Institutional Review Boards Essay

In this case study, there were a few incidents of violations of ethics. In 1998, Callahan recommends that researchers should follow the three ethical issues: Autonomy, beneficence, and human justice. Autonomy is the first ethical principle that a researcher should respect the participate and make sure that informed consent has been given. The participates of this study was not aware the risk or what the study was about and actually could not give consent legally because they were minors. Johnson and Tudor did not give full disclosure of this research to the minors, teachers, or matrons at the orphanage. Beneficence is the second ethical principle; the researcher should maximize

In addition to censoring research, IRBs, “...shall have authority to suspend or terminate approval of research…”(§46.113, Common Rule). This allows IRBs to end a study completely, licensing not only the speech of researchers, but also their actions. This stops scientists from being able to freely study what they choose without first gaining the approval of an Institutional Review Board, which stops the free growth of the scientific community. Another issue that arises when considering the power of IRBs is the responsibility of members. In a study on the commitment of IRB members, researchers at Johns Hopkins found that members thought,”...compensation for IRB service was an important factor regarding role responsibilities…”(Currie). This shows that IRB members cannot always be considered a reliable source, which is important when dealing with crucial scientific research. Supporters will say that the Intervention of IRBs protects the subjects of human research subjects, but this isn’t the case. For instance, an IRB at Johns Hopkins University ended a study on the effects of infections patients receive from cardiac catheterization, but not before the research could be published, saving over 1,500 lives and $200,000,000 in 18 months(Hamburger). Institutional Review Boards do nothing to help human subjects. They only hurt scientific growth.

The development of programs, like the Institutional Review Board, are essential in making sure that the guidelines are followed. I think it is important to maintain boundaries when it comes to what research can and cannot be done using human subjects. The diversity of the IRB is necessary make sure the experiments that are being approved are in the best interest of both the subjects and the scientists pursuing

Tissot E, Cornette C, Limat S, et al. Observational study of potential risk factors of medication

The first ethical principle stated by the Belmont Report is respect for persons. “Respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection” (The Belmont Report). The researcher must respect the subjects decisions and be obliged to allow them to take part of the experiment voluntarily. The second

It is also imperative to reevaluate the purpose of the research and its methods of how to go about doing it. The fact that there was no consideration of the patient as another party in the research was big loophole in the research. Moreover, I think the results were biased because the clinical staffs were briefed on the purpose before the observation. It left rooms for the participant to circumvent its screening approach to fit the study. Evaluating this research opened my mind to understanding researches results just by looking at the approached being used. In which helps me to answer my practice-based question.

The utilization of prescription drug has increased in recent times. The availability of these medications has resulted in the treatment of numerous infections and ailments. These drugs alleviate chronic pain, depression and anxiety, sleep apnea, and much more. For an efficient health system, the main goal is to provide quality health care to all patients. However, over the years, there have been many legal and health controversies over drugs and the effects that they have on the body. The process of prescription drug starts from a lab and ultimately sojourns with the end-user. The drugs undergo testing and are often developed to treat a specific disease before being reviewed by the Food and Drug Administration (FDA).

| Supporting this subcommittee are Brooks Daverman and Tony Greer. Rich Johnson also participated in subcommittee teleconferences.

Though these rules are essential to make an experiment ethical, there has to be a fine balance on what is actually protecting the subjects and what is just unnecessary. In this kind of debate, there is no one extreme way to handle such a subject. Not having any rules leaves the subjects to be mistreated, but creating more just limits a researcher even more. There should be a middle ground that IRBs should agree to each individual case that would protect the test subjects and give the researcher

The atrocities involved in unethical human research led to the National Commission to establish the Protection of Human Subjects of Biomedical and Behavioral Research resulting in development of ethical codes of conduct and principles to guide research. The foundation of research rest on the principles of: Respect of Person, Beneficence, and Justice. Certainly as unethical practice overlaps in its occurrence, so does application of the Belmont Principles, research relies on complete data, as a result the consideration for protection of human subjects must include all aspects of human

Harm of treatment is the difference in the outcome for patients without the disease who receive treatment compared to those who do not.

Causes of disease : The individual patient usually does not benefit from the results of such research. The character of the research may vary greatly, from non-intrusive epidemiological studies to surgical removal of tissue for examination. In the latter case, patients are necessarily intimately involved and there is a clear need to protect them from unwillingly or unwittingly being subjected to discomfort or hazard.

I, as a member on this institutional review board, have decided to approve the request made by Dr. Beringer, Dr. Haslet, and Dr. Haslet’s team of researchers to continue their clinical trials. The study, as brought before the board, appears to satisfy the criteria needed for approval. This criteria includes, but is certainly not limited to, the minimization of possible risks for research subjects, risks are relatively reasonable when compared to the anticipated benefits, subject selection is equitable, and the research subject provides an informed and voluntary consent to the study in its entirety.

One of the main responsibilities of the IRB is to weigh the levels of acceptable risks for the participant against the possible benefits. If the known risks to the participants are considered to be low and potential benefits to society or the participants are sizeable, the research is likely to be approved. Consequently, the IRB must agree that the study although deceitful in nature would prove to serve some benefit and not cause harm to the students (3.04/8.07, American Psychological Association, 2002).

The great strength of the review as an essential information gathering methodology is its flexibility.