The Purpose, Composition, and Function, Essay Example

The Institutional Review Board (IRB) is responsible for reviewing the ethics related to research practices at a given institution. When researchers wish to complete projects that involve humans, it is necessary for the board to analyze the potential benefit of the research findings in addition to the potential harm that could befall the participants. The IRB committee typically discusses these consequences with one another and attempt to clarify the goals of an applicant’s project based on the information that was provided to them prior to the meeting in addition to the information presented (Enfield et al., 2008).

After experimental atrocities such as the Nazis experimentation and the Milgram obedience experiment, the United States government established the National Research Act of 1974 in addition to the Belmont Report, which stated that “respect for persons”, “beneficence”, and “justice” would need to be followed for human experimentation to be permissible. These practices include ensuring that participants in these studies are aware of potential health risks and benefits, and are not subjected to treatments in which the harm will outweigh the good. The purpose of these studies must be reasonable and have potential to benefit future patient populations in order to be considered ethical.

The organization I selected to analyze IRB requirements is Montefiore Medical Center in Bronx, New York due to the center’s involvement in cancer research. All patients must be provided with informed consent to be able to participate in a research study. Generally, physicians approach their patients and explain the protocol in addition to any advantages and harms that could come as a consequence of participation. The physicians then allow the patients to take the informed consent slip home to read and discuss with family members before agreeing to participate. However, the hospital has different guidelines with regards to the type of individual being consented. Normal men and women over the age of 18 can be consented in the aforementioned manner, but this process becomes more complex for consenting children, pregnant women, minorities, and cognitively impaired subjects.

Montefiore Medical Center requires the informed document to be signed by at least one parent if the child who wishes to join the study is under the age of 18. Furthermore, the child must demonstrate that he or she wants to be placed on the study and is not being coerced by the parent. In addition, women who are to be placed on study cannot typically be pregnant for testing experimental pharmaceuticals. In extreme cases in which a pregnant women must undergo chemotherapy, most doctors would recommend waiting for the birth of the child or terminating the pregnancy. While there are some studies that require the involvement of pregnant women, this is typically an exclusion criterion for a majority of studies that are not related to gynecology or women’s health.

In addition, the IRB wishes to consider the rights of minority participants based on the understanding that many research studies that offer compensation may encourage individuals to participate on this basis. As a consequence, minorities living in low income neighborhoods are more likely to give up their safety to earn money from the study. It is therefore the responsibility of research teams to educate potential participants about the risks of participating in the study in addition to finding ways to achieve a study population that is representative of the disease population. Last, cognitively impaired subjects may be able to consent to a study, but this depends on the severity of their impairment. The hospital will consult family members to confirm this participation, or they may decide to allow the patient to enter the study if they believe that it offers the best treatment option available for an individual in this state.

References

Enfield, K. B. & Truwit, J. D. (2008). The Purpose, Composition, and Function of an Institutional Review Board: Balancing Priorities. Respiratory Care, 53: 1330-1336.