This document discusses ethics in nursing research. It begins by defining ethics and explaining concepts like bioethics and professional codes of ethics. It then discusses requirements for obtaining human research ethics clearance and the types of human participation in research. The document outlines three main ethical principles from the Belmont Report - respect for human dignity, beneficence, and justice. It also discusses informed consent, national ethical guidelines, ethical dilemmas in research, and deception in research.

1. ETHICS IN NURSING RESEARCH
Mr. Jayesh Patidar
Associate Professor
GCSN

2. MEANING OF ETHICS
Ethics is derived from the Greek word “ethos” meaning custom or character.
Rules that govern “right” conduct, what “ought to be”/right thing to do, the
“should” of human behavior.
ETHICS
It refers to the study of philosophical ideals of right and wrong behavior.
Ethics judges good, bad, right or wrong in human behavior.
BIOETHICS
It is ethics as applied to life (i.e. to life and death decision making). It is
concerned with human behavior in health care.
PROFESSIONAL CODE OF ETHICS
It is a set of collective statement about group’s expectations and standard of
behavior, and serves as guidelines to assist nurse and other health professional
groups when conflict or disagreement arises about correct practice or
behavior.

3. REQUIREMENT FOR HUMAN RESEARCH ETHICS
CLEARANCE
CODE OF ETHICS
Who needs to apply for human research ethics clearance?
Human research is “research which is conducted with or about people, or their data
or tissue”
Anybody wishing to conduct any research involving:
 Human participants
 Human tissue
 Personal records, or unpublished human research; must obtain ethics approval
before the research commences

4. TYPES OF HUMAN PARTICIPATION IN RESEARCH
As persons whose body organs or tissues are obtained and/or retained
for research.
As research participants from whom information is obtained.
As people who might be identified in official documents.
As people whose information (identified or de-identified) is part of an
existing, unpublished source.

5. ETHICAL PRINCIPLES (BELMONT REPORT)
I. RESPECT FOR HUMAN DIGNITY
It is the concept that all people deserve the right to fully exercise
their autonomy and assume that every individual is able to make a choice. It
comprises of two essential moral requirements:
a. Right for Autonomy (Self Determination)
An autonomous person is defined as an individual who is capable to make
judgments and actions based on his/her particular set of values, preferences,
and beliefs.
It also requires that subjects be treated in a non-degrading manner or out of
respect for their dignity. Respect for persons is practiced by doing followings
Obtaining informed consent
 Protecting the autonomy of all people
Treating them with courtesy and respect

6. b. The Right to Full Disclosure
Researchers must have fully disclosed information about the study and
explained the voluntary nature of participation (including the right to
refuse without repercussion) and possible benefits and risks related to
study participation. Without complete information, a potential
participant cannot make a truly informed decision. People have a right
to make informed, voluntary decisions about study participation which
requires full disclosure. Full disclosure can be troublesome for some
researchers based on their study designs and research questions

7. II. BENEFICENCE (ABOVE ALL, DOES NO HARM)
The philosophy of "Do no harm" while maximizing benefits for the research project and
minimizing risks to the research subjects. There are four aspects of beneficence i.e.
a. Freedom From Harm
Researchers may strive to minimize all types of physical, psychological, social and
economic harm and discomfort and achieve balance between potential benefits and risks
of being a participant.
b. Freedom From Exploitation
Involvement in a research study should not place participants at a disadvantage or expose
them to a situation for which they have not been prepared for. Assure participants that the
information provided by them will not be used against them in any way.
c. Benefits From Research
People agree to participate in research investigations for a number of reasons such as
direct personal benefits, benefits to society and other individuals or participate in desire to
be helpful. Researcher may communicate potential benefits to participants.

8. d. The Risk/Benefit Ratio
In designing a research study, carefully assess the risks and benefits that would be
incurred. In evaluating risk/benefit ratio researcher should consider how
comfortable he would feel if his family participated in the study.

9. III. PRINCIPLE OF JUSTICE
In research ethics, justice is the fair selection of research participants.
Justice is the ideal distribution of risks and benefits when scientists
conducting clinical research are recruiting volunteer research
participants to participate in study. In this, non-exploitative and well-
considered procedures are administered fairly — the fair distribution of
costs and benefits to potential research participants. There are two
aspects of justice i.e.
a. The Right to Fair Treatment
 Study participants have the right to fair and equitable treatment
before and during their participation in the study. Fair treatment
includes:
The fair and non-discriminatory selection of participants.
Respect for culture and other form of human diversity.
The non-prejudicial treatment of those who decline to participate or
who withdraw from the study after agreeing to participate.

10. b. The Right to Privacy
Researchers must keep any shared information in their strictest
confidence. Upholding the right to privacy often involves procedures for
anonymity or confidentiality. For participants’ data to be completely
anonymous means that the researcher cannot connect participant to their
data.

