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Discuss the role of the Institutional Review Board (IRB)
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The IRB, or institutional review board, serves to either approve or deny biomedical and behavioral research. The IRB was created after several cases of inhumane treatment or improperly conducting or performing experiments. Therefore the IRB was created to help regulate and prevent such catastrophes from happening again. However, much has changed now. I believe that there is an issue with regulations and procedures that govern research regarding human subjects. There needs to be smart, streamlined regulation rather than numerous regulations that prevent creative experiments or tests that may push the boundaries, within reason, to provide knowledge. Furthermore, certain regulations by the IRB are extraneous. This is why there needs to be a change to smarter regulation within the IRB.
The IRB has certain regulations that I deem as unneeded on. One policy I disagree with is what is known as “The Common Rule”. The regulation within The Common Rule states that, “14 other Federal departments and agencies joined HHS in adopting a uniform set of rules for the protection of human subjects”. I believe this is bound to slow progress down. With so many different agencies involved it
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If the IRB makes a set of rules for individuals it essentially creates a boundary line that one cannot cross. While this boundary line was created in order to prevent horrible occurrences from happening such as the Guatemala syphilis experiment in which 1500 Guatemalans were purposefully given syphilis. These rules and boundaries are now obsolete and need to be changed or removed. We are in an age where human rights are in place and effectively protect those that these IRB regulations were created to protect. In history huge discoveries were made when the limits were pushed and creative thinking was employed. Now it is time the rues surrounding and governing these studies and experiments to
Ethical violations committed on underprivileged populations first surfaced close to 50 years ago with the discovery of the Tuskegee project. The location, a small rural town in Arkansas, and the population, consisting of black males with syphilis, would become a startling example of research gone wrong. The participants of the study were denied the available treatment in order further the goal of the research, a clear violation of the Belmont Report principle of beneficence. This same problem faces researchers today who looking for an intervention in the vertical transmission of HIV in Africa, as there is an effective protocol in industrialized nations, yet they chose to use a placebo-contro...
Introduction During the process of research, professionals collect data or identifiable private information through intervention or interaction. While this is a vital part of the scientific and medical fields, every precaution must be taken by researchers to protect the participants' rights. Ethics, outlined by the Belmont report; requirements, described by the Department of Health and Human Services (DHHS); and regulations, laid out by the Food and Drug Administration (FDA) are verified by an Institutional Review Board (IRB). This procedure ensures that all human rights are safeguarded during the entire research process. The Institutional Review Board The IRB is an administrative body which has been established to make sure research participants' rights are protected.
In 1981, the United States, federal regulations (known as the Common Rule) was developed. It was influenced by the Belmont Report, written in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Common Rule establishes the core procedures for human research subject protections, which include informed consent and review by an Institutional Review Board (IRB).
All colleges in the United States who offer doctorate degrees have an Institutional Review Board (IRB). The purpose of this protocol is for the protection of human subjects used in research studies. During the dissertation process, the third milestone is the IRB application and approval process. Once the Dissertation Proposal is approved, the doctoral candidate must submit the IRB application for approval from the IRB. Because data collection requires the approval from IRB,
...ing. Moreover, if a treatment has the possibility of curing a child, but is unproven, even parents (who are eager to prolong the life of their children but lack the technical expertise to properly assess the risks involved) are not permitted to consent to it. Furthermore, Munson proposes that the IRB should be required to include outside experts to assess risks and benefits of experimental treatments.15
To sum things up, the ethical demeanor of research involves respect for the safety and rights of subjects during the sequence of the trial. This includes protecting privacy and confidentiality, monitoring the condition of research subjects to assure their safety, terminating study participation in the case of hostile events, and notifying enrolled subjects about new risks, benefits, or other information that may bear upon subjects’ decisions to continue enrollment in the research. As new evidence shows itself, trial investigators and data safety monitoring boards (DSMBs) can alter the study plan, initiate notice of enrolled subjects, make changes to the informed consent policies, or stop the trials earlier than intended. Investigators should soon classify a technique for ensuring effective communication between the IRB and DSMB throughout these studies.
