Lect 6.7.8. Code of Ethics in Research

ETHICS & ETHICAL
ISSUES IN
RESEARCH
Presented by
Ms. Gulshan Umbreen
Sr. Lecturer, GNC
By: Ms. Gulshan Umbreen

Learning Objectives
• Define ethics and nursing ethics
• Explain Historical Events and Development
of Code of Ethics
• Describe Nuremberg code
• Explain 10 elements of the Nuremberg code
• Delineate Declaration of Helsinki (1964)
• Describe the importance of ethics in
nursing research
• Elaborate Ethical Principles by Belmont
report
• Elaborate Ethical Principles by ANA
guidelines
• Describe the Issues related to principle of respect
• Explain risk benefit ratio in ethics
• Elaborate informed consent
• Explain elements/contents of informed consent
• Explain how to format a consent format
• Define therapeutic misconception
• Define the research misconduct
• Describe the code of ethics for different discipline
• Define External Reviews and Protection of Human
Rights
• Describe roles of IRB

• Explain three levels of review
• Define duration of time for review
• Delineate the critiquing quantitative research
by ethical point of view
• Describe Ethical concerns in qualitative research
• Describe Ethical concerns in quantitative research
• Describe Ethical concerns in mixed research

ETHICS
• The branch of philosophy that deals with morality.

Ethics is concerned with distinguishing between
good and evil in the world, between right and
wrong human actions, and between virtuous and
non virtuous characteristics of people-The
American Dictionary of Cultural Literacy (2005)

• Nursing ethics is defined as the principles of
proper professional conduct concerning the
rights and duties of nurses themselves, their
patients, and their fellow practitioners, as well
as their actions in the care of patients and in
relations with their families- U S National
Library of Medicine (2014)

HISTORICAL EVENTS
AND DEVELOPMENT OF CODE
OFETHICS

NAZI MEDICALEXPERIMENTS
(1933-1945)

• Nazi human experimentation was a series
of medical experiments on large numbers of
prisoners, including children, by Nazi
Germany in its concentration camps in the early
to mid 1940s, during World War II

• Medical experiments involved freezing temperature,
poisons, untested drugs and surgery without
anaesthesia
• Selection of subjects was racially based
• The studies were unethical not only because

they exposed these people to permanent
physical harm and even death but because
subjects could not refuse participation.

TUSKEGEE SYPHILIS
STUDY(1932)

• U S Public Health Service initiated the study
in town of Tuskegee,Alabama
• Research subjects were divided into two groups
• One group of 400 men who had untreated syphilis
• Control group of 200 men without syphilis
• The subjects were recruited with misleading
promises of “special free treatment,” which were
actually spinal taps done without anesthesia to
study the neurological effects of syphilis, and they
were enrolled without their informed consent.

WILLOWBROOK STUDY (1950-
1970)

• Research on hepatitis by Dr. Krugman at
Willowbrook among mentally retarded children
• Early subjects were fed extracts of stool from
infected individuals
• Later subjects received injections of
purified virus
• Parents were forced to give permission for the
child to be a subject

JEWISH CHRONIC DISEASE HOSPITAL
STUDY(1960)

• Study conducted to determine patients’
rejection responses to live cancer cells
• Twenty two patients were injected with a
suspension containing live cancer cells
• Physician from Sloan-Kettering Institute for cancer
research directed the study
• Study conducted without the informed
consent

NUREMBERG CODE-
1949

Mistreatment of human subjects in Nazi
experiments led to the development of Nuremberg
Code (1949)
The Nuremberg Code is a set of research ethics
principles for human experimentation created as a
result of the Nuremberg trials at the end of the
Second World War
Nuremberg Code contains guidelines for a set of
ten ethical principles for human experimentation.

