Nursing Research
Topic: Ethics in Research
Declaration of Helsinki (1964)
 is a statement about ethical principles, initially
applied to medical research, but which now
guides all types of research
Three Core Principles
 Respect of People
 Beneficence
 Justice
Ethical Principles for Protecting Study
Participants
1. Beneficence
- One of the most fundamental ethical
principles in research is that of beneficence,
which imposes a duty on researchers to
minimize harm and to maximize benefits.
- Human research should be intended to
produce benefits for participants themselves
or—a situation that is more common—for
other individuals or society as a whole.
- This principle covers multiple dimensions.
a. The Right to Freedom from Harm and
Discomfort (Nonmalificence)
 Researchers have an obligation to
avoid, prevent, or minimize harm
(nonmaleficence) in studies with
humans.
 Participants must not be subjected to
unnecessary risks of harm or
discomfort, and their participation in
research must be essential to
achieving scientifically and
societally important aims that could
not otherwise be realized.
 In research with humans, harm and
discomfort can take many forms;
 they can be physical (e.g.,
injury),
 emotional (e.g., stress),
 social (e.g., loss of social
support), or
 financial (e.g., loss of
wages).
 Ethical researchers must use
strategies to minimize all types of
harm and discomfort, even ones that
are temporary
b. The Right to Protection from Exploitation
 Participants need to be assured that
their participation, or information
they might provide, will not be used
against them in any way.
 Study participants enter into a
special relationship with researchers,
and it is crucial that this relationship
not be exploited.
 In qualitative research, the risk of
exploitation may become especially
acute because the psychological
distance between investigators and
participants typically declines as the
study progresses.
2. Respect for Human Dignity
- Respect for human dignity is the second
ethical principle articulated in the Belmont
Report.
- This principle includes the right to self-
determination and the right to full disclosure
a. The Right to Self-Determination
 Researchers should treat
participants as autonomous
agents, 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 penalty or
prejudicial treatment.
 It also means that people have
the right to ask questions, to
refuse to give information, and
to withdraw from the study.
 A person’s right to self-
determination includes freedom
from coercion of any type.
b. 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
and benefits.
 Full disclosure can sometimes
create two types of bias:
Nursing Research
Topic: Ethics in Research
 biases affecting the
accuracy of the data and
 biases reflecting sample
recruitment problems
 One technique that researchers
sometimes use in such situations is
covert data collection or
concealment
 A more controversial technique is
the use of deception
 Full disclosure has emerged as a
concern in connection with data
collection over the Internet
3. Justice
- The third broad principle articulated in the
Belmont Report concerns justice, which
includes participants’ right to fair treatment
and their right to privacy
a. The Right to Fair Treatment
 One aspect of the justice
principle concerns the equitable
distribution of benefits and
burdens of research. The
selection of study participants
should be based on research
requirements and not on the
vulnerability or compromised
position of certain people.
 Distributive justice also imposes
duties to neither neglect nor
discriminate against individuals
and groups who may benefit
from advances in research.
 The right to fair treatment
encompasses other obligations.
It means that researchers must
treat people who decline to
participate in a study or who
withdraw from it in a no
prejudicial manner
b. Right to Privacy
 Participants have the right to
expect that any data they
provide will be kept in strictest
confidence.
 REPUBLIC ACT NO. 10173
”AN ACT PROTECTING
INDIVIDUAL PERSONAL
INFORMATION IN
INFORMATION AND
COMMUNICATIONS
SYSTEMS IN THE
GOVERNMENT AND THE
PRIVATE SECTOR,
CREATING FOR THIS
PURPOSE A NATIONAL
PRIVACY COMMISSION,
AND FOR OTHER
PURPOSES”
Procedures for Protecting Study Participants
1. Risk-Benefit Assessments
- One strategy that researchers use to protect
participants is to conduct a risk– benefit
assessment. Such an assessment is designed
to determine whether the benefits of
participating in a study are in line with the
costs, be they financial, physical, emotional,
or social (i.e., whether the risk-to-benefit
ratio is acceptable).
