1 Colegio de San Agustin-Bacolod College of Health & Allied Professionals.

HEALTHCARE ETHICS

MODULE 1:
ETHICS IN RESEARCH

Why study Research?

Knowing what constitutes ethical research is important for all people who conduct research
projects or use and apply the results from research findings. All researchers should be familiar
with the basic ethical principles and have up-to-date knowledge about policies and procedures
designed to ensure the safety of research subjects and to prevent sloppy or irresponsible
research, because ignorance of policies designed to protect research subjects is not considered
a viable excuse for ethically questionable projects. Therefore, the duty lies with the researcher
to seek out and fully understand the policies and theories designed to guarantee upstanding
research practices. Research is a public trust that must be ethically conducted, trustworthy, and
socially responsible if the results are to be valuable. All parts of a research project – from 7 the
project design to submission of the results for peer review – have to be upstanding in order to
be considered ethical. When even one part of a research project is questionable or conducted
unethically, the integrity of the entire project is called into question.

Guiding Principles for Ethical Research

“When people are invited to participate in research, there
is a strong belief that it should be their choice based on
their understanding of what the study is about, and what
the risks and benefits of the study are,” said Dr. Christine
Grady, chief of the NIH Clinical Center Department of
Bioethics, to Clinical Center Radio in a podcast.

Clinical research advances the understanding of science and promotes human health. However, it
is important to remember the individuals who volunteer to participate in research. There are
precautions researchers can take – in the planning, implementation and follow-up of studies – to
protect these participants in research. Ethical guidelines are established for clinical research to
protect patient volunteers and to preserve the integrity of the science.

MODULE 1. NCM 108 Endterm Coverage Eden Shiz Parpa, RN,MAN

 Colegio de San Agustin-Bacolod College of Health & Allied Professionals. HEALTHCARE ETHICS 2

NIH Clinical Center researchers published 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

 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.

MODULE 1. NCM 108 Endterm Coverage Eden Shiz Parpa, RN,MAN

3 Colegio de San Agustin-Bacolod College of Health & Allied Professionals. HEALTHCARE ETHICS

 Respect for potential and enrolled participants

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

Worth some thoughtful reflections..

1. What current issues you have observed that

signifies certain confusion or misinterpretation of
the principles stated by the National Insitute for
Health (NIH)?

DISCUSSION FORUM:
Join in the discussion forum in your LMS. Share your insights in not less than 3
sentences; make it clear, interesting and sincere.
ONLINE SURVEY:
Fill out a quick survey to indicate your impression, stand or thoughts on the
relevant issues and scenarios provided.

MODULE 1. NCM 108 Endterm Coverage Eden Shiz Parpa, RN,MAN

 Colegio de San Agustin-Bacolod College of Health & Allied Professionals. HEALTHCARE ETHICS 4

Research ethics provides guidelines for the responsible conduct of biomedical research. In
addition, research ethics educates and monitors scientists conducting research to ensure a high
ethical standard.

BRIEF HISTORY The birth of modern research ethics began with a desire to protect
human subjects involved in research projects. The first attempt to craft regulations began
during the Doctors Trial of 1946-1947. The Doctors Trial was a segment of the Nuremberg Trials
for Nazi war criminals (see photo* ). In the Doctors Trial, 23 German Nazi physicians were
accused of conducting abhorrent and torturous “experiments” with concentration camp
inmates. The accused physicians tortured, brutalized, crippled, and murdered thousands of
victims in the name of research. Some of their experiments involved gathering scientific
information about the limits of the human body by exposing victims to extreme temperatures
and altitudes. The most gruesome and destructive experiments tested how quickly a human
could be euthanatized in order to carry out the Nazi racial purification policies most efficiently.
To prosecute the accused Nazi doctors for the atrocities they committed, a list of ethical
guidelines for the conduct of research – the Nuremberg Code – were developed. * Thomas J.
Dodd Papers website. http://www.lib.uconn.edu/DoddCenter/ASC/dodphot1.htm. Accessed
2/05/03. 4

The Nuremberg Code consisted of ten basic ethical principles that the accused violated.1 The
10 guidelines were as follows:
1. Research participants must voluntarily consent to research participation
2. Research aims should contribute to the good of society
3. Research must be based on sound theory and prior animal testing
4. Research must avoid unnecessary physical and mental suffering
5. No research projects can go forward where serious injury and/or death are potential
outcomes
6. The degree of risk taken with research participants cannot exceed anticipated benefits of
results
7. Proper environment and protection for participants is necessary
8. Experiments can be conducted only by scientifically qualified persons
9. Human subjects must be allowed to discontinue their participation at any time

