ETHICS IN NURSING

RESEARCH
 INTRODUCTION

The rights of the research subjects in all

disciplines must be protected to the fullest
possible extent . When subjects are vulnerable ,
the research proposal must explain how
subjects rights will be protected.
 DEFINITION

Ethics in nursing can be defined as the act of

moral principles that the researcher has to
follow while conducting nursing research to
ensure the rights and welfare of individuals ,
groups or community under study.
 IMPORTANCE OF ETHICS IN NURSING
RESEARCH
• Protect the vulnerable group and other study
participants from harmful effects of the
experimental interventions.
• Safeguard the participants from exploitation by
researchers
• Establish the risk-benefit ratio for the study subjects.
• Ensure thefullestrespect,dignity,privacy,disclosure of
information and fair treatment for study subjects.
• Build the capability of subjects to accept or
reject participation in study and to have
access to informed or written consent for
participation in research study.
CODE OF ETHICS IN NURSING RESEARCH

The code of ethics is a very important tool for

nurses to have because nursing is a very
complex and dynamic profession that deals with
human lives; omissions, substandard of care and
negligence are not tolerated. The code reminds
nurses of their primary focus which is centered
around the care and the rights of their patients.
 PRINCIPLE OF BENEFICENCE
• The principle of beneficence is a moral
obligation to act for the benefit of others.
There are 2 aspects of beneficence:
1.Providing benefits
2.Balancing benefits and risks/harms.
The principle of beneficence supports the
following moral rules or obligations:
 Protect and defend the rights of others.
 Prevent harm from occurring to others.
 Remove conditions that will cause harm.
 Help persons with disabilities.
 Rescue persons in danger.
 PRINCIPLE OF JUSTICE
Justice in health care is usually defined as a form
of fairness, or as Aristotle once said, "giving to each
that which is his due." This implies the fair
distribution of goods in society and requires that we
look at the role of entitlement. The question of
distributive justice also seems to hinge on the fact
that some goods and services are in short supply,
there is not enough to go around, thus some fair
means of allocating scarce resources must be
determined.
• To each person an equal share
• To each person according to need
• To each person according to effort
• To each person according to contribution
• To each person according to merit
• To each person according to free-market
exchanges
 PRINCIPLE OF RESPECT TO HUMAN
DIGNITY
• Participants have full right to question the
researcher for any additional information or
clarification of doubts.
• Participants have right to quit from the study
at any stage of the research study.
• A fully informed consent must be taken from
the participants.
 INFORMED CONSENT
Informed consent is the process in which a
health care provider educates a patient about
the risks, benefits, and alternatives of a given
procedure or intervention. The patient must be
competent to make a voluntary decision about
whether to undergo the procedure or
intervention.
 The informed consent process makes sure that the health care
provider has given the information about the condition along
with testing and treatment options before person decide what
to do.

This information can include:

 The name of the condition
 The name of the procedure or treatment that the health care
provider recommends
 Risks and benefits of the treatment or procedure
 Risks and benefits of other options, including not getting the
treatment or procedure
 SIGNING INFORMED CONSENT MEANS

 You have received all the information about your treatment options
from your health care provider.
 You understand the information and you have had a chance to ask
questions.
 You use this information to decide if you want to receive the
recommended treatment option(s) that have been explained to you.
Sometimes, you may choose to receive only part of the recommended
care. Talk to your health care provider about your options.
 If you agree to receive all or some of the treatment options, you give
your consent (agree) by signing a consent form. The completed and
signed form is a legal document that lets your doctor go ahead with
the treatment plan.
 WAIVER OF INFORMED CONSENT

