Code of Federal Regulations: Definition of Ethics

Research ethics is a doubtlessly significant part of any scientific project, especially when the project in question is carried out within the realm of the biomedical or behavioral studies. To assure that no harm is done to the participants involved, the Institutional Review Board was created.

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Though it is traditionally believed that the responsibilities of the Institutional Review Board are restricted to monitoring researches, they actually include checking whether the participants’ consent was informed, as well as whether the research is scientific, ethical, and regulatory (FDA, 2014a, para. 5).

The issue of informed consent check should not be left out of the list of the IRB responsibilities as well. According to the official data, signing the document of informed consent provided by the organization is not enough. The participant must be made aware of every possible outcome that the research may result in and base their judgment concerning the project in question.

It should be noted that the instructions provided by the Institutional Review Board cannot be changed depending on the state – the principles of the monitoring, checking and evaluation process are the same across the USA (FDA, 2014, para. 1).

The directions provided by the IRB are important for such organizations as the Nemours Biomedical Research (NBMR), which is a branch of the Nemours Foundation (Nemours Biomedical Research, 2014). Located in Delaware Valley, FL, the organization specializes in carrying out cancer-related studies with human subjects involved. The NBMR Organization acts in accordance with the IRB rules, which its policy statement shows.

NBMR has a specific set of rules and regulations concerning the participants that are under age, participants with impairments and disabilities, etc. For example, the organization guarantees that children will take part only in the studies “not involving greater than minimal risk” (Code of Federal Regulations, 2009, p. 2).

In addition, for the researches that include such participants as “children, prisoners, pregnant women, or handicapped or mentally disabled persons” (Code of Federal Regulations, 2009, p. 6), specialists in working with the aforementioned type of participants will be invited to facilitate fully harmless environment for the research subjects and terminate the research in case the participants are in peril.

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It is quite peculiar that the organization does not provide any regulations concerning the inclusion of participants belonging to minorities. Despite the recent introduction of equality principles into the relationships between not only people of different ethnicities but also different gender and sexual orientation, the rights of minorities are often infringed due to the imperfection of the legal system. Hence, Nemours’s rules on minorities’ participation must be looked into a bit closer.

Despite minor dents in the policies concerning the participation of minorities in the biomedical researches carried out by the organization, Nemours seems to have passed the test on ethics in human research quite successfully.

One of the major organizations for human research in Florida, Nemours should be credited for its outstanding adherence to ethical principles. As soon as Nemours updates its policies concerning people traditionally included in a minority group, its ethical regulations may be considered exemplary by the IRB standards.

The IRB is, therefore, crucial for defining organizations’ adherence to ethics in terms of human research. Even though the Institutional Review Board is often viewed as the body that observes the research process, it is also responsible for approving the research in question, as well as checking whether the patients’ consent was informed, whether the research is regulatory and ethically correct and whether the project assurance has been provided. Thus, its actions must be appreciated and encouraged.

Reference List

Code of Federal Regulations (2009). Web.

FDA (2014). IRB organization. Web.

FDA (2014a). Informed consent process. Web.

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Nemours Biomedical Research (2014). Welcome to Nemours Biomedical Research. Web.

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