Introduction to Research Ethics

Learning objectives
 At the end of this session you should be able
to:
o Define of Ethics

o Fundamental ethical principles in research

o Describe the characteristics of Good research

o Identify the process and content of informed consent

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Research ethics
 Every research can potentially cause ethical concerns!!

 Before you embark on research with human subjects,

you are likely to require ethical approval.

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Why do we need ethical approval?

♣ Before you embark on research with human subjects, you are likely
to require ethical approval.

♣ Why do we need all this bureaucracy?

♣ History shows us that prior to the development of ethical and human

rights over the last 60 years, patients’ rights were often ignored and
many individuals were seriously harmed by medical experimentation.

Three such examples are:

♣ Atrocities committed during World War II in the Nazi Germany which

led to the 1947 Nuremberg Code of Practice (Germany) and in turn the
1964 Declaration of Helsinki (Finland )

♣ A study to examine the natural progression of cervical carcinoma in

New Zealand (1980s) - conventional treatment was withheld from
women in trial and women were not asked for their consent.
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 Researchers from the U.S. Public Health Service conducted
• experiments on 696 male and female patients housed at Guatemala's
National Mental Health Hospital from 1946 to 1948.

• The scientists injected the Guatemalan mental patients with

gonorrhea and syphilis -- and even encouraged many of them to pass
the disease on to others.

• Such reprehensible (highly unacceptable) research was carried out under

the guise of public health.
• This was exposed by an academic researcher (prof. Susan Reverby)

• Secretary of State Hillary Clinton and Health and Human Services

Secretary Kathleen Sebelius issued a formal apology to the
Central American nation, and to Guatemalan residents of the
United States after 64 years.
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Definition of
Ethics
 Ethics

Derived from the Greek ethos meaning “moral

character or custom” “the set of moral principles” or “a
system of moral principles” or “rules of behaviour”.
 Morality

comes from the Latin word moralis – “custom or

manner”.
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Definition of….
 Both words deal with the customs or the manner in

which people do things.

 Their modern meanings relate to the way people act -

either good or bad.

 Ethics - a branch of philosophy that deals with moral

principles that may be connected to beliefs about what

may be considered wrong or right.
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Definition of….
 The necessary pre-conditions of morality are rationality,

sociality and freedom – all defining attributes of humans.

 Ethics is a branch of moral philosophy concerned
with the rational evaluation of;
right and wrong, justice and injustice, virtue and vice,

good and bad, and related concepts and principles.

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Fundamental principles of
ethics
 Four fundamental principles of ethics have usually been

recognized and widely discussed in moral literature:

1. Autonomy

2. Beneficence

3. Non-maleficence

4. Justice

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1.
Autonomy
 Two Greek words: nomos (“rule”) and autos (“self ”),
giving it the literal meaning of “self-rule” or “self-
governance”.
 Implies an individual who is master of himself/herself

and can act, make free choices and take decisions

without the constraint of another.
 Respect for Persons:
Autonomous agents, persons with

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diminished autonomy are entitled to protection.
1.
Autonomy....
 The application of this principle is seen in the informed
consent process.
 The application starts with the respect for a person’s

right by providing them with adequate & relevant

information.
 The process of informed consent is begun when initial

contact is made with a prospective subject and continues

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throughout the course of the study.
1.
Autonomy....
 Pre-conditions of autonomy are;
 Competence (the capacity to be a moral agent)
 Liberty or freedom
 Individual autonomy may be diminished or completely

absent, as in the case of minor children, mentally

handicapped or incapacitated persons, prisoners, etc.

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1.
Autonomy....
 In health care and health research ethics, the principle of

autonomy issues directly to the requirement of informed

consent/refusal,
which is the necessary though not sufficient condition for
ethical medical research/practice on humans.
 Involving Human Subjects, is the “center piece” of the

ethics of medical research.

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2.Beneficence and non-maleficence
 In simple terms, beneficence means doing good and non-

maleficence means avoiding evil/harm.

 The principles of beneficence and non-maleficence

translate into the duties to maximize benefits while

minimizing harms, especially for the research subjects.

