ethical considerations in international collaboration for translational and clinical research

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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