After reviewing the DHHS and/or FDA regulatory documents, and the background documents that underlie those regulations (the Belmont Report, Nuremberg Code, and Declaration of Helsinki), write a brief...

Running Head: DHHS AND FDA REGULATIONS                     1
DHHS AND FDA REGULATIONS                                2
DHHS AND FDA REGULATIONS
Table of Contents
Introduction    3
The Comparative Overview: DHHS and FDA Regulation    3
Clinical Ideology and Human Subjects    5
Conclusion    6
References    8
Introduction
The subjective application of humans in the clinical trials has remained an issue that various regulatory entities monitor on legal grounds. The approach of clinical trials—other than the fact that it initiates with animals trials—is to ensure that full safety is given to the population against some new or known threat (US Department of Health and Human Services, 2018).
The regulations, however, about taking precautions and doing experiments on human subjects keep changing. This is more like the kind of evolution at document level, which is further taken to the regulator provisions in practice. The DHHS and FDA documents of regulation are driven from this ideology, given that they are linked closely to the relatable documents in which, the need for human subjects and their safety is clearly mentioned.
The Comparative Overview: DHHS and FDA Regulation
At first, it is important to compare and contrast the two major documents in the context of using human subjects as research projects during clinical trials. These documents are DHHS regulation as well as FDA document that contains significant amount of guidelines and provisions, which should be followed during such projects under any condition. For example, under Code of federation regulations part 46 published in year 2009, the subpart B mentions fairly to avoid the inclusion of pregnant women as human subjects (Code of Federal Regulations, 2018).
Section 46.201 to section 46.207 clearly indicates towards the use of guidelines pertaining to safeguard the use of neonates as well as how to avoid the application of pregnant females in the process of research. The duties of IRB are also explained in this document and at the same time, it ensures what should be applied to
ing in the capacity of the document to the fullest.
Additionally, the subpart B of this document gives insights about using distinctive methods about dealing with human subjects. This subpart is also associated with the generalized impacts of the research findings especially the ones in which, human subjects are used. This is clearly mentioned in the subpart D of the same document under sections such as 46.406 and 46.407.
These two sections hint at the possibilities of receiving any direct profit through showing consent about the research project. This may have ethical implications as well and they should be taken for consideration here...