2/17/2021

RESEARCH ETHICS
By Chih-Ming Liang
Graduate Institute of Health
and Biotechnology Law

Summary

 Course Structure

 Course Requirement

 History of Research Ethics

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Course Structure

MAKE SURE THAT YOU CHECK

YOUR I'M@TMU EMAIL
REGULARLY

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Goals

 This course attempts to help

students understand the history,
basic principles, main subject
areas, and regulatory structure in
the field of research ethics.

Expections
 Not asking you to memorize details

 Not providing answers to all potential ethical problems

 True challenge is how to deal with actual ethical concerns

 Each concern might be unique and contextual

 This course attempts to help you:

 Know where to find relevant information

 Know where to find needed assistance

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Class Schedule
 9-Week Course
 Week 1: Online lecture 1 — Introduction and history
 Week 2: Film watching A
 Week 3: Online lecture 2
 Week 4: Online lecture 3
 Week 5: Online lecture 4
 Week 6: Film watching B + Online lecture 5
 Week 7: CTAREE Online Course
 Week 8: CTAREE Online Course
 Week 9: CTAREE Online Course

Week 2: Film watching A

 The Whistle Blower -- Dr. Hwang Woo Suk

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Week 2: Film watching A

Week 2: Film watching A

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Week 2: Film watching A

 Post-watching: leave comment on I'm@TMU

 Go to the Discussion section on I'm@TMU

 Find the Whistle Blower discussion thread.

 Use no more than 200 words to discuss:

 1. What exactly did Dr. Lee do wrong?

 2. If you were the whistleblower, what

would you do?

Week 3: Online Lecture 2

 Week 3: Online lecture 2

 Examples of research scandals

 Landmark documents for research ethics

 Handling research misconducts

 Conflict of interest policies

 Followed by an online quiz

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Week 4: Online Lecture 3

 Week 4: Online lecture 3

 Human subject protections

 Human subject protections in the US

 Establishing IRBs in the US

 How IRBs in the US review research protocol?

 Human subject protections in Taiwan

 Followed by an online quiz

Week 5: Online Lecture 4

 Week 5: Online lecture 4

 Animals in Research

 Professional responsibility

 Good Clinical Practice (GCP)

 Followed by an online quiz

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Week 6: Film Watching B

 On Being a Scientist
 by Centre for Innovation -

Leiden University
 http://tinyurl.com/y4wyoeeo

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On Being a Scientist

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Week 6: Film watching B

 Post-watching: leave comment on I'm@TMU
 Go to the Discussion section on I'm@TMU
 Find the On Being a Scientist discussion thread.
 Use no more than 200 words to:
 1. identify at least 2 ethical concerns/gray
areas raised in the movie.
 2. tell me how you personally would handle
those ethical concerns/gray areas.

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Week 6: Online Lecture 5 (bonus)

 Week 6: Online lecture 5

 FDA regulation on drug approval

 FDA regulation on medical device approval

 TFDA regulation on drug & medical device approval

 Will not be followed by an online quiz

Main subject areas

1. History and landmark documents

2. Institutional Responsibility: the role of the institution

3. Human Participation in Research: protect your subject

4. Using Animals in Research: when animals are involved

5. Professional Responsibility: data and publication

6. FDA regulation on drug and medical device approval

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Main subject areas

 Institutional Responsibility: the role of the institution

 Handling research misconducts
 Maintaining conflict of interest policies
 Establishing Institutional Review Board（IRB）
 Establishing Institutional Animal Care & Use Committee（IACUC）

Main subject areas

 Human Participation in Research: protect your subject

 Informed consent;
 Protecting privacy and confidentiality
 Protecting vulnerable populations
 Conducting IRB review based on levels of risk

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Main subject areas

 Using Animals in Research: when animals are involved

 Animal pain and distress
 Institutional Animal Care & Use Committee（IACUC）
 Basic principles: 3Rs

Main subject areas

 Professional Responsibility: how you should do search

 Proposing research
 Process of collaboration
 Data retention and access
 Presenting and publishing results
 Peer review

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Week 7~9: CTAREE ONLINE COURSE

 CTAREE Online Courses https://ethics.moe.edu.tw/

 WAIT FOR THE ID/PW PROVIDED BY THE UNIV. BEFORE

REGISTERING (mid-March).

