The Medici Medical Research it’s an investigational site conducting clinical trials to subjects (Phase 2-4) in conjunction with Pharmaceuticals/Sponsors under the supervision of the Investigational Review Board (IRB) and Clinical Research Organizations (CRO’s). The optimal function of the site is to follow specific protocols, which will help the Food and Drug Administration (FDA) with the approval of new drugs and medical devices to help the targeted population.
Making the Difference.
We treat individuals as autonomous persons capable of choosing for themselves. In the case of persons with limited autonomy, additional protection even to the extent of excluding them from activities that may harm them should be advocated. The extent of protection would depend on the nature of the potential risk of harm and the likelihood of benefit. The application of this principle involves an informed consent process during which subjects are provided all information (in a comprehensible form) necessary for an individual to make a decision to voluntarily participate in a study.
This requires an assessment of the potential risks (probable harm) to the anticipated benefits (promotion of health, well-being, or welfare). Investigators are required to devise mechanisms that maximize the benefits and reduce the risk that may be involved in the research. The public too needs to take cognizance of the risks and benefits that may result from novel medical, psychological, and social processes and procedures.
This principle advocates fair treatment for all and a fair distribution of the risks and benefits of the research. It forbids exploitation of vulnerable people (for instance, economically disadvantaged or those with limited cognitive capacity) or those who are easily manipulated as a result of their situation. It also requires that the researcher verifies that the potential subject pool is appropriate for the research and that the recruitment of volunteers is fair and impartial.
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Aylin Z. Vidal Aira, MSN, BSN, RN, CRC President & CEO
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Roberto R. Rodriguez, BBA
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