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Beneficence and non-maleficence....
 Medicine aims at achieving good/benefits (beneficence)

goes without saying but non-maleficence has been

emphasized and enshrined in the medical slogan “above
all, first do no harm!”.
 Generally, research, like other human activities, to be

ethical, must, at least aim at achieving good while

avoiding harm.
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Beneficence and non-maleficence....
 Not all achievable good is ethically mandatory; some

good is supererogatory (that is to say, desirable or

commendable but not obligatory); but harm ought
always to be avoided.
 Some people consider non-maleficence to be the most basic

of all the cardinal principles of ethics; it lays down the

minimum condition for ethical correctness, as if to say:
“even if you would not do good, at least do no harm”.
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Beneficence and non-maleficence....
Beneficence (Maximizing benefits: considerations)
 Communication of study results
 Provision of health care
 Training of local health staff

Non-maleficence (Minimizing harm:

considerations)

 Respect local social and cultural norms

 Confidentiality
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 Disclosure of conflict of
Non-maleficence....
Careful use of local health resources and respect for
local priorities

Propose measures against eminent risks observed during

the study

 Avoid stigmatization, prejudice, economic loss

 Prepare research staff for special situations

 Avoid harmful publicity

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Justic
e Justice is “fairness”
 or “entitlement”; it implies giving to each
his/her due. Justice requires that “equals be treated equally and
un-equals unequally”.
 Implies that human beings as moral equals should be treated

equally unless there is a reasonable justification for treating them

differently.
 The general moral idea underlying the principle of justice is that

which states: “Do unto others as you would have them do unto

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you if you were in their place and they in yours”.
Justice....
 The principle of justice demands

 fairness in the treatment of individuals and communities

the equitable distribution of the burdens and
benefits of research.

 Has important implications for such issues as

 choice of study population,

 recruitment into study,
 study and post-study benefits, etc.
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Basic principles for good research
practice
 These are principles combined from various
guidelines
1. Social and/or scientific value

2. Scientific validity

3. Fair subject selection

4. Favorable risk-benefit ratio

5. Independent review

6. Informed consent

21 7. Respect for potential and enrolled subjects

Informed consent
 Process of informed consent consists of:

 transfer of information

understanding of its significance, followed by explicit consent

of the person (or responsible proxies) to take part in the

intervention/research
 Elements of informed consent (one gives an informed consent if

(and perhaps only if) one:

is competent to act,

receives a thorough disclosure,

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Informed consent….
 comprehends the disclosure,
 acts voluntarily, and
 consents to take part in the research

In research disclosures should generally encompasses :

 The aims and methods of the research,
 anticipated benefits and risks,
 any anticipated inconvenience or discomfort, and
 thesubject’s right to withdraw, without penalty,
from the
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Informed consent….
 The consent form need to include the following
(Sarantakos, 2005)
 Identification of the researcher
 Identification of the sponsoring institution
 Indication of how the participants were selected
 Identification of the purpose of the research
 Identification of the benefits for participating
 Identification of the level and type of participant involvement

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Informed consent….
 Notation of risks to the participant
 Guarantee of confidentiality to the participant
 Assurance that the participant can withdraw at any time
 Provision of names of persons to contact if questions
arise
Confidentiality
 Confidentiality necessary in diagnostic, therapeutic
and
is research

 context
Confidential information is both private and voluntarily imparted
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in confidence and
Confidentiality….
 If research subject authorizes release of the information to others, then

there is no violation of rights or confidentiality

 Research may involve collecting and storing data relating to

individuals and groups such data, if disclosed to third parties, may

cause harm or distress.
 investigators should make arrangements for protecting the
confidentiality of such data by:
 omitting information that might lead to identification of individual
subjects
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 limiting access to the data, or by other
The Tuskegee Syphilis Study (1932-
1972)
 Study the natural evolution of syphilis infection in the long-term
 Conducted at Tuskegee by the United States Public Health
Service.
 More than 400 black men with syphilis participated, and about

200 men without syphilis served as controls

 The men were recruited without informed consent and, in fact,

were misinformed that some of the procedures done in the

interest of research (e.g., spinal taps) were actually “special free
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The Tuskegee
Syphilis…
 As early as 1936, it was clear that many more infected men than

controls had developed complications, and 10 years later, a

report of the study indicated that the death rate among those
with syphilis was about twice as high as it was among the
controls.
 In the 1940s, penicillin was found to be effective in the treatment

of syphilis.
 This study continued, nonetheless, and the men were neither

28 informed nor treated with the antibiotic.

The Tuskegee
Syphilis…
 The first accounts of this study appeared in the national press in
1972 following the revelation of one of the participating nurse
called Rivers.
 It was only in 1997 that a public acknowledgement of
Government responsibility was made by President Bill Clinton,
and the compensation of surviving participants and the families of
deceased participants continues.

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