Requirements for ethical justification of clinical trials
Conduction of the clinical trials on human subjects in order to gain data about efficiency and safety of the new drugs, medical devices and behavioral interventions is the essential part of the process of improvement in medical science. Yet, there are many potential risks of mistreat or abuse of the...
Ausführliche Beschreibung
Autor*in: |
Živojinović Dragica [verfasserIn] |
---|
Format: |
E-Artikel |
---|---|
Sprache: |
Englisch ; srp |
Erschienen: |
2012 |
---|
Schlagwörter: |
---|
Übergeordnetes Werk: |
In: Zbornik Radova: Pravni Fakultet u Novom Sadu - University of Novi Sad, Faculty of Law, 2017, 46(2012), 1, Seite 331-347 |
---|---|
Übergeordnetes Werk: |
volume:46 ; year:2012 ; number:1 ; pages:331-347 |
Links: |
Link aufrufen |
---|
DOI / URN: |
10.5937/zrpfns46-1790 |
---|
Katalog-ID: |
DOAJ050222325 |
---|
LEADER | 01000caa a22002652 4500 | ||
---|---|---|---|
001 | DOAJ050222325 | ||
003 | DE-627 | ||
005 | 20230503071012.0 | ||
007 | cr uuu---uuuuu | ||
008 | 230227s2012 xx |||||o 00| ||eng c | ||
024 | 7 | |a 10.5937/zrpfns46-1790 |2 doi | |
035 | |a (DE-627)DOAJ050222325 | ||
035 | |a (DE-599)DOAJ902c563b54d14e9f95cdd8953f6a8db6 | ||
040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
041 | |a eng |a srp | ||
100 | 0 | |a Živojinović Dragica |e verfasserin |4 aut | |
245 | 1 | 0 | |a Requirements for ethical justification of clinical trials |
264 | 1 | |c 2012 | |
336 | |a Text |b txt |2 rdacontent | ||
337 | |a Computermedien |b c |2 rdamedia | ||
338 | |a Online-Ressource |b cr |2 rdacarrier | ||
520 | |a Conduction of the clinical trials on human subjects in order to gain data about efficiency and safety of the new drugs, medical devices and behavioral interventions is the essential part of the process of improvement in medical science. Yet, there are many potential risks of mistreat or abuse of the subject's legal rights and safety once they are involved in these trials. Determinations of generally accepted demands of ethical justification for clinical trials provide decrease of risks for subjects that undergo the clinical trials. After analyzing the content of the international and regional declarations, ethical guidelines and local legal regulations, author finds that basic ethical requirements for conduction of the clinical trials are: scientific and social values and scientific validity, risk benefit ratio, fair subject selection, voluntary informed consent, respect of the subject's personal rights and independent ethical comity review. In this work, author explains the purpose of these demands, determines their correlation and conclude that all of them stand in mutual connection and interrelation. Only cumulative fulfillment of all of the named requirements allows ethically acceptable approach to conduction of clinical trials with avoiding the exploitation and providing the fair and dissent environment for subjects with full respect to their legal rights and safety. | ||
650 | 4 | |a clinical research | |
650 | 4 | |a ethical requirements | |
650 | 4 | |a Declaration of Helsinki | |
650 | 4 | |a exploitation of clinical research subject | |
653 | 0 | |a Law | |
653 | 0 | |a K | |
773 | 0 | 8 | |i In |t Zbornik Radova: Pravni Fakultet u Novom Sadu |d University of Novi Sad, Faculty of Law, 2017 |g 46(2012), 1, Seite 331-347 |w (DE-627)627314120 |w (DE-600)2557007-9 |x 24061255 |7 nnns |
773 | 1 | 8 | |g volume:46 |g year:2012 |g number:1 |g pages:331-347 |
856 | 4 | 0 | |u https://doi.org/10.5937/zrpfns46-1790 |z kostenfrei |
856 | 4 | 0 | |u https://doaj.org/article/902c563b54d14e9f95cdd8953f6a8db6 |z kostenfrei |
856 | 4 | 0 | |u http://scindeks-clanci.ceon.rs/data/pdf/0550-2179/2012/0550-21791201331Z.pdf |z kostenfrei |
856 | 4 | 2 | |u https://doaj.org/toc/0550-2179 |y Journal toc |z kostenfrei |
856 | 4 | 2 | |u https://doaj.org/toc/2406-1255 |y Journal toc |z kostenfrei |
912 | |a GBV_USEFLAG_A | ||
912 | |a SYSFLAG_A | ||
912 | |a GBV_DOAJ | ||
912 | |a SSG-OLC-PHA | ||
912 | |a GBV_ILN_11 | ||
912 | |a GBV_ILN_20 | ||
912 | |a GBV_ILN_22 | ||
912 | |a GBV_ILN_23 | ||
912 | |a GBV_ILN_24 | ||
912 | |a GBV_ILN_31 | ||
912 | |a GBV_ILN_39 | ||
912 | |a GBV_ILN_40 | ||
912 | |a GBV_ILN_60 | ||
912 | |a GBV_ILN_62 | ||
912 | |a GBV_ILN_63 | ||
912 | |a GBV_ILN_65 | ||
912 | |a GBV_ILN_69 | ||
912 | |a GBV_ILN_70 | ||
912 | |a GBV_ILN_73 | ||
912 | |a GBV_ILN_95 | ||
912 | |a GBV_ILN_110 | ||
912 | |a GBV_ILN_120 | ||
912 | |a GBV_ILN_151 | ||
912 | |a GBV_ILN_161 | ||
912 | |a GBV_ILN_206 | ||
912 | |a GBV_ILN_213 | ||
912 | |a GBV_ILN_230 | ||
912 | |a GBV_ILN_285 | ||
912 | |a GBV_ILN_293 | ||
912 | |a GBV_ILN_370 | ||
912 | |a GBV_ILN_602 | ||
912 | |a GBV_ILN_2001 | ||
912 | |a GBV_ILN_2003 | ||
912 | |a GBV_ILN_2005 | ||
912 | |a GBV_ILN_2006 | ||
912 | |a GBV_ILN_2009 | ||
912 | |a GBV_ILN_2010 | ||
912 | |a GBV_ILN_2011 | ||
912 | |a GBV_ILN_2014 | ||
912 | |a GBV_ILN_4012 | ||
912 | |a GBV_ILN_4035 | ||
912 | |a GBV_ILN_4037 | ||
912 | |a GBV_ILN_4112 | ||
912 | |a GBV_ILN_4125 | ||
912 | |a GBV_ILN_4126 | ||
912 | |a GBV_ILN_4249 | ||
912 | |a GBV_ILN_4305 | ||
912 | |a GBV_ILN_4306 | ||
912 | |a GBV_ILN_4307 | ||
912 | |a GBV_ILN_4313 | ||
912 | |a GBV_ILN_4322 | ||
912 | |a GBV_ILN_4323 | ||
912 | |a GBV_ILN_4324 | ||
912 | |a GBV_ILN_4325 | ||
912 | |a GBV_ILN_4326 | ||
912 | |a GBV_ILN_4335 | ||
912 | |a GBV_ILN_4338 | ||
912 | |a GBV_ILN_4367 | ||
912 | |a GBV_ILN_4700 | ||