- The general guideline is that the degree of
risk to be taken by participants should never
exceed the potential humanitarian benefits
of the knowledge to be gained.
- All research involves some risks, but in
many cases, the risk is minimal. Minimal
risk is defined as a risk expected to be no
greater than those ordinarily encountered in
daily life or during routine physical or
psychological tests or procedures. When the
risks are not minimal, researchers must
proceed with caution, taking every step
possible to reduce risks and maximize
benefits
2. Informed Consent
- One particularly important procedure for
safeguarding participants and protecting
their right to self-determination involves
obtaining their informed consent.
 Informed consent means that
participants have adequate
information regarding the research,
comprehend the information, and
have the power of free choice,
enabling them to consent to or
decline participation voluntarily
- Researchers rarely obtain written informed
consent when the primary means of data
collection is through self-administered
Nursing Research
Topic: Ethics in Research
questionnaires. Researchers generally
assume implied consent (i.e., that the return
of the completed questionnaire reflects the
respondent’s voluntary consent to
participate).
- In a qualitative study, consent may be
viewed as an ongoing, transactional process,
referred to as process consent. In process
consent, researchers continuously
renegotiate the consent, allowing
participants to play a collaborative role in
the decision-making process regarding their
ongoing participation
3. Confidentiality Procedures
- Study participants have the right to expect
that any data they provide will be kept in the
strictest confidence.
- Participants’ right to privacy is protected
through various confidentiality procedures
4. Anonymity
- Anonymity, the most secure means of
protecting confidentiality, occurs when even
the researcher cannot link participants to
their data
5. Confidentiality in the Absence of Anonymity
- 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.
- Researchers generally develop elaborate
confidentiality procedures. These include:
 securing confidentiality assurances
from everyone involved in
collecting or analyzing research
data;
 maintaining identifying information
in locked files to which few people
have access;
 substituting identification (ID)
numbers for participants’ names on
study records and computer files to
prevent any accidental breach of
confidentiality; and
 reporting only aggregate data for
groups of participants or taking
steps to disguise a person’s identity
in a research report
- Anonymity is rarely possible in qualitative
studies because qualitative researchers
become thoroughly involved with
participants.
- Confidentiality is especially salient in
qualitative studies because, due to their in-
depth nature, there may be a greater invasion
of privacy than in quantitative research.
- It should be noted that there are situations in
which confidentiality can create tensions
between researchers and legal authorities,
especially if study participants are involved
in criminal activity (e.g., substance abuse)
6. Debriefings and Referrals
- Researchers can show their respect for study
participants—and proactively minimize
emotional risks—by carefully attending to
the nature of the interactions they have with
them.
- Debriefing is especially important when the
data collection has been stressful or when
ethical guidelines had to be “bent” (e.g., if
any deception was used)
- Researchers can also demonstrate their
interest in participants by offering to share
study findings with them once the data have
been analyzed (e.g., by mailing them a
summary).
7. Treatment of Vulnerable Groups
- Vulnerable subjects may be incapable of
giving fully informed consent (e.g., mentally
retarded people) or may be at high risk of
unintended side effects because of their
circumstances (e.g., pregnant women
Other Ethical Issues
1. Ethical Issues in Using Animals in Research
- Some nurse researchers who focus on
biophysiologic phenomena use animals
rather than human beings as their subjects.
- Ethical considerations are clearly different
for animals and humans.
Nursing Research
Topic: Ethics in Research

- Holtzclaw and Hanneman (2002), in

discussing the use of animals in nursing
research, noted several important
considerations
2. Research Misconduct
- Research misconduct, as defined by a U. S.
Public Health Service regulation that was
revised in 2005 (42 CFR Part 93, Subpart
A), is fabrication, falsification, or plagiarism
in proposing, conducting, or reviewing
research, or in reporting results. Research
misconduct does not include honest errors.
- Research misconduct covers many other
issues including improprieties of authorship,
poor data management, conflicts of interest,
inappropriate financial arrangements, failure
to comply with governmental regulations,
and unauthorized use of confidential
information
- Research dishonesty and fraud are major
concerns in nursing
3. Critiquing the Ethical Aspects of a Study