Clinical Trials

Third world countries and underdeveloped nations have become the new proverbial Petri dish of experimentation and offer particular conditions which researchers would never be able to find in their home countries. This only serves to highlight the problem that inherently faces all research studies, the ethical debate in regards to the protection and rights of their subjects. Is it feasible to expect the same standards to apply in certain countries where an economical imbalance between what is possible and what is not can be the largest hurdle to overcome? These are key issues examined in the New England Journal of Medicine by author Marcia Angell, M.D., and co-authors Harold Varmus, M.D. and David Satcher, M.D. in their respective articles

Due to the lack of money but the high demand of need of specific regimens in developing countries, researchers from developed countries are allowed to conduct trials on those citizens. In this article, Baruch Brody argues against moral criticisms given towards clinical trials in developing countries. His three arguments are the subjects weren’t treated unjustly (following an appropriate standard of justice), the subjects weren’t coerced (in terms of any plausible interpretation of the word), and the subjects weren’t being exploited (if they themselves gain access to the treatment after the study).

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

Healthcare professionals have an ethical obligation to respect patient’s wishes. Consequently, many legal and ethical dilemmas arise in healthcare in response to clinical decisions related to the needs, beliefs, and preferences of patients and families. Other dilemmas result over concerns about the integrity, competence, or actions of other healthcare professionals. Preserving human dignity, relieving suffering, equality, integrity, and accountability are essential nursing values (Kangasniemi, Pakkanen, & Korhonen, 2015). Nurse leaders have an

After termination of the study, the government implemented and has regulated several changes that impact nursing and public policy today. After ethical concerns had been publically raised and the study was terminated, the National Research Act was signed into law in 1974. This policy was used in the creation of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which proved helpful in identifying policy issues such as the lack of identified basic principles of research conduct and lack of informed consent. Regulations were passed according to this panel’s recommendations that required voluntary consent from all persons involved in studies which are funded or conducted by the Department of Health, Education and Welfare (DHEW) (CDC, 2013). For nurses, this involves a responsibility to ensure that research participants are advocated for and the consent being obtained is used as an educational, informative

Nurses are always the front line care giver of patients. A review of literature of nursing ethics about informed consent has been performed. It strongly demonstrates the importance of informed consent and that nurses are the key players for the advocacy role to protect the patient’s right.

The research ethics, especially with the human subjects, is a very complex topic, and the completion of the certification opened my eyes on many aspects of research process. I learned how important it is to fully understand the research purpose and the methodology especially when selecting participants. I learned which populations are considered vulnerable, how to balance risk and potential benefits of research, and the importance of obtaining an informed, voluntary consent. I learned how important it is for researchers to ensure subjects confidentiality and privacy. Hardicre (2014) said that the research would be impossible without volunteers, and that the researchers “must act as patient advocates to ensure that every stage of the research

The implementation of Right to Try laws in the majority of our country calls for nurses to stand as patient advocates, educate patients on the risks and benefits of treatments, and expand our own knowledge of trial drugs. In order for a patient to exercise the Right to Try laws the patient must be diagnosed as terminally ill, undergone all appropriate approved treatments, and obtain the support and supervision of their recommending physician (Dresser, 2015). After the physician recommends an experimental drug, nurses should work alongside the physician to educate the patient on the risks and benefits of the drug and to obtain a signed informed consent (“Right to Try,” 2017).

In this article Munro, Watson, and McFadyen, (2006) conduct a controlled trial in which assesses the significance of the training personnel who work directly with people who possess mental health and substance e abuse problems receive. The sample was administered in a NHS mental health service and incorporated a sample size of 49 (27.8%) mental health nurses, either in adult generic mental health or addictions services, out of 176 nurses who were initially invited to take the survey. 24 of the nurses were assigned to the experimental group (receiving training) and the rest (25) of the nurses were sent to the control group (receiving no training). Data was retrieved at three different times using surveys. The first survey was taken before training , training would last for 4 days, and then the latter two surveys were allotted following right after and then again 6 months later.

There are several ethical principles that need to be addressed within the nurse researcher-participant relationship, which are autonomy, beneficence, and justice (Judkins-Cohn, Kielwasser-Withrow, Owen, & Ward, 2014). The ethical principles should relate directly to informed consent, for the nursing research process (Judkins-Cohn et al., 2014). In this type of research the nurse faced with a dual role, as researcher and care taker (Judkins-Cohn et al., 2014). Nurses have the dual role, which consist of significant responsibility and demands. Therefore, it is essential that the nurses have a thorough understanding of the research process and informed consent (Judkins-Cohn et al., 2014). “This includes having an understanding of the institutional

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.

Critical issued of the appropriateness of conducting clinical trials in emerging countries has arisen over years. Being a leading company in biopharmaceutical industry, Novo Nordisk faces the critiques of whether it is justice to offshoring their clinical trials in developing economies. With the consistency of ethical principles brought up by Novo Nordisk, the company would be able to move their trials into emerging economies with the best interest for stakeholders. I will also propose ideas to Mr, Dejgaard for possible approach to media as well as the practices that Novo Nordisk could have changed over time at the end.

In many cases, medical researchers would take advantage of clinical trial patients living in developing countries by not giving them the appropriate information they need, stripping them of their freedom of choice without their knowledge. Numerous people in these countries live in poverty, having no money to not only provide themselves with food, clothes, or shelter, but also the

This paper will critique a qualitative research study published in the Journal of Medical Ethics in 2004, By Dr Helen Aveyard, about how nurses manage patients who refuse nursing care procedures. The article explains how nurses view informed consent as not being essential to nursing care procedures.

Therefore, more human subject research sponsored by the United States is carried out in third world countries (Klitzman, 2012). Consequently, a popular reason for the current trend to conduct human subject research in third world countries is that clinical trials are cheaper (Klitzman, 2012). In addition, the epidemics of malaria, TB, and HIV/AIDS are more prevalent in developing countries (Klitzman, 2012). As a result, wealthier countries such as the United States want to conduct clinical trials where it is cheaper and the prevalence of diseases is higher. However, research participants in developing countries have a higher chance of being exploited for their participation (McMillan, 2010). Therefore, it is essential that scientists and researchers who conduct human subject research abroad still conduct research with the highest standards. However, Institutional Review Boards are gaining popularity overseas and more are being established although, majority of the members lack expertise and resources (Klitzman, 2012). As a result, human subject are more vulnerable in third world countries. In addition, a variety of health systems overseas participate in a variety of corruption acts (Klitzman, 2012). Overall, if researchers are going to conduct research overseas they need to respect the individual and protect their dignity and rights. Overall, if researchers are