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Regulation Issues

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Regulation Issues in Health Care
Amanda R. Williams
HCS/430
February 3, 2014
Ann Nevers

Regulation Issues in Health Care
The Nevada Institutional Review Board (IRB) is a group that is designated to oversee research that is done that involves human participants. This committee or group is to make sure that the rights and welfare of the human subjects remain intact. According to the University of Nevada, Las Vegas (UNLV), “Each Institutional Review Board (IRB) at UNLV falls under the umbrella of the Federal Wide Assurance (FWA) #00002305, which assures that the university will adhere to federal regulations regarding human subjects’ research. The FWA is approved by the Department of Health and Human Services, Office for Human Research Protection.” The legislature created this board in 2005. However, over the years the committee of this board has become corrupt. The article states that the board was designed to for scientific research, however, the legislature granted the IRB to be run by the Board of Homeopathic Medical Examiners instead of a board that had more regulations over more traditional medicine. According to the article, “The Nevada IRB was crafted to allow the Board of Homeopathic Medical Examiners to review, approve, oversee and control certain research studies which use drugs and other therapies it regulates. In theory, the IRB was created for the very necessary and infinite hope offered by stem-cell research. In reality, it's a massive testing ground where the unending pockets of the pharmaceutical companies can exert power over measly state boards and the lawmakers who create them” (Neff, 2006).
The article states there is an audit that is set to take place because the IRB is in debt and have found ways to hide money that could otherwise be delegated to the research that is being conducted. By January of 2007, the estimated debt the organization will have is $ 72,000. This debt is owed to the Attorney General’s Office and includes legal advice the organization has requested. The article also states how minutes from the board meetings that have been held have been altered. “The minutes of one board meeting, for example, do not accurately reflect audio recordings of the meeting. The minutes of another board meeting - posted on the board's Web site - were different than the ones approved by the board. The board's secretary-treasurer, F. Fuller Royal, hadn't even submitted minutes for the board to approve from the past five meetings. Board members have been replaced” (Neff, 2006). This causes many concerns not only for individuals in which the research is being done, but the citizens of Nevada as well. If this board is able to change minutes from meetings and hide money, what else are they capable of getting away with?
Another issue the board is faced with is the accreditation of the members. “Dr. Wayne Woo Suk was noted as one of the most influential people of 2004 by Time magazine before it was determined this year that he faked much of his cloning research” (Neff, 2006). The article also states that the president of the board, Osteopath Daniel Royal, was involved in an anthrax scare in 1998. After searching his office and tests were ran on the materials that were found, the results showed the material to be harmless, and the charges filed were later dropped.
In a situation that has been presented in the article it is very crucial for the law to step in and make sure that regulations are being followed in the correct manner. Regulations are set to protect the welfare of the people and to make sure all laws are being followed. Regulations are very important for the safety of many individuals. In an organization that has board members that are not abiding by the regulations and laws that have been set, the legislation or source governing the organization should step in and have the board member replaced. Organizations should be trust worthy and not have to wonder if the regulations are being followed accordingly. An organization that loses the trust of the community many times has a very hard time recovering from the situation after being resolved. There are often times that an organization may never regain the rust of the community and be completely dissolved. Trust of the community is a vital ingredient an organization needs to evolve.

Reference
Neff, E. (2006, Feb 28). 'Critical' to nevada health care? Las Vegas Review - Journal. Retrieved from http://search.proquest.com/docview/260198510?accountid=458 University of Nevada, Las Vegas. (2014). Institutional Review Boards. Retrieved from http://www.unlv.edu/research/ORI-HSR/review-boards

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