Research Unit II Ethics in Nursing Research

Unit - II
Ethics in Nursing Research

By
Hidayatullah
Lifesaving college of Nursing
hidayat.khan10@yahoo.com 1
Ethics
Definitions
1. The moral code which guides the members
of the profession in proper conduct of their
duties & obligations.
2. The philosophical study of moral values and
rules
3. Ethics is central to the way we care, and to
the way we envision ourselves as professionals.
Scientific misconduct
Scientific misconduct or fraud involves such

practices as Fabrication (untruth), falsification
(deception), or forging (copy) of data;
dishonest manipulation of the designs and
methods with protocols violations;
misrepresentative of findings; and plagiarism
(Rankin & Esteves, 1997)
Elements of Ethical research
Protecting subjects/human rights

Obtaining informed consent
Obtaining institutional approval of research
Balancing the benefits and the risk in the
study.
Understanding scientific misconduct
It may define as fabrication, falsification,

plagiarism, or other practices, that seriously
deviated from those, that are commonly
accepted with in the scientific community for
proposing conducting or report research.
Research never occurred, but data
reported
finding were consciously distorted
Understanding scientific misconduct
Right to Anonymity & Confidentiality
Anonymity (Ambiguity):
o has been taken care if the subjects identity is not linked with their
data the
haven given.
A breach (break) of confidentiality
o y can occur when a researcher, by ac or direct action, allows an
unauthorized
person to gain access to raw data of a study.
Confidentiality
o can also be breached in reporting or publishing a study if a subject is
accidentally revealed (exposed), violating the subject's right to
anonymity.
(Ramos 1989).
Predict the
outcome of the Assess benefits Assess risks
study
Benefit risk ratio Benefit are great or Risks outweigh

equal to risk benefits
Understanding
Approved study Reject study Scientific
Misconduct
Examine the benefit-risk Ratio of a study
Balance or risk benefit ratio

sampling method, consent process, procedures,
and potential outcomes
Therapeutic is benefit, helps in add the
knowledge
If benefit and risk equals
• see that the researcher is able to take care of the
risk
• with proper consent signed
Historical contexts for development of Ethical codes and
regulation
Nazi medical experience.

