Document Of World Medical AssociationWorld medical association declaration of Helsinki Ethical principles for medical research involving human subjects
The World Medical Association’s Declaration of Helsinki(DoH)serves as a key document of ethical guidance advocating principles of medical research involving human participants.Since its inception in 1964,the DoH has ...The World Medical Association’s Declaration of Helsinki(DoH)serves as a key document of ethical guidance advocating principles of medical research involving human participants.Since its inception in 1964,the DoH has undergone several revisions,reflecting a dynamic evolution in our understanding of research ethics,spurred by gaps identified within the document,harms discovered,challenges identified during ongoing research activities,scientific advancements and societal shifts in values.The DoH addresses a challenge and a conflict that may arise between two key aspects of medical research:On one hand,the fundamental obligation of physicians to do no harm,and on the other,the essential need to ensure the efficacy and safety of medical interventions by testing them on human research participants or healthy volunteers.With each revision,increasing emphasis is given to distributive justice and beneficence and not only to patient autonomy.Despite being a comprehensive and concise document,occasional criticism is reported,such as with regards to the impracticability of obtaining informed consent amongst other challenges.This essay will examine the key changes across the DoH's iterations,highlighting the progressive strengthening of participant protection and the evolving relationship between research,societal benefit,and individual rights.展开更多
Our study describes the reported rate of the Institutional Review Board(IRB)approval,declaration of Helsinki(DoH),and informed consent in the case reports and case series and investigates factors associated with the e...Our study describes the reported rate of the Institutional Review Board(IRB)approval,declaration of Helsinki(DoH),and informed consent in the case reports and case series and investigates factors associated with the ethical approval report.We searched PubMed for case reports and case series from 2006 to 2017.Annually,we obtained the first 20 articles of a case report cluster from 20 distinct publications.This analysis initially contained at least 2400 papers,with 100 papers each study design and year.Only 26(5.4%)of 480 included studies reported IRB approval,DoH approval,and participant informed consent;58(12.1%)reported two out of three ethical statements(DoH,informed consent,IRB);and 151(31.5%)reported only one,leading to nearly 245 studies(51.0%)did not report any ethical approval item.Both clusters mentioned the DoH the least.Only years,ages,ethical item types,and cluster types were associated with ethical reporting practices.This study found the serious under‐reporting of ethical practices in both case reports and case series.展开更多
文摘Document Of World Medical AssociationWorld medical association declaration of Helsinki Ethical principles for medical research involving human subjects
基金acknowledge Dr Thirumoorthy S/O Thamotharampillai for his inputs that were incorporated into the writing of this manuscript.
文摘The World Medical Association’s Declaration of Helsinki(DoH)serves as a key document of ethical guidance advocating principles of medical research involving human participants.Since its inception in 1964,the DoH has undergone several revisions,reflecting a dynamic evolution in our understanding of research ethics,spurred by gaps identified within the document,harms discovered,challenges identified during ongoing research activities,scientific advancements and societal shifts in values.The DoH addresses a challenge and a conflict that may arise between two key aspects of medical research:On one hand,the fundamental obligation of physicians to do no harm,and on the other,the essential need to ensure the efficacy and safety of medical interventions by testing them on human research participants or healthy volunteers.With each revision,increasing emphasis is given to distributive justice and beneficence and not only to patient autonomy.Despite being a comprehensive and concise document,occasional criticism is reported,such as with regards to the impracticability of obtaining informed consent amongst other challenges.This essay will examine the key changes across the DoH's iterations,highlighting the progressive strengthening of participant protection and the evolving relationship between research,societal benefit,and individual rights.
文摘Our study describes the reported rate of the Institutional Review Board(IRB)approval,declaration of Helsinki(DoH),and informed consent in the case reports and case series and investigates factors associated with the ethical approval report.We searched PubMed for case reports and case series from 2006 to 2017.Annually,we obtained the first 20 articles of a case report cluster from 20 distinct publications.This analysis initially contained at least 2400 papers,with 100 papers each study design and year.Only 26(5.4%)of 480 included studies reported IRB approval,DoH approval,and participant informed consent;58(12.1%)reported two out of three ethical statements(DoH,informed consent,IRB);and 151(31.5%)reported only one,leading to nearly 245 studies(51.0%)did not report any ethical approval item.Both clusters mentioned the DoH the least.Only years,ages,ethical item types,and cluster types were associated with ethical reporting practices.This study found the serious under‐reporting of ethical practices in both case reports and case series.
