The Items that have shaped the Modern IRB Directives
The Items that have shaped the Modern IRB Directives
Introduction
IRB or Institutional Review Board is considered as the safeguarding body responsible in ensuring the ethical treatment of human subjects and or participants in a research (Blackburn.edu, n. d.). IRB implements policies and requirements needed in research studies that involve human subjects. Their review includes overseeing the welfare and rights of the involved subjects, the appropriate methods used and it informed consent were obtained and ensuring the right balance between the benefits of the investigation and potential risks. Despite the many scientific breakthroughs brought by research, ethical consideration still needs to be adhered upon and it is in IRB’s initiative to make sure that human rights and welfare are not being violated for the sake of advancement. Directives and polices were created to minimize the risk in using human subjects and there are factors that shaped the modern IRB directives to meet socially acceptable method of using human subjects in research. This paper will discuss items that have shaped the modern IRB directives such as Nuremberg Code, Declaration of Helsinki and Belmont report.
The Nuremberg Code
The Nuremberg Code was promulgated in 1947 containing 10 essential key points regarding the use of human subject in research. According to this code, the subject should constitute voluntary submission or consent to the research. The results obtained from the research should only be used for the good of the society, which means the results should be limited within the concept of social advancement. All the experiments conducted using human subjects should also be based on prior research done on animal subjects. Research should not be conducted using human subjects immediately without prior animal tests (Columbia University, 2000). Experiments performed on human subjects should not result to mental suffering and physical injuries. If there would be an instance of unavoidable risk, its extent should not exceed level determined by humanitarian importance of the problem aimed to be resolved by the research. Prior determination of potential risk such as death and injury should be considered as a significant justification to stop pursuing the research. This provision can only be disregarded if the physician will also serve as the subject. Proper preparations of appropriate facilities is also necessary in ensuring that the subject will in anyway be exposed to external risks that would bring injury, disability or death to the subject (Research.buffalo.edu. n. d.). The people engaged in conducting the experiment should have the most appropriate skills and expertise in the field of study and should poses scientific qualifications. The human subject should be granted the liberty to end the experiment if he has reached the maximum physical and mental capacity wherein the continuation of the experiment appears to be impossible (Research.buffalo.edu. n. d.). Lastly, in case that the research scientist had a reason to believe that the experiment would cause substantial injuries and death, he will in good faith, superior skills and reasonable judgment should be prepared to terminate the research.
Declaration of Helsinki
The Declaration of Helsinki was promulgated in 1953 to guide the medical doctors in the field of biomedical research that involves the use of human subjects. It has been amended several times and the latest its version was made in 2000 (Columbia University, 2000). The events that led to the declaration include the apparent existence of vulnerable population of inmates in concentration camps that are being used as for vile, lethal and inhuman procedures on the grounds of medical research. The declaration is a response to the determination of war related medical crimes during the Nazi era. It is generally culminated during the Nuremburg trial in Germany in 1946 (Tyebkhan, 2003). The declaration emphasizes safeguarding the interest of the human subjects, their protection, well being and safety. The declaration guidelines also place the patient’s health on the dignity and privacy of the physician along with other essential elements of the declaration. These elements include taking consideration of safeguarding the patient’s welfare before advancement of science. In the field of human research, the interest of society and science should not overshadow the considerations related to the subject’s well-being. Therefore, it is apparent the welfare of the patients comes first before any development towards science. It is based on a utilitarianism theory stating that the benefits should justify the common good. Another pivotal element of the Helsinki declaration is the informed consent. Health volunteers are responsible in making the patient aware of the study. The volunteer should also equip with appropriate information to allow them to take the position as volunteer for the study. In addition, the informed consent should also clearly stipulate the rights of the human subject in a language that he can best relate. Usually, the patients are not aware and fully understand the jargons and parlance of medical research. Therefore, it is required that the patient provides his voluntary informed consent.
Belmont Report
The Belmont Report is regarded as the ethical foundation of protection for human subjects and regulation. The National Research Act of 1974 has created the National Commission of Protection of Human Subjects of Biomedical and Behavioral Research. The report administered the congressional hearings chaired by Senator Ted Kennedy. It is not just any other report or advisory, the commission was given a statutory authority, which would write rules that later become law (Jensen, 2008). It is necessary for DHEW to accept recommendations or explain the reasons why change should be adopted or implemented. Despite the very sensitive nature of the subjects they handle, the commission is still operated in public. In fact, the commissioners more reports than usual, which is not normal for a federal for a federal commission. The Belmont Report is focused on the contradiction between researches versus practice. It involves the basic ethical principles of respect for the person wherein each person’s right to autonomy should be treated with utmost importance. However, those with no autonomy should otherwise be entitled to protection. Beneficence is also an essential element of Belmont report, wherein the possibilities of benefits should be maximized and risk to be minimized. It also includes justice, which constitutes fairness in distribution (Columbia University, 2000). There are three basic protective mechanisms for human subjects, which involve IRB review of research, informed consent and institutional assurance of compliance (Columbia University, 2000).
Discussion
The three factors that influenced and shaped the modern IRB ethic directives may have synonymous initiatives. However, they have significant differences that set their concept from one another. The Nuremberg Code is basically is more focused on the ethical standards of research when it comes to protecting the human subjects. The Nuremberg code was able to define the concepts that clearly stipulate the requirements needed in order to ensure that the patient is protected from apparent risks. On the other hand, the Declaration of Helsinki also emphasizes the welfare of the human subject used in research. However, it is being used more as a guideline for biomedical research, which means it directives are limited within the confines of medical research. Human subjects are being used not only within biomedical research, but also in other fields. Therefore, the Nuremberg Code covers a broader spectrum of concerns when it comes to the use of human when it comes to the safety of human subjects. Humans in general possess universal rights and Nuremberg Code stipulates every possible notion that is detrimental to human rights. The characteristics of Nuremberg cannot be compared to Belmont report because it is geared towards the realization of the benefits that Nuremberg Code has already outlined. Nuremberg Code is much more adequate insuring safety of the human subjects.
References
Blackburn.edu (n.d.). Institutional Review Board. Blackburn College. Retrieved December 14, 2012, from http://www.blackburn.edu/cs_institutional_research_board.html
Columbia University (2000). Brief History of the Protection of Human Subjects in Research. Epiville. Retrieved December 15, 2012, from http://epiville.ccnmtl.columbia.edu/assets/pdfs/insert5-6slides.pdf
Ohsr.od.nih.gov (n.d.). Nuremberg Code. Vice President for Research & Economic Development. Retrieved December 15, 2012, from http://www.research.buffalo.edu/rsp/irb/forms/nuremberg_code.pdf
Tyebkhan, G. (2003). Declaration of Helsinki: The ethical cornerstone of human clinical research. Research Methodology, 69(3). Retrieved from http://www.ijdvl.com/article.asp?issn=0378-6323;year=2003;volume=69;issue=3;spage=245;epage=247;aulast=Tyebkhan.