Nuremberg Code
Declaration of Helsinki
Tuskegee Syphilis study
Willow brook Study
Jewish Chronic Disease Hospital
Department of health education and welfare regulation
National Commission for the protection of Human
Subjects of Bio medical and Behavioral research
Nazi Medical Experience
 1935-45, inhuman, deadly unethical experiments done to
people who had no choice.
 The program of Nazi regime included sterilization, euthanasia,
and medical experimentation for the purpose of producing a
population of “racially pure”
 Medical experiments conduct on prisoners of war and persons
considered to be racially valueless who were confined in
concentration camps
 Experiments involved exposing subjects to high altitudes,
freezing temperature, malaria, poisons or untested drugs and
performing surgical procedures without anesthesia.
 Nazi experiments violated human rights of the research
subjects
 Selection of subjects were racially based and unfair.
Tuskegee Syphilis study
US Public Health Services in 1932 did a study of syphilis in
African Americans men in the small town Tuskegee, Alabama.
Continue and blocked for 40 years to look a natural course of
syphilis
Subjects did not know the purpose of the study and some
didn’t even know they were in the study, did not receive
history for syphilis and information
Subjects examined periodically but not treated for syphilis
even penicillin was effective treatment for disease in 1940
History/ findings was/were deliberately withheld this went on
for 40 years until stopped by a newspaper article and the
public became upset
Willow brook Study
1950's-70's a doctor conducted a study at willow brook, an
institute for mentally retarded children in New York.
Children deliberately infected with hepatitis
Researchers thought the children would get hepatitis when
admitted.
Jewish Chronic Disease Hospital Study
Study Conducted in Jewish Chronic Disease Hospital New York in
1960's, looking at patients rejection responses to live cancer cells,
injected into patients that had been generated from human cancer
tissues
Patients not informed that they were in study so infected with live
cancer cells.
The physicians caring for the patients were unaware.
Codes of Ethics
Definition
1. The set of standards that a professional is bound to observe.
2. A set of ethical behavioral rules developed by organization
or a professional society.
During the past 04 decades, largely in response to human
rights violations, various codes of ethics have been
developed.
First internationally recognized efforts to establish ethical
standards is referred to as the Nuremberg Code
o developed after Nazi atrocities (slaughter, violence
Other most notable is Declaration of Helsinki
o Adopted in 1964 by the World Medical Association and then later
revised, most recently in 2000.
Most disciplines established their own code of ethics
The American Nurses’ Association (ANA) put forth a
document in 1995 entitled ethical Guidelines in the Conduct,
Dissemination, and Implementation of Nursing Research
The American Sociological Association published a revised
Code of Ethics in 1997
Guidelines for psychologists were published
by the American Psychological Association (1992) in Ethical
Principles of Psychologists an Code of Conduct.
The Belmont Report articulated three primary ethical
principles on which standards of ethical conduct in research
are based: beneficence, respect for human dignity, and
justice.
Ethical Principles
In undertaking research, certain ethical principles are
used as a framework to guide the researcher through
the research process and its subsequent use.
They help to ensure the highest possible standards in
every aspect of research.
The Belmont Report(1978) articulated three primary
ethical principles on which standards of ethical conduct
in research are based:
1. Beneficence
2. Respect for human dignity
3. Justice.
1. Beneficence
Encourages the researcher to do good and “above all, do no
harm”.
It contains multiple dimensions.
1. Freedom From Harm: - Physical (e.g., injury, fatigue),
psychological (e.g. stress, fear), social (e.g. loss of friends), and
economic (e.g. loss of Wages).
2. 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.
3. Benefits From Research: Maximize benefits & to communicate
potential benefits to participants
4. The Risk/Benefit Ratio: risks and benefits that individual
participants might experience should be shared with them that
they can evaluate whether it is in their best interest to participate.
2. Respect for Human Dignity
People should be treated as autonomous agents with the right to self
determination and the freedom to participate or not in research.
The right to self-determination and the right to full disclosure are the
two major Elements on which informed consent is based
The Right to Self-Determination
Humans should be treated as autonomous age capable of controlling
their own activities. The principle of self- determination means that
prospective participants have the right to decide voluntarily whether
to participate in a study, without risking any penalty or prejudicial
treatment
The Right to Full Disclosure
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 an benefits.
3. Justice
Human subjects should be treated fairly in terms of the benefits
and the
risks of research
It includes participants’ right to fair treatment and their right to
privacy.
1. The Right to Fair Treatment

Study participants have the right to fair and equitable treatment
before, during, and after their participation in the study.
2. The Right to Privacy
Participants have the right to expect that any data they provide
will be kept in strictest confidence. This can occur either through
anonymity or through other confidentiality procedures.
Ethical Principles in Nursing Research
THE INVESTIGATOR . . .
1. Respects autonomous research participants’ capacity
to consent to participate in research a to determine
the degree and duration of that participation without
negative consequences.
2. Prevents harm, minimizes harm, and/or promotes
good to all research participants, including vulnerable
groups and others affected by the research.
3. Respects the personhood of research participants,
their families, and significant other valuing their
diversity.
4. Ensures that the benefits and burdens of
research are equitably distributed in the
selection of research participants.
5. Protects the privacy of research participants t
the maximum degree possible.
6. Ensures the ethical integrity of the research
process by use of appropriate checks and
balances throughout the conduct,
dissemination, and implementation of the
research.
7. Reports suspected, alleged, or known incidents
of scientific misconduct in research to
appropriate institutional officials for investigation
8. 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.
9. Involved in animal research maximizes the
benefits of the research with the least possible
harm or suffering to the animals.
What are Human Rights & how they protected during research?
Human rights are claims and demands that have been

justified in the eyes of an individual or by the
consensus
(Agreement) of a group of people.
According to (ANA, 2001 and APA, (2002)Human rights
that require protection in research are as under.
1. Right to self-determination
2. Right to privacy
3. Right to anonymity & confidentiality
4. Right to fair treatment
5. Right to protection from discomfort and harm
1. Right to self-determination
Based on the ethical principle of respect for

persons and it indicates that humans are capable
of controlling their own destiny
Human should be treated as an autonomous
agents
If the researcher has;
o informed them about the study
o allow them to choose to participate or not participate
o Allow them to withdraw from the study at any time with
out penalty
Coercion
occurs when an overt threat of harm or an
excessive reward is intentionally presented by
one person to another to obtain compliance
Covert data collection
subjects are unaware that research data are being
collected
Deception
Misinforming the subjects for the research
purposes
Persons with diminished autonomy
Neonates and children

