5. • Research involving humans
– ranges widely, including attempts to understand
the broad sweep of history, the workings of the
human body and the body politic, the nature of
human interactions and the impact of nature on
humans
• research is defined as an undertaking intended to extend
knowledge through a disciplined inquiry or systematic
investigation.
From Canada Tri-Council Policy Statement, p.7
08/22/13
一、什麼是人類研究？
國外定義
5
6. • Research on human subjects
– Human subject means a living individual about
whom an investigator (whether professional or
student) conducting research obtains
• Data through intervention or interaction with the
individual, or
• Identifiable private information
– Research means a systematic investigation, including research
development, testing and evaluation, designed to develop or
contribute to generalizable knowledge
From USA common rule 45CFR 46.102
08/22/13
一、什麼是人類研究？
國外定義
6
12. 四、國內外研究倫理規範介紹
國際公約
• 紐倫堡公約（ The Nuremberg Code ）
• 赫爾辛基宣言（ Declaration of Helsinki)
• 世界人權宣言 (The Declaration of Human
Rights)
• International Declaration on Human Genetic
Data
• Universal Declaration on Bioethics and
Human Rights
08/22/1312
13. 08/22/13
四、國內外研究倫理規範介紹
USA & Canada
Belmont Report,
USA
– Respect for Persons
– Beneficence
– Justice
Tri-Council Policy
Statement, Canada
– Respect for Persons
– Concern for Welfare
– Justice
13
14. • Framework for Research Ethics, UK ESRC
– Research should be designed, reviewed and undertaken to ensure
integrity, quality and transparency
– Research staff and participants must normally be informed fully about
the purpose, methods and intended possible uses of the research, what
their participation in the research entails and what risks, if any, are
involved. Some variation is allowed in very specific research contexts
– The confidentiality of information supplied by research participants and
the anonymity of respondents must be respected
– Research participants must take part voluntarily, free from any coercion
– Harm to research participants must be avoided in all instances
– The independence of research must be clear, and any conflicts of
interest or partiality must be explicit
08/22/13
四、國內外研究倫理規範 介紹
UK
14
15. • EU Codes of Ethics for Socio-Economic Research:
1. The research aims of any study should both benefit society and minimize
social harm.
2. Researchers should endeavour to balance professional integrity with
respect for national and international law.
3. Researchers should endeavour to ensure that research is commissioned and
conducted with respect for, and awareness of, gender differences.
4. Researchers should endeavour to ensure that research is commissioned and
conducted with respect for all groups in society, regardless of race,
ethnicity, religion and culture.
5. Researchers should endeavour to ensure that research is commissioned and
conducted with respect for underrepresented social groups and that
attempts are made to avoid their marginalisation or exclusion.
08/22/13
四、國內外研究倫理規範介紹
European Union
15
16. • Ethical socio-economic research encompasses the following
principles:
6. Researchers should endeavour to ensure that the concerns of relevant
stakeholders and user groups are addressed.
7. Researchers should endeavour to ensure that an appropriate research
method is selected on the basis of informed professional expertise.
8. Researchers should endeavour to ensure that the research team has the
necessary professional expertise and support.
9. Researchers should endeavour to ensure that the research process does
not involve any unwarranted material gain or loss for any participants.
10. Researchers should endeavour to ensure factual accuracy and avoid
falsification, fabrication, suppression or misinterpretation of data.
08/22/13
四、國內外研究倫理規範介紹
European Union
16
17. • Ethical socio-economic research encompasses the following
principles:
11. Researchers should endeavour to reflect on the consequences of research
engagement for all participants, and attempt to alleviate potential
disadvantages to participation for any individual or category of person.
12. Researchers should endeavour to ensure that reporting and dissemination
are carried out in a responsible manner.
13. Researchers should endeavour to ensure that methodology and findings
are open for discussion and peer review.
14. Researchers should endeavour to ensure that any debts to previous
research as a source of knowledge, data, concepts and methodology
should be fully acknowledged in all outputs.
15. Researchers should endeavour to ensure that participation in research
should be voluntary.
08/22/13
四、國內外研究倫理規範介紹
European Union
17
18. • Ethical socio-economic research encompasses the following
principles:
16. Researchers should endeavour to ensure that decisions about
participation in research are made from an informed position.
17. Researchers should endeavour to ensure that all data are treated with
appropriate confidentiality and anonymity.
18. Researchers should endeavour to ensure that research participants are
protected from undue intrusion, distress, indignity, physical
discomfort, personal embarrassment, or psychological or other harm.
08/22/13
四、國內外研究倫理規範介紹
European Union
18
22. 五、國際知名研究倫理案例介紹
(1)
• Case study:
– The Public Health Service Syphilis Study (1932-
1972)
• Ethical concerns: lack of informed consent, deception,
withholding information, withholding available treatment,
putting men and their families at risk, exploitation of a
vulnerable group of subjects who would not benefit from
participation. < 引自 CITI 線上課程內容 “ History and Ethical principles”
https://www.citiprogram.org/Default.asp? >
08/22/1322
23. 五、國際知名研究倫理案例介紹
(2)
08/22/13
• Case study:
– Stanley Milgram‘s “Obedience to Authority
Study” (1963) ( 短片播放) (Discovery版)
• Ethical concerns: Deception experiment, unanticipated
psychological harms. < 引自 CITI 線上課程內容 “ History and Ethical
principles” https://www.citiprogram.org/Default.asp? >
23
24. 五、國際知名研究倫理案例介紹
(3)
08/22/13
• Case study:
– Laud Humphreys’ “Tea Room Trade" (1970)
• Ethical concerns: use of a vulnerable population, reinforced
image that social scientists use deception casually in research.
< 引自 CITI 線上課程內容 “ History and Ethical principles”
https://www.citiprogram.org/Default.asp? >
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