Study on good clinical practices among researchers in a tertiary healthcare institute in India

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.

PRIMARY RESEARCH ON SUBJECTIVITY GEOMETRY

The so-called 'Subjectivity Geometry'' herein is a course for studying the relationship between the abstracted object configuration and its observed record by means of mathematical methods and described by matlieinatical language. There are many features differing from the common geometry when the effects of the subjectivity (such as the position of the observer, the functions of the visual system of human) are taken into account during the observing-recording process. In this paper, some basic assumptions are made; spherieal observing record is suggested: the fundamental relationship between the abstracted object configuration and its corresponding observed record is studied and an example of apiriication of the above theory is presented. We anticipate that the study of subjectivity geometry will influencc, or will be associated with the study of physiology of the visual system, applied optics etc., and will be useful in surveying, pilotage and imitative biology, etc.

The Internal Examination of Ideology and Politics Education in Colleges and Universities under the Perspective of Social Subject Research Method

Human is the subject of social and historical development process.The essence of human is the sum of social relations,and the masses are the creators of history.This is the basic content of social subject research methods,and also an important principle that must be followed by the subject category in ideology and politics education in colleges and universities.From the perspective of social subject research methods,the internal examination of the thought and politics education activities in colleges and universities should include three basic dimensions:adhering to examine the ideological and political moral construction activities via communicative practice,adhering to the principle of"all members,whole process and all dimensions(three-all principle)"to examine the"macro ideological and political"education concept,and adhering to the examination of the innovation of the ideology and politics education method system in higher education for the promotion of students’subjectivity.

World Medical Association Declaration of HelsinkiE thical Principles for Medical Research Involving Human Subjects

Document Of World Medical AssociationWorld medical association declaration of Helsinki Ethical principles for medical research involving human subjects