Module 9- Introduction to Bioethics

Introduction

Bioethics is a subfield of ethics that explains ethical questions related to the life sciences
specifically helping people make decisions about their behavior and about policy questions that
governments, organizations, communities and individuals may face when they consider how
best to use new biomedical knowledge, technology and innovations and research.

Bioethics was borne out of a rapidly changing environment in the 1900s and has since been
interested primarily on moral issues in the domains of health research and care. Between
1945 and 1970 antibiotics, antihypertensive, anti-hypoglycemic and cancer drugs came into full
use; surgery entered the heart and brain, organ transplantation was initiated and life
sustaining devices, the dialysis machine, the pacemaker and the ventilator were initiated on
one hand. On the other, psychological and behavioral/social research and interventions were
being made to gain new knowledge to address health and wellness concerns of various
population groups. Today, bioethics help address decision-making that attend to problems
arising from health care issues as well as research.

In general, this module is intended to present basic ethical principles that govern the uses of
biological and medical technology as the specifically relate to human life and the conduct of
ethically sound research.

Learning Outcomes:

After reading the module, the student must be able to:

1. manifest a comprehension of the definition and concerns of the ethical subfield of bioethics,

2. formulate informed thoughtful choices and decisions on the ethical dimensions of a

scientific, health-related and public policy issues , concerns and practices as they relate to the
basic principles of bioethics,

3. and cultivate critical thinking and reasoning when discussing cases of research abuses that
require the resolution of moral dilemma

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Activity 1

The Tuskegee Syphilis Study

In the 1920s syphilis rates were extremely high in the United States. The Rosenwald
Foundation, a private foundation teamed with the United States Public Health Service (USPHS)
to begin efforts to control the disease using the drug Neosalvarsan, an arsenic compound.
Tuskegee in Alabama was targeted as test site as it registered the highest number of syphilis
cases. The interest of the study was to determine the natural course of the disease
(progression). At that time, Tuskegee’s rate was 22% among African men with a 62% congenital
syphilis cases. The surgeon general then suggested that 399 African Americans should be
observed, rather than treated and compared with 200 African American men who were
uninfected. The men were not told of their disease and were simply informed that they have
bad blood. They underwent painful, nontherapeutic spinal taps to provide data about
the natural history of syphilis and that they were being treated for their bad blood. They were
given free meals and treatment for other diseases other than syphilis. Even after penicillin was
discovered in the 1940s they were not offered this treatment.

This unethical research continued for 40 years in which several articles about the study were
published. No one attempted to stop the research. Finally, a medical reporter learned of the
study and the unethical issues were exposed. This even led to President Bill Clinton’s issuance
of a public apology.

You are going to view a film clip on the experiment and research on Tuskegee, and while you
watch the film, answer the following questions:

1. Describe some of the unethical malpractices you think are involved in the study? Does the
argument from new knowledge justify these malpractices?

2. What should have been done to assure that participants in the study are not abused?

3. Which procedures are in place today that seeks to prevent unethical practices in research?

The Hippocratic Oath is acknowledged to be the basis of the conduct of physicians in their
practice of medicine. The Oath requires a new doctor to uphold accepted standards of behavior
in dealing with patients and their families by swearing upon a number of healing gods that he
will ascribe to a number of professional ethical standards. “ It also binds him to his teacher and
his community of physicians with responsibilities similar to everyone. “ ( From the translation
of Michal North, National Library of Medicine 2002,in www.nlm.nih.gov/hmd/greek)

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Over the centuries, this Oath has become the standard upon which research involving human
participation has been based. Today, one can say that the principles of bioethics have largely
been inspired by do no harm implications of the Oath.

Activity 2 The Hippocratic Oath and the NAZI Experiments

Form 5 groups of 4 members each. These groups will be given a copy of well known research
conducted involving human participation that abused their dignity and rights as human
persons. The groups will be required to discuss various indications of unethical practices using
the Oath of Hippocrates as a yardstick. To date, are you familiar with some malpractices of
health care givers?

Ethical Principles

Due to several lapses and abuses committed in research involving human participants,
researchers and health workers became particularly conscious of ethical malpractices and
pitfalls in the conduct of biomedical and behavioral research. Because of this truism, several
groups and commissions were organized to intensely look at guidelines and principles
involving human subjects. In 1978, the Belmont Report was issued which outlined the basic
principles for all research involving human participants to include respect for persons,
beneficence and justice. In 1979, the principle of nonmaleficence was added. Making ethical
decisions and justification using these principles or sometimes known as ethical principlism
without involving the use of a theory or a formal decision making model have been criticized as
resulting in a linear way of doing ethics. It has been contended that such a determination of
moral decisions glosses over the nuances present in relationship-based situations.
Nevertheless, principlism using the four principles as outlined by Beauchamp and Childress
(2013) continue to be the most popular tools used in analyzing and resolving bioethical
problems.

