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
The 10^(th) version of the Declaration of Helsinki,adopted by the World Medical Association(WMA)General Assembly in October 2024,marks a significant milestone in the evolution of medical ethics.By replacing the term“...The 10^(th) version of the Declaration of Helsinki,adopted by the World Medical Association(WMA)General Assembly in October 2024,marks a significant milestone in the evolution of medical ethics.By replacing the term“subject”with“human participants”in its headline,this revision reaffirms the centrality of humanism as the ethical cornerstone of modern medical practice.1,2 This seemingly small yet profound change underscores that individuals involved in clinical trials are not mere data sources but active contributors to the advancement of medical science.展开更多
Document Of World Medical AssociationWorld medical association declaration of Helsinki Ethical principles for medical research involving human subjects
Purpose:Despite advances in modern medicine,traumatic brain injuries(TBIs)are still a major medical problem.Early diagnosis of TBI is crucial for clinical decision-making and prognosis.This study aims to compare the p...Purpose:Despite advances in modern medicine,traumatic brain injuries(TBIs)are still a major medical problem.Early diagnosis of TBI is crucial for clinical decision-making and prognosis.This study aims to compare the predictive value of Helsinki,Rotterdam,and Stockholm CT scores in predicting the 6-month outcomes in blunt TBI patients.Methods:This cohort study was conducted on blunt TBI patients of 15 years or older.All of them were admitted to the surgical emergency department of Shahid Beheshti Hospital in Kashan,Iran from 2020 to 2021 and had abnormal trauma-related findings on brain CT images.The patients’demographic data such as age,gender,history of comorbid conditions,mechanism of trauma,Glasgow coma scale,CT images,length of hospital stay,and surgical procedures were recorded.The Helsinki,Rotterdam,and Stockholm CT scores were simultaneously determined according to the existing guidelines.The included patients'6-month outcome was determined using the Glasgow outcome scale extended.M Data were analyzed by SPSS software version 16.0.Sensitivity,specificity,negative/positive predictive value and the area under the receiver operating characteristic curve were calculated for each test.The Kappa agreement coefficient and Kuder Richardson-20 were used to compare the scoring systems.Results:Altogether 171 TBI patients met the inclusion and exclusion criteria,with the mean age of(44.9±20.2)years.Most patients were male(80.7%),had traffic related injuries(83.1%)and mild TBIs(64.3%).Patients with lower Glasgow coma scale had higher Helsinki,Rotterdam,and Stockholm CT scores and lower Glasgow outcome scale extended scores.Among all the scoring systems,the Helsinki and Stockholm scores showed the highest agreement in predicting patients’outcomes(kappa=0.657,p<0.001).The Rotterdam scoring system had the highest sensitivity(90.1%)in predicting death of TBI patients,whereas the Helsinki scoring system had the highest sensitivity(89.8%)in predicting the 6-month outcome in TBI patients.Conclusion:The Rotterdam scoring system was superior in predicting death in TBI patients,whereas the Helsinki scoring system was more sensitive in predicting the 6-month outcome.展开更多
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The 10^(th) version of the Declaration of Helsinki,adopted by the World Medical Association(WMA)General Assembly in October 2024,marks a significant milestone in the evolution of medical ethics.By replacing the term“subject”with“human participants”in its headline,this revision reaffirms the centrality of humanism as the ethical cornerstone of modern medical practice.1,2 This seemingly small yet profound change underscores that individuals involved in clinical trials are not mere data sources but active contributors to the advancement of medical science.
文摘Document Of World Medical AssociationWorld medical association declaration of Helsinki Ethical principles for medical research involving human subjects
基金This study was supported by deputy of research,Kashan University of Medical Sciences(Grant no:99116).
文摘Purpose:Despite advances in modern medicine,traumatic brain injuries(TBIs)are still a major medical problem.Early diagnosis of TBI is crucial for clinical decision-making and prognosis.This study aims to compare the predictive value of Helsinki,Rotterdam,and Stockholm CT scores in predicting the 6-month outcomes in blunt TBI patients.Methods:This cohort study was conducted on blunt TBI patients of 15 years or older.All of them were admitted to the surgical emergency department of Shahid Beheshti Hospital in Kashan,Iran from 2020 to 2021 and had abnormal trauma-related findings on brain CT images.The patients’demographic data such as age,gender,history of comorbid conditions,mechanism of trauma,Glasgow coma scale,CT images,length of hospital stay,and surgical procedures were recorded.The Helsinki,Rotterdam,and Stockholm CT scores were simultaneously determined according to the existing guidelines.The included patients'6-month outcome was determined using the Glasgow outcome scale extended.M Data were analyzed by SPSS software version 16.0.Sensitivity,specificity,negative/positive predictive value and the area under the receiver operating characteristic curve were calculated for each test.The Kappa agreement coefficient and Kuder Richardson-20 were used to compare the scoring systems.Results:Altogether 171 TBI patients met the inclusion and exclusion criteria,with the mean age of(44.9±20.2)years.Most patients were male(80.7%),had traffic related injuries(83.1%)and mild TBIs(64.3%).Patients with lower Glasgow coma scale had higher Helsinki,Rotterdam,and Stockholm CT scores and lower Glasgow outcome scale extended scores.Among all the scoring systems,the Helsinki and Stockholm scores showed the highest agreement in predicting patients’outcomes(kappa=0.657,p<0.001).The Rotterdam scoring system had the highest sensitivity(90.1%)in predicting death of TBI patients,whereas the Helsinki scoring system had the highest sensitivity(89.8%)in predicting the 6-month outcome in TBI patients.Conclusion:The Rotterdam scoring system was superior in predicting death in TBI patients,whereas the Helsinki scoring system was more sensitive in predicting the 6-month outcome.