The 10 elements of the Nuremberg code
1. Voluntary consent is essential

2. The results of any experiment must be for the
greater good of society
3. Human experiments should be based on
previous animal experimentation
4. Experiments should be conducted by avoiding
physical/mental suffering and injury
5. No experiments should be conducted if it is
believed to cause death/disability

6. The risks should never exceed the benefits
7.Adequate facilities should be used to protect
subjects
8.Experiments should be conducted only by
qualified scientists
9.Subjects should be able to end their
participation at any time
10.The scientist in charge must be prepared to
terminate the experiment when injury, disability,
or death is likely to occur

DECLARATION OF
HELSINKI (1964)
• Greater care can be exercised
to protect subjects from harm
• Strong, independent
justification for exposing a
healthy volunteer to
substantial risk of harm
• Investigators must protect life

and health of research
subjects

IMPORTANCE OF ETHICS IN
RESEARCH
• Protects the vulnerable group and other study
participants
• Participants are safeguarded from exploitation
• Establishes risk-benefit ratio for study subjects
• Ensures fullest respect, dignity, privacy,
disclosure and fair treatment for subject
• Builds capability of subjects to accept or reject
participation in study

ETHICALPRINCIPLES
The Belmont report articulates three primary
ethical principles
 Beneficence (Ethical Principle 2 of the ANA
guidelines addresses beneficence).
 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)

• 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).

BENEFICENCE
• Imposes duty on researchers to minimise
harm and to maximise benefits
 The right to protect from harm and discomfort
 Freedom from exploitation
 Benefits from research

RISK BENEFIT RATIO
MAJOR MAJOR POTENTIAL
POTENTIAL RISKS TO
BENEFITS TO PARTICIPANTS
PARTICIPANTS
• Access to an intervention that • Physical harm

otherwise be unavailable to • Boredom ,fatigue,physical
them discomfort
• Comfort to discuss situation • Psychological or emotional
with a friendly person discomfort
• Increased knowledge of • Social risks
themselves • Loss of privacy
• Satisfaction in helping others • Loss of time

THE PRINCIPLE OF RESPECT OR
HUMAN DIGNITY
• The right to self determination-
, The right to self-determination means that
prospective participants have the right to decide
voluntarily whether to participate in a study,
without risking penalty. It also means that people
have that right to ask question, to refuse to give
information, and to withdraw from the study.

• The right to full disclosure-
• Researcher should fully describe the nature of
study, subject’s right to refuse participation,
researcher’s responsibility and risks and benefits

ISSUES RELATED TO PRINCIPLE OF
RESPECT
• Inability of individuals to make well
informed judgements
• Bias:
• Concealment: Collection of information
without participant knowledge
Also called covert data collection
• Deception: entails that participants are not fully
informed of the purpose of the study

THE PRINCIPLE OF
JUSTICE
• The right to fair

treatment
• The right to privacy

e.g Anonymity

The 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:
• The fair and nondiscriminatory selection of
participants such that any risks and benefits will be
equitably shared; participants should be selected
based on research requirements and not on the
vulnerability or compromised position of certain
people

• Respect for cultural and other forms of
human diversity
• The nonprejudicial treatment of those who
decline to participate or who withdraw from
the study after agreeing to participate
• The honoring of all agreements between
researchers and participants, including
adherence to the procedures described to
them and payment of any promised stipends

• Participants’ access to research personnel at
any point in the study to clarify information
• Participants’ access to appropriate professional
assistance if there is any physical or
psychological damage
• Courteous and tactful treatment at all times

The Right to Privacy
• Researchers should ensure that their research is

not more intrusive than it needs to be and that
participants’ privacy is maintained throughout
the study.
• 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

• Anonymity occurs when even the researcher
cannot link participants to their data. For
example, if questionnaires were distributed to
a group of nursing home residents and were
returned without any identifying information
on them, responses would be anonymous.

• When anonymity is impossible, appropriate
confidentiality procedures need to be implemented.
• 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.
• This means that research information should not be
shared with strangers nor with people known to the
participants (e.g., family members, physicians, other
nurses), unless the researcher has been given
explicit permission to share it.

• Researchers can take a number of steps to
ensure that breaches of confidentiality do not
occur, including the following:
• Obtain identifying information (e.g., name,
address) from participants only when
essential.
• Assign an identification (ID) number to each
participant and attach the ID number rather
than other identifiers to the actual data

• Maintain identifying information in a locked
file.
• Restrict access to identifying information to a
small number of people on a need-to-know
basis.
• Enter no identifying information onto
computer files.
• Destroy identifying information as quickly as
practical
• Make research personnel sign confidentiality
pledges if they have access to data or
identifying information.
• Report research information in the aggregate;
if information for a specific participant is
reported, take steps to disguise the person’s
identity, such as through the use of a fictitious
name.

INFORMED
CONSENT

INFORMED CONSENT
• Informed consent is process of ensuring that

subjects understand the research and
voluntarily decide to participate. As part of
this process, participants learