Ethic review in clinical research :risk/benefit analysis

Abstract

Abstract: One of the major responsibilities of the IRB is how to assess the risks and benefits ofProposed research.The IRB' s assessment involves a series of steps,including identification and assessment of risks,determination of minimized risks,assessment of anticipated benefits,determination of reasonable risks in related to anticipated benefits,disclosure of risks and benefits,and continuing review.

Key words: medical ethic, clinical research, institutional review board, ethic review, risk benefit

CLC Number:

R96
R969

WANG Xiu-Qin, XIONG Ning-Ning, LIU Shen-LIn, LI Qi-Yi, JIANG Meng, LIU Fang, ZOU Jian-Dong, BO Qing-Yan, GAO Wei-Min. Ethic review in clinical research :risk/benefit analysis[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2003, 8(6): 718-720.

[1]	ZHONG Wei, SHI Shuxia, QIN Qinyue, YU Guo. Measurement tools and rationality evaluation of clinical research coordinator's work ability and workload [J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2023, 28(8): 937-947.
[2]	LI Qingna, HUANG Ke, LU Fang, ZHAO Yang, QIU Panbo, WANG Shuge, GAO Rui. Characteristic and development of standard operating procedure of electronic data management in traditional Chinese medicine clinical research [J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2020, 25(5): 550-554.
[3]	GUO Wei, XIE Linli, CAO Liya, XIE Jiangchuan, XIA Peiyuan, CHEN Yongchuan. Analysis of the current status of clinical drug trial institutions in Chongqing and reflections on the establishment of regional institutions [J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2020, 25(10): 1125-1130.
[4]	CHE Jinjing. Application of biomarkers in clinical development of biologics and bioanalytical strategies [J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2020, 25(1): 22-31.
[5]	CHANG Qingqing, PENG Ying, WANG Guangji, SUN Jianguo. Clinical research progress of small molecule tyrosine kinase inhibitors as anti-hepatocellular carcinoma agents [J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2019, 24(8): 948-956.
[6]	XIAO Liang, ZHENG Gaozhe, HUANG Yumin. Research progress on risk-based management in clinical trials [J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2017, 22(8): 955-960.
[7]	SHAN Jiao-jiao,TANG Yi-qun,SHI Mei-qi, XIA Guo-hao, WANG Li,FANG Ying,ZHAO Jie. Impact of clinical pharmacists on protocol deviation in anti-cancer drug clinical trial [J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2014, 19(1): 33-37.
[8]	WANG Hui, HU Si-yuan. Clinical research design technical points on child anorexia treated by new TCM drugs [J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2012, 17(10): 1191-1195.
[9]	LI Wei, BO Qing-yan, ZOU Jian-dong, XIONG Ning-ning. Application of edit checks in clinical research data management [J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2009, 14(1): 76-79.
[10]	WANG Xiu-qin, XIONG Ning-ning, LIU Shen-lin, LI Qi-yi, JIANG Meng, LIU Fang, ZOU Jian-dong, GAO Wei-min, XUE Xue-kun. Ethic review in clinical research:cognitively impaired persons [J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2006, 11(8): 943-946.
[11]	WANG Xiu-qin, XIONG Ning-ning, LIU Shen-lin, LI Qi-yi, JIANG Meng, LIU Fang, ZOU Jian-dong, GAO Wei-min, XUE Xue-kun. Ethic review in clinical research:persons who are serving a sentence or receiving reeducation through labour [J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2006, 11(7): 837-840.
[12]	LIU Shen-lin, WANG Xiu-qin, XIONG Ning-ning, LI Qi-yi, JIANG Meng, LIU Fang, ZOU Jian-dong, GAO Wei-min, XUE Xue-kun. Ethic review in clinical research:women and pregnant women [J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2006, 11(4): 477-480.
[13]	. Key activities involved in conduct of clinical trials [J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2006, 11(3): 357-360.
[14]	BO Qing-yan, XIONG Ning-ning, ZOU Jian-dong, JIANG Meng, LIU Fang, WANG Xiu-qin, GAO Wei-min. Key role in clinical trial:clinical research coordinator [J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2006, 11(10): 1190-1193.
[15]	WANG Xiu-qin, XIONG Ning-ning, LIU Shen-lin, LI Qi-yi, JIANG Meng, LIU Fang, GAOWei-min. Ethic review in clinical research:medical devices [J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2005, 10(12): 1437-1440.

Ethic review in clinical research :risk/benefit analysis

PDF (PC)

Knowledge

Abstract

Cite this article

share this article

References

Related Articles 15

Recommended Articles

Metrics

Comments