Consent refers to the provision of approval

or assent, particularly and especially after
thoughtful consideration. A waiver of consent
relieves a person or organization required to
obtain consent from actually getting that
consent. .
• The research involves no more than minimal risk
to subjects;
• The research could not be carried out
practicably without the waiver or alteration;
• The waiver or alteration will not adversely affect
the rights and welfare of the subjects; and,
• Where appropriate, the subjects will be
provided with additional information about their
participation.
• A study on nurses time utilization in
productive and nonproductive activities during
working period.
• Behavior of the nurses with patients and their
family in surgical wards.
• Performance observation of the nurses in
medical ward.
Such ethical dilemma must be dealt carefully.
 GOALS OF THE INFORMED CONSENT
PROCESS
 Give the subject information about the research
 Make sure the subject has time to consider all options
 Answer all of the subject’s questions before the decision is
made
 Make sure that all information is understood by the subject
 Obtain the subject’s voluntary informed consent to
participate
 Continue to inform the subject throughout the research
study
 Continue to re-affirm subject consent to participate
throughout the research study
 INVESTIGATOR RESPONSIBILITIES IN
REGARD TO INFORMED CONSENT
• Obtain consent before initiating study-specific
procedures.
• Provide a quiet, comfortable, and private setting for
the informed consent process whenever possible.
• Explain the consent process to the subject.
• Make sure the subject has time to consider all
options; allow subject to take
 the form home before signing (whenever
possible).
 Answer all questions
• To the extent possible, make sure the subject
understands enough information about the
research study to give informed consent.
• To the extent possible, make sure the subject
can consent free from coercion or other
undue influence.
• Since the informed consent process continues
throughout the subject’s participation in the
study, consent should be informally verified on
a continuing basis.
• Significant new information must be given to
the subject, and continuing
consent documented in some way; for example,
new risk information presented to the subjected
in an addendum to be signed by subjects who
agree to continue to participate.
 ICMR ETHICAL GUIDELINES FOR BIO-
MEDICAL RESEARCH
Principle of essentiality: whereby after due
consideration of all alternatives in the light of
existing knowledge, the use of human
participants is considered to be essential for the
proposed research. This should be duly vetted
by an ethics committee (EC) independent
of the proposed research.
 Principle of voluntariness whereby respect for
the right of the participant to agree or not to
agree to participate in research, or to withdraw
from research at any time, is paramount. The
informed consent process ensures that
participants’ rights are safeguarded.
Principle of non-exploitation whereby research
participants are equitably selected so that the
benefits and burdens of the research are
distributed fairly and without arbitrariness
or discrimination. Sufficient safeguards to
protect vulnerable groups should be ensured
• Principle of social responsibility whereby the
research is planned and conducted so as to
avoid creation or deepening of social and
historic divisions or in any way disturb social
harmony in community relationships
Principle of ensuring privacy and confidentiality
whereby to maintain privacy of the potential
participant, her/his identity and records are kept
confidential and access is limited to only those
authorized.
• Principle of risk minimization whereby due
care is taken by all stakeholders (including but
not limited to researchers, ECs, sponsors,
regulators) at all stages of the research to
ensure that the risks are minimized and
appropriate care and compensation is given if
any harm occurs.
• Principle of professional competence
whereby the research is planned, conducted,
evaluated and monitored throughout by persons
who are competent and have the
appropriate and relevant qualification,
experience and/or training
• Principle of maximization of benefit whereby
due care is taken to design and conduct
the research in such a way as to directly or
indirectly maximize the benefits to the research
participants and/or to the society
• Principle of institutional arrangements
whereby institutions where the research is
being conducted, have policies for appropriate
research governance and take the
responsibility
• to facilitate research by providing required
infrastructure, manpower, funds and training
opportunities.
• Principle of transparency and accountability
whereby the research plan and outcomes
• emanating from the research are brought into
the public domain through registries,
• reports and scientific and other publications
while safeguarding the right to privacy of
• the participants. Stakeholders involved in
research should disclose any existing conflict
• of interest and manage it appropriately
 Principle of totality of responsibility whereby
all stakeholders involved in research are
responsible for their actions. The professional,
social and moral responsibilities compliant
with ethical guidelines and related regulations
are binding on all stakeholders directly
or indirectly.
• Principle of environmental protection
whereby researchers are accountable for
ensuring protection of the environment and
resources at all stages of the research, in
compliance with existing guidelines and
regulations.
 CODE OF ETHICS IN INDIA

INC has published the code of ethics in

India in the year 2006.Ethical considerations are
vital in any area dealing with human beings
including nursing research because they
represent values,rights and relationship.
The nurse respects the uniqueness of individual in provision of
care - Nurse

• Provides care of individuals without

consideration of caste, creed, religion,
culture, ethnicity, gender, socio-economic
and political status, personal attributes, or any
other grounds.
• Individualizes the care considering the
beliefs, values and cultural sensitivities.
 Appreciates the place of individual in
the family and community and facilitates
participation of significant others in the
care.
Develops and promotes trustful
relationship with individual(s)
 Recognizes uniqueness of response of
individuals to interventions and adapts
accordingly
 The nurse respects the rights of individuals as partner in
care and help in making informed choices –
• Nurse
 Appreciates individual’s right to make decisions about
their care and therefore gives adequate and accurate
information for enabling them to make informed choices
 Respects the decisions made by individual(s) regarding
their care
 Protects public from misinformation and misinterpretations
 Advocates special provision to protect vulnerable
individuals/groups
The nurse respects individual’s right to privacy, maintains confidentiality, and shares information judiciously- Nurse

• Respects the individual’s right to privacy of

their personal information
• Maintains confidentiality of privileged
information except in life threatening
situations and uses discretion in sharing
information.
• Takes informed consent and maintains
anonymity when information is required for
quality assurance/ academic/legal reasons
• Limits the access to all personal records
written and computerized to authorized
persons only.
 Nurse maintains competence in order to
render Quality Nursing Care
• Nursing care must be provided only by
registered nurse
• Nurse strives to maintain quality nursing
care and upholds the standards of care
• Nurse values continuing education, initiates
and utilizes all opportunities for self
development.
• Nurses values research as a means of
development of nursing profession and
participates in nursing research adhering to
ethical principles.
The nurse if obliged to practice within the framework of
ethical, professional and legal boundaries- Nurse

 Adheres to code of ethics and code of

professional conduct for nurses in India
developed by Indian Nursing Council
 Familiarizes with relevant laws and practices in
accordance with the law of the state.
 Nurse is obliged to work harmoniously with
members of the health team - Nurse
• Appreciates the team efforts in rendering care
• Cooperates, coordinates and collaborates with
members of the health team to meet the
needs of people
 Nurse commits to reciprocate the trust
invested in nursing profession by society Nurse
• Demonstrates personal etiquettes in all
dealings
• Demonstrates professional attributes in all
dealings
 ETHICAL RESPONSIBILITIES OF A NURSE
RESEARCHER
• Assure the anonymity of participants, where
appropriate.
• Assure the confidentiality of information, where
appropriate.
• Respect the privacy of participants (and avoid
undue intrusion)
• Operate with transparency (open dealings with
participants)
• Provide equality of treatment.