Objectives

At the end of this session, the students will be able to:

 Define Ethics

 Assess the need of ethics in research

 Discuss some historical events, which have influence

on ethics in research
 Discuss some ethical guidelines required for research

 Understand the concept of research misconduct from

ethics point of view

Ethical Researcher

 "Many people say that it is the intellect which

makes a great scientist. They are wrong: it is
character." -- Albert Einstein
Integrity

 A character trait inwardly focused on the

self… of being faithful to moral values and
standing up in their defense (Oxford
Dictionary)
Integrity is doing right when no one is
watching.

02/01/25 4
A branch of philosophy

A set of principles of right

conduct.

02/01/25 5
What is Ethical Research
“ A system of moral values that is concerned
with the degree to which research procedures
adhere to professional, legal, and social
obligations to the study participants.”
(Polit, beck, Hungler)

02/01/25 6
Nazi Trial (1935-1945)
 The Nazi medical experiments of the 1930s and
1940s are the most famous example of recent
disregard for ethical conduct.
 23German Nazi physicians tortured and murdered
thousands of victims in the name of research
 Experiments done on prisoners of wars with out
their permission

02/01/25 8
Cont…
 Exposing substances to high altitudes, freezing
temperatures, malaria, poisons, typhus, &
untested drugs and operations without any form
of anesthesia
 Violated numerous rights of human research
subjects.
Tuskegee Syphilis study 1932 - 1972

Tuskegee Syphilis a Study, sponsored by the

U.S. Public Health Service, investigated the
effects of syphilis among 400 men from a poor
African-American community.
Medical treatment was deliberately withheld

to study the course of the untreated disease.

02/01/25 10
Cont…
 Over one hundred of the infected men died
and others suffered from serious syphilis
related conditions.
 Participants did not know sign consent
 Treatment was deliberately withheld
Willow brook Study (1963-1966)
Institution for “mentally defective persons.”
New York
Designed to :

– Gain an understanding of the natural history of

infectious hepatitis.
– Test the effects of gamma globulin to prevent
the disease.

02/01/25 12
Cont…
 Mentally retarded children were deliberately
infected with hepatitis virus
 During the study the school closed door to all
sections except the “hepatitis section
Problems with the Willowbrook study

 Lacked child assent

 Lacked parental consent for the most part
 Perception that little choice is given to
participate in research
 Research conducted with no regard of the
protection of the subjects
Jewish Chronic Disease Hospital Study
(1960)
 Another well-known case of unethical
research involved the injection of live
cancer cells into elderly patients at the
Jewish Chronic Disease Hospital in
Brooklyn, without the consent of those
patients.
Cont…
 The purpose was to assess participants’
rejection responses to Cancer cells
injected into them.
 The elderly were infected with live
cancer cells.
Historical context
 1947: Nuremberg trials
 1948: United Nations Declaration of Human
Rights
 1964: Declaration of Helsinki
 1966: United Nations Covenant on Economic,
Social and Cultural Rights, Civil and Political
Rights
Codes of Ethics
 One of the first internationally recognized
efforts to establish ethical standards is
referred to as the Nuremberg Code,
developed after the Nazi trials.
Cont…
 Several other international standards have
subsequently been developed, the most
notable of which is the Declaration of
Helsinki, which was adopted in 1964 by the
World Medical Association and then later
revised, most recently in 2008.
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
02/01/25 20
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

02/01/25 21
8. Experiments can be conducted only by scientifically
qualified persons

9. Human subjects must be allowed to discontinue their

participation at any time

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

02/01/25 22
Declaration of Helsinki (1964)
Highlights
 Well being of the subject takes precedence over
science and society.
 Respect for persons & protection of subjects health
& rights.
 Vulnerable populations require special protection.
 Procedures must be detailed in a protocol &
submitted to an ethical review committee, including
the monitoring of information
Cont…
 Assessment of risks and benefits to the
subjects or others before conducting the
research.
– INFORMED consent is a must.
– INFORMED consent must be
DOCUMENTED.
Belmont Report 1979
Respect for Persons:
 – Concerns the ability of a person to direct

his/her actions.
Beneficence :
 Balance the risks and benefits.

