responded to in your Ethics Protocol
submission.
The questions are keyed to the National Statement on Ethical Conduct in Human Research
(updated May 2013). NS1.1 (a) means National Statement Paragraph 1.1 sub paragraph (a).
RESEARCH MERIT
Research merit (NS 1.1-1.3 p.12)
Research justifiable by potential benefit
NS 1.1(a)
Uses appropriate methods to achieve aims
NS 1.1(b)
Based on current knowledge in literature
NS 1.1 (c)
Respect for participants not compromised by
aims, methods or results
NS 1.1 (d)
Conducted / supervised by those with
appropriate experience, qualifications &
competence.
NS 1.1 (e)
Use appropriate facilities & resources
NS 1.1 (f)
RESEARCH(ER) INTEGRITY
Research(er) Integrity (NS 1.3, p.12)
Researchers with integrity have commitment
to:
Searching for knowledge and understanding
NS 1.3(a)
Following recognized principles of research
conduct
NS 1.3(b)
Conducting research honestly; and
NS 1.3 (c)
Disseminating / communicating results, to
permit public scrutiny & add to public
knowledge / understanding
NS 1.3 (d)
Questions HREC will want to see you have
addressed in your Ethics Protocol
What is the benefit, to whom, & why does it
justify research?
Why are the methods appropriate?
What is the current knowledge? What
specific gap in the literature are you
addressing?
How do you demonstrate you have not
compromised respect for participants?
Explain why the experience, qualification
and competence of yourself, your
supervisor, or any third parties, who might
participate in the study, are appropriate to
use the methods proposed?
Why are the facilities and resources you
propose to utilise appropriate to the
research?
Questions HREC will want to see you have
addressed in your Ethics Protocol
What is the knowledge and understanding
that the researchers are seeking?
What are the recognised principles of
research conduct that the researchers will
use?
How will the research be conducted
honestly?
How will the results be disseminated to
permit scrutiny and contribute to public
knowledge and understanding?
1
A Primer on the ACT Ethics Protocol for Candidates and Supervisors
JUSTICE
Justice (fair recruitment etc) (NS 1.4, 1.5
p.12)
Within the scope and objectives of research,
selection, exclusion, inclusion of research
participants is fair, and accurately described
NS 1.4(a)
Process of recruiting participants is fair
NS 1.4(b)
No unfair burden of participation in research
on groups
NS 1.4 (c)
Fair distribution of benefits of participation
in research
NS 1.4 (d)
No exploitation of participants
NS 1.4 (e)
Fair access to the benefits of research
NS 1.4 (f)
Outcomes accessible to participants in
timely and clear manner
NS 1.5
BENEFICENCE
Beneficence (NS 1.6-1.9 p.13)
Likely benefit to participants or community,
must justify risks of harm / discomfort to
participants (NS 1.6, p.13)
Researchers responsible:
To design research to minimize risks of harm
and discomfort
NS 1.7(a)
To clarify potential benefits & risks; and
NS 1.7(b)
For welfare of participants in research
NS 1.7 (c)
Where no likely benefits to participants, risk
to participants lower than where likely
benefits
NS 1.8 p.13
Questions HREC will want to see you have
addressed in your Ethics Protocol
Why are the selection, inclusion and
exclusion criteria for the research fair?
How will they be accurately described in the
results?
Why is the recruitment process fair?
Why is there no unfair burden of
participation on particular groups?
How is the distribution of benefits of
participation fair?
Why is there no exploitation of participants?
How is access to the benefits of the research
fair?
How will timely and clear access to the
outcomes of the research be provided to
participants?
Questions HREC will want to see you have
addressed in your Ethics Protocol
Why do likely benefits of the research justify
any risks of harm or discomfort to
participants? What constitutes harm or
discomfort? (NS 2.1, p. 16)
How does the design minimize the risk of
harm / discomfort?
How are potential benefits and risks clarified
for participants?
How will researchers fulfil responsibility for
welfare of participants?
How have risks to participants been reduced
where participants will not benefit?
2
A Primer on the ACT Ethics Protocol for Candidates and Supervisors
RESPECT
Respect (NS 1.10, - 1.13, p.13)
Requires due regard for the welfare, beliefs,
perceptions, customs & cultural heritage of
individuals and collectives
NS 1.10
Respect for privacy, confidentiality & cultural
sensitivities
NS 1.11
Give due scope to capacity of human beings
to make own decisions
NS 1.12
Consent (NS2.2.2 p.19)
Where participants are unable to make own
decisions / have diminished capacity, respect
involves empowering and providing
protection
Voluntary participation based on
 Sufficient information about the research
 Adequate understanding of the purpose,
methods, demands
 Risks and potential benefits of the
research
Questions HREC will want to see you have
addressed in your Ethics Protocol
How does the research give due respect for
welfare, beliefs, perceptions, customs &
cultural heritage of participants?
How will researchers respect privacy,
confidentiality, customs & cultural
sensitivities of participants?
How will the research give due scope to the
capacity of participants to make their own
decisions?
Why is there sufficient information on which
participants can give informed consent?
Why will there be adequate understanding?
3
Download