The Ethics Of Drug Trials

In the famous Belmont Report, several guidelines regarding informed consent, assessment of risk and benefits, and selection of subjects in addition to ethical practice and procedure in the area of human research are outlined. The Belmont Report attempts to summarize the basic ethical principles identified by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (Belmont Report, 1979). In particular I would like to discuss the standards for informed consent, assessment of risk and benefits, and selection of test subjects drawn out by the Belmont Report. These three areas of interest are said to be the applications of the general

Informed consent is the basis for all legal and moral aspects of a patient’s autonomy. Implied consent is when you and your physician interact in which the consent is assumed, such as in a physical exam by your doctor. Written consent is a more extensive form in which it mostly applies when there is testing or experiments involved over a period of time. The long process is making sure the patient properly understands the risk and benefits that could possible happen during and after the treatment. As a physician, he must respect the patient’s autonomy. For a patient to be an autonomous agent, he must have legitimate moral values. The patient has all the rights to his medical health and conditions that arise. When considering informed

It’s very important to obtain written consent from each patient/human participating in clinical trials because written consents are designed to protect the safety and the rights of people participating in the trials. The informed consent document gives information to the patient describing all parts of the clinical trial, and all patients/humans participating have to sign the document before the study can be conducted. Joining a clinical trial is a big decision. If you’re unsure of what you’re getting yourself into you should always ask questions. If you decide a clinical trial is the right thing for you, be sure to ask for a copy of your informed consent document for your records. The informed consent process doesn’t end after you sign the document-it’s an ongoing process with researchers and the health care team and your allowed to ask questions/concerns related to the clinical trial or treatment (Pozgar,

The definition of exploitation is the use of utilization, mostly in regards of profit. Nowadays, there are many pharmaceutical companies that have a vested interest in profit rather than caring for patients. This false façade will be promoted through randomized clinical trials where data can be easily fabricated. This brings into question whether this is ethical or not – so epistemic information must be examined. However, conducting these randomized clinical trials will bring into detail the method of informed consent and its purpose within equipoise. Miller argues that equipoise is incoherent in terms of its methods as well as the appearance of the step process appearing very deceptive. As for informed consent, there are times where patients

This temptation happens when the research question, such as a cure for cancer, is extremely important and the answer could save lives. If the investigators cared more about the scientific or medical advancement than the well-being of their participants, they would cross a line that prohibits treating human subjects as a means to an end. When this line is crossed, there is little left to protect patients from a callous disregard of their welfare for the sake of research goals. Informed consent would not matter because of the unbalanced relationship between the knowledge and authority among the researcher and the subject. Approval by an institutional board, although it is important, can be subject to change in its responsiveness to patients’ interests when they conflict with the welfares of the researchers. Going back to Paul’s case, he agrees to enter a clinical trial which was suggested by his oncologist. The study, that Paul has agreed to enter, has claimed that this research team has created a new drug that may be on its way to cure cancer. Obviously to a father and husband, this trial looks very appealing. However, the researchers knowingly form two groups that will compare two treatments. What Paul doesn’t know, is that one of the treatments is better than the other. One group will receive this new drug and the other group will receive a placebo. Comparing this new treatment

The author believes that biomedical research is the way of better understanding medicine and without randomized clinical trials the field of medicine will have insufficient information. He argues that randomized clinical trials are the most scientifically sound and ethically correct means of evaluating new therapies. The belief of a physician being unethical when running randomized clinical trials is rejected by this article because previous trials on patients can have a better outcome on future patients. This article stresses that randomized clinical trials must be carefully designed that has an intended purpose of gathering data to improve the wellbeing of patients. If the patient is to endure a clinical trial he/she must be properly informed of the risks of the trial and the health of the patient should be high priority. Overall this article explains the importance of randomized clinical trials and debunks the idea of randomized clinical trials as being unethical. This article uses a utilitarian point of view and gives reasons why these trials can be in the best interests for both the patient and society.