MODULE 1. NCM 108 Endterm Coverage Eden Shiz Parpa, RN,MAN

5 Colegio de San Agustin-Bacolod College of Health & Allied Professionals. HEALTHCARE ETHICS

10. Scientists must be prepared to terminate the experiment if there is cause to believe that
continuation will be harmful or result in injury or death The Nuremberg Guidelines paved the
way for the next major initiative designed to promote responsible research with human
subjects, the Helsinki Declaration.
The Helsinki Declaration was developed by the World Medical Association and has been
revised and updated periodically since 1964, with the last update occurring in 2000.
The document lays out basic ethical principles for conducting biomedical research and specifies
guidelines for research conducted either by a physician, in conjunction with medical care, or
within a clinical setting. The Helsinki Declaration contains all the basic ethical elements
specified in the Nuremberg Code but then advances further guidelines specifically designed to
address 5 the unique vulnerabilities of human subjects solicited to participate in clinical
research projects.
The unique principles developed within the Helsinki Declaration include:
• The necessity of using an independent investigator to review potential research projects
• Employing a medically qualified person to supervise the research and assume responsibility
for the health and welfare of human subjects
• The importance of preserving the accuracy of research results
• Suggestions on how to obtain informed consent from research participants
• Rules concerning research with children and mentally incompetent persons
• Evaluating and using experimental treatments on patients
The importance of determining which medical situations and conditions are appropriate and
safe for research Following the Helsinki Declaration, the next set of research ethics guidelines
came out in the Belmont Report of 1979 from the National Commission for the Protection of
Human Subjects of Biomedical and Behavioral Research.
The report outlines:
1. The ethical principles for research with human subjects
2. Boundaries between medical practice and research
3. The concepts of respect for persons, beneficence, and justice
4. Applications of these principles in informed consent (respect for persons), assessing risks
and benefits (beneficence), and subject selection (justice)3
The Nuremberg, Helsinki, and Belmont guidelines provided the foundation of more ethically
uniform research to which stringent rules and consequences for violation were attached.

MODULE 1. NCM 108 Endterm Coverage Eden Shiz Parpa, RN,MAN

Colegio de San Agustin-Bacolod College of Health & Allied Professionals. HEALTHCARE ETHICS 6

Governmental laws and regulations concerning the responsible conduct of research have since
been developed for research that involves both human and animal 6 subjects.
The Animal Welfare Act provides guidelines and regulations for research with animals. It goes
into detail about sale, licensure, facilities, transport, and other care instructions. For research
with human subjects Title 45, Part 46 from the Code of Federal Regulations (45 CFR 46): The
Protection of Human Subjects Regulations outlines the purpose and policies of Institutional
Review Board (IRB) oversight and approval, informed consent, and protections and policies for
research with children, pregnant women, fetuses, prisoners, and mentally incompetent
individuals. Currently, the focus of research ethics lies in the education of researchers
regarding the ethical principles behind regulations as well as the oversight and review of
current and potential research projects. The field has expanded from providing protections for
human subjects to including ethical guidelines that encompass all parts of research from
research design to the truthful reporting of results. There are several avenues for people who
wish to seek education on basic ethical principles, and avenues for education on how to
comply with policies at the institutional, state, and national levels. The University of
Minnesota’s Center for Bioethics (www.bioethics.umn.edu) and many other universities and
professional associations around the country continually offer education for researchers and
scientists on ethical research issues. Curriculum is available in frequently offered conferences,
classroom settings, and on-line (www.research.umn.edu/curriculum).
BELMONT REPORT https://www.youtube.com/watch?v=M6AKIIhoFn4

Worth some thoughtful reflections..

2. How has the Nuremberg, Helsinki and Belmont

Guidelines established the conduct of Research
that made progress in science and technology a
worthy endeavor?

DISCUSSION FORUM:
Join in the discussion forum in your LMS. Share your insights in not less than 3
sentences; make it clear, interesting and sincere.
READ FURTHER :
Take time to read through this article .
https://www.researchgate.net/publication/11631736

MODULE 1. NCM 108 Endterm Coverage Eden Shiz Parpa, RN,MAN