 –Do no harm
Cont…
Justice :
 fair and equitable distribution of benefits and

burdens.
Ethical Principles in Nursing
Research:
 The American Nurses’ Association (ANA)
put forth a document in 1995 entitled Ethical
Guidelines in the Conduct, Dissemination,
and Implementation of Nursing Research
(Silva, 1995).
Cont…
 Following are the nine ethical principles outlined in
that document.
 Respects autonomous research participants’ capacity to
consent to participate in research and to determine the
degree and duration of that participation without negative
consequences.
 Prevents harm, minimizes harm, and/or promotes good to
all research participants, including vulnerable groups and
others affected by the research.
 Respects the personhood of research participants, their
families, and significant others, valuing their diversity.
Cont…
 Ensures that the benefits and burdens of research
are equitably distributed in the selection of
research participants.
 Protects the privacy of research participants to the
maximum degree possible.
 Ensures the ethical integrity of the research
process by use of appropriate checks and balances
throughout the conduct, dissemination, and
implementation of the research.
Cont…
 Reports suspected, alleged, or known incidents of
scientific misconduct in research to appropriate
institutional officials for investigation.
 Maintains competency in the subject matter and
methodologies of his or her research, as well as in other
professional and societal issues that affect nursing
research and the public good.
 Involved in animal research maximizes the benefits of the
research with the least possible harm or suffering to the
animals.
 Coercion

 Coercion is the practice of forcing another party to

behave in an involuntary manner by use of threats,
rewards, or some other form of pressure or force.
 Covert data collection

 Subjects are unaware that research data are being

collected
 Deception

 Misinforming the subjects for the research purposes

02/01/25 31
Fabrication
• Making up data or results and reporting them
especially untruthful
Falsification
• Manipulating research materials or processes
such that the research is not accurately
presented
Plagiarism
• Owning others’ ideas

02/01/25 32
Principles of Ethics in Research
THE PRINCIPLE OF BENEFICENCE
 One of the most fundamental ethical

principles in research is that of beneficence,

which encompasses the maxim: Above all, do
no harm.
 Ethical Principle 2 of the ANA guidelines

addresses beneficence.

02/01/25 33
Different dimensions of Beneficence
principle:
 Freedom From Harm:
 Researchers should strive to minimize all types
of harm and discomfort and to achieve insofar
as possible a balance between the potential
benefits and risks of being a participant.
Cont…
 Freedom From Exploitation:
 Participants need to be assured that their
participation, or information they might
provide, will not be used against them in any
way.
Cont…
 Benefits From Research:
 Researchers should strive insofar as possible to
maximize benefits and to communicate
potential benefits to participants.
Cont…
 The Risk/Benefit Ratio:
 In designing a study, researchers must carefully
assess the risks and benefits that would be
incurred.
 The general guideline is that the degree of risk to
be taken by those participating in the research
should never exceed the potential humanitarian
benefits of the knowledge to be gained.
THE PRINCIPLE OF RESPECT
FOR HUMAN DIGNITY:
 Respect for human dignity is the second
ethical principle articulated in the Belmont
Report.
 This principle, which includes the right to
self-determination and the right to full
disclosure, is covered in the ANA guidelines
under principles 1 and 3.
The Right to Self-Determination:

Human should be treated as Autonomous

agents
A person’s right to self-determination includes
freedom from coercion of any type.
They are allowed to participate or not
participate
They have the right to withdraw from the

study at any time with out penalty

02/01/25 39
The Right to Full Disclosure:
 The principle of respect for human dignity
encompasses people’s right to make
informed, voluntary decisions about study
participation, which requires full disclosure.
Cont…
 Full disclosure means that the researcher has
fully described the nature of the study, the
person’s right to refuse participation, the
researcher’s responsibilities, and likely risks
and benefits.
 Participants need to have full

information about the study

THE PRINCIPLE OF JUSTICE
 The third broad principle articulated in the
Belmont Report concerns justice.
 Justice, which includes participants’ right to
fair treatment and their right to privacy, is
covered in the ANA guidelines under
principles 4 and 5
Right to Fair Treatment
Study participants have the right to fair and
equitable treatment before, during, and after
their participation in the study. Fair treatment
includes the following features:.
 It includes fair selection of participants such

that any risks and benefits will be equitably

shared
Cont…

Participants should be selected based on

research requirements, not on the vulnerability
position
Respect for cultural and other forms of human

diversity should be maintained

 Participants’ Should have access to research

personnel at any point in the study to clarify

information
02/01/25 44
 Right to Privacy

It is the freedom an individual has

to determine the time, extent, and
general circumstances under which
private information may be shared
with or withheld from others

