Name: Prado, Catherine A. Year and Section: BSN III-B Module 2 Activity Ethico-Legal Considerations in Nursing Research

Name: Prado, Catherine A.
Year and Section: BSN III-B
MODULE 2 ACTIVITY
Ethico-Legal Considerations in Nursing Research
SYNTHESIS PAPER
Research is encompassed and motivated by a positive assurance that its results will be applied for
the benefit of humankind, as we can often read. Ethical conduct literally means doing the right
thing, but it means more. It involves acting in the right soul, out of an abiding respect and concern
for one's fellow creatures. Human research is research conducted with or about people, or their
data or part of the body, with the intention to do good. Human research involves significant risks
and it is possible for things to go wrong. Despite the best of intentions and care in planning and
practice, sometimes things go wrong from what is planned. Now and then accidents may arise
because of technical errors or an ethical insensitivity, neglect or disregard. Prior to World War II
there was little concern with the treatment of human subjects or participants in research. In the
history of research ethics there are a number of key events that have had an immense impact on
how we think about research ethics and have influenced the expectations placed on researchers in
the 21st century. By considering events from the past, we should be better able to understand why
it is so important to ensure that research is always conducted to the highest ethical standards.
Ethics for human subject protection began with the ancient Hippocratic Oath, which stated the
prime duty of a physician-to avoid bringing harm to the patient. Unfortunately, this once highly
regarded oath has been neglected when pertaining to human experimentation, with most advances
in protection spawning from responses to human abuse (Bhatt, 2010). Although the 1931
guidelines are claimed to be the first recorded ethical perspectives for human research, there
existed a prior code, the Berlin Code 1900. The Berlin Code 1900 was initiated by the Prussian
Government, but was disregarded when the Empire gave way to the German Republic (Ghooi,
2011). In August of 1947, in Nuremberg, Germany American judges sat in judgment of 23 Nazi
doctors and scientist accused of conducting murderous and torturous human experiments in
concentration camps. Some of the accused suggested that warrants for such horrific crimes,
experiments and research, was the pursuit of scientific knowledge, the advancement of medical
practice, and would help further understanding in order to develop procedures and cures to benefit
humanity. The guiding principles included: voluntary consent, informed consent, the right to
withdraw, avoidance of harm and suffering, the expertise and qualification of the researcher, and
the acknowledgement of the responsibilities of the researcher to the participant. These principles
are replicated in contemporary codes and guidelines for human experiment ethics. (Kenny, 2008).
The first version of the Declaration of Helsinki was adopted by the World Medical Assembly in 1964
in order to articulate general principles and specific guidelines for human subjects in medical
research. It stated that the well-being of the individual takes precedence over science interests,
experimental procedures must be detailed in protocol and reviewed by an ethical committee, legal
documents of subject informed consent, and a detailed assessment of risk and benefits (Perlman,
2004). The Declaration of Helsinki is a current document that serves to take in account the quick
evolving nature of science and research. The new version states for the first time that people who
are injured during a medical trial must receive compensation and treatment. It also pushes for a
higher degree of protection for vulnerable population groups (Arie, 2013).
This gruesome history of clinical research ethics left a stain on most people, causing suspicion of
clinical trials and the motives of those who conduct them. One of the saddest examples of unethical
human research is the Tuskegee syphilis study. The participants were never told they had syphilis.
Instead of alerting the study participants, the researchers continued the trials and refused to treat
their syphilis. The study finally concluded 25 years later due to an article published in the 1972
New York Times, which exposed the unethical atrocities. A congressional advisory panel deemed
the Tuskegee Study “ethically unjustified” (Ryan, 2011). In 1974 The National Research Act was
passed, authorizing the formation of the National Commission of the Protection for Human Subjects
of Biomedical and Behavioral Research. In 1978 the commission began to draft the Belmont Report
on the grounds that “although scientific research has produced substantial social benefits, it has
also posed several troubling ethical questions (Bhatt, 2010). The report articulated three major
core ethical principles: respect for persons, which included voluntary informed consent;
beneficence, which included maximizing benefits and minimizing risks; and justice, which
encompassed the idea of equitable selection of subjects (Perlman, 2004).
With all of the events it is too easy to get caught up in the emotions of what happened, and the harm
that was caused to innocent people, but it is also important to reflect more carefully on what we can
learn. It is only through such reflections that we can help to ensure that participants can engage in
research knowing that it is being undertaken ethically and is influenced by a history that has
repeatedly demonstrated what happens when research ethics is not taken seriously. The guidelines
and codes of practice for research are important but it is only by considering the historical context
within which these were developed that researchers can understand the need to adhere to
acceptable ethical standards.

Name: Prado, Catherine A. Year and Section: BSN III-B Module 2 Activity Ethico-Legal Considerations in Nursing Research

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