ethical considerations in international collaboration for translational and clinical research
DESCRIPTION
In international collaboration, the normal practice is that researchers write consent form in one language, usually in English, and then they translate it into Chinese. Usually in international collaborations, we still try to follow Euro-American ethical codes for informed consent, confidentiality, subject protection and compensation. However, ethics are socially and culturally constructed. Is there universality of research ethics? How do researchers respond to local cultures and act ethically ?TRANSCRIPT
Ethical Considerations in International Collaboration for
Translational and Clinical Research
Airong Luo, PhDHaihong Zhang, MA
Margaret Ann Murphy, PhD
UM-PUHSC Joint Institute Symposium 2012
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Research Questions
Is there universality of research ethics?
How do researchers respond to local cultures and act
ethically ?
Methods
Semi structured interviews with:
16 patients at PUHSC and 16 patients at UM
What Motivates Patients to Participate in Clinical Research?
Both US and Chinese Patients Altruism
Chinese Patients Reputation of physicians and institution Financial considerations Peer influence Trust for the country (esp. rural
patients)
If Shenzhou 9 spacecraft was launched and couldn’t return, what shall the researchers do? This research is for our country, but not for individuals…… This is also a research project. As long as it is research, it doesn’t matter. Also they (researchers) are confident. If they are not confident, they will not ask you to participate in the research project. No matter they treat you with shots or drugs, if they are not confident, they will not give you a shot. These shots are not for free. One shot costs a lot. – A Chinese patient from rural areas
Blood Draw
Martin Pettitt, Red Apples
Examples of food Chinese patients believe are linked to increased blood circulation
Privacy and Confidentiality
• In the consent
• All personal information will be de-identified
• All documents
will be locked in cabinets or stored in password protected computers.
• Chinese patients’ understanding
• “I have no privacy”
• Privacy as “secret” but not “right”-- something too “bad” to tell
Should the patients be educated about their rights?
Who should educate them?
Theory vs.
Practice
Theory
Researchers should try by all means to protect patient information.
Practice
Many Chinese hospitals, two physicians share a clinical office to see patients. It is difficult to find a private room to perform
informed consent.
Patients’ Understanding of
Consent
Chinese Patients
US Patients• Indirect benefit (e.g.,
advance the knowledge, benefit future patients)
• Direct benefit perceived by the patients (e.g., free test, easier access to physicians)
• Not clear about difference between treatment and research
• Some know about but are not very clear about the follow-up visit frequency or procedures
• Indirect benefit (e.g., “compare research results with China”, “find a cure”)
• Not clear about difference between treatment and research
• Know about follow-up visit
How do researchers know whether patients understand the consent?
What should be included in the consent?
Family Consent?
Chinese Patients
US Patients
• Believe family will agree with the patient’s decision
• When there is disagreement, most will decide by themselves, while a few will follow their family’s decisions.
• Follow other family members’ suggestions
• Decide for themselves
• Don’t want family to be informed about their illness.
Is Monetary Compensation a
Must?
Chinese Patients
US Patients
• Not needed
• Not a must, but would be happy if paid
• Prefer free test or convenience to receive treatment
• Not needed
• Travel costs should be covered.
• Needed if substantial risks are involved
Thanks for
Dr. Anna Lok Mr. Ted Hanss Dr. Ray DeVries Dr. Ray
Hutchinson
Dr. Lai Wei Dr. Huiying
Rao Dr. Bo Feng Dr. Yali Cong
Questions? Comments?
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