02/01/25 45
Right to Anonymity and
Confidentiality
 Anonymity: It occurs when even the
researcher cannot link participants to their
data.
 A promise of confidentiality is a pledge that
any information participants provide will not
be publicly reported in a manner that
identifies them and will not be made
accessible to others.

02/01/25
46
Cont…
 Confidentiality: It is defined such that any
information participants provide will not be
publicly reported in a manner that identifies
them and will not be made accessible to
others.
Steps to Maintain Confidentiality
 Obtain identifying information (e.g., name,
address) from participants only when
essential.
 Assign an identification (ID) number to each
participant and attach it to the actual data.
 Maintain identifying information in a locked
file.
Steps Cont…
 Restrict access to identifying information to a
small number of people on a need-to-know
basis
 Destroy identifying information as quickly as
practical.
 Make research personnel sign confidentiality
pledges if they have access to data or
identifying information.
02/01/25 50
Informed Consent:
 Informed consent means that participants
have adequate information regarding the
research, are capable of comprehending the
information, and have the power of free
choice, enabling them to consent to or decline
participation voluntarily.
Informed Consent Cont…
 The right to self-determination and the right
to full disclosure are the two major elements
on which informed consent is based.
 Participants must know that they are getting
involved before they commit
 Must consent to participate is study as a
participant

02/01/25 52
Essential Information for Consent

Comprehension of Consent Information

Competency to give consent

Voluntary consent
02/01/25 53
 Essential Information
Introduction of research activities.
Purpose of the research
Why they were selected as potential subjects
Procedure is explained
Risks or discomforts explained
Benefits described

Any alternatives. E.g. history that may be

available 02/01/25 54
Cont…
Assure anonymity (confidentiality)
Offer to answer question
Non coercion with discussion their participation
is voluntary
Option withdraw
If information being deliberately withheld need
to inform that certain information withheld until
with the study.
02/01/25 55
02/01/25 56
Vulnerable Subjects
 Vulnerable subjects are those who may be
incapable to give fully informed consent
e.g. Mentally Retarded People
Or
 People who are at high risk of unintended side
effects because of their circumstances e.g.
pregnant women).
Vulnerable Groups
 Children.
 Mentally or emotionally disabled people.
 Severely ill or physically disabled people.
 The terminally ill.
 Institutionalized people.
 Pregnant women.
Children’s Assent
 Assent refers to the child’s affirmative
agreement to participate.
 If the child is at least 7 years of age,
obtaining Child’s Assent is also important.
Cont…
 If the child is developmentally mature enough
to understand the basic information involved
in informed consent (e.g., a 13-year old), it is
advisable to obtain written consent from the
child as well, as evidence of respect for the
child’s right to self-determination.
 An independent body constituted of
medical ,scientific , and non scientific members
whose responsibility it is to ensure the protection of
the rights, safety and well being of human subjects
by; reviewing, approving, and providing continuing
review of protocols, amendments of the
methods ,material to be used in obtaining and
documenting informed consent of the human
subject.
 Every institution where an individual might
conduct research must have an IRB
 The Primary goal is to protect the rights of
research participants

02/01/25 62
Common Role of the IRB
 Review of research.
 Informed consent.
 Assurance of compliance of the institution
 Should the study be done at all?
 Do the benefits outweigh the risks?
 What constitutes an adequate informed
consent?
Polit, D. F., & Beck, C. T. (2008). Nursing
research: generating and assessing evidence
for nursing practice (8th ed.). Williams and
Wilkins: Philadelphia

University of Minnesota, Center for Bioethics.

(2003). A guide to research ethics .

02/01/25 64
THANK YOU

02/01/25 65