Ethical Considerations in International Collaboration for Translational and Clinical Research
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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 ?
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Ethical Considerations in International Collaboration for Translational and Clinical Research
- 1. Ethical Considerations in International Collaboration for Translational and Clinical Research UM-PUHSC Joint Institute Symposium 2012 Airong Luo, PhD Haihong Zhang, MA Margaret Ann Murphy, PhD Unless otherwise noted, this material is made available under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/3.0/
- 2. Research Questions Is there universalityof research ethics? How do researchers respond to local cultures and act ethically ?
- 3. Methods Semi structured interviews with: 16 patients at PUHSC and 16 patients at UM
- 4. What Motivates Patients to Participate in Clinical Research?
- 5. Both US and Chinese Patients Altruism Chinese Patients Reputation of physicians and institution Financial considerations Peer influence Trust for the country (esp. rural patients)
- 6. 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
- 7. Blood Draw Examples of food Chinese patients believe are linked to increased blood circulation Martin Pettitt, Red Apples
- 9. • In the consent • Chinese patients’ understanding • All personal information will be • “I have no de-identified privacy” • All documents will be locked in • Privacy as cabinets or stored “secret” but not in password “right”-- protected something too computers. “bad” to tell
- 10. Should the patients be educated about their rights? Who should educate them?
- 12. Theory Researchers should try by all means to protect patient information.
- 13. 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.
- 14. Patients’ Understanding of Consent
- 15. Chinese Patients US Patients • Indirect benefit • Indirect benefit (e.g., advance the (e.g., “compare research knowledge, benefit future results with China”, “find a patients) cure”) • Direct benefit perceived by the patients (e.g., free test, easier access to physicians) • Not clear about difference • Not clear about difference between treatment and between treatment and research research • Know about follow-up visit • Some know about but are not very clear about the
- 16. How do researchers know whether patients understand the consent? What should be included in the consent?
- 17. Family Consent?
- 18. Chinese Patients US Patients • Believe family will • Follow other family agree with the patient’s members’ decision suggestions • Decide for • When there is themselves disagreement, most will decide by themselves, • Don’t want family to while a few will follow be informed about their family’s decisions. their illness.
- 19. Is Monetary Compensation a Must?
- 20. Chinese Patients US Patients • Not needed • Not needed • Not a must, but would • Travel costs should be happy if paid be covered. • Prefer free test or • Needed if convenience to substantial risks receive treatment are involved
- 21. Thanks for Dr. Anna Lok Dr. Lai Wei Mr. Ted Hanss Dr. Huiying Rao Dr. Ray DeVries Dr. Bo Feng Dr. Ray Dr. Yali Cong Hutchinson
- 23. Attribution Key for more information see: http://open.umich.edu/wiki/AttributionPolicy Use + Share + Adapt { Content the copyright holder, author, or law permits you to use, share and adapt. } Public Domain – Government: Works that are produced by the U.S. Government. (17 USC §105) Public Domain – Expired: Works that are no longer protected due to an expired copyright term. Public Domain – Self Dedicated: Works that a copyright holder has dedicated to the public domain. Creative Commons – Zero Waiver Creative Commons – Attribution License Creative Commons – Attribution Share Alike License Creative Commons – Attribution Noncommercial License Creative Commons – Attribution Noncommercial Share Alike License GNU – Free Documentation License Make Your Own Assessment { Content Open.Michigan believes can be used, shared, and adapted because it is ineligible for copyright. } Public Domain – Ineligible: Works that are ineligible for copyright protection in the U.S. (17 USC § 102(b)) *laws in your jurisdiction may differ { Content Open.Michigan has used under a Fair Use determination. } Fair Use: Use of works that is determined to be Fair consistent with the U.S. Copyright Act. (17 USC § 107) *laws in your jurisdiction may differ Our determination DOES NOT mean that all uses of this 3rd-party content are Fair Uses and we DO NOT guarantee that your use of the content is Fair. To use this content you should do your own independent analysis to determine whether or not your use will be Fair.
Editor's Notes
- 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.
- To answer these questions, we conduct a pilot qualitative study. We interviewed 16 patients who participated in the Liver HCV research project in A Chinese and US hospital.
- First, what motivates patients from the two countries to participate in Clinical Research?
- First we’re happy to see that patients from both countries have shown altruism. They want to contribute to research and contribute to the cure of HCV.
- This Chinese patient participated in two research projects at the same time the Liver HCV study and a clinical trial sponsored by a Pharm company. Even though the sponsors and research goals are clearly stated in the consent form and he claimed that he read the consent form, he actually didn’t care about who was the sponsor of the project. He trusted the researchers because he trusted the country. Patriotism really influenced his thoughts. When this interview was done, a hot news issue was that China launched a spacecraft. He related clinical research to the launching of spacecraft because he saw that the two projects shared the same goal to glorify his motherland. In the Statement on Professional and Ethical Responsibilities, the first clause is to reveal our research goals and sponsorship to the subjects. But for people who has never been to a research lab or read a research article, research is a far-fetched idea . They start to impose their thoughts on what research is.
- “Blood has a different meaning in Chinese medicine than it does in Western medicine. Blood not only transports nourishment, but also vitality. Blood is a material form of Qi. The Zang Fu organs form blood from food and drink. Blood is the basis for the formation of our skin, bones, muscles, and organs. Illness may be caused by Deficient Blood, Stagnant Blood, or Heat in the Blood.”http://www.healthcommunities.com/traditional-chinese-medicine/alternative-medicine/overview-of-tcm.shtmlChinese patients think their blood is very precious. They love to talk to you about different kinds of food they eat to increase blood circulation. Thus, when they decide to participate in a research project, the amount of blood draw is a critical factor for them to make decision. They have their own idea about the limit of blood draw and don’t necessarily trust the doctors. Chinese patients tend to be very concerned about the amount of blood draw when they participate in clinical research.
- When patients do not know understand their privacy rights, should they be educated and who should educate them?
- Theoretically, researchers should try all means to protect patient information.
- In reality, in many Chinese hospitals, two physicians share a clinical office to see patients. It is difficult to find a private room to perform informed consent.