Transcript Why conduct ethically-sound research?

Ethical Standards for
Conducting Research
at Unitec
Guidelines and Information for
research at Unitec
Prepared by Unitec Research Ethics Committee
(UREC)
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Why conduct ethically-sound research?
• Moral obligation
• Credibility
• Legal requirements
• Consequences
With ethics approval:
– secure legal position (researcher and Unitec indemnified)
– ACC & professional coverage
– Completion of dissertation / thesis
Without ethics approval:
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researcher, supervisor or even Unitec accepts legal liability
professional misconduct
inability to publish (not always)
failure to meet dissertation/thesis requirements
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Ethical considerations apply when…
Humans (or animals) are used as participants in projects
involving:
• questionnaires, interviews, focus groups
• clinical trials (medical intervention)
• some observational studies
• bodily tissues and fluids are collected
• treatments or exercises applied
• genetic modification
• use of personal, non-public information
• using property/material which is culturally, historically or
spiritually significant
• depiction of people in creative works
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What UREC do...
1. Our MAIN ROLE is to protect the research participants
2. PRIOR APPROVAL must be SOUGHT and GAINED
before research can commence
3. We consider ALL aspects of the research
Note: it is possible to make changes to approved
applications but the researcher must apply to UREC to
have the amendment approved. An amendment judged to
be significant by UREC may require a new application
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What are the principles of ethically sound
research?
• informed and voluntary consent
• doesn’t breach privacy
• minimisation of physical and emotional harm
• cultural and social sensitivity
• limitation of deception
• respects intellectual and cultural property ownership
• avoids conflicts of interest
• adequate research design to meet objectives
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Informed Consent
• Informed consent and ability to withdraw
involvement/data
• Special concern for:
• Children as participants – parental & child consent? (Note
that there is no set age of consent – depends on child’s
ability to give informed consent)
• Participants in relationship with researcher where researcher
can exercise power over the participant e.g. teacher-student,
doctor-patient, principal-teacher
• Other vulnerable subjects
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Anonymity & confidentiality
• Anonymity & confidentiality
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What is collected?
Who else has access to data or personal information?
Where is the information stored?
Note: provisions of the Privacy Act 1993 and any associated
codes e.g. The Health Information Privacy Code
Anonymity is when no information is collected about the
person’s ID
Confidentiality is when it is known but remains unrevealed
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Specific but common ethical issues (1)
• Cultural awareness
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Maori involvement
Intellectual and cultural property
Research involving participants of a specific ethnic group
Dealing (personally and collectively) with other cultures
• Sample size
• Recruiting participants (bias)
• Sensitive questions
e.g. Have you ever broken the law?
Are you using drugs?
What is your sexual orientation?
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Specific but common ethical issues (2)
• Conflict of interest
eg. Sponsoring agency influences outcome
Researcher benefits from a particular outcome
Note: may be closely associated with bias in research design or
process.
• Starting before approval is granted
• Intellectual property violation
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What then is the PROCESS for
seeking approval?
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Forms
• Forms, support documents and templates for staff are found on the
Unitec Intranet. For researchers these are on the Postgraduate &
Student Resources Moodle site and the UREC Moodle site for external
member reference
• Ensure that applicants are completing the current form
• Form A vs Form B (vs Form C)
– Form B is for non-contentious anonymous surveys - read by 1
reader.
– Form A is for all other applications - read by 3 readers.
– Form C is a blanket approval for a paper with a research component
• Applicants are Unitec staff, undergraduate and postgraduate students
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What should be included?
• Application form
• Information sheet – with sufficient information provided to allow for
informed consent
• Consent form (not required for anonymous survey as consent given
by completion of survey)
• Questionnaire, Interview material
• Organisational consent to recruit and/or research within the
organisation if researcher is recruiting and/or carrying out research
at a particular organisation (e.g. company, school, hospital, etc)
good template available for use in this situation
• Any other supporting documentation
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Process
• Principal researcher (applicant)
– applies for ethical approval (students should do this with supervisor)
• Supervisor (for student research)
– guides and informs student researcher
– signs application
• Head of Department
– signs application
• Completed forms submitted to research office by required
date.
• UREC ( Unitec Research Ethics Committee)
– evaluates ethics applications and informs applicant of decision
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Process Form A - Readers
• Research office allocates readers to applications by email about 10 days
ahead of each UREC meeting
• Form A has 1 primary reader, 2 secondary readers
• Secondary readers try to respond to primary reader within 2 days, where
possible. A carefully prepared application will facilitate this process
• Primary reader compiles comments from all readers and emails the
researcher with avaialable information AND advice that more comments
might be coming
• Researcher makes required/requested amendments, sends back to
primary reader
• The WHOLE committee then considers the application and changes
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Process From B - Readers
• Form B has one reader.
– Is normally fairly straight forward and can be
approved quickly
– Often noted at meeting with little discussion unless
any issues have arisen
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Readers contacting researchers
• Readers undertake to:
– Be polite, summarise comments in a logical order
– provide a contact phone number where appropriate recognising
that discussing the application is normally much faster than
emailing
– In extreme cases may choose to meet with the researcher
(easier for internal members)
• Notes:
– Often, all that is needed is more explanation or detail from the
researcher
– With students, the researcher will ensure that the supervisor is
involved in all communication (CC emails etc)
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At the UREC meeting
• The committee members work through the applications
– Give brief summary
– Ask for discussion
– Make a recommendation
• Possible Recommendations:
– Approve - all okay, research can start
– To be ratified (TBR) - if only minor changes required, committee
gives delegated authority to the primary reader to approve between
meetings, researcher can start, then committee ratifies the decision
at the next meeting
– On hold - large changes to be made. Re-reviewed at next meeting
– Decline
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What readers & UREC look for
• Ethical issues
– Following the principles previously discussed
• Procedural issues
– All forms completed and submitted, Unitec logo, standard ethics
statement on info and consent form, organisational consent
• Other
– Study design* (on an ethical basis), spelling, communication etc.
* We are not trying to tell researchers how to conduct
their study, but wasting participant time (or worse)
with poor research is part of our mandate.
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