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20-23 2010

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2010

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- - , , . , , , , 㳿 , , , , , , . , . , - . , 㳿, ( - Bio Brick). , . 140 .

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㳿. 2010 , , , , . , . - , ó, - . , , . . , 1,08 - . ֳ , , , - , . ³ , . . - , 30 , , - , - , (jus cosmopoliticum), 璺 , . . . , . . , , , , , . , , - - , , , ... - - - . . , , , - - , , - . ʳ - , , . , , . , , . -, ᒺ, . - .

, - 35 . 2) . , , , - , . . . 51,4 % , , 2. - . - , . - ;

59% , - , - , . - - . - , , - , . , , , - , . - , , - ;

23% . , - , . - / - , , ;


37% , , . - , / - . - , . , . - ;

34% , , / , . . - , 6% , - , - , , .

. . - 3) , . , - , - , ᒺ 򳺿 . . . , , - . ̳ , - ( 3, , . ), , , , ( 32), ( 52), , , , - ( , , - 55), - . , - . ( . , - - 13 . - , - , 32 % - . , , - , , . , . ( 34 , 3. ), A1/ : - - ( 42), ˲ֲ : ² , - ( 54) ( 13) . - , , - : .. ̳ , 1) - , , - 볻.

. , . 4) 1. - , , , - , . , , - . , , - . , - ̳ , 32 ticipants, and a gap has developed between law ̳ 쒿, ᒺ, - 30 % , and policy, on the books and in action.

, ̳ - , ).

, ̳ , ̳ The Common Rule regulations and Belmont . 4. , - principles apply to both biomedical & behavioral , - , research. There have been numerous complaints - (GCP) , by investigators about the fit between the federal ̳ ˳- . , - regulations and its IRB review requirements as , , they relate to social science research. Broad com- - - plaints range from the legitimacy of IRB review, . , . the lack of physical risks in social science (e.g., - - unneeded, over-burdensome requirements), par- , . . ticipants consent documentation (i.e., consent , - forms). . - ̳ , , - Dr. Lin will discuss bioethical problems in hu- .

man subject protections including IRB review of - : , social behavioral research, ethical challenges in , . , , biological sample and possible conflict of inter- 2. , , - ests at the individual and institution levels. - . . ..

, - , , - , A1/ , - . Ͳ ˲ , , , - () . ˲ Ͳ , - , , - , . , -.

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.). A1/ , - - , BIOETHICAL PROBLEMS IN HUMAN , , ˳ SUBJECT PROTECTION , - - . - - Melody Lin Office for Human Research Protection - , , US , ˳ - . , An institutional review board (IRB), also - , known as an independent ethics committee - ( ), (IEC) or ethical review board (ERB), is a com- , . 䳿 mittee that has been formally designated to ap- 50 , 3. - ..

prove, monitor, and review biomedical and be- - - havioral research involving humans with the aim . , to protect the rights and welfare of the research ᒺ, - . . subjects. In the United States, the Food and Drug . , Administration (FDA) and Department of Health , 5 - , .

and Human Services (specifically Office for Hu- , man Research Protections) regulations have em- - powered IRBs to approve, require modifications in , . , , planned research prior to approval, or disapprove , - .

research. An IRB performs critical oversight func- - tions for research conducted on human subjects - A1/ that are scientific, ethical, and regulatory. , , , - The system is governed by regulations under , - a Common Rule which has been adopted by 17 . : government agencies. The Common Rule lays out , .. procedures for Institutional Review Boards, what : ( kinds of research are exempt from their purview, , , 1. - 690 23.09. and what kinds of research should receive expe- .), dited review since there is minimal risk to partici- - - , - XX XXI pants. The difficulty has arisen, there are growing , - fault lines in the system that protects human par- , ( : 70 % , , 34 , , - , , , - , - - , . . XIX .. . , , , , (8.1). - - - , - , - . - , - (2.3), . . . . ( - ), , .. (2.4).

A1/ . 㳿 , , ò, XX - . : 2.5, ò: , - 2.6, 2.7, 2.10, 2.11, 3.15, 4.3, 4.5, 7.1, 7.5.

- - .. . - 㳿 - .. . . , - . , - ᒺ (2.12) , - - - . , . , , . - - , , , , . , - ˳.

A2/ 㳿, , ˲ - - ˲ֲ 2/ . - . - Ͳ ο , .. ղò: ² - 30 , . .. . ᒺ, , .. , .. , - , , , , .. - -, , , 㳿 . . ..

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