 Take at least 18 units (at your own pace)

 Take the final exam and receive a 6hr certificate
 Submit the copy of Certificate by 4/23 to I'm@TMU.

 If you have already taken the course within the past year
and received a 6-hour certificate, you don’t have to
retake the course again. Simply upload the previous
certificate by 4/23.

Week 7~9: CTAREE ONLINE COURSE

 If correct course units are taken, the

CTAREE certificate can also serve as a
proof for 3-hr IRB training for
international students and 6-hr IRB
training for Taiwanese students.

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IRB Training Certificate

 For international students:

 1. CTAREE  Selecting the following units (available in English)

 Unit 0101、0102、0103、0113、0114、0115、0116、0201、

0204、0205

 Count as 3hr 20 minutes toward IRB training

 2. The instructor will also contact the TMU-IRB after the class is

over to see if they can issue an additional 3-hr IRB training hour

certificate for international students (no guarantee).

IRB Training Certificate

 For Taiwanese students
 Selecting any 18 units listed on the TMU-JIRB
website（https://tinyurl.com/yygufwaw）, which
will give you 6hrs toward IRB training.
 For meeting IRB training hour requirement, you
can also take external IRB training courses, but
in that case you still need to obtain a 6-hour
certificate for CTAREE online course to pass
this course.

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Course Requirements

Course Requirement

 Pass/Fail

 1. Watch online lectures 2~5 and complete following quizzes

 2. Watch The Whistle Blower and On Being a Scientist and

leave comments in the Discussion section of I'm@TMU

 3. Finish the CTAREE online course and submit the certificate

 4. Play The Lab interactive movie and report your process

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Quizzes
 The online lecture 2, 3, and 4 will each be followed by an
online quiz on I'm@TMU.

 You can re-take the quizzes as many times as you want

until you got 80-point or more.

 The access to the quizzes will be closed on 4/23, by

which time the instructor will make the answers public.

 Students can use I'm@TMU to discuss questions

regarding the quizzes even after the class is over.

Week 7~9: CTAREE ONLINE COURSE

 CTAREE Online Courses https://ethics.moe.edu.tw/

 WAIT FOR THE ID/PW PROVIDED BY THE UNIV. BEFORE

REGISTERING (mid-March).

 Take at least 18 units (at your own pace)

 Take the final exam and receive a 6hr certificate
 Submit the copy of Certificate by 4/23 to I'm@TMU.

 If you have already taken the course within the past year
and received a 6-hour certificate, you don’t have to
retake the course again. Simply upload the previous
certificate by 4/23.

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The Lab assignment

 The Lab（interactive movie on research misconduct）

 https://ori.hhs.gov/TheLab/

 Click Next and watch the introductory video.

The Lab assignment

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The Lab assignment

 Select one character and play with the movie until
you get a positive result

 In one page, write down the ethical challenges the

character faced and the choices made to overcome
the challenge and get to the positive result

 Submit the process report to “The Lab assignment

section” on I'm@TMU by 4/23.

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History behind Research Ethics

History and landmark documents

Human Subjects Research Training:

"Protecting Human Subjects" – Module 1

Produced by the Health Resources &

Services Administration, US Department
of Health and Human Services

https://www.youtube.com/watch?v=174SkSszRVg

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History and landmark documents

 Why research ethics became an important issue?

 How we respond to these challenges?
 Nuremburg Code 1947（Int’l）
 Helsinki Declaration 1964（Int’l）
 Belmont Report 1978（USA）
 Common Rules 1991（USA）
 Good Clinical Practice by ICH（Int’l）

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Thank you and see you soon

for online lecture 2

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