11. NATIONAL ETHICAL GUIDELINES (ICMR 2017)
 PRINCIPLE OF ESSENTIALITY
 PRINCIPLE OF VOLUNTARINESS
 PRINCIPLE OF NON-EXPLOITATION
 PRINCIPLE OF SOCIAL RESPONSIBILITY
 PRINCIPLE OF ENSURING PRIVACY AND CONFIDENTIALITY
 PRINCIPLE OF RISK MINIMIZATION
 PRINCIPLE OF PROFESSIONAL COMPETENCE
 PRINCIPLE OF MAXIMIZATION OF BENEFIT
 PRINCIPLE OF INSTITUTIONALARRANGEMENTS
 PRINCIPLE OF TRANSPARENCY AND ACCOUNTABILITY
 PRINCIPLE OF TOTALITY OF RESPONSIBILITY
 PRINCIPLE OF ENVIRONMENTAL PROTECTION

12. INFORMED CONSENT
It is a voluntary agreement to participate in research. It is not merely a form
that is signed but is a process, in which the subject has an understanding of
the research and its risks. Informed consent is essential before enrolling a
participant and ongoing once enrolled. The ethics code of the American
psychological association describes that the researcher should inform
participants about followings
1. The purpose of the research, expected duration and procedures.
2. Their right to decline to participate and to withdraw from the research
once participation has begun.
3. The expected consequences of declining or withdrawing.
4. Reasonably expected factors that may influence their willingness to
participate such as potential risks, discomfort or adverse effects.
5. Any prospective research benefits.
6. Limits of confidentiality.
7. Incentives for participation

13. ELEMENTS OF INFORMED CONSENT
RESEARCHERS CREDENTIALS
SUBJECT SELECTION PROCESS
PURPOSE OF THE STUDY
STUDY PROCEDURES
POTENTIAL RISKS
POTENTIAL BENEFITS
COMPENSATION IF ANY
ALTERNATIVE PROCEDURES
ANONYMITY OR CONFIDENTIALITY
OFFER TO ANSWER ALL QUESTIONS
MEANS OF OBTAINING STUDY RESULTS

14. DEVELOPING A CONSENT FORM
• Organize the consent form coherently.
• Use large font so that form is easily read, use spacing that
avoids making document too dense.
• Make form attractive.
• Use clear, consistent terminology and avoid technical terms.
• If possible, use a readability formula to estimate the form’s
reading level and make revisions to ensure an appropriate
reading level for the group under study.
• Test the form with people similar to those who will be
recruited and ask for feedback.

15. ELECTRONIC CONSENT
Electronic media can be used to provide information as in the written
informed consent document, which can be administered and documented
using electronic informed consent systems.
GATEKEEPERS CONSENT
Permission of the gatekeepers, that is, the head/leader of the group or
culturally appropriate authorities, may be obtained in writing or audio/video
recorded on behalf of the group and should be witnessed.
COMMUNITY CONSENT
In certain populations, the community plays an important role in the consent
process. Some participants may not participate in the research unless the
community’s consent is available. There may be situations when individual
consent cannot be obtained as it will change the behaviour of the individual.
In such situations community consent is required.

16. WAIVER OF CONSENT
The researcher can apply to the EC for a waiver of consent if the
research involves less than minimal risk to participants and the waiver
will not adversely affect the rights and welfare of the participants.
ASSENT
A child’s agreement to participate in research is called assent. In
addition to consent from parents or legal guardian, verbal/oral or written
assent, as approved by the ethical committee, should be obtained from
children of 7–18 years of age.

17. ETHICAL DILEMMAS IN CONDUCTING RESEARCH
An ethical dilemma is a problem in the decision-making
process between two possible ethical principles, neither of which is
absolutely acceptable from an ethical perspective. Ethical dilemmas are
extremely complicated challenges that cannot be easily solved.
Therefore, the ability to find the optimal solution for ethical dilemmas is
critical to researcher.

18. HOW TO SOLVE AN ETHICAL DILEMMA
Following approaches can help to some extent to solve ethical dilemma.
Primary Consideration: decision on the basis of welfare of the
prospective study participants.
Value theory approach: Choose the alternative that offers the greater
good and the lesser harm.
Find alternative solutions: In some cases, the problem can be
reconsidered, and the new alternative solutions may arise.
Seek advice from institutional ethics committee:- Health care
institutions use an ethics committee to process dilemma. These
committees generally are multidisciplinary and include representatives
who are nurses as well as representatives from other disciplines.