912 | |a GBV_ILN_4753 | ||
951 | |a AR | ||
952 | |d 46 |j 2012 |e 1 |h 331-347 |
author_variant |
ž d žd |
---|---|
matchkey_str |
article:24061255:2012----::eurmnsoehclutfctoo |
hierarchy_sort_str |
2012 |
publishDate |
2012 |
allfields |
10.5937/zrpfns46-1790 doi (DE-627)DOAJ050222325 (DE-599)DOAJ902c563b54d14e9f95cdd8953f6a8db6 DE-627 ger DE-627 rakwb eng srp Živojinović Dragica verfasserin aut Requirements for ethical justification of clinical trials 2012 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Conduction of the clinical trials on human subjects in order to gain data about efficiency and safety of the new drugs, medical devices and behavioral interventions is the essential part of the process of improvement in medical science. Yet, there are many potential risks of mistreat or abuse of the subject's legal rights and safety once they are involved in these trials. Determinations of generally accepted demands of ethical justification for clinical trials provide decrease of risks for subjects that undergo the clinical trials. After analyzing the content of the international and regional declarations, ethical guidelines and local legal regulations, author finds that basic ethical requirements for conduction of the clinical trials are: scientific and social values and scientific validity, risk benefit ratio, fair subject selection, voluntary informed consent, respect of the subject's personal rights and independent ethical comity review. In this work, author explains the purpose of these demands, determines their correlation and conclude that all of them stand in mutual connection and interrelation. Only cumulative fulfillment of all of the named requirements allows ethically acceptable approach to conduction of clinical trials with avoiding the exploitation and providing the fair and dissent environment for subjects with full respect to their legal rights and safety. clinical research ethical requirements Declaration of Helsinki exploitation of clinical research subject Law K In Zbornik Radova: Pravni Fakultet u Novom Sadu University of Novi Sad, Faculty of Law, 2017 46(2012), 1, Seite 331-347 (DE-627)627314120 (DE-600)2557007-9 24061255 nnns volume:46 year:2012 number:1 pages:331-347 https://doi.org/10.5937/zrpfns46-1790 kostenfrei https://doaj.org/article/902c563b54d14e9f95cdd8953f6a8db6 kostenfrei http://scindeks-clanci.ceon.rs/data/pdf/0550-2179/2012/0550-21791201331Z.pdf kostenfrei https://doaj.org/toc/0550-2179 Journal toc kostenfrei https://doaj.org/toc/2406-1255 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_95 GBV_ILN_110 GBV_ILN_120 GBV_ILN_151 GBV_ILN_161 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 GBV_ILN_4753 AR 46 2012 1 331-347 |
spelling |
10.5937/zrpfns46-1790 doi (DE-627)DOAJ050222325 (DE-599)DOAJ902c563b54d14e9f95cdd8953f6a8db6 DE-627 ger DE-627 rakwb eng srp Živojinović Dragica verfasserin aut Requirements for ethical justification of clinical trials 2012 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Conduction of the clinical trials on human subjects in order to gain data about efficiency and safety of the new drugs, medical devices and behavioral interventions is the essential part of the process of improvement in medical science. Yet, there are many potential risks of mistreat or abuse of the subject's legal rights and safety once they are involved in these trials. Determinations of generally accepted demands of ethical justification for clinical trials provide decrease of risks for subjects that undergo the clinical trials. After analyzing the content of the international and regional declarations, ethical guidelines and local legal regulations, author finds that basic ethical requirements for conduction of the clinical trials are: scientific and social values and scientific validity, risk benefit ratio, fair subject selection, voluntary informed consent, respect of the subject's personal rights and independent ethical comity review. In this work, author explains the purpose of these demands, determines their correlation and conclude that all of them stand in mutual connection and interrelation. Only cumulative fulfillment of all of the named requirements allows ethically acceptable approach to conduction of clinical trials with avoiding the exploitation and providing the fair and dissent environment for subjects with full respect to their legal rights and safety. clinical research ethical requirements Declaration of Helsinki exploitation of clinical research subject Law K In Zbornik Radova: Pravni Fakultet u Novom Sadu University of Novi Sad, Faculty of Law, 2017 46(2012), 1, Seite 331-347 (DE-627)627314120 (DE-600)2557007-9 24061255 nnns volume:46 year:2012 number:1 pages:331-347 https://doi.org/10.5937/zrpfns46-1790 kostenfrei https://doaj.org/article/902c563b54d14e9f95cdd8953f6a8db6 kostenfrei http://scindeks-clanci.ceon.rs/data/pdf/0550-2179/2012/0550-21791201331Z.pdf kostenfrei https://doaj.org/toc/0550-2179 Journal toc kostenfrei https://doaj.org/toc/2406-1255 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_95 GBV_ILN_110 GBV_ILN_120 GBV_ILN_151 GBV_ILN_161 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 GBV_ILN_4753 AR 46 2012 1 331-347 |
allfields_unstemmed |