The Four Principles and Related Issues

1. Respect for Autonomy

It has been argued that human beings are rational and are endowed with a capacity to be
engaged in various situations and relationships freely expressing personal choices
independent of external interference or pressure. Of course, these decisions are expected to be
honored and respected by others. In the domains of health care and involvement in research,
respecting another person’s autonomy includes obtaining informed consent for informed
participation as well a capacity to recognize options regarding treatment regimens that he will
most likely receive or his participation in a research project. It is sometimes argued that while
the patient has a right to receive the care that he chooses, this is often contraindicated by a

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need to respect and recognize the Hippocratic oath of health practitioners as well as the their
own professional autonomy. Saving lives is of utmost importance in a health care setting that to
oblige a patient to die because his religion disdains the practice of blood transfusion, for
example is not warranted. However, this issue must be discuss because saying no to treatment
may be part of a person’s autonomy.

Is it possible in some cases to intentionally not disclose all information to a research

participant? What situations will merit this intentional non disclosure? Is it possible to withhold
from a patient his high blood pressure as it can trigger other reactions in his vital signs?

Securing informed consent requires that a researcher discloses to a participant enough

information for an individual to make a personal decision to be involved or not in a research
activity. In the health care setting informed consent is secured when a patient is not coerced to
receive a treatment plan and is able communicate the same competently. It is permissible,
when the patient is incompetent to provide consent to find a suitable surrogate who will also
receive the same required information before final consent for the incompetent patient is
secured. What if it happens that everyone who has been asked to give consent belongs to the
same religion? Will consent be waived? In a research setting is the consent of a parent to allow
his son to participate in a study enough to say that consent has been taken?

B. Nonmalificence/Beneficence

The principle of nonmalificence translates to the obligation to do no harm. While health care
providers are encouraged to do good (beneficence), if there are situations that no good can be
done, they are required to at least do no harm. Some maintain that these principles are one
and the same. However, many ethicists including Beauchamp (2013) make a distinction
between these two principles.

Nonmalificence stems from the maxim “one ought not to inflict evil or harm” (Beauchamp and
Childress ,2013,p.152), whereas beneficence includes the following concepts: “one ought to
prevent or remove evil or harm and one ought to do or promote good” (p152). As indicated
beneficence involves actions to help someone and maleficence requires conscious avoidance of
actions that cause harm. Beuchamp (2013) lists the following as the obligations of researchers:

1. Upholding standards of due care by abiding by the standards that are specific to one’s
profession.

2. Negligence is the absence of due care and imposing a risk of harm, imposing an unintended
careless risk of harm or imposing an intentional reckless risk of harm. This includes adopting a
methodology in data gathering that can cause real or potential harm to the participant.

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3. Making distinctions of and rules governing non treatment and end of life decisions as in :

a. withholding and withdrawing treatment

b. extraordinary treatment

c. sustenance technologies and medical treatments

d. killing and letting die

The principle of beneficence consists of performing deeds of mercy, kindness, friendship,

charity, and the like which promote the welfare of other individuals. Beuchamp (200 3) lists
examples of obligations and moral rules underlying this principle as:

1. protect and defend the rights of others

2. prevent harm from occurring to others

3. remove conditions that will cause harm to others.

4. help persons with disabilities

5. rescue persons in danger and treat when necessary

Activity 3: Students will be grouped into 2 teams and debate on the issue of Dengvaxia. What
should be the limits of beneficence/non-malificence in this situation in an attempt to
eradicate dengue in the Philippines)?

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C. JUSTICE

Justice refers to fairness, treating people equally and without prejudice or discrimination, and
the equitable distribution of benefits and burdens, both in healthcare and biomedical research.
In real terms, however, allocation off health resources , for example, is a decision based on
the consideration to questions such as: who has the right to health care, how much health care
a person is entitled to, and who will pay for healthcare costs. This debate continues to peril the
adoption of universal coverage of PhilHealth, for example. In health research that involves the
conduct of clinical trials , one asks the questions who will participate in the trial, who will
benefit from the trial and what happens when there are adverse results.

Distributive justice refers to the allocation of resources, whereas social justice represents the
position that benefits and burdens must be distributed fairly among members of a society and
that all should have the same rights, privileges , opportunities and benefits. But of course,
these notions are as yet not clearly agreed upon. But points of agreement have been reached
that justice relates to fair treatment and that similar cases must be handled similarly bereft of
paternalism, cooptation or prejudice. However, the intrinsic import of the notions of the
common good or the good for the greatest number contraindicate with the prevention of
social injustice with respect to poverty, disease or even hunger. One conundrum that must be
resolved, of course, is in terms of the profit motivations in people who control and manipulate
the economy and all attendant structures including healthcare. In some places, universal
coverage of the health system is in place while in most underdeveloped economies, medicines
and treatment continue to be an important barrier to wellness.

In the Philippines the provision of free antiretroviral treatment by the Department of Health to
HIV infected individuals is a continuing concern as the country faces moribund epidemiology on
the top ten communicable but preventable diseases.

