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Clinical research: is it ethical?

Clinicalresearch is one of the hottest topics of debate nowadays. This ismuch thanks to the fact that a lot of people question its ethicalaspects. Namely, the questions which arise are most often thoseconcerning the safety of the procedures, as well as the motives ofthe drug companies (because those who condemn the research tend to perceive the driving motives as being purely profit-oriented).

Withthis said, it is good to find out that the actual reality of thesituation flows in quite a different direction. This means that thereare certain ethical requirements (delineated by JAMA – The Journalof American Medical Association) which need to be met whileconducting all or any research. There are seven points to the list ofrequirements, and they are: value, scientific validity, fair subjectselection, favorable risk-benefit ratio, independent review, informedconsent and lastly, but not the least important, respect for theenrolled subjects.

Theprevious requirements are designed to hinder any chance of exploitation. They are also designed to make sure the research headsin a direction which contributes the most to the greater social good.Without further ado, we will now further discuss, in somewhat closerdetail, each of the points.

If aproject must have "value", it must have the potential to improve wealth and general well-being. It's either that, or it mustgenerate knowledge of structure or function concerning the humanbody.

Nextoff, "scientific validity" requires that the research mustbe conducted in a methodical and rigorous fashion. These methods mustbe scientifically valid as well as practically feasible. Also, theirobjective must be crystal clear.

Fairsubject selection means that the subjects to be included in the research must be picked according to the criteria of the goals ofstudy rather than vulnerability, privilege or other marginal factors.

Favorablerisk-benefit ratio involves satisfying the following sub-requirements:the potential risk to the subject must be minimal, the benefits areenhanced and lastly the potential benefits are to outweigh therisks.

Allowingan independent review, in turn allows for a fair amount of politicalcorrectness concerning the research. It also helps eliminateconflicts of interests as it is an important element of socialaccountability.

Informedconsent is another strong point down the list. This means thesubject must be accurately informed both about the methods andpotential risks as well as the goal of the research and its potential benefits. It is also important to make it crystal clear that eachsubject's participation is voluntary, which means that each subjecthas the legal right to terminate his or her participation at anypoint.

Lastly, the privacy of each subject must furthermore be protected by means ofconfidentiality rules – this is what is meant by "respect forpotential and enrolled subjects". This also means that all newconditions which are discovered during the course of research must beproperly communicated to the subject, and accordingly, treatedproperly. The subject is also to be informed about the scientificprogress which has been achieved thanks to his or her participation.

Conclusively,it is perfectly normal to be concerned about participation in clinicalresearch. That's why asking a lot of questions ahead of enrollment isstrongly recommended in order to make sure that the subject is makinga choice he or she truly wants to make.

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