Ethical Issues Facing The Clinical Research

A 35-year-old man named Paul, who has a supportive wife and two adventurous kids, has been diagnosed with a very severe case of bone cancer for 1 year now. Since this type of cancer is so severe, chemotherapy is starting to not work as well. Paul’s oncologist unfortunately had to suggest a final option for Paul to try which was a clinical research trial. Clinical research trials are experimental studies that deem whether or not a medical drug, treatment, surgery, or device is safe and beneficial for humans to use ("National Heart, Lung, and Blood Institute"). As explained in Marcia Angell’s Article, “The Ethics of Clinical Research in the Third World”, the Declaration of Helsinki of the World Health Organization (WHO) provides a guideline

In the field of medicine, clinical trials are known to be a reliable source of information. Although ethical issues do arise, to which the theory of equipoise was proposed, which states that there should be a balance of forces of interests (Weijer et al., 95). There are two types of equipoise; clinical and theoretical. Clinical equipoise is the assignment of multiple treatments to be tested on patients with the disagreement in the medical community in which medical professionals have differing views that one treatment is better than the others (Weijer et al., pg. 97). Theoretical equipoise is between a physician and researcher and the belief that the risks and benefits of the treatments are in perfect balance (Wiejer et al., 96). The differing factor of the two, being that clinical equipoise focuses on the difference in views of certain treatments involving much of the medical community to form an insightful conclusion on the procedure to which the evidence supporting each treatment does not have to be balanced, whereas theoretical equipoise focuses on the equal amount of risks and benefits within each treatment (Weijer et al., 97). With that being said I personally believe researchers must be in a state of clinical equipoise to run morally acceptable clinical trials.

Bringing Henrietta to Life: Creating Dialogue on Disparities across Disciplines Henrietta Lacks was a woman who made an eye-opening breakthrough in medicine in the early 1950s. Her cells were the first immortal cells to be discovered which paved the way for developing the polio vaccine, cloning, gene mapping, in-vitro fertilization, and more. Unfortunately, there are two sides to every story. Although, modern medicine would not be where it is today without Hela cells, Henrietta’s family continued to struggle with her legacy because of the health disparities associated with ethics, race, and medicine. Henrietta’s cells were taken without her knowledge and used to cure various medical conditions.

An article was chosen from the University Library to evaluate the issue of unethical business research conduct. The article chose is called Flacking for Big Pharma: Drugmakers Don't Just Compromise Doctors; They Also Undermine the Top Medical Journals and Skew the Findings of Medical Research . The identification of the unethical business research involved in the article is given. The parties involved along with effected party is mentioned. The evaluation of the article also identifies how the unethical behavior affected the organization, injured party, and society. A proposition of

Review Ethics boards should be considerate of the patient’s they are using to conduct their research by first having them fill out an agreement to participate in the research. This idea is reinforced by a field researcher who had to get the patients to sign permission slips before interviewing them and the research wouldn’t reveal their identity. The field researcher found this was an effective way to make the patients whom the experiment is being conducted on comfortable and willing to participate. It allows the patients to have a say on whether they are willing to have specific research done on them whether related to psychological reasons such as asking questions or to have biological research

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.

Conducting quality research requires the researcher to perform within both ethical and legal guidelines. “Ethics is the study of right and wrong” (Houser, J., 2012, pg.50). Ethics provide the avenue for decision making and are guided by the researcher’s integrity. Legal guidelines provide direction to the researcher by specifying what is required by law to conduct research. As a nurse researcher, it is an ethical duty to advocate for patients when incompetent, unethical or illegal practices are observed.

“Obligation of sponsoring and host countries”, which highlights some of the most important aspects of clinical research, case in point, that ethically, it should be a sweeping consensus. I always find, when thinking of the powers that be, scientifically, it would be rather easy for a big pharm or clinical research sponsoring organization, to seek out human subjects in developing nations, simply because research guidelines aren’t as stringent there, because regulation isn’t as intrusive. Thus, guideline 15, is paramount, because it holds external sponsoring agencies, as well as the host country, accountable. Guideline 15, hallmarks the importance of holding high ethical standards, regardless of where the research is being

There are many ethical issues in the healthcare field. These issues range from insurance coverage, senior care, childhood immunizations, beneficence, abortion, medicinal marijuana, honesty and medical research (Fritzsche, D., 2004). Today we will discuss the ethical concerns in only one aspect of heath care and that topic is research (Benatar, S., 2000). Medical research is necessary in order to make strides in health care, introduce new medications, to discover new symptoms and disorders and to test new treatment options for current medical problems. Students of medicine, universities and pharmaceutical companies conduct this research primarily. Much of this research is time consuming and costly, therefore obtaining funding is not

For clinical research to be considered ethical, the question it poses must be equipoise: in other words, it must be in a state of genuine uncertainty (Freedman, 1987, p. 141). In the case of this study, the question was definitely uncertain. Although the benefits of COX-2 inhibitors could be very real, the question as to its affects on cardiovascular health was worth exploring. Thus, the study is equipoise in it’s seeking an answer to the very valid question: are COX-2 inhibitors worth using?

For example, Vedula (2012) notes that FDA guidelines state pharmaceutical companies can use peer-reviewed articles to publicize evidence of a drug’s effectiveness for off-label uses, as long as a number of conditions are met—perhaps the most essential of which is that “the information disseminated must not be false or misleading.” However, Vedula continues, there is no unyielding regulation that all research findings have to be published. Therefore, a company can still choose to selectively disseminate favorable findings. His article concludes that there is now a copious amount of evidence that suggests selective reporting of study results, based on the strength and direction of findings, is performed extensively by the pharmaceutical industry.

Another question we come across in this case is "Should these pharmaceutical companies have a moral obligation to make the drugs available to the people who they performed clinical trials on?". Again we clearly should see that the pharmaceutical companies should allow the access of these drugs to the people that are being used to test their products. There is a huge risk for these people who are taking a new drug, not knowing exactly what the outcome can be and are merely treated as guinea pigs for the

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.

The pharmaceutical industry confronts several dilemmas every year. Most of these dilemmas revolve around money or whether or not to sacrifice now for a bigger payoff in the end concerning money and/or lives. Pharmaceutical companies tend to use shortcuts that create ethical problems. Drug companies have spent millions/billions of dollars in research, and they obviously want to see

Nuremberg Code is a set of 10 sophisticate principles regarding ethical clinical research on human being (Grodin, 1994). It is mainly for protection of subjects’ human right (Shuster, 1997), such as compulsory of informed consent and the equal authority of subjects as the physician-researcher to end the experiment.