The clinical investigation needs special ethics requirements. Why? Because the clinical trials use subjects, and it can be confused that those subjects were forced to enter either way to sign the informed consent. That’s why is important to establish some rules needed to avoid that type of situations.
The main purpose in clinical research is to generate generalized knowledge that can work to improve health and wellness plus increasing the understanding of human biology. Consequently, in every clinical trial there is the possibility of subject’s exploitation because you put them in difficult situations in order to obtain a common benefit. Reasons why the ethics requirements are aimed to reduce the minimum possibility of exploitation, in order to ensure that the research subjects not only are used for a purpose, but also that they are treated with respect while contributing to the social good.
In the past 50 years, the principal source documents that talks about the ethics in the first clinical trials are:
- The Nuremberg Code.
- Helsinki declaration
- Belmont report
- In addition, the CIOMS standards.
However, those documents written as consequence of some specific events that occurred in the past and they are focused in only resolving those events. That’s why in the absence of a systematic delineation of the requirements ethics that could be universally applicable and needed for clinical research, some people involved in this environment, such as Researchers, IRB members, sponsors and others, lack of a coherent and rational framework, through which they can ensure that clinical research proposals are ethical.
They are some ethic requirements that promote a systematic and rational framework that they will help to determinate if the clinical investigation is ethic. These were made to guide the development and execution of the clinical trials and allow supervising them all in the same way. Therefore, they were not made to evaluate the individual actions of the principal investigator, or of the clinical research company. As such, these requirements are made to be universal, not limited in response to a tragedy, scandal or specific problem, nor limited to practices in a country or by a group of researchers.
Here in Althian we know the importance of always try to update our team, with the new Good clinical practices. We have staff highly qualified in treating the patients, so they won’t feel forced to do something. Please contact us and we will be more than happy to assist you in the whole process.