Sample Case Study On Bethesda Clearly Captures The Belmont Report And Tries To Expound On It, Especially The 45 CFR Part 46.

Question 1

Experimentation in research has led to the scientific improvements in our lives today, like the drugs tested in the clinical trials could only be proven through testing. Testing of these drugs is prior done in animals and perfected at its best before being applied or tested in human beings. Over the years, such experimentations have led to the disregard of basic ethical principles and some human rights that are basic. For instance, human experimentation might lead to the disregard of the basic right to privacy in the sense that the research studies are basically invading the subject’s circle of privacy like probing about an individual’s private life. Therefore, the Office of Human Research Protections (OHRP) seeks to protect and ensure that the rights of these subjects being tested upon are ensured within the research environment as well as the ethics are observed regarding the research.
Dr. Jones seeks to test his hypotheses using research and experimentation but his research goes against several protocols that have been set by the OHRP. According to the Belmont report on research, Dr. Jones’ study lacks respect for persons. The aspect of research should care about the ethical respect for both a deliberate autonomous and reduced autonomous individuals. With the first regard, Dr. Jones research violates the respect to the autonomous individuals a great deal by holding information from the subjects thus the latter are unable to make informed decisions about the study (HHS.gov). If autonomous individuals are hindered in such mannerisms, those with limited abilities to make their own deliberate decisions and act on them are also hindered in the sense that the withholding of the information by the researcher is resulting in lack of respect.
The main reason as to why the Office for Human Research Protections (OHRP) was initiated was to ensure that the research subjects in whatever study are protected from any kind of harm as this is against the research code of ethics (HHS.gov). Dr. Jones study is deviating from the required ethical manner it is strictly supposed to follow. For instance, the study hypothesis involves the labeling of children that are ‘normal’ as ‘stutterers’ will eventually make them the latter, whereas the stutterers will even become worse in that manner. Therefore, with this regard, this study seeks to make the subjects to be in a worse condition that when they signed up for the study. In this, case, the individuals’ formal speech patterns are being interfered with in order to test a hypothesis and so it is not an ethical research.
In accordance with the Nuremberg code describing the 45 CFR part 46, particularly the tenth code, and a researcher out to stop the research study or prepare to stop the exercise whenever he or she believes that the exercise of his skill in the research study will lead to injury, disability or death to the subject (HHS.gov). In this regard, a researcher that seeks not to be flagged by the OHRP system needs to understand this rule inside-out. DR. Jones’ research involved the making of his subjects distort their speech by making them worse than they already were at the beginning of the study. Therefore, this is a direct disregard of the Nuremberg code which strictly prohibits the researcher from causing disability in his research subject. From Dr. Jones’ sketches, it is plausible to determine that a total of six individuals from the group labeled ‘stutterers’ were able to speak normally but coming at the end of the study, five out of the six were already turned to be real stutters and the already stutters within the group became worse.
Apart from the aspect of respect and beneficence, the aspect of risk springs up from within Dr. Jones study. According to Bethesda 2001 (bioethicsarchive.georgetown.edu), it is a matter of ethical concern for the protection of research subjects for an independent reviewer or investigator to clearly assess and outline any risks that can arise from a particular research study.1 This investigator must also be clear of connections with the researcher or subject, in other words, independent. Bethesda clearly states that “No one should participate in research unless independent review concludes that the risks are reasonable in relation to the potential benefits.” This is clearly not the case with Dr. Jones study in the sense that there was no assessment of the risk involved and this raises a lot of flags by the Office for Human Research Protection (OHRP).
Before performing any form of research procedure on a subject in clinical trials of any kind, the researcher must retrieve a voluntary informed consent from the subject (HHS.gov). This is to provide evidence that the procedure of any kind that was probably affecting his or her rights or freedoms was done in accord to his own approval after being informed of the risks involved. The bringing of the researcher to court with the presence of the document will only clarify the matter that the study was done within the regulations offered by the OHRP offices. However, this proves to be not the case in Dr. Jones study in the sense that there is no mention of the voluntary informed consent to the subjects. In addition, the researcher does not explain the risks involved in the study and so flags are raised in the OHRP offices.

