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IRB Oral Sharing

Introduction

The objective of this assignment is to examine the Human Subjects Research approval process. This process will be inspected within the cultural context of a New York Medical Institution. Further examination will include a comparative analysis of Institutional Review Board (IRB) guidelines. Although the Polit and Beck textbook has not yet been obtained, the Clinical Nurse Specialist Journal offers a comparable history of the IRB.

Defining IRB

A comprehensive understanding of an IRB must include a historical reference to its origination and purpose. According to Dr. Buelow, when a nurse engages in a medical research project involving human subjects, there are ethical considerations. Researchers need to determine associated risks for participants involved in the study. Researchers must also evaluate whether the participant is engaging in the study based on their own desire (Buelow, 2011 pg. 277).

An enforcement group was established to ensure medical research involving human subjects follows stringent guidelines. The group that protects persons against instances of duress or harm is known as the Institutional Review Board (IRB). A series of incidents led to the eventual creation of an IRB. One incident included the 1946 group of Nazi physicians charged with crimes against humanity (Buelow, 2011).

The Helsinki Declaration was another historical event that established systematic guidelines for informed consent. It reinforced the philosophy of the researchers’ responsibility for safeguarding the health of patients, especially those engaged in medical research. Then in 1974 the United States established the National Research Act. This was symbolic as it led to the creation of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (Buelow, 2011).

The commission’s work as outlined in the Belmont Report ultimately became the framework for IRB rules. Associated principles include participant veneration, magnanimity, impartiality, and informed consent. Subsequently each medical institution must submit proposed research to the IRB for prior approval (Buelow, 2011).

Columbia University Medical Center

Columbia University has established an all-inclusive Human Research Protection Program (HRPP). A key stakeholder and leader in the implementation of HRPP is the Executive VP for Research. The organization chart for Columbia is extensive and also includes a compliance oversight team, board coordinator, expedited review manager, and IRB specialists. Columbia seeks to ensure all human research studies exceed standards established by the Association for Accreditation of Human Research Protection Programs (AAHRPP) (Columbia University Medical Center, 2015).

Columbia is unique as it has three legal bodies governing the human research studies. The studies occur at either Columbia University (CU) or New York Presbyterian Hospital (NYPH). The Federal wide Assurances (FWAs) include one at Columbia University Medical Center (CUMC), Morningside, and one at New York Presbyterian Hospital. All human research is approved by the same HRPP (Columbia University Medical Center, 2015). Based on examined literature the Human Subject Research Process and the IRB work collectively to protect human subjects. Although the IRB provides a safeguard against unethical practices, researchers must also take personal responsibility.

References

Buelow, P. A. (2011). Using Research to Advance Nursing Practice. Clinical Nurse Specialist, 25(6), 277-280. doi:10.1097/NUR.0b013e318235adce

Columbia University Medical Center. (2015). http://www.cumc.columbia.edu/dept/irb/about.html. Retrieved from http://www.cumc.columbia.edu/dept/irb/about.html

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