Clinical Trials Are Medically Based Experiments

Based from this experiments, The Belmont Report Ethical Principles and Guidelines for the Protection of Human Subjects of Research was submitted in April 18,1979 to …….? (“Impact,” n.d.).

Ethics, in our society, are the moral principles that govern our behavior, dictating what is right from wrong. The specifics of ethics changes as values in our society change and evolve. This occurs in Rebecca Skloots book, The Immortal Life of Henrietta Lacks. One major reoccurring theme in the book is the lack of informed consent and autonomy. Fortunately, now there are safeguards which protect human rights in regard to health care and research. The Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, now part of the Department of Health and Human Services, created The Belmont Report, which is one such safeguard establishing principles for all human research (USDHHS, 1979). This paper will discuss the ethical issue of informed consent within The Immortal Life of Henrietta Lacks, the disregard to parts of the Belmont Report, as well as compare the role of the nurse in charge of Henrietta’s care versus the standards of care set for modern nurses.

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

Science, medicine, and psychology are powerful tools capable of increasing human understanding of the world, curing diseases, or assisting individuals in living more fulfilling lives. The potential for good is drastic; however, a potential for hurt exists as well. Although history is full of stories documenting the positives of research, events of scientific research hurting individuals still haunt history. These events, including the Holocaust and the Tuskegee experiments, demonstrate instances where scientific research on human beings is clearly unethical and damaging. Due to horrific events such as these, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research published the Ethical Principles and Guidelines for the Protection of Human Subjects of Research, or Belmont Report, in 1979.

The Belmont Report: Ethical principles and guidelines for the protection of human subjects of research. Retrieved December 13, 2011, from hhs.gov/ohrp/humansubjects/guidance/belmont.html

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

Now we have the Belmont Report and the Declaration of Helsinki to guide researchers in the most ethical direction when they are conducting their research for studies. Luckily now researchers have to basically write out their entire plan throughout the study step by step. They must write out any way that the human subject may be harmed, what they will do if someone is harmed, any potential costs, and much more. Once all of this is written out researchers then have to get their study approved before they can move forward with their study (Neutens & Rubinson, 2014). The steps that have to be taken to conduct research may seem like a lot, however, it may save a lot of time and energy in court if something happens to go wrong during the trial.

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.

One ethical principle is that of respect for persons who are involved in the research. According to the Belmont Report (1979) this principle should honor a person and their autonomous choices, however, the report observes that not all individuals are “capable of self-determination” (sec. Part B 1. Respect for Persons). This incapability requires that those persons be protected (Belmont Report, 1979). Wertheimer (2011) corroborates this in stating that group soft-paternalism is implicit that research should not capitalize on or abuse vulnerable populations, or those population groups who are not able to make rational self-determination. The presence of group soft-paternalism by Wertheimer (2011) in exploiting vulnerable groups also supports the Belmont Report (1979) ethical principle of justice. This principle ensures that persons selected for research are not merely being selected based on their vulnerability (Belmont Report, 1979, sec. Part B 3.

The first ethical principle stated by the Belmont Report is respect for persons. “Respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection” (The Belmont Report). The researcher must respect the subjects decisions and be obliged to allow them to take part of the experiment voluntarily. The second

Data protection requirements, such as the privacy rule enacted in 2003 as part of the Health Insurance Portability and Accountability Act (HIPAA), regulate the way in which protected health information is handled (Quorum Review, 2012).

Observations and experiments are required for each level. Systematic review is “the application of scientific strategies that limit bias by systematic assembly, critical appraisal, and synthesis of all relevant studies on a specific topic.” Systematic reviews offer strong evidence. “For example, for a given research question, high-quality systematic reviews including high-quality trials would yield stronger inferences than systematic reviews of lower quality trials.” A randomized controlled trial is a study design that randomly assigns individuals into an experimental group or control group. When the individuals get divided into groups, one of the groups uses the treatment being tested. “The experiences of the other group of people provide control or comparison of the data.” This makes it possible to see what effects the treatment actually has. These studies work well with drug trials. Cohort studies are a type of medical research used to investigate the causes of disease. In retrospective cohort studies, researches look at data that already exists and try to identify the risk factors for a certain condition. In prospective cohort studies, researchers come up with a question to form a hypothesis about the potential cause of the disease. They observe a group of people over a long period of time. A case report is a report of the symptoms, signs, diagnosis, and treatment of a patient. According to the Journal of the

Research ethics review is vital to the advancement of ethically sound research. Before individuals can be enrolled in a clinical study, the research must be approved by a research ethics board (REB), an independent committee composed of medical and scientific experts, ethicists, researchers and healthcare professionals, as well as non-scientific members such as legal and privacy experts and members representing the community. The REB’s role is to ensure that the proposed research adequately protects the rights, safety and well-being of the research participants.

This event gave power and gave a voice to patients who are being treated, surveillance, or participating any human involvement of clinical research, or any investigations. The policy was in acted to protect the rights and welfare of human subjected involved in an investigation or clinical research studies. According to Sparks (2002), Status: U.S. policy, Description:, All human subject research requires independent prior review. Origin of Institutional Review Boards (IRBs) Para 13). This U.S. Policy created guidelines for informed and

Ethics in clinical research focuses largely on identifying and implementing the acceptable conditions for exposure of some individuals to risks and burdens for the benefit of society at large. The Nuremberg Code was the first international code laying ethical principles for clinical research. The Indian Council of Medical Research has laid down the ‘Ethical Guidelines for Biomedical Research on Human Subjects’ in the year 2000 which were revised in 2006. These guidelines have elaborated the three basic ethical principles: respect for person, beneficence and justice. [J. Sanmukhani et al]. The basic responsibility of the Ethics Committee is to ensure an independent, competent and timely review of all ethical aspects of the project proposals