The aspect of justice is very important in a research study and it comes about in the sense of fairness in the whole research process. The distribution of what is deserved by the subjects is very important for a successful and ethical study to be perfectly successful. For instance, the giving of certain benefits to the subjects within the study should not be based on a biased decision that leaves out a chunk of the subjects out of the benefits. Rather, the decision should be unbiased and involve all the members of that particular study. Dr. Jones sought to improve the speech of those he had turned from normal to stutterers, maybe in a bid to reverse the effects of his study approach. He does not seek to improve the speech of others within the normal group of subjects hence injustice to these individuals.
As a result of the mention of the various forms of disregard of the ethical research principles, the OHRP offices should indeed be involved in the reviewing of Dr. Jones study. In addition, Dr. Jones procedures should be investigated thoroughly in various accords dictated in the guidelines regarding a proper research experiment on fellow human beings. For instance, the respect to both autonomous and less-autonomous individuals, beneficence of the subjects, lack of voluntary and informed consent, lack of the independent review of the risks involved in the study, are just but some of the ill mannerisms that are to be detected from Dr. Jones study. There is also need for the Office for Human Research protection (OHRP) to get into contact with the Foods and Drugs Authority (FDA) with regards to the FDA-approved steroid pills given to the teachers, staff and students not involved in the study.

Question 2

First and foremost, the application of this study in Malawi will require a number of several things be included within the study. First and foremost, the informed consent from the subject should not only be retrieved from the subject, but also documented. As mentioned earlier, this is to serve as a proof that everything was done in accordance with the guiding ethics of the OHRP or IRB. Secondly, an assessment of the possible risks of the study in Malawi together with the possible benefits must be carried in advance before the study is carried. These two distinct variables should be perfectly weighed against each other and should be used among the determinants of whether or not to carry out the study. In addition, the possible physical, psychological or emotional traumas as a result of the study be assessed in terms of the procedures involved in order to know the risk posed on the subjects (HHS.gov).
Social justice should also be considered in this study that Dr. Jones wishes to perform in Malawi in terms of the selection of the subjects for the study. In this sense, the subjects are determined in terms of preference where the preference dictates that adults should be selected first before children are considered, in accordance to the guidelines by the IRB guidelines (HHS.gov). In addition, competent subjects are considered before incompetent fellows whereas the non-institutionalized persons are prioritized rather than the institutionalized persons. Finally, a research to be performed needs to consider the privacy concerns for the subjects being studied in a particular research, particularly involving the methods of data retrieval from them and the sharing of the obtained personal information. In other words, the study needs to monitor the circulation of private data within the research to only those individuals authorized to access it and use the data for the research purposes.

Question 3

First and foremost, the safety of the subjects comes first regarding the site selected. Questions such as the security issues within Kenya are of utmost importance. Considering that the OHRP is based on the foundation of ensuring and protecting the human subjects in researches, then the deaths and suffering of these researches should be avoided at all costs. When talking about the safety of these subjects, then physical injuries, psychological and emotional traumas are all to be avoided in order to ensure that they are safe all round. For instance, the insurance of their adaptation in order to avoid sicknesses due to changing of the environments is based on the study of the new area allocated for the study. In other words, the study location should be extensively prepared and research to create a relatively stable environment that would accommodate these subjects while they are in the research study.
Apart from the fact that the security of the lands where the study is going to take place, the site selected for the study should be properly installed with the appropriate facilities necessary to cater for the study. In addition, the facilities should accommodate the research subjects with negligible stress on the facilities with inclusive of their care. In other words, the facilities that the research wishes to carry out in Kenya must be prepared on due time by ensuring that there is a proper installation of the required facilities in Kenya that would satisfy the research study requirements by law and ethical codes of clinical trials. Clinical trials including the use of fellow humans as subjects is a tricky matter in the loop is a very tricky subject and involves a lot of principles that all need to be ensured for one to successfully perform a clinical trial.

Works cited

Bethesda, Maryland. “Ethical and Policy Issues in Research Involving Human Participants.” National Bioethics Advisory Commission, n.p., 2001. Web. 20 March, 2015. https://bioethicsarchive.georgetown.edu/nbac/human/oversumm.html
“Chapter 3: Institutional Review Board.” Hhs.gov. OHRP, 1993. Web. 20 March, 2015. http://www.hhs.gov/ohrp/archive/irb/irb_chapter3.htm
“Human Subjects Research: The Belmont Report.” HHS.gov. OHRP, Office of the secretary, 18 April, 1979. Web. 20 March, 2015. http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html#xjust
“The Nuremberg code.” Hhs.gov. OHRP, 2005.Web. 20 March, 2015. http://www.hhs.gov/ohrp/archive/nurcode.html