Transcript Slide 1

Research Ethics
Workshop (2010)
Overview
 Ethical considerations
 Preparing your ethics application
 Q&A
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Foundations – the Belmont Report
Three key principles
 Respect for persons
A research participant is treated as autonomous human
being who makes his/her own decisions and acts upon them
 Persons who are not able to do this must be protected from
coercion and from activities that harm them
 Beneficence
 Maximize possible benefits and minimize possible harm to
participants
 Both the researcher and society (university) have a
responsibility toward potential research participants
 Justice
 Benefits and burdens should be justly distributed
 Don’t just draw from pools of persons because you have
easy access to them … choose according to the
requirements of the research problem
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Ethical Principles
Application to Research Ethics
Respect for persons
Clear information (informed consent)
Voluntary participation
Anonymous participation
Ability to withdraw at any time
Beneficence
Assess potential benefits
Assess potential harm
Justice
Fair selection of participants
Fair access to benefits
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Respect for persons – some issues to
consider
 Are you providing enough information about the research
procedures?
 Copies of questionnaires and interview protocols
 What are participants expected to do? For how long?
 What will you ask participants to do and for how long? How
disruptive will it be?
 Who will have access to the data? For how long?
 What steps will you take to promote anonymity?
 What will you do with data from participants who are no
longer in the study?
 Should you provide participants a chance to review what you
write about them?
 Is the information you provide easy to understand?
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Beneficence – some issues to consider
 Have you identified potential benefits to the field and to participants in
particular?
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“Pilot studies suggest the new techniques should be beneficial”
“The study is expected to improve our understanding of …”
“Participants will be given the results of the assessment of …”.
 Have you identified potential harm?
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Physical harm
Privacy risks
Unusual stress
Changes to the learning environment
Potential for inferior examination results
 Have you considered the balance of potential benefits and potential
harms? … Is the intervention (disruption, inconvenience, invasion of
privacy, etc.) worth “the trouble”?
 Will participants be able to obtain the results of the research?
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Justice – some issues to consider
 Mostly for the academic review (funding
agency, supervisor), but have a sound
research design
 Do students in a course taught by the
researcher REALLY have the freedom to
refuse to participate?
 Could your recruitment practices be
coercive?
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A few stories from the field (1)
 “Johnny and May, please sit over there.” (Teacher asks two P-5
students to move away from the group while a class discussion
is video taped.) What do you think?
 Your experiment has a pre-test, post-test, and delayed post-test.
You started with 29 participants at the pre-test. Two participants
were absent from the post-test. Three different participants
withdrew from the study after the post-test. What would you do
with the data already collected from the participants who
withdrew?
 “The researcher has emailed me three times to ask to
participate in his study. I don’t want to be asked again. This is
harassment!” (An irate teacher) How would you handle it?
 A participant tells you something that might incriminate a person
if it became known. How would you handle it?
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A few stories from the field (2)
 “This letter is very threatening to our parents! What
do you mean, if you have concerns you may contact
xxx? What could happen that would lead a parent to
do that?” (P-4 teacher) How would you handle it?
 “I want to analyze the comments people make on
YouTube videos. Why do I need approval for that.
They are available to anyone!” What do you think?
 “I want to analyze the comments people make on
Facebook. Do I need prior approval for this?” What
do you think?
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Monitoring the ethics of research
procedures – goals and requirements
 To promote high ethical standards – respect
for persons, beneficence, and justice
 To protect the rights of research participants
 To protect the university from legal action
University requires:
 application for ethical approval
 Annual reporting, including withdrawals and
unusual incidents
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Is an application needed for my project? …
Yes! And before data collection begins
 “All research involving human participants by HKU
faculty members, MPhil, PhD, EdD, and TPG and
undergraduate students.”
 This includes research where the PI is at another
university and you are the co-I
Three types of review (for Staff, MPhil,PhD and EdD)
1.
2.
3.
Expedited review
Double review
Full review
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Preparing an application
(Staff and Postgraduates)
1.
2.
3.
4.