4. Assess the motivation of drug companies that test overseas? This question is obvious; Pharma companies need a large sample size for their case studies to treat certain dieses. These companies are providing free treatment to those who participate in the study. Therefore, yes I feel that Pharma companies provide testing to the less fortunate is morally justified. They select prime candidates that may not be able to benefit from medicines that may improve or save their lives. I do not believe that these individuals are being exploited. They are receiving medicines that may not have received.

“Respect for human beings involves giving due scope to peoples capacity to make their own decisions. In the research context, this normally requires that participation be the result of a choice made by the participants” (NHMR, 2007, p.3).  Freegard 2012 (p.60), states that “respecting the rights of others,” includes a responsibility for Health professionals “to let others know about their rights” and that this forms the basis of an informed consent.

Although scholars have obtained verbal histories and generic written documentation evidencing the general research activities of these low-status prisoner doctors, little identifying information has been found recording the names of these prisoner doctors, or the roles they played in specific experiments. However, there are a few examples where identifying information about specific prisoner doctors was recorded and retained. For example, typhus began to spread feverishly through the ranks of the German front line, and SS officials such as Heinrich Himmler and Medical Chief Ernst-Robert Grawitz, were impatient for a vaccine. When the facility where typhus vaccine research was being conducted was bombed by the allies, the head physician, Dr.

Due to the fact that because drug trials were poorly regulated in the early 1970’s Phase I research was conducted on prisoners. The FDA was granted authority to monitor research that involved humans in the 1978; at which time, the FDA ordered each institution to devise an Institutional Review Board (IRB). The IRB was to generate and monitor the rules of the trials on all studies done within the universality. The IRB was comprised of faculty members who volunteered to evaluate their colleagues’ studies. Unfortunately, before 2005, FDA inspectors’ primary focus was on verifying the clinical trial data, not the human subjects involved in them.

When Pharmaceutical companies are trying to develop a new drug they begin the process of a clinical trial. A clinical trial in drug testing is when researchers test a new drug on live participants and record information such as side effects and results. Recently, pharmaceutical companies are trying to increase their profits so they have been outsourcing. Outsourcing is when clinical trials go to a clinical research organization (CRO), which are big businesses. One crucial step in a clinical trial is informed consent. The participants must know they are part of a research study, the possible risks, and outcomes. This information should be presented in a manor in which the individual can understand. However, after watching the videos this crucial step is sometimes overlooked or not taken seriously during overseas drug testing. Often times testing is done overseas in areas that are over populated and have a large gap between the wealthy and the poor. When researchers are conducting the trial they have been known to just completely skip over this step or they give individuals the information on the clinical trial but the participants are illiterate and unable to understand any part of it. This is seen as unethical practice. Ethically, all participants are required to know they are part of a clinical trial and they need to know all risks and outcomes projected before participating.

In the pharmaceutical field, there is a lot of controversy when it comes to doctors prescribing certain medications to patients; such as oxycodone. Some citizens hold the government accountable for addicting patients to oxycodone, but in reality the ones to blame are the doctors and pharmaceutical scientist. The government may have allowed doctors to prescribe these medications but there are also laws created to prevent doctors from abusing the right to prescribe oxycodone. The most common controlled substance that is prescribed is oxycodone which is also known as a narcotic.

According to the NIH website, “informed consent explains risks and potential benefits about a clinical trial before someone decides whether to participate.” 4 When the researcher obtains consent they are respecting the patient and enabling them to self-governing plus upholding the principle of respect for persons. IRBs have been a good standard for ethical research; however with the advancing fields of research in genetics, reproduction, and neurology, it may be time to develop more regulations.

Role I would play as a King of the World to improve the fate of mankind and benefit the lives of people by using Ethics in research 12

As students of BBA, our course instructor of Ethics in Corporate Society, Ms. Tania Danish authorized us to make a report on the “PHARMACEUTICAL MARKETING-the growing ethical concern?” We were required to make a report in accordance to our learning in the course of Ethics in Corporate Society and simultaneously increase our knowledge in regard with the ethics of Pharmaceutical Marketing in Pakistan.