The national research act of 1974
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The Nuremburg trials became the first significant action against medical research without
human consent (Cizik School of Nursing, 2017). Doctors exposed patients to excruciating pain
by injecting subjects with salt water, freezing them to death and inflicting fatal wounds for the
purpose of study. It established the Nuremburg code became the first ever international statement
advocating for the essential need of voluntary consent of the human subjects used in trials (Cizik
School of Nursing, 2017). Experiments would only occur after researchers had identified that
there was no prior reason to believe that death would occur. Nuremburg trials and code educates
nurses on the history of trials without consent. Nurses who still help in assisted euthanasia and
delivery of death penalties to make their decisions based on knowledge acquired from past
events.
The National Research Act of 1974 was passed into law paving the way for the national
commission which established the ethical principles through which medical research involving
human subjects would be carried out (Daigle, 2014). The act is important because it marked the
end of the Tuskegee Syphilis study involving 600 African-American participants. Throughout 40
years, participants never received information about the condition they were infected with even
after a cure was found (Daigle, 2014). Many participants were denied treatment and left to die.
The national research act is important because it represents a point in history in which medical
research not only violated medical ethics but also exposed targeted racism on the AfricanAmerican community. The commission ensured that ethical issues involving human subjects
without prior consent were eliminated.
The Belmont report established a summary of principles and guidelines to govern
bioethical research involving human subjects (Irbmed Part 1, 2011). It gives three basic
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provisions in which researchers are instructed on how to make the best ethical judgements. The
three ethical principles include respect for persons, beneficence and justice. Particularly, respect
for persons is based on the concept of autonomy, where medical practitioners recognize that
every person has the right to make decisions on their health (Irbmed Part 1, 2011). It also
protects individuals whose autonomy is at greater risk, for example, the disabled. The Belmont
report is important because it laid the foundation of medical autonomy in the modern era. It
begun the debate on the ethical concerns in how much say children should have in their
participation in medical research.
Assessment of risk and benefit in bioethical research is a crucial aspect that researchers
must carefully assess before proceeding with a medical trial (Irbmed Part 2, 2011). The Belmont
report identifies the risk and benefit ratio as an area of concern in any research model. Research
ethics committees are obligated to conduct assessments to verify if the research has validity and
distinguish the risk probability. Potential risks that the participants would be exposed to must be
necessary, justifiable and minimized by all means (Irbmed Part 2, 2011). Researchers must prove
that the benefits and expected outcomes outweigh the risks. The assessment of risk to benefit
ratio is important because it has allowed researchers to identify favorable ratios that are
important in making precise judgements.
Justice is a principle established by the IRB ensuring that there is fair distribution of the
participants and fair results in the research study. Justice eliminates situations in which one
population takes all the risks and burdens while another population receives all the benefits (John
Hopkins Medicine, 2015). Research should not overburden hospitalized persons with further
risks of participating in a medical trial. Such persons can only participate in a trail if it directly
relates to their condition (John Hopkins Medicine, 2015). This principle is important because it
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stipulates that subjects are not only selected on the basis of voluntary consent to a study but also
under consideration of other factors such as age and health. It prevents unethical practices such
as the Tuskegee trails where one race suffered all the risk.
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References
Cizik School of Nursing. (2017, February 25). CARING CORRUPTED – The Killing Nurses of
The Third Reich [Video]. YouTube. https://www.youtube.com/watch?v=Rz8ge4aw8Ws
Daigle, D. (2014, May 4). Research Ethics involving Human Subjects [Video]. YouTube.
Irbmed. (2011, October 11). The Belmont Report (Part One: Basic Ethical Principles) [Video].
YouTube. https://www.youtube.com/watch?v=86zWBjDaXPk
Irbmed. (2011, October 11). The Belmont Report (Part Two: Applying the Principles) [Video].
YouTube. https://www.youtube.com/watch?v=cIafASIIU70
John Hopkins Medicine. (2015, October 8). Guiding Principles of Institutional Review Boards
(IRB) [Video]. YouTube. https://www.youtube.com/watch?v=iFik0of3iUM
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