Application form
a)
Use the correct (Staff/MPhil/PhD/EdD or TPG) and current form
b)
Should have a self-contained description of the research
procedures
Attach questionnaires & interview protocols
a)
Describe the intent of these if not yet developed
b)
If in Chinese, provide description in English
Attach all the appropriate consent forms
a)
Parents/guardians, adults, principals
b)
In the dominant language – if Chinese, a close translation in
English is required
Attach Research proposal
a)
Not a substitute for (1)
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Preparing an application
(Undergraduates)
 Simplified procedure for undergraduate
students:
 one-page application form
 one-page summary research proposal
(attaching questionnaires and interview
questions, if applicable)
 consent form for school principals
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IMPORTANT
 Ethical approval prior to data collection
 Allow sufficient time for processing: ≥ 4 weeks
before the planned data collection
 Data collected prior to formal ethical approval
cannot be used
 UG and TPG students who have collected
research data before obtaining ethical
approval may be given a Fail grade for their
dissertation/project
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Where to send your application
 Staff, MPhil and PhD: Polly Yiu
([email protected])
 EdD, TPG and UG: Sharon Lim
([email protected])
 Please check website for updates regarding
contact persons and deadlines
 You need to send all files by email as well as
a signed hard-copy
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The application form (for Staff & PG)
Part B: Details of Research Proposal
Give a 1-page summary of the methods section of the
proposal
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Objectives and rationale of the study
Participants and their recruitment
Description of instruments and procedures
Any special procedures to improve ethics (e.g., making
participants comfortable, participant checks. Etc.)
 Put the reviewers “at ease” as early in the
application as possible!
 Don’t send reviewer to the proposal to try to find the
necessary details (they won’t do it)
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The application form
Part C: risk assessment for new data (1)
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Check appropriate boxes (a) through (j)
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k.
Answer (k) through (t) ONLY if you checked “Yes”
for at least one of (a) to (j)
Selection and recruitment of participants
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l.
Note that these boxes have changed recently; they
now ask separately about similar risks (e.g., privacy,
medical, stress)
Describe the procedures for obtaining informed consent (oral
and written)
Rationale for sample size calculation
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Explain why the sample size is appropriate for the study. “n =
27 is sufficient for detecting d = 0.5 at a power of 0.8. Allowing for
some attrition, a sample of 32 should be sufficient for the study.”
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The main concern is whether you are making unnecessary
demands on potential participants (cf. justice)
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The application form
Part C: risk assessment for new data (2)
m. How will participants be recruited/identified?
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n.
What are the inclusion and exclusion criteria?
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o.
Recall issues around justice. Are you collecting data from a given
population just because you can or is the sample necessary for the
study?
Are you using recruitment tactics that may seem overly aggressive?
Briefly explain if there are such criteria. “Only students diagnosed with
ADD will be included”. “All students in the course will be included in the
study.”
Description of specific data collection, such as
interviews, questionnaires
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The application form
Part C: Risk assessment for new data (3)
p.
Who will perform the data collection, how long will it
last and where will it be conducted?
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q.
Briefly answer. “Each child will be asked to undergo an
interview lasting 20 to 30 minutes. The interview will be
conducted, audio recorded, and transcribed verbatim by a
research assistant.”
Can the participants be allowed to withdraw at any
time without prejudice?
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Your answer must be “Yes!”
Make it clear that it is without prejudice. “Participants may
withdraw from the study at any time without giving reason.
If they do, it will not affect their grade and educational
experience.”
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The application form
Part C: Risk assessment for new data (3)
r.
Will there be any stress/discomfort to participants?
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“No” is not always convincing
If there are some things that may cause some stress explain them, and
explain what you intend to do to limit stress. “Some teachers are
uncomfortable with answering questions on the spot. Therefore, they will
be given the interview questions by email the evening before. The
interviewer will also try to create a relaxed atmosphere (e.g., by
interviewing in a familiar setting and beginning with small-talk before
moving to the main questions.”
s.
Please provide details of any audio and/or video
recording including the justifications for the
recording
t.
Please identify any potential conflict of interests and
how that potential conflict will be addressed
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E.g. You are the teacher and the researcher
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The application form
Part D: Using Existing documents or records
 NOTE: This applies only if you are using
personal data from these sources (not
curriculum documents, reports in the public
domain)
 Don’t forget to mention any direct benefits to
the participants – if there are some
 Not mentioned on the form: You need to
ensure that you also have permission from
the owner to use the data, if they are not in
the public domain
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The application form
Part F: Benefits
 Be as explicit as possible
 Don’t forget to mention any direct benefits to
the participants – if there are any
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The consent form
See helpful hints PPT on web site
 Keep the language simple. Most parents will not understand
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“students will engage in collaborative knowledge construction.”
Use the language used most typically at the school. Even at EMI
schools, communication with parents may be in Chinese.
Watch out for potentially coercive language.
The information you provide to parents/students MUST include:
 A summary of the procedures to be followed
 That participation is voluntary and can be withdrawn without
prejudice
 The potential for stress/discomfort
 How to contact the PI and the HRECNCF
 The potential benefits of the study
But don’t overdo it! There is no need to scare away potential
participants
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