Ethical Considerations in

Doing Research

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 OBJECTIVES
At the end of this period, the students are expected to :

1. Discuss the ethical considerations in doing research;

2. Identify examples of violations to ethics in research;
3. Recognize the importance of following ethical research;
4. Develop respect to every individuals especially to those
who are considered as vulnerable persons;
5. Apply ethical considerations in deciding the research
problem and in choosing research methods and subjects.
Not everything that is lawful is ethical.
 VULNERABLE PERSONS

• The Poor
• Those with
limited
education
• Those with
difficult
access to
health services
• Women
 SPECIAL CLASSES OF SUBJECTS

• Pregnant Women

• Fetuses and (in In

Vitro Fertilization)

• Children and Minors

• Cognitively Impaired
Persons

• Traumatized and
Comatose

• Terminally Ill Patients

• Prisoners

• Students, Employees
and Volunteers

• Elderly/Aged Persons

• Minorities
 VULNERABLE COMMUNITIES

• Limited economic
development
• Inadequate protection
of human rights
• Inadequate
understanding of
scientific research
• Limited availability of
health care and
treatment options

• Limited ability of
individuals in the
community to provide
informed consent
The ethical mandate is to protect the rights
and welfare of human beings as research
subjects.
 UNIVERSAL PRINCIPLE OF ETHICAL PRACTICE

»Respect for Person

»Beneficence
»Justice

• Transcend political, geographical, cultural,

economic and legal boundaries.
 RESPECT OF PERSON

• Autonomy and self-discrimination -

recognizes the capacity and rights of all
individuals to make their own decision and
choices.

• Vulnerable persons need special protection.

• Respect of person is
ensured by the
informed consent.

• Participant can
withdraw anytime.
 BENEFICENCE
• Minimal risk – a risk is minimal when the
probability and magnitude of harm and
discomfort are not greater than those
ordinarily encountered in daily life or during
the performance of routine physical or
psychological examinations or tests.

• The concept of minimal risk is evaluative not

subjective.
 JUSTICE
• Justice involves inclusion in studies with
likely benefits.

• Care should be taken not to overburden

institutionalized persons who are already
burdened by their infirmities and
environment.
• Subjects should not be selected because they
are available or easy to manipulate.

• Social justice indicates order of preference in

selection of classes of subjects (adults before
children).

• Subjects should not be selected because they

are held in disdain (involving undesirable
persons in risky research).
 Informed Consent is a
Contract
• A contract is the law
between the parties.

• Absence of informed
consent may be a
source of liability.
 Informed Consent is a Process

• Starts with the recruitment.

• Ends with the withdrawal of the
subject or termination of the
research.
• Requirement of informed consent continues
during the duration of the research study
and applies to new or changing risks.
 General Requirements for Informed Consent

• Sufficient opportunity/time to consider

whether or not to participate.
• No coercion or undue influence.
• Information is given in a language
understandable to the subject or his
representative.
• No waiver or releases of liability.
 Disclosure of Information

• Disclosure must take place in a manner that is

designed to facilitate understanding, rather
than impede it.

• In general, the medical jargon should be

translated into terms that laypeople are likely
to grasp, and presented in a format that is
conducive to comprehension.
 Dealing with Illiterate Subjects

• Requires a translator familiar with the

patient’s dialect and with the
technical/medical terms.
• Translator address and background
should be on file.
• Translator should be cautioned not to speak for
the patient.
 Informed Permission
• Applies to surrogate or
proxy decision maker.
To the extent possible,
the consent of the Generally, children over 16
participants should be years may be assumed
sought. capable of giving consent
but this will vary
depending on the nature
of research and needs of
special guidance.
 RESEARCH IN CHILDREN AND MINORS

• If children or minors are involved in research, the assent of the child or

minor and the permission of the parent(s), in place of the consent of the
subjects is needed.

• When the research offers the child the possibility of

direct benefit that is important to the health of the
child, the assent of the child is not necessary.
 DEVELOPMENTALLY OR COGNITIVELY IMPAIRED

The research question focuses on an issue

unique to subjects in this population;

Their vulnerability is characterized by

diminished decision making; and

The research involves no more than minimal

risk.
ETHICAL
ISSUES/
CASES
 SCENARIO – TUSKEGEE STUDY

• 1932 until 1972, nearly 400 black men were

injected with syphilis. There researchers
wanted to see how long it took syphilis to kill
so none of the men treated.

• By 1972, 128 were dead and many of their

family members were infected.
Edward Jenner
injected healthy
eight-year-old
James Phillips first
with cowpox then
three months later
with smallpox .
Jenner was hailed as
discoverer of
smallpox vaccine.

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1900: Walter Reed injected 22
Spanish immigrant workers in Cuba
with the agent for yellow fever paying
them $100 if they survive and $200 if
they contract the disease.

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Dr. Richard Strong, a professor of tropical medicine
at Harvard,

experimented with cholera on prisoners in the

Philippines killing 13 people. 31
 Tea room trade study
– Laud Humphreys was a PhD student – Subject of research: the act
sociologist in the 1960's at of fellatio between two
Washington University. anonymous men in public
restroom.
– Observation was done by pretending
to be a lookout for these men,
copied plate numbers to get
addresses, interviewed the men by
pretending to be a market
researcher.
– Some men were arrested.

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THANK YOU!