19. DECEPTION
This is a process where participants are misled or wrongly informed about the aims of the
research. There are two possible types of deception include
1. Deliberate misleading, for example informing participants that the present study will
assess their health practices but the actual purpose of study is to assess the prevalence of
substance abuse..
2. Deception by omission, e.g., failure to disclose full information about the study, or
creating ambiguity.
The researcher should avoid deceiving participants about the nature of the research unless
there is no alternative and even then this would need to be judged acceptable by an
independent expert. However, there are some types of research that cannot be carried out
without at least some element of deception. Some researchers argue that deception can
never be justified and object to this practice as it
Violates an individual’s right to choose to participate.
It is a questionable basis on which to build a discipline.
 Leads to distrust of researcher in the community.

20. THE AMERICAN PSYCHOLOGICAL ASSOCIATION
PROVIDED STANDARDS GUIDELINE FOR USE OF
DECEPTION IS AS FOLLOW
Non-deceptive alternative procedures are not feasible:-
Researchers do not conduct a study involving deception unless they
have determined that the use of deceptive techniques is justified by the
study's significant prospective scientific, educational or applied value
and that effective non-deceptive alternative procedures are not
feasible.
No physical pain or severe emotional distress:- Researchers do not
deceive prospective participants about research that is reasonably
expected to cause physical pain or severe emotional distress.
Earliest disclosure of deception:- Researchers must disclose
deception to participants as early as is feasible, preferably at the
conclusion of their participation.

21. DEBRIEFING
Debriefing is a process that can be undertaken at the conclusion of any research
activities, regardless of whether deception is part of the research design. It is
appropriate to provide participants with a simple, clear, and informative
explanation of the research purpose and the methods that were used.
The APA outlines three basic requirements for debriefing:
 Researchers provide prompt and appropriate information about the nature, results,
and conclusions of the research, and correct misconceptions of participants.
 If scientific or humane values justify delaying or withholding this information,
researchers take reasonable measures to reduce the risk of harm.
 When research procedures have harmed a participant, researcher must take
reasonable steps to minimize the harm.

22. DEHOAXING
It is the process of convincing subjects who have been
deceived as part of a research study that they have in
fact been deceived. The purpose of dehoaxing is to
prevent possible future harm to the subject. For
example, subjects may be given false pretest scores in
order to test the effect of these scores on subsequent
tests of motivation levels. If subjects believe that the
false scores represent their true abilities, their level of
self-esteem would be high and put the person at risk.

23. ETHICS COMMITTEE
Research ethics committees have an important role to play in ensuring the
ethical standards and scientific merit of research involving human subjects.
There are three important obligations placed on the ethics committee.
1. Firstly and most importantly, the ethics committee must ensure that the
rights of research participants are protected. This is achieved by ensuring
that individuals receive sufficient information which can be easily
understood and ensuring that appropriate strategies are in place to protect
participants from potential adverse consequences of the research.
2. Secondly, the research ethics committee has an obligation to society which
provides the resources for research and will ultimately be affected by the
results.

24. Thirdly, the research ethics committee has an obligation to the
researcher. The research proposal should be treated with respect and
consideration. The research ethics committee should strive to meet each
of these obligations

25. COMPOSITION OF ETHICAL COMMITTEE
CHAIRPERSON/ VICE
CHAIRPERSON
NON-AFFILIATED A WELL-RESPECTED
PERSON FROM ANY
BACKGROUND WITH PRIOR
EXPERIENCE OF HAVING
SERVED/ SERVING IN AN EC
CONDUCT EC MEETINGS
Member Secretary Affiliated (Should be a staff
member of the institution)
Should have knowledge and
experience in clinical research and
ethics.
Schedule EC meetings, prepare the
agenda and minutes
Basic Medical Scientist(s) Affiliated/ non-affiliated Non-medical or medical person
with qualifications in basic medical
sciences
Scientific and ethical review with
special emphasis on the
intervention.
Clinician(s) Affiliated/ non-affiliated Individual/s with recognized
medical qualification, expertise
and training
Thorough review of protocol/
intervention.
Legal expert/s Affiliated/ non-affiliated Basic degree in Law from a
recognized university.
Interpret and inform EC members
about legal regulations.

26. SOCIAL
SCIENTIST/
PHILOSOPHER/
ETHICIST
AFFILIATED/
NON-
AFFILIATED
INDIVIDUAL
WITH SOCIAL/
BEHAVIOURAL
SCIENCE/
PHILOSOPHY/
RELIGIOUS
QUALIFICATION
ASSESS IMPACT
OF RESEARCH
PROPOSAL ON
COMMUNITY
INVOLVEMENT.
Lay person(s) Non-affiliated Literate person and
representative of the
community from
which the
participants are to be
drawn
Evaluate benefits and
risks from the
participant’s
perspective.

27. TYPE OF DECISION BY ETHICAL COMMITTEE
Approved with or
without
suggestions or
comments
Revision with
minor
modifications/
amendments
Revision with
major
modifications for
resubmission
Not approved