locate one article either from the library or the Internet regarding an ethical issue in clinical...

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Biology

locate one article either from the library or the Internetregarding an ethical issue in clinical research. Choose one of theclinical research roles described in the environment and state howthis group would interact with others to handle the situation.Remember to provide references.

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Clinical research in recent times has become synonymous with drug research with special emphasis on Clinical trials although it literally refers to all types of research involving human participants related to generation of new knowledge for diagnosis treatment and prevention in the field of human health and diseases scanning molecular genetics on one end and epidemiology and public health research on the other end Many do not realize that a systematic testing of a hypothesis by analyzing data from patients case records or application of new technologies on stored human biological materials also come under the purview of clinical research As per the current national and international debate on this issue the present definition of clinical research includes any study conducted on human beings themselves their biological materials and human biological data with the potential to improve well being of the human race THE ETHICAL ISSUES IN CLINICAL RESEARCH PRIMARILY INVOLVES PROTECTION OF RIGHTS SAFETY AND WELL BEING OF THE RESEARCH PARTICIPANTS All national and international guidelines lay emphasis on the code of conduct to be followed by researchers and the other stakeholders in clinical research to uphold this basic commitment to safeguard the rights and safety of the research participants who play a central role in research without whomeither themselves their data or their biological samplesno research is possible However reviewing and constant monitoring of the research activities to ensure adherence to the principles laid down in these guidelines or policies or legislation are the main concerns of the Ethics Review Committees ERCEC whether institutional or independent which are entrusted with the responsibility of protecting the rights and safety of the research participants Although all the guidelines are based on the cardinal principles of autonomy nonmaleficence beneficence and justice the ethical issues to be tackled are increasing day by day with the advancement of new technologies a wide range of research activities and globalization of clinical research While majority of the countries have only guidelines and few have regulations or laws related to clinical research as in the USA the threat posed to the human participants are similar all over the world and there is a need for wider dissemination of these principles to all stakeholders of clinical research including the public at large and the participants in addition to the researchers sponsors institutions members of ethics committees regulators and the policy makers so that the rights of the research participants and the responsibilities of those involved in research are well understood by all concerned This will lead to constant updating of guidelines developing new guidelines proposing new policies and enacting appropriate regulations so that the human research participants and the community rest assured that they are well protected while participating in any research As of now the crucial structure to ensure such protection is the wellconstituted well functioning ERCEC whose capability strengthening is the main focus of the different national and international fora such as FERCI Forum for Ethics Review Committees in India FERCAP Forum for Ethics Review Committees in Asia and Western Pacific region SIDCER Strategic Initiatives in Developing Capacity for Ethical Review etc to name a few THE FUNDAMENTAL ETHICAL CONCERN RAISED BY CLINICAL RESEARCH IS WHETHER AND WHEN IT CAN BE ACCEPTABLE TO EXPOSE SOME INDIVIDUALS TO RISKS AND BURDENS See Answer

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