10.5937/zrpfns46-1790 doi (DE-627)DOAJ050222325 (DE-599)DOAJ902c563b54d14e9f95cdd8953f6a8db6 DE-627 ger DE-627 rakwb eng srp Živojinović Dragica verfasserin aut Requirements for ethical justification of clinical trials 2012 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Conduction of the clinical trials on human subjects in order to gain data about efficiency and safety of the new drugs, medical devices and behavioral interventions is the essential part of the process of improvement in medical science. Yet, there are many potential risks of mistreat or abuse of the subject's legal rights and safety once they are involved in these trials. Determinations of generally accepted demands of ethical justification for clinical trials provide decrease of risks for subjects that undergo the clinical trials. After analyzing the content of the international and regional declarations, ethical guidelines and local legal regulations, author finds that basic ethical requirements for conduction of the clinical trials are: scientific and social values and scientific validity, risk benefit ratio, fair subject selection, voluntary informed consent, respect of the subject's personal rights and independent ethical comity review. In this work, author explains the purpose of these demands, determines their correlation and conclude that all of them stand in mutual connection and interrelation. Only cumulative fulfillment of all of the named requirements allows ethically acceptable approach to conduction of clinical trials with avoiding the exploitation and providing the fair and dissent environment for subjects with full respect to their legal rights and safety. clinical research ethical requirements Declaration of Helsinki exploitation of clinical research subject Law K In Zbornik Radova: Pravni Fakultet u Novom Sadu University of Novi Sad, Faculty of Law, 2017 46(2012), 1, Seite 331-347 (DE-627)627314120 (DE-600)2557007-9 24061255 nnns volume:46 year:2012 number:1 pages:331-347 https://doi.org/10.5937/zrpfns46-1790 kostenfrei https://doaj.org/article/902c563b54d14e9f95cdd8953f6a8db6 kostenfrei http://scindeks-clanci.ceon.rs/data/pdf/0550-2179/2012/0550-21791201331Z.pdf kostenfrei https://doaj.org/toc/0550-2179 Journal toc kostenfrei https://doaj.org/toc/2406-1255 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_95 GBV_ILN_110 GBV_ILN_120 GBV_ILN_151 GBV_ILN_161 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 GBV_ILN_4753 AR 46 2012 1 331-347 |
allfieldsGer |
10.5937/zrpfns46-1790 doi (DE-627)DOAJ050222325 (DE-599)DOAJ902c563b54d14e9f95cdd8953f6a8db6 DE-627 ger DE-627 rakwb eng srp Živojinović Dragica verfasserin aut Requirements for ethical justification of clinical trials 2012 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Conduction of the clinical trials on human subjects in order to gain data about efficiency and safety of the new drugs, medical devices and behavioral interventions is the essential part of the process of improvement in medical science. Yet, there are many potential risks of mistreat or abuse of the subject's legal rights and safety once they are involved in these trials. Determinations of generally accepted demands of ethical justification for clinical trials provide decrease of risks for subjects that undergo the clinical trials. After analyzing the content of the international and regional declarations, ethical guidelines and local legal regulations, author finds that basic ethical requirements for conduction of the clinical trials are: scientific and social values and scientific validity, risk benefit ratio, fair subject selection, voluntary informed consent, respect of the subject's personal rights and independent ethical comity review. In this work, author explains the purpose of these demands, determines their correlation and conclude that all of them stand in mutual connection and interrelation. Only cumulative fulfillment of all of the named requirements allows ethically acceptable approach to conduction of clinical trials with avoiding the exploitation and providing the fair and dissent environment for subjects with full respect to their legal rights and safety. clinical research ethical requirements Declaration of Helsinki exploitation of clinical research subject Law K In Zbornik Radova: Pravni Fakultet u Novom Sadu University of Novi Sad, Faculty of Law, 2017 46(2012), 1, Seite 331-347 (DE-627)627314120 (DE-600)2557007-9 24061255 nnns volume:46 year:2012 number:1 pages:331-347 https://doi.org/10.5937/zrpfns46-1790 kostenfrei https://doaj.org/article/902c563b54d14e9f95cdd8953f6a8db6 kostenfrei http://scindeks-clanci.ceon.rs/data/pdf/0550-2179/2012/0550-21791201331Z.pdf kostenfrei https://doaj.org/toc/0550-2179 Journal toc kostenfrei https://doaj.org/toc/2406-1255 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_95 GBV_ILN_110 GBV_ILN_120 GBV_ILN_151 GBV_ILN_161 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 GBV_ILN_4753 AR 46 2012 1 331-347 |
allfieldsSound |
