MODULE 3.

BIOETHICS AND RESEARCH

With all the scientific and technological advances in especially in health research. Principles of Ethics
and Principles of Bioethics must be applied in such a way the subject/client/patient have rights that has
to be protected. It is not only applied to humans, some animal advocates also pushing through animal
rights because it also has life like humans.

The Objectives of this module is for the students:

GUIDING PRINCIPLES FOR ETHICAL RESEARCH

SEVEN MAIN PRINCIPLES TO GUIDE THE CONDUCT OF ETHICAL RESEARCH

Social and Clinical Value

Every research study is designed to answer a specific question. The answer should be important enough
to justify asking people to accept some risk or inconvenience for others. In other words, answers to the
research question should contribute to scientific understanding of health or improve our ways of
preventing, treating, or caring for people with a given disease to justify exposing participants to the risk
and burden of research.

Scientific validity

A study should be designed in a way that will get an understandable answer to the important research
question. This includes considering whether the question asked is answerable, whether the research
methods are valid and feasible, and whether the study is designed with accepted principles, clear
methods, and reliable practices. Invalid research is unethical because it is a waste of resources and
exposes people to risk for no purpose.

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Fair subject selection

The primary basis for recruiting participants should be the scientific goals of the study — not vulnerability,
privilege, or other unrelated factors. Participants who accept the risks of research should be in a position
to enjoy its benefits. Specific groups of participants (for example, women or children) should not be
excluded from the research opportunities without a good scientific reason or a particular susceptibility to
risk.

Favorable risk-benefit ratio

Uncertainty about the degree of risks and benefits associated with a clinical research study is inherent.
Research risks may be trivial or serious, transient or long-term. Risks can be physical, psychological,
economic, or social. Everything should be done to minimize the risks and inconvenience to research
participants to maximize the potential benefits, and to determine that the potential benefits are
proportionate to, or outweigh, the risks.

Independent review

To minimize potential conflicts of interest and make sure a study is ethically acceptable before it starts,
an independent review panel should review the proposal and ask important questions, including: Are
those conducting the trial sufficiently free of bias? Is the study doing all it can to protect research
participants? Has the trial been ethically designed and is the risk–benefit ratio favorable? The panel
also monitors a study while it is ongoing.

Informed consent

Potential participants should make their own decision about whether they want to participate or
continue participating in research. This is done through a process of informed consent in which
individuals (1) are accurately informed of the purpose, methods, risks, benefits, and alternatives to the
research, (2) understand this information and how it relates to their own clinical situation or interests,
and (3) make a voluntary decision about whether to participate.

Respect for potential and enrolled participants

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Individuals should be treated with respect from the time they are approached for possible participation
— even if they refuse enrollment in a study — throughout their participation and after their participation
ends. This includes:
• respecting their privacy and keeping their private information confidential
• respecting their right to change their mind, to decide that the research does not match their
interests, and to withdraw without a penalty
• informing them of new information that might emerge in the course of research, which might
change their assessment of the risks and benefits of participating
• monitoring their welfare and, if they experience adverse reactions, unexpected effects, or
changes in clinical status, ensuring appropriate treatment and, when necessary, removal from
the study
• informing them about what was learned from the research

THE NUREMBERG CODE

Created more than 70 years ago following the notorious World War II experiments, this written document
established 10 ethical principles for protecting human subjects.

What Is the Nuremberg Code?

When World War II ended in 1945, the victorious Allied powers enacted the International Military Tribunal
on November 19th, 1945. As part of the Tribunal, a series of trials were held against major war criminals
and Nazi sympathizers holding leadership positions in political, military, and economic areas. The first
trial conducted under the Nuremberg Military Tribunals in 1947 became known as The Doctors’ Trial, in
which 23 physicians from the German Nazi Party were tried for crimes against humanity for the atrocious
experiments they carried out on unwilling prisoners of war. Many of the grotesque medical experiments
took place at the Auschwitz concentration camp, where Jewish prisoners were tattooed with
dehumanizing numbers onto their arms; numbers that would later be used to identify their bodies after
death.

