Child Health Research | The Institutional Review Board | Discussion

1) What special ethical issues exist when the patient is a child under 18?

First of all, according to Fernandez (2008), it is necessary to note that “children may be particularly vulnerable and require special considerations in the design and conduct of the medical research”. It means that health care professionals should take into account special ethical issues that exist regarding the patients under the age of 18.

Children, being vulnerable to different situations and having developmental peculiarities, have special needs as the subjects of medical research. All health care professionals who deal with children must know the main biological differences between adults and children and respect children’s individuality and autonomy, as well as take into accounts children’s specific attitude to medical procedures. Thus, remembering that children under the age of 18 experience a lack of full personal autonomy, doctors may respect children’s rights.

The next point is confidentiality because this concept is a basic principle of good medical practice. In ethical sense, children as well as adults have a right to medical confidentiality. In addition, it is important to remember that children are not small adults, even in a case when the same ethical principles are used for them because children have a unique set of interests.

Thus, health care professionals who are directly working with children should always take into account psychological features of their patients, their emotions, and feelings. For instance, older children, especially girls, are the most sensitive in the early days of hospital stay, and this leads to their unfriendly attitude and fear of medical procedures. So, for a better understanding of the status of children is important, in addition to knowing individual psychological characteristics of the child, to know the situation in the family, social and official status of parents. All these components are necessary for the organization of proper care for a sick child in the hospital and the child’s effective treatment.

2) Explain the role of the Institutional Review Board in your organization? Who sits on this Board? Are staff nurses aware of this Board and its activities?

The Institutional Review Board (IRB) is a specific group of people that has been formally created to review and monitor all varieties of biomedical research involving human subjects. Moreover, the Institutional Review Board’s role in my organization is to protect the rights and welfare of human research subjects and to provide humans participating as subjects in the research with safe conditions. The process of review and monitoring is accomplished through a constant review of all research protocols and some related materials (it can be investigator brochures, informed consent documents, etc.).

Observing the issues of membership, it is possible to note that the regulations accepted regarding the IRB require a presence of diverse membership, but one member may satisfy more than one membership category in the Board. According to FDA (2014), “In fact, the FDA regulations [21 CFR 56.107(a)] require that, as part of being qualified as an IRB, the IRB must have “… diversity of members, including consideration of race, gender, cultural backgrounds and sensitivity to such issues as community attitudes ….” Thus, the IRB should consist of at least five members, and all the members must have a big experience in expertise for the purpose of being able to make an informed decision on ethical side of the research.

Yes, staff nurses are aware of the IRB, and its activities. The work of the IRB is regulated by many documents, and it is not a secret organization. Of course, staff nurses are not aware of all the activities of the IRB and have no access to the records, but general information is available for them.

 

References

FDA. (2014). Information Sheet – Guidance for Institutional Review Boards and Clinical Investigators.

Fernandez, C. (2008). Ethical issues in health research in children. Paediatr Child Health, 13 (8): 707–712.

The terms offer and acceptance. (2016, May 17). Retrieved from

[Accessed: March 28, 2024]

"The terms offer and acceptance." freeessays.club, 17 May 2016.

[Accessed: March 28, 2024]

freeessays.club (2016) The terms offer and acceptance [Online].
Available at:

[Accessed: March 28, 2024]

"The terms offer and acceptance." freeessays.club, 17 May 2016

[Accessed: March 28, 2024]

"The terms offer and acceptance." freeessays.club, 17 May 2016

[Accessed: March 28, 2024]

"The terms offer and acceptance." freeessays.club, 17 May 2016

[Accessed: March 28, 2024]

"The terms offer and acceptance." freeessays.club, 17 May 2016

[Accessed: March 28, 2024]
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