10.5937/zrpfns46-1790 doi (DE-627)DOAJ050222325 (DE-599)DOAJ902c563b54d14e9f95cdd8953f6a8db6 DE-627 ger DE-627 rakwb eng srp Živojinović Dragica verfasserin aut Requirements for ethical justification of clinical trials 2012 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Conduction of the clinical trials on human subjects in order to gain data about efficiency and safety of the new drugs, medical devices and behavioral interventions is the essential part of the process of improvement in medical science. Yet, there are many potential risks of mistreat or abuse of the subject's legal rights and safety once they are involved in these trials. Determinations of generally accepted demands of ethical justification for clinical trials provide decrease of risks for subjects that undergo the clinical trials. After analyzing the content of the international and regional declarations, ethical guidelines and local legal regulations, author finds that basic ethical requirements for conduction of the clinical trials are: scientific and social values and scientific validity, risk benefit ratio, fair subject selection, voluntary informed consent, respect of the subject's personal rights and independent ethical comity review. In this work, author explains the purpose of these demands, determines their correlation and conclude that all of them stand in mutual connection and interrelation. Only cumulative fulfillment of all of the named requirements allows ethically acceptable approach to conduction of clinical trials with avoiding the exploitation and providing the fair and dissent environment for subjects with full respect to their legal rights and safety. clinical research ethical requirements Declaration of Helsinki exploitation of clinical research subject Law K In Zbornik Radova: Pravni Fakultet u Novom Sadu University of Novi Sad, Faculty of Law, 2017 46(2012), 1, Seite 331-347 (DE-627)627314120 (DE-600)2557007-9 24061255 nnns volume:46 year:2012 number:1 pages:331-347 https://doi.org/10.5937/zrpfns46-1790 kostenfrei https://doaj.org/article/902c563b54d14e9f95cdd8953f6a8db6 kostenfrei http://scindeks-clanci.ceon.rs/data/pdf/0550-2179/2012/0550-21791201331Z.pdf kostenfrei https://doaj.org/toc/0550-2179 Journal toc kostenfrei https://doaj.org/toc/2406-1255 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_95 GBV_ILN_110 GBV_ILN_120 GBV_ILN_151 GBV_ILN_161 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 GBV_ILN_4753 AR 46 2012 1 331-347 |
language |
English |
source |
In Zbornik Radova: Pravni Fakultet u Novom Sadu 46(2012), 1, Seite 331-347 volume:46 year:2012 number:1 pages:331-347 |
sourceStr |
In Zbornik Radova: Pravni Fakultet u Novom Sadu 46(2012), 1, Seite 331-347 volume:46 year:2012 number:1 pages:331-347 |
format_phy_str_mv |
Article |
institution |
findex.gbv.de |
topic_facet |
clinical research ethical requirements Declaration of Helsinki exploitation of clinical research subject Law K |
isfreeaccess_bool |
true |
container_title |
Zbornik Radova: Pravni Fakultet u Novom Sadu |
authorswithroles_txt_mv |
Živojinović Dragica @@aut@@ |
publishDateDaySort_date |
2012-01-01T00:00:00Z |
hierarchy_top_id |
627314120 |
id |
DOAJ050222325 |
language_de |
englisch |
fullrecord |
<?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01000caa a22002652 4500</leader><controlfield tag="001">DOAJ050222325</controlfield><controlfield tag="003">DE-627</controlfield><controlfield tag="005">20230503071012.0</controlfield><controlfield tag="007">cr uuu---uuuuu</controlfield><controlfield tag="008">230227s2012 xx |||||o 00| ||eng c</controlfield><datafield tag="024" ind1="7" ind2=" "><subfield code="a">10.5937/zrpfns46-1790</subfield><subfield code="2">doi</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627)DOAJ050222325</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-599)DOAJ902c563b54d14e9f95cdd8953f6a8db6</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-627</subfield><subfield code="b">ger</subfield><subfield code="c">DE-627</subfield><subfield code="e">rakwb</subfield></datafield><datafield tag="041" ind1=" " ind2=" "><subfield code="a">eng</subfield><subfield code="a">srp</subfield></datafield><datafield tag="100" ind1="0" ind2=" "><subfield code="a">Živojinović Dragica</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">Requirements for ethical justification of clinical trials</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2012</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">Text</subfield><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">Computermedien</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">Conduction of the clinical trials on human subjects in order to gain data about efficiency and safety of the new drugs, medical devices and behavioral interventions is the essential part of the process of improvement in medical science. Yet, there are many potential risks of mistreat or abuse of the subject's legal rights and safety once they are involved in these trials. Determinations of generally accepted demands of ethical justification for clinical trials provide decrease of risks for subjects that undergo the clinical trials. After analyzing the content of the international and regional declarations, ethical guidelines and local legal regulations, author finds that basic ethical requirements for conduction of the clinical trials are: scientific and social values and scientific validity, risk benefit ratio, fair subject selection, voluntary informed consent, respect of the subject's personal rights and independent ethical comity review. In this work, author explains the purpose of these demands, determines their correlation and conclude that all of them stand in mutual connection and interrelation. Only cumulative fulfillment of all of the named requirements allows ethically acceptable approach to conduction of clinical trials with avoiding the exploitation and providing the fair and dissent environment for subjects with full respect to their legal rights and safety.