Significant changes in NIH clinical research

2018/01/23 Agirre Ruiz de Arkaute, Aitziber - Elhuyar Zientzia Iturria: Elhuyar aldizkaria

• Genetika
• Medikuntza
• Farmakologia

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The National Health Institute (NIH) announces a change in its biomedical research funding policy. The aim is to achieve transparency, rigor and repeatability in clinical research, as well as commitment to society.

To do this, the research funded must meet a number of requirements. For example, the clinical protocols to be used must be registered beforehand. On the other hand, all the results of the study should be published. These two measures aim to avoid the selective publication of results so that no results are hidden. In addition, in research requiring experimental human participation, researchers should be trained in good clinical practices every three years. Among other things, to guarantee the rights, security and confidentiality of the participants.

These measures will be taken only in studies defined as “clinical trials.” Although changes have generally been valued as positive, scientists do not agree at all. The very definition of the clinical trial is confusing. P. Francis The member of the European Covenant on Good Clinical Practices Crawley has stated that “unfortunately, NIH has crossed two sacred lines: the line between basic research and clinical research, and between biomedical sciences and sciences that analyze human behavior.” This change of definition has generated international concerns and has been claimed by 3,580 researchers.

While this policy change only affects research in the United States, it is to be assumed that this trend is broadened in view of the influence that the measures previously adopted by NIH have had. The changes will begin on January 25, 2018.