The “informed consent principle” in human clinical trials is the product of the extension of the concept of human rights in the field of human trials and a reflection of the progress of human civilization in biomedi...The “informed consent principle” in human clinical trials is the product of the extension of the concept of human rights in the field of human trials and a reflection of the progress of human civilization in biomedical research. In recent years, the legal protection of the right to informed consent for research subjects has been gradually improved in China. The right to informed consent for research subjects has been improved from an ethical norm to a legal norm. The legal status of legal norms has also been gradually improved. Based on the public law regulations, private law relief has been added to the legal relief system for the infringement of the right to informed consent for research subjects. As a result, the protection of rights has been enhanced. The domestic informed consent protection system is partially in line with international norms. The protection of the right to informed consent depends on the perfection of the legal system and the social consensus to respect human rights and the right to self-determination.展开更多
BACKGROUND Good clinical practice(GCP)is put in place to protect human participants in clinical trials as well as to ensure the quality of research.Non-adherence to these guidelines can produce research that may not m...BACKGROUND Good clinical practice(GCP)is put in place to protect human participants in clinical trials as well as to ensure the quality of research.Non-adherence to these guidelines can produce research that may not meet the standards set by the scientific community.Therefore,it must be ensured that researchers are wellversed in the GCP.But not much is known about the knowledge and practices of the GCP in the medical colleges of North India.AIM To assess the knowledge and practices of researchers about GCP and analyze these with respect to the demographics of participants.METHODS This is a cross-sectional study.A self-structured questionnaire about GCP,after expert validations,was circulated among researchers,at a tertiary healthcare institute,All India Institute of Medical Sciences(AIIMS),Rishikesh.A total of 59 individuals,who were selected by universal sampling,participated in the study.All healthcare workers who have been investigators of Institutional Ethics Committee-approved research projects,except residents and faculty,and are still a part of the institute have been included in the study.The study was approved by the Institutional Ethics Committee of AIIMS,Rishikesh.We used descriptive analysis and the Chi-squared test to analyze data.P value<0.05 was considered significant.RESULTS Out of 59 participants,only 11(18.6%)were certified for GCP.Most of the participants(64.4%)had“Average”knowledge,33.9%had“Good”knowledge and 1.7%had“Poor”knowledge.Only 49%of participants had satisfactory practices related to GCP.There was a significant difference in the knowledge based on the current academic position for the items assessing knowledge of institutional review board(P=0.010),confidentiality&privacy(P=0.011),and participant safety&adverse events(P<0.001).There was also a significant difference in knowledge of research misconduct(P=0.024)and participant safety&adverse events(P=0.011)based on certification of GCP.There was a notable difference in the practices related to recruitment&retention on the basis of current academic position(P<0.001)and certification of GCP(P=0.023).We also observed a considerable difference between the knowledge and practices of GCP among the participants(P=0.013).CONCLUSION Participants have basic knowledge of GCP but show a lack thereof in certain domains of GCP.This can be addressed by holding training sessions focusing on these particular domains.展开更多
文摘The “informed consent principle” in human clinical trials is the product of the extension of the concept of human rights in the field of human trials and a reflection of the progress of human civilization in biomedical research. In recent years, the legal protection of the right to informed consent for research subjects has been gradually improved in China. The right to informed consent for research subjects has been improved from an ethical norm to a legal norm. The legal status of legal norms has also been gradually improved. Based on the public law regulations, private law relief has been added to the legal relief system for the infringement of the right to informed consent for research subjects. As a result, the protection of rights has been enhanced. The domestic informed consent protection system is partially in line with international norms. The protection of the right to informed consent depends on the perfection of the legal system and the social consensus to respect human rights and the right to self-determination.
文摘BACKGROUND Good clinical practice(GCP)is put in place to protect human participants in clinical trials as well as to ensure the quality of research.Non-adherence to these guidelines can produce research that may not meet the standards set by the scientific community.Therefore,it must be ensured that researchers are wellversed in the GCP.But not much is known about the knowledge and practices of the GCP in the medical colleges of North India.AIM To assess the knowledge and practices of researchers about GCP and analyze these with respect to the demographics of participants.METHODS This is a cross-sectional study.A self-structured questionnaire about GCP,after expert validations,was circulated among researchers,at a tertiary healthcare institute,All India Institute of Medical Sciences(AIIMS),Rishikesh.A total of 59 individuals,who were selected by universal sampling,participated in the study.All healthcare workers who have been investigators of Institutional Ethics Committee-approved research projects,except residents and faculty,and are still a part of the institute have been included in the study.The study was approved by the Institutional Ethics Committee of AIIMS,Rishikesh.We used descriptive analysis and the Chi-squared test to analyze data.P value<0.05 was considered significant.RESULTS Out of 59 participants,only 11(18.6%)were certified for GCP.Most of the participants(64.4%)had“Average”knowledge,33.9%had“Good”knowledge and 1.7%had“Poor”knowledge.Only 49%of participants had satisfactory practices related to GCP.There was a significant difference in the knowledge based on the current academic position for the items assessing knowledge of institutional review board(P=0.010),confidentiality&privacy(P=0.011),and participant safety&adverse events(P<0.001).There was also a significant difference in knowledge of research misconduct(P=0.024)and participant safety&adverse events(P=0.011)based on certification of GCP.There was a notable difference in the practices related to recruitment&retention on the basis of current academic position(P<0.001)and certification of GCP(P=0.023).We also observed a considerable difference between the knowledge and practices of GCP among the participants(P=0.013).CONCLUSION Participants have basic knowledge of GCP but show a lack thereof in certain domains of GCP.This can be addressed by holding training sessions focusing on these particular domains.