</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">clinical research</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">ethical requirements</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Declaration of Helsinki</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">exploitation of clinical research subject</subfield></datafield><datafield tag="653" ind1=" " ind2="0"><subfield code="a">Law</subfield></datafield><datafield tag="653" ind1=" " ind2="0"><subfield code="a">K</subfield></datafield><datafield tag="773" ind1="0" ind2="8"><subfield code="i">In</subfield><subfield code="t">Zbornik Radova: Pravni Fakultet u Novom Sadu</subfield><subfield code="d">University of Novi Sad, Faculty of Law, 2017</subfield><subfield code="g">46(2012), 1, Seite 331-347</subfield><subfield code="w">(DE-627)627314120</subfield><subfield code="w">(DE-600)2557007-9</subfield><subfield code="x">24061255</subfield><subfield code="7">nnns</subfield></datafield><datafield tag="773" ind1="1" ind2="8"><subfield code="g">volume:46</subfield><subfield code="g">year:2012</subfield><subfield code="g">number:1</subfield><subfield code="g">pages:331-347</subfield></datafield><datafield tag="856" ind1="4" ind2="0"><subfield code="u">https://doi.org/10.5937/zrpfns46-1790</subfield><subfield code="z">kostenfrei</subfield></datafield><datafield tag="856" ind1="4" ind2="0"><subfield code="u">https://doaj.org/article/902c563b54d14e9f95cdd8953f6a8db6</subfield><subfield code="z">kostenfrei</subfield></datafield><datafield tag="856" ind1="4" ind2="0"><subfield code="u">http://scindeks-clanci.ceon.rs/data/pdf/0550-2179/2012/0550-21791201331Z.pdf</subfield><subfield code="z">kostenfrei</subfield></datafield><datafield tag="856" ind1="4" ind2="2"><subfield code="u">https://doaj.org/toc/0550-2179</subfield><subfield code="y">Journal toc</subfield><subfield code="z">kostenfrei</subfield></datafield><datafield tag="856" ind1="4" ind2="2"><subfield code="u">https://doaj.org/toc/2406-1255</subfield><subfield code="y">Journal toc</subfield><subfield code="z">kostenfrei</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_USEFLAG_A</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">SYSFLAG_A</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_DOAJ</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">SSG-OLC-PHA</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_11</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_20</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_22</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_23</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_24</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_31</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_39</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_40</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_60</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_62</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_63</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_65</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_69</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_70</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_73</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_95</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_110</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_120</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_151</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_161</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_206</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_213</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_230</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_285</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_293</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_370</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_602</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2001</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2003</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2005</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2006</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2009</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2010</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2011</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2014</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4012</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4035</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4037</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4112</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4125</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4126</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4249</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4305</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4306</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4307</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4313</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4322</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4323</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4324</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4325</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4326</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4335</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4338</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4367</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4700</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4753</subfield></datafield><datafield tag="951" ind1=" " ind2=" "><subfield code="a">AR</subfield></datafield><datafield tag="952" ind1=" " ind2=" "><subfield code="d">46</subfield><subfield code="j">2012</subfield><subfield code="e">1</subfield><subfield code="h">331-347</subfield></datafield></record></collection>