Mentally or physically disabled
Institutionalized persons
coerced to participate due to lack of care or loss
of job.
Pregnant women and fetuses
Terminally ill patient
Autonomy
Self-determination (Participation & withdrawing)
No coercion
Full disclosure, no deception
Voluntary consent
Conduct research on them only if
o the research is therapeutic
o the researchers are willing to use vulnerable and non-
vulnerable subjects
o the risk is minimize
o the consent process is strictly followed to insure the
rights of the prospective subjects
Protecting Human Rights
Right to Privacy
Privacy 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
Invasion of privacy: information is shared with out
subjects will.
Right to Anonymity & Confidentiality
When the data is not linked with the personal responses
Is the researchers management of private information
shared by the subject ( provide ID number).
4. Right to Fair Treatment
It means that the participants receive equitable treatment
before, during, & after their participation in the study
It includes aspects; fair and non-discriminatory selection of
participants, non prejudicial treatment of individuals,
honoring of all the agreements made between the
researcher and the participant and respectful and courteous
(polite) treatment at all time.
It comes under principle of Justice
Injustice in selection
o especially suitable for research e.g. poor
o favorite patients receives the intervention
o Randomization
o benefits should be provided (promised)
5. Right to Protection from Discomfort and Harm
Beneficence
o Freedom from harm
o Freedom from exploitation
o Risk/benefit ratios
o High anticipated benefit may balance high risk
harm could be physical, social, economical
Reynolds 1972 identified five categories for the level of
discomfort
o No anticipated effects
o temporary discomfort
o unusual level of temporary discomfort
o risk of permanent damage
o certainty of permanent damage
Informed Consent Process
Consent is the prospective subject’s agreement to participate in
study as a subject.
It is a conversations between study subject and the research team.
In which he/she
decide to participate in the research study and consent by signing
the document.
Participant will be given a copy of the informed consent document.
He/she can us it as an information resource throughout study.
Both written consent and verbal consent participation in research
must involve an
informed consent process.
Informed consent involves an education and information exchange
that takes place
between the researcher and the potential subject.
Elements of Informed Consent
Essential Information for Consent

Comprehension of Consent Information
Competency to give consent
Voluntary consent
Informed Consent-Essential Information
Informed consent requires researcher disclose specific information to

all prospective subjects, which is as follow;
Introduction of research activities.
Purpose of the research
Why they were selected as potential subjects
Procedure is explain
Potential Risks, cost and Benefits described
Disclosure of alternatives
Assurance of anonymity and confidentiality
Offer to answer question
Voluntary participation
Contact information
Opinion to withdraw
Consent to incomplete disclosure
Informed Consent Essential Information
What is involved in a letter:

Non coercion with discussion participation is
voluntary
Option of withdraw
If information being deliberately withheld
need to inform that certain information is
withheld with the study.
Elements of Informed Consent
Comprehension of Consent Information

teach about the study
discuss the purpose and outcome
advocate for subject for potential risk and benefit for
him/her
Competency to give consent
use competent person for consent in case of presence of
less autonomous subject e.g. child, terminally ill, disabled
Voluntary consent
consent with out coercion

Research Unit II Ethics in Nursing Research

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Unit - II

Ethics in Nursing Research

Scientific misconduct or fraud involves such

(Rankin & Esteves, 1997)

Protecting subjects/human rights

It may define as fabrication, falsification,

Benefit risk ratio Benefit are great or Risks outweigh

Balance or risk benefit ratio

Nazi medical experience.

1. The Right to Fair Treatment

Human rights are claims and demands that have been

Based on the ethical principle of respect for

Neonates and children

Essential Information for Consent

Informed consent requires researcher disclose specific information to

What is involved in a letter:

Comprehension of Consent Information

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