The Doctors’ Trial is officially titled “The United States of America v. Karl Brandt, et al.,” and it was
conducted at the Palace of Justice in Nuremberg, Bavaria, Germany. The trial was conducted here
because this was one of the few largely undamaged buildings that remained intact from extensive Allied
bombing during the war. It is also said to have been symbolically chosen because it was the

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 ceremonial birthplace of the Nazi Party. Of the 23 defendants, 16 were found guilty, of which seven
received death sentences and nine received prison sentences ranging from 10 years to life
imprisonment. The other 7 defendants were acquitted.

The verdict also resulted in the creation of the Nuremberg Code, a set of ten ethical principles for
human experimentation.

What are the Nuremberg Code's Ethical Guidelines for Research?

The Nuremberg Code aimed to protect human subjects from enduring the kind of cruelty and
exploitation the prisoners endured at concentration camps. The 10 elements of the code are:
1. Voluntary consent is essential
2. The results of any experiment must be for the greater good of society
3. Human experiments should be based on previous animal experimentation
4. Experiments should be conducted by avoiding physical/mental suffering and injury
5. No experiments should be conducted if it is believed to cause death/disability
6. The risks should never exceed the benefits
7. Adequate facilities should be used to protect subjects
8. Experiments should be conducted only by qualified scientists
9. Subjects should be able to end their participation at any time
10. The scientist in charge must be prepared to terminate the experiment when injury, disability, or death is
likely to occur

The Significance of the Nuremberg Code

The Nuremberg Code is one of several foundational documents that influenced the principles of Good
Clinical Practice (GCP).

Good Clinical Practice is an attitude of excellence in research that provides a standard for study design,
implementation, conduct and analysis. More than a single document, it is a compilation of many thoughts,
ideas and lessons learned throughout the history of clinical research worldwide.

Several other documents further expanded upon the principles outlined in the Nuremberg Code, including
the Declaration of Helsinki, the Belmont Report and the Common Rule.

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Although there has been updated guidance to Good Clinical Practice to reflect new trends and
technologies, such as electronic signatures, these basic principles remain the same. The goal has always
been—and always will be—to conduct ethical clinical trials and protect human subjects.

BELMONT REPORT

On July 12, 1974, the National Research Act (Pub. L. 93-348) was signed into law, there-by creating the
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. One
of the charges to the Commission was to identify the basic ethical principles that should underlie the
conduct of biomedical and behavioral research involving human subjects and to develop guidelines which
should be followed to assure that such research is conducted in accordance with those principles. In
carrying out the above, the Commission was directed to consider: (i) the boundaries between biomedical
and behavioral research and the accepted and routine practice of medicine, (ii) the role of assessment
of risk-benefit criteria in the determination of the appropriateness of research involving human
subjects, (iii) appropriate guidelines for the selection of human subjects for participation in such research
and (iv) the nature and definition of informed consent in various research settings.

The Belmont Report attempts to summarize the basic ethical principles identified by the Commission in
the course of its deliberations. It is the outgrowth of an intensive four-day period of discussions that were
held in February 1976 at the Smithsonian Institution's Belmont Conference Center supplemented by the
monthly deliberations of the Commission that were held over a period of nearly four years. It is a
statement of basic ethical principles and guidelines that should assist in resolving the ethical problems
that surround the conduct of research with human subjects. By publishing the Report in the Federal
Register, and providing reprints upon request, the Secretary intends that it may be made readily available
to scientists, members of Institutional Review Boards, and Federal employees. The two-volume
Appendix, containing the lengthy reports of experts and specialists who assisted the Commission in
fulfilling this part of its charge, is available as DHEW Publication No. (OS) 78-0013 and No. (OS) 78-
0014, for sale by the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C.
20402.

Unlike most other reports of the Commission, the Belmont Report does not make specific
recommendations for administrative action by the Secretary of Health, Education, and Welfare. Rather,
the Commission recommended that the Belmont Report be adopted in its entirety, as a statement of the
Department's policy. The Department requests public comment on this recommendation.

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Sources / References:

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