Law and Animal Experimentation: A Critical Primer,” the author, Stephen Latham, begins his writing with expressing his views and thoughts on the reform needed to benefit animals while being experimented on. Latham describes the current system as being majorly flawed and having many gaps that could be completely modified to improve the current system in reference to the United States animal testing laws, standards, and regulations. Latham argues that “Even proponents of medical research on animals can see obvious ways in which the regulatory structure could be changed to benefit animals” (S35). Furthermore, the author achieves the purpose of stating his views while justifying himself in the attempt of achieving rational reform extremely well. Latham accomplished his purpose thoroughly because he provides detailed evidence and description of that evidence while explaining and supporting his thoughts of reform relating to the subject of animal
There should be more restrictions on how the animals are treated and the situations in which they can be experimented on. Hundreds of millions of vertebrate animals worldwide undergo animal experimentation each year. The animals being experimented on can become severely injured or sick because of what is tested on them and because of the conditions they are kept in. Over the years, many laws and regulations have been passed to improve the conditions in which the animals have to live. Testing on these animals has created multitudes of scientific breakthroughs. However, animal testing can be very cruel and can lead to the animals being killed or re-used for other experiments after if they do not die during the procedures. Using animals for testing should only be used for necessary experiments that need to be tested to save the lives of many people and should be regulated to not endanger or abuse
January 1st, 1959, W.M.S. Russell and R.L. Burch describes how there should not be a lot of animal testing. Russell and Burch publish “The Principles of Humane Experimental Technique,” which introduces the principles of Refinement, Reduction, and Replacement which are called the Three R’s. Reduction explained that people should use fewer animals in experiments. Replacement explained the use of non-animal alternatives over animals whenever possible. Refinement explained how people should use techniques to alleviate or minimize the invasive procedures that could potentially cause pain, suffering or distress, and to the enhancement animal welfare for the animals still used. The testing of animals have been going on for a long time and even some people have tried to help animals have less extreme conditions while being tested on. There are cases when animals are being treated badly, The Huntington Life Science was beating the anim...
The morals of a modern society entails protections for all species of life. Humans do not have the nature to not inflict harm on innocent animals around the world.Animal research is unjust and neglectful to species in every animal kingdom.The animal kingdom has been disturbed since men step foot on this earth. Some people are so selfish that the only thing that look over is about their own selves and not other humans or living things in this world. Animal rights is a big thing to some people and to others it not this paper talks about how it's cruel to research on animals, how research doesn't improve health,and how it's not regulated.
There are many ways to gather information and learn about a new subject and some of those ways are cruel, inhumane, and plain torturous. There is no hiding the fact that there are unethical experiments happening everyday all throughout the world, but there is also no hiding the fact that some unethical experiments have helped researchers and scientists significantly. Everyone’s who acts on these unethical experiments have the goal to be able to understand the world and how everything fits and works well together. The lab rats or test subjects pay a price of pain and can even lead to death all for nothing because, more than likely, there is a better, more ethical, way of finding the same information. There are many different opinions on these
In December 1946, the War Crimes Tribunal at Nuremberg indicted 20 Nazi physicians and 3 administrators for their willing participation in carrying out the harmful research on unwilling human subjects. Thus, Nuremberg code was the first international code for the ethics to be followed during human subject research. It was permissible medical experiments implemented in August 1947. The code also provides few directives for clinical trials (3). Syphilis study at Tuskegee in 1974 was the most influential event that led to the HHS Policy for Protecti...
Disease ravages the population, killing hundreds, and researchers scramble to find a vaccine. How far will they go in their pursuit for prevention? What is worth progress? The debate of human experimentation is long-lived and there is still no clear answer. Human experimentation has had a controversial past, simultaneously beneficial and detrimental to humankind. Its ambiguity has continued in the 21st century, but despite continued harm to the human race, human experimentation has few restrictions in the present day. There should be more restrictions, and countries should be more serious about following them in order to prevent further unnecessary pain and suffering.
One of the main objectives that need to be addressed by the government is how to protect reproductive materials outside the body and protect individuals by making sure they give permission for their materials to be used. Consent plays a key factor in medical research due to the fact that failure to receive consent violates the principles of individual independence and respect for others.
These standards must be met in the specific field standards are set for. There are many different regulatory bodies that set standards for the different fields of work, but the most common regulatory bodies for the emergency medical care setting is the HPCSA or Health Professions Council of South Africa, OSHA or Occupational Safety and Hazards association, NFPA and the Western Cape Government.