Research Ethics Workshop

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Research Ethics Workshop

• Dr Bob Fox
• bobfox_at_hku.hk
• adapted from earlier presentation by
• Dr Jan van Aalst

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Overview

• Ethical considerations
• Preparing your ethics application
• Looking at some examples
• QA

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Foundations the Belmont ReportThree 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
• Dont 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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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 do to participants and for how
  long? How disruptive will it be?
• Who will have access to the data?
• What steps will you take to promote anonymity?
• How will you deal with situations where you do
  not have consent from ALL students in a class you
  are studying?
• 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 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?
• 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?
• Physical harm
• 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 of the research
  proposal (funding agency, supervisor) but
• 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

• A participant tells you something that might
  incriminate a person if it became known. How
  would you handle this situation?
• Do students really need to sign this? I just
  expect the researcher would not harm students.
  (A university lecturer)
• 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)
• These procedures are very common in our school.
  We cant expect parents to sign a form every time
  we want to run a questionnaire. Can we simply
  inform them and ask them to contact us if they
  object or have questions? (School principal)

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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

• All research involving human participants by HKU
  faculty members, MPhil, PhD, EdD, TPG and
  undergraduate students.
• This includes research where the PI is at another
  university and you are the co-I
• But two types of review
• Expedited review (submitted to FREC for vetting,
  then approved by HRECNCF in 1 week)
• Full review (submitted to FREC for vetting, then
  approved in HRECNCF in 3 weeks)

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Preparing an application

• Application form
• Use the correct (Staff/MPhil/PhD/EdD or TPG or
  UG) and current form
• Application forms submitted by staff and
  postgraduates should have a self-contained
  description of the research procedures
• Attach questionnaires interview protocols
• Describe the intent of these if not yet developed
• If in Chinese, provide description in English
• Attach all the appropriate consent forms
• Parents/guardians, adults, principals
• In the dominant language if Chinese, a close
  translation in English is required
• Research proposal
• Not a substitute for (1b)
• Needed when the proposal has not been reviewed
  before (e.g., by grants foundation or Rpg panel)

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Simplified procedure for undergraduate students

• One-page application form
• One-page summary of the proposed research-
  briefly describe the goals of your action
  research, the action you have planned, and a
  brief sequential description of the procedures to
  be used (i.e. data collection)
• Consent form for the school principal(Note For
  lab-based projects at SHS, the consent form for
  research participants is also required.)
• The questionnaires and interview questions to be
  used should be enclosed or at least described

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Sample applications
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Where to send your application

• Polly Yiu 2241 5460, Email pollyyiu _at_ hkucc.hku.h
  k (for Staff and MPhil/PhD Students)Simon Fung
  2859 8015, Email tcfung _at_ hkucc.hku.hk (for EdD,
  Undergraduate Taught Postgraduate Students)
• Please check website for updates regarding
  contact persons and deadlines

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The application formPart B Details of Research
Proposal

• Very helpful to give a 1 to 1 ½ page summary of
  the methods section of the proposal
• Goals and rationale for 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!
• Dont send reviewer to the proposal to try to
  find the necessary details

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The application formPart C risk assessment for
new data (1)

• Check appropriate boxes. Answer (a) through (h)
  ONLY if you checked Yes for at least one
• Selection and recruitment of participants
• Describe the procedures for obtaining informed
  consent (oral and written)
• Rationale for sample size calculation
• 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.
• The main concern is whether you are making
  unnecessary demands on potential participants
  (cf. justice)
• Remember that at the university level, reviewers
  may come from a medical research paradigm

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The application formPart C risk assessment for
new data (1)

• How will subjects be recruited/identified?
• 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?
• What are the inclusion and exclusion criteria?
• 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 formPart C Risk assessment for
new data (2)

• Who will perform the data collection, how long
  will it last and where will it be conducted?
• 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.
• Will participants be allowed to withdraw without
  prejudice?
• 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 formPart C Risk assessment for
new data (3)

• Will there be any psychological stress/discomfort
  to participants?
• 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.
• How will data be retained/destroyed/handled?(only
  in the form for TPG)
• Be specific on what you will do. The data will
  be kept in a locked filing cabinet at the PIs
  university office. Unprocessed data will be
  destroyed within 6 months of collecting it.
• Mention your plans for archiving data
• Dont give away the farm! No one is saying you
  must destroy data that you will need later.
• Think about how to minimize the potential for
  information getting into the wrong hands

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The application formPart F Benefits

• Be as explicit as possible
• Dont forget to mention any direct benefits to
  the participants if there are some

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The consent form See helpful hints PPT on web
site

• Keep the language simple. Most parents will not
  understand 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 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 dont overdo it! There is no need to scare
  away potential participants