Ethical dilemmas will put an individual where he is compelled to choose between two sets of
actions that will affect the welfare of an individual. Using the four principles of bioethics, one
may be able to identify the ethical dimensions or questions in a given situation, this often
described by ethicists as moral sensitivity, keeps an individual from simply glossing over the
surface of a question thus missing its ethical implications. Fortunately, one can develop this
skill with sustained practice. Such a capability starts with the development of what is known as
ethical imagination, enabling him to distinguish scientific, ethical, legal, or even personal
questions.

The individual, for example knows that before government embarks on a dengue vaccination
program the efficacy of the vaccine must be determined a scientific question, from the need
to secure informed consent which is an ethical question. Sometimes, it may not be possible to

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gather all the relevant facts and one can either do some more research or deal with the facts on
hand. It is important to initially reflect on the range of individuals or groups that may be
affected by the decision- the stakeholders. Oftentimes, it is not possible to protect the interest
of everyone and one will have to prioritize and to provide a justification to favor the interest of
one over another. This justification often rests by taking the core ethical consideration
(respect for persons, minimizing harm while maximizing benefits and justice.

Once all these are considered a decision or a recommendation may be made. Sound ethical
reasoning demand that the recommendations or decisions are explained or justified . A
decision is said to be supported by a strong justification when:

1. there exists a high degree of relevance to the ethical question

2. there is reference to the most relevant scientific or social facts

3. there is a description of potential effects of a decision on others

4. there is an identification of the relevant core ethical considerations

5. there is an analysis of the ways by which the recommendation addresses the core ethical
considerations and the strength or weaknesses of other solutions and

6. there is logical reasoning that follows from the reasons given.

Conclusion: The field of bioethics enables us to utilize previous discussions on ethics and
morality, specifically the process of moral reasoning and decision-making. As applied ethics, the
subfield protects from abuse vulnerable participants by guaranteeing their voluntary and
informed participation in research or in clinical trials.

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Core Readings:

Beauchamp, T.L. and Childress, J.F. (2013) Principles of Biomedical Ethics (7th ed). New York:
Oxford University Press.

The Belmont Report in www.nih.gov/Belmont Report 2002

Rich, K. (2015) Introduction to Bioethics and Ethical Decision Making.New Yorl: Mc Graw Hill.

Jonsen A.R. (2010) Clinical Ethics: A Practical Approach to Ethical Decisions in Clinical
Medcine.New York: McGraw Hill

Readings:

A. On line sources

https//books. Google.com/books/about/Beyond a Western Bioethics.html id55momC6vMWIC

http//www.eubios.info/ASIAE/BIAE103.htm

http//www.fercap-sidcer.org/2013/PPT

http//unesdoc.org./images/0019/00192370epdf

http//unesdoc.org/images/0019/001923/19237epdf

B. Books and Journals

Rich, K. (2015) Introduction to Bioethics and Ethical Decision Making. New York: Mc Graw Hill.

Jonsen A.R. (2010) Clinical Ethics: A Practical Approach to Ethical Decisions in Clinical
Medcine.New York: McGraw Hill : Harvard University Press.

Lo. B. (2009) Resolving Ethical Dilemmas. Philadelphia, PA: Walter Kluwer

Mappes, T.A. (2006) . Biomedical Ethics. Boston: McGraw Hill

Post,G.G. (2004) Encyclopedia of Bioethics 3rd ed. New York: McMillan Reference

Ryan,C (1988)The Effect of new Evidence on Euthanasia’s Slippery Slope, Journal of Medical
Ethics, 24, 341-344.

Weston,A. (2011) a Practical Companion to Ethics. New York: Oxford University Press

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Summative Evaluation:

Students will be asked to reflect on 2 questions in the following list:

1. Is informed consent always written? How do you document the act of securing
informed consent specially among vulnerable population groups? How do we protect
vulnerable population groups – women, children, terminally ill, etc from abuse?
2. What are the elements of good clinical practice? How do we preserve the privacy and
confidentiality of research participants and data?

3. Must undergraduate seminar papers go through ethics review?

4. In behavioural research, do we consciously move away from studying vulnerable groups?

Writing Assignment: There will be a short (500 words max )writing assignment due on the
discussion day of Module 9 at 9am, submitted online. All writing assignments must be double
spaced and typed in 12pt font. There will be no late/makeup assignment. The point of the
writing assignments is to serve as an opportunity for assessment and to provide you with a
space to practice the philosophical skills you will need to master for the final paper for the
course.

Write a short case study on an ACTUAL health care provider malpractice/abuse that you have
experienced or are acquainted with. Surface the unethical practice(s) and suggest ways by
which clinical practice may be more acceptable and empowering.

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 TEACHER’S GUIDE

The teacher introduces ethics and bioethics. She/he also provides examples of bioethical
examples/decisions in research involving human participants.

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