Research Ethics: The Beecher Article and the Belmont Principle

I waive any possibility of compensation for injuries that I may receive as a result of participation in this research.

Informed consent is a document that the patient must sign which allows the process of the treatment to be begin. The paper must be sign to protect the patient as well as the doctor from any legal issues. Before the heath care professional can perform treatment(s), the patient must be informed of all possible dangers and possible side effects. The basic principles that are in an informed consent document include the followings. The patient must have a clear understanding about the situation.

The first step in developing a drug is pre-clinical testing. The experimental drug is tested in a laboratory and in animal studies. The drug has to meet safety standards and show potential for being a new drug. If this criterion is met, the drug moves on to the next phase. Phase 1 is concentrated on making sure the drug is safe to use on humans. This is the first time the experimental drug is used on people. Different measures of dosages of the drug are given to a small number of the volunteers. This allows the researchers to be able to measure the body’s response to the drug. The things they measure include how the drug is absorbed, its duration in the bloodstream, and what dosage levels are safe and well accepted by the body. If the experimental drug is deemed safe, it passes on to Phase 2 (Phases of Development, par. 6-7).

While the steps to bring a new drug to market may seem extensive and costly, they are a necessity. Clinical drug trials provide options for people with diseases while also allowing doctors to improve the way they diagnose and treat these diseases. The process is long, but the benefits that new drugs have to offer, is

Each and every member of the team will understand the science behind the clinical trial provides significant background for the tasks that will be allocated and related decisions will be considered. We will take help from medical monitor or other suitable expert to arrange an outline of the therapeutic part and sign, to talk about the specific mechanisms pertinent to the manufactured goods being evaluated, and to talk about earlier and rival trials that may offer context to our

To start out, it is important to differentiate between practice and research, especially in this discussion of therapeutic research trials. Practice is meant to treat an individual in order to improve upon their quality of life. The practice of medicine generally yields good outcomes and is not inherently risky, with some exceptions. However, research on the other hand includes subjects or participants to learn something about people or a topic as a whole. While it seems that the differences are clear, there are many times when the lines between the two may blur. One of the ways that the differences are more ambiguous is in the case of

behind rather or not the patient should have been given to this young Patient when the in trials

The healthcare rofessional explain the process of obtaining the investigational product to the patient is of prime importance especially when the patient has exhausted all the available medications and therapies. During the clinical trials, Andrea or any patient cannot obtain the drug until the drug becomes approved or the patient is eligible for the study according to the protocol. Current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. Because a sponsor will probably want to ship the investigational drug to clinical investigators in many states, it must seek an exemption from that legal requirement. The investigational new drug (IND) is the means through which the sponsor technically obtains this exemption from the FDA. The IND is not an application for marketing approval. Rather, it is a

Randomized clinical trial (RCT) is the most effective way of conducting research on the efficacy and safety of newly developed drugs and medical treatment for public consumption. Like most experiments, there are usually two groups in conducting an RCT: the placebo group and experimental group. In the placebo group, the subjects receive a placebo drug or a drug that is already available and is used to treat a particular disease and in the treatment group, the subject receives the newly developed drug or treatment. However, in the RCT, the subjects that agreed to participate in the clinical trial are randomly assigned in either placebo or experimental group in order to eliminate observer bias and distribute the subjects’ variables evenly on all groups. Furthermore, RCT is either single-blinded or double-blinded. In single blinded RCT, the subjects cannot know if they are placed on placebo or experiment group. Moreover, the subject cannot know anything about the progress of the trial. As for the double-blinded RCT, both the subject and the physician-scientists who are conducting the trial do not know which subject are in which group and whether a particular treatment’s progress.

A. My research study will be a prospective non-experimental study more specially a longitudinal research method. The reasoning for this is when the treatments are over I want to see if patients are experiencing any long term adverse side effects and if so for how long after the treatment are the side effects persisting. So this will be a long term study that will see the effects of the treatments over a 10 year period of time.

Section 1: Inquiring Introduction (Short paragraph). Identify clinical question and search body of knowledge: Select a diagnostic test, pharmacologic intervention or other specific management plan that was instituted for a patient during your NUR 568 clinical rotation. Briefly describe the case and reason you made this encounter the inquiry for your assignment. Describe you literature search process (ie, databases searched; key words used, literature search results [number and type of studies found], how studies used were determined to be the best choice for informing your PICO question). State a well-constructed question (in PICO format) regarding the

Drug trials are at the heart of many of today’s medical breakthroughs and advancements, thanks in no small part to the individuals that take the risk and participate in them. The standard of care that as we as a society have come to know is possible not only because of scientific breakthroughs, but also because of rigorous and thorough testing to find if a drug or treatment is not only safe but effective as well. Human drug trials can accomplish this in ways simple lab testing cannot and lead to better healthcare for all of society. But one must consider the ethics behind the practice of drug trials in modern medical research. Not only from the perspective of the participants in the trials, but also in how medical professionals present the information and carry out the trials. What ethical considerations, if any, need to be taken into account when starting and participating in a drug trial? The ethics of consent also need to be considered when examining human testing, for consent goes hand in hand with any type of drug trials and cannot be ethically or legally be separated from them.

The Belmont Report was created in order to prevent unhuman research such as the Guatemala Syphilis Experiment (case 1). The Common Rule is a version of the report that founded the Institutional Review Boards. IRB manage all human research requests. These organized assigned codes are an acceptable way to prevent unmoral human research. At the same time the IRB can take a very long time to accept projects that are actually not part their rules.

The three principles mentioned respect for persons, beneficence, and justice are the Belmont Report principles.

Thousands of people voluntarily enroll in clinical drug trials every year. They are putting their health and safety at risk by participating in a drug trial. One would think they would be doing this to promote medical advancement, but in all actuality, it is for the high dollar amounts they receive for compensation. People that frequently enroll in drug trials are often called “guinea pigs.” The monetary amount people are paid can go as high seventy-five hundred dollars. The more invasive the procedure is the higher the compensation. These “Guinea pigs” are required to pay taxes on the money they do make. (Elliott, 2008)