|
author |
Živojinović Dragica |
spellingShingle |
Živojinović Dragica misc clinical research misc ethical requirements misc Declaration of Helsinki misc exploitation of clinical research subject misc Law misc K Requirements for ethical justification of clinical trials |
authorStr |
Živojinović Dragica |
ppnlink_with_tag_str_mv |
@@773@@(DE-627)627314120 |
format |
electronic Article |
delete_txt_mv |
keep |
author_role |
aut |
collection |
DOAJ |
remote_str |
true |
illustrated |
Not Illustrated |
issn |
24061255 |
topic_title |
Requirements for ethical justification of clinical trials clinical research ethical requirements Declaration of Helsinki exploitation of clinical research subject |
topic |
misc clinical research misc ethical requirements misc Declaration of Helsinki misc exploitation of clinical research subject misc Law misc K |
topic_unstemmed |
misc clinical research misc ethical requirements misc Declaration of Helsinki misc exploitation of clinical research subject misc Law misc K |
topic_browse |
misc clinical research misc ethical requirements misc Declaration of Helsinki misc exploitation of clinical research subject misc Law misc K |
format_facet |
Elektronische Aufsätze Aufsätze Elektronische Ressource |
format_main_str_mv |
Text Zeitschrift/Artikel |
carriertype_str_mv |
cr |
hierarchy_parent_title |
Zbornik Radova: Pravni Fakultet u Novom Sadu |
hierarchy_parent_id |
627314120 |
hierarchy_top_title |
Zbornik Radova: Pravni Fakultet u Novom Sadu |
isfreeaccess_txt |
true |
familylinks_str_mv |
(DE-627)627314120 (DE-600)2557007-9 |
title |
Requirements for ethical justification of clinical trials |
ctrlnum |
(DE-627)DOAJ050222325 (DE-599)DOAJ902c563b54d14e9f95cdd8953f6a8db6 |
title_full |
Requirements for ethical justification of clinical trials |
author_sort |
Živojinović Dragica |
journal |
Zbornik Radova: Pravni Fakultet u Novom Sadu |
journalStr |
Zbornik Radova: Pravni Fakultet u Novom Sadu |
lang_code |
eng srp |
isOA_bool |
true |
recordtype |
marc |
publishDateSort |
2012 |
contenttype_str_mv |
txt |
container_start_page |
331 |
author_browse |
Živojinović Dragica |
container_volume |
46 |
format_se |
Elektronische Aufsätze |
author-letter |
Živojinović Dragica |
doi_str_mv |
10.5937/zrpfns46-1790 |
title_sort |
requirements for ethical justification of clinical trials |
title_auth |
Requirements for ethical justification of clinical trials |
abstract |
Conduction of the clinical trials on human subjects in order to gain data about efficiency and safety of the new drugs, medical devices and behavioral interventions is the essential part of the process of improvement in medical science. Yet, there are many potential risks of mistreat or abuse of the subject's legal rights and safety once they are involved in these trials. Determinations of generally accepted demands of ethical justification for clinical trials provide decrease of risks for subjects that undergo the clinical trials. After analyzing the content of the international and regional declarations, ethical guidelines and local legal regulations, author finds that basic ethical requirements for conduction of the clinical trials are: scientific and social values and scientific validity, risk benefit ratio, fair subject selection, voluntary informed consent, respect of the subject's personal rights and independent ethical comity review. In this work, author explains the purpose of these demands, determines their correlation and conclude that all of them stand in mutual connection and interrelation. Only cumulative fulfillment of all of the named requirements allows ethically acceptable approach to conduction of clinical trials with avoiding the exploitation and providing the fair and dissent environment for subjects with full respect to their legal rights and safety. |
abstractGer |
Conduction of the clinical trials on human subjects in order to gain data about efficiency and safety of the new drugs, medical devices and behavioral interventions is the essential part of the process of improvement in medical science. Yet, there are many potential risks of mistreat or abuse of the subject's legal rights and safety once they are involved in these trials. Determinations of generally accepted demands of ethical justification for clinical trials provide decrease of risks for subjects that undergo the clinical trials. After analyzing the content of the international and regional declarations, ethical guidelines and local legal regulations, author finds that basic ethical requirements for conduction of the clinical trials are: scientific and social values and scientific validity, risk benefit ratio, fair subject selection, voluntary informed consent, respect of the subject's personal rights and independent ethical comity review. In this work, author explains the purpose of these demands, determines their correlation and conclude that all of them stand in mutual connection and interrelation. Only cumulative fulfillment of all of the named requirements allows ethically acceptable approach to conduction of clinical trials with avoiding the exploitation and providing the fair and dissent environment for subjects with full respect to their legal rights and safety. |
abstract_unstemmed |
Conduction of the clinical trials on human subjects in order to gain data about efficiency and safety of the new drugs, medical devices and behavioral interventions is the essential part of the process of improvement in medical science. Yet, there are many potential risks of mistreat or abuse of the subject's legal rights and safety once they are involved in these trials. Determinations of generally accepted demands of ethical justification for clinical trials provide decrease of risks for subjects that undergo the clinical trials. After analyzing the content of the international and regional declarations, ethical guidelines and local legal regulations, author finds that basic ethical requirements for conduction of the clinical trials are: scientific and social values and scientific validity, risk benefit ratio, fair subject selection, voluntary informed consent, respect of the subject's personal rights and independent ethical comity review. In this work, author explains the purpose of these demands, determines their correlation and conclude that all of them stand in mutual connection and interrelation. Only cumulative fulfillment of all of the named requirements allows ethically acceptable approach to conduction of clinical trials with avoiding the exploitation and providing the fair and dissent environment for subjects with full respect to their legal rights and safety. |
collection_details |
GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_95 GBV_ILN_110 GBV_ILN_120 GBV_ILN_151 GBV_ILN_161 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 GBV_ILN_4753 |
container_issue |
1 |
title_short |
Requirements for ethical justification of clinical trials |
url |
https://doi.org/10.5937/zrpfns46-1790 https://doaj.org/article/902c563b54d14e9f95cdd8953f6a8db6 http://scindeks-clanci.ceon.rs/data/pdf/0550-2179/2012/0550-21791201331Z.pdf https://doaj.org/toc/0550-2179 https://doaj.org/toc/2406-1255 |
remote_bool |
true |
ppnlink |
627314120 |
mediatype_str_mv |
c |
isOA_txt |
true |
hochschulschrift_bool |
false |
doi_str |
10.5937/zrpfns46-1790 |
up_date |
2024-07-03T13:41:29.978Z |
_version_ |
1803565494422208512 |
fullrecord_marcxml |
<?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01000caa a22002652 4500</leader><controlfield tag="001">DOAJ050222325</controlfield><controlfield tag="003">DE-627</controlfield><controlfield tag="005">20230503071012.0</controlfield><controlfield tag="007">cr uuu---uuuuu</controlfield><controlfield tag="008">230227s2012 xx |||||o 00| ||eng c</controlfield><datafield tag="024" ind1="7" ind2=" "><subfield code="a">10.5937/zrpfns46-1790</subfield><subfield code="2">doi</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627)DOAJ050222325</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-599)DOAJ902c563b54d14e9f95cdd8953f6a8db6</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-627</subfield><subfield code="b">ger</subfield><subfield code="c">DE-627</subfield><subfield code="e">rakwb</subfield></datafield><datafield tag="041" ind1=" " ind2=" "><subfield code="a">eng</subfield><subfield code="a">srp</subfield></datafield><datafield tag="100" ind1="0" ind2=" "><subfield code="a">Živojinović Dragica</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">Requirements for ethical justification of clinical trials</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2012</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">Text</subfield><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">Computermedien</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">Conduction of the clinical trials on human subjects in order to gain data about efficiency and safety of the new drugs, medical devices and behavioral interventions is the essential part of the process of improvement in medical science. Yet, there are many potential risks of mistreat or abuse of the subject's legal rights and safety once they are involved in these trials. Determinations of generally accepted demands of ethical justification for clinical trials provide decrease of risks for subjects that undergo the clinical trials. After analyzing the content of the international and regional declarations, ethical guidelines and local legal regulations, author finds that basic ethical requirements for conduction of the clinical trials are: scientific and social values and scientific validity, risk benefit ratio, fair subject selection, voluntary informed consent, respect of the subject's personal rights and independent ethical comity review. In this work, author explains the purpose of these demands, determines their correlation and conclude that all of them stand in mutual connection and interrelation. Only cumulative fulfillment of all of the named requirements allows ethically acceptable approach to conduction of clinical trials with avoiding the exploitation and providing the fair and dissent environment for subjects with full respect to their legal rights and safety.</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">clinical research</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">ethical requirements</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Declaration of Helsinki</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">exploitation of clinical research subject</subfield></datafield><datafield tag="653" ind1=" " ind2="0"><subfield code="a">Law</subfield></datafield><datafield tag="653" ind1=" " ind2="0"><subfield code="a">K</subfield></datafield><datafield tag="773" ind1="0" ind2="8"><subfield code="i">In</subfield><subfield code="t">Zbornik Radova: Pravni Fakultet u Novom Sadu</subfield><subfield code="d">University of Novi Sad, Faculty of Law, 2017</subfield><subfield code="g">46(2012), 1, Seite 331-347</subfield><subfield code="w">(DE-627)627314120</subfield><subfield code="w">(DE-600)2557007-9</subfield><subfield code="x">24061255</subfield><subfield code="7">nnns</subfield></datafield><datafield tag="773" ind1="1" ind2="8"><subfield code="g">volume:46</subfield><subfield code="g">year:2012</subfield><subfield code="g">number:1</subfield><subfield code="g">pages:331-347</subfield></datafield><datafield tag="856" ind1="4" ind2="0"><subfield code="u">https://doi.org/10.5937/zrpfns46-1790</subfield><subfield code="z">kostenfrei</subfield></datafield><datafield tag="856" ind1="4" ind2="0"><subfield code="u">https://doaj.org/article/902c563b54d14e9f95cdd8953f6a8db6</subfield><subfield code="z">kostenfrei</subfield></datafield><datafield tag="856" ind1="4" ind2="0"><subfield code="u">http://scindeks-clanci.ceon.rs/data/pdf/0550-2179/2012/0550-21791201331Z.pdf</subfield><subfield code="z">kostenfrei</subfield></datafield><datafield tag="856" ind1="4" ind2="2"><subfield code="u">https://doaj.org/toc/0550-2179</subfield><subfield code="y">Journal toc</subfield><subfield code="z">kostenfrei</subfield></datafield><datafield tag="856" ind1="4" ind2="2"><subfield code="u">https://doaj.org/toc/2406-1255</subfield><subfield code="y">Journal toc</subfield><subfield code="z">kostenfrei</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_USEFLAG_A</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">SYSFLAG_A</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_DOAJ</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">SSG-OLC-PHA</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_11</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_20</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_22</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_23</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_24</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_31</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_39</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_40</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_60</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_62</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_63</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_65</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_69</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_70</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_73</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_95</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_110</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_120</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_151</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_161</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_206</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_213</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_230</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_285</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_293</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_370</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_602</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2001</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2003</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2005</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2006</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2009</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2010</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2011</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2014</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4012</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4035</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4037</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4112</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4125</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4126</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4249</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4305</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4306</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4307</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4313</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4322</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4323</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4324</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4325</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4326</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4335</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4338</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4367</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4700</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4753</subfield></datafield><datafield tag="951" ind1=" " ind2=" "><subfield code="a">AR</subfield></datafield><datafield tag="952" ind1=" " ind2=" "><subfield code="d">46</subfield><subfield code="j">2012</subfield><subfield code="e">1</subfield><subfield code="h">331-347</subfield></datafield></record></collection>
|
score |
7.398531 |