Research Ethics Workshop (2010)

Overview

Ethical considerations Preparing your ethics application Q&A

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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 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 participationAnonymous participationAbility to withdraw at any time

Beneficence Assess potential benefitsAssess potential harm

Justice Fair selection of participantsFair 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? “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 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. Expedited review

2. Double review

3. Full review

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Preparing an application (Staff and Postgraduates)1. Application form

a) Use the correct (Staff/MPhil/PhD/EdD or TPG) and current formb) Should have a self-contained description of the research

procedures2. Attach questionnaires & interview protocols

a) Describe the intent of these if not yet developedb) If in Chinese, provide description in English

3. Attach all the appropriate consent formsa) Parents/guardians, adults, principalsb) In the dominant language – if Chinese, a close translation in

English is required4. 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 (pollyyiu@hkucc.hku.hk)

EdD, TPG and UG: Sharon Lim(limsl@hku.hk)

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 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 formPart C: risk assessment for new data (1) Check appropriate boxes (a) through (j)

Note that these boxes have changed recently; they now ask separately about similar risks (e.g., privacy, medical, stress)

Answer (k) through (t) ONLY if you checked “Yes” for at least one of (a) to (j)

k. Selection and recruitment of participants Describe the procedures for obtaining informed consent (oral

and written)

l. 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)

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The application formPart C: risk assessment for new data (2)

m. How will participants 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?

n. 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.”

o. Description of specific data collection, such as interviews, questionnaires

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The application formPart 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?

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.”

q. Can the participants be allowed to withdraw at any time 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)

r. Will there be any 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.”

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

E.g. You are the teacher and the researcher

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The application formPart 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 formPart 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

“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