Gaining approval for clinical research
نویسندگان
چکیده
منابع مشابه
Need for ethics approval and patient consent in clinical research.
A key principle in clinical research is the need to obtain approval from a Research Ethics Committee before commencing a study, and then to obtain consent from each subject enrolled into the study. This tenet is highlighted in the Helsinki Declaration and reinforced in subsequent principles such as Good Clinical Practice/International Committee on Harmonisation. However, not all clinical studie...
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This paper reflects on the experiences of facilitating and maintaining qualitative research access into a sample of international hotel groups. The existing research methodology literature tends to simplify the access process by explaining it through a number of stages. The fieldwork experience of the authors suggests that the propositions stated in literature are partly relevant; however, ther...
متن کاملResearch and the Approval Process ∗
An agent (such a pharmaceutical company) sequentially collects information (through clinical trials) to obtain a principal’s (the FDA) approval (to introduce a new drug). Principal and agent both pay the cost of information, but they derive different payoffs from adoption. We characterize how the principal can benefit from commitment to an approval standard and how the commitment solution compa...
متن کاملNeed for Clinical Trial Registry and Institutional Review Board Approval in Human Subjects Research
Declaration (revised edition of 2004) and in principle undergo scrutiny of an independent IRB which reviews ethical issues of the human experiment. But, in clinical studies, the approval of the IRB and patient’s consent must be received and stated on paper.” We must change our guidelines according to the revised act by changing ‘clinical studies’ to “human subjects research.” Some researchers m...
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Zebrafish are an increasingly popular vertebrate model organism in which to study biological phenomena. It has been widely used, especially in developmental biology and neurobiology, and many aspects of its development and physiology are similar to those of mammals. The popularity of zebrafish relies on its relatively low cost, rapid development and ease of genetic manipulation. Moreover, the o...
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ژورنال
عنوان ژورنال: British Journal of Hospital Medicine
سال: 2016
ISSN: 1750-8460,1759-7390
DOI: 10.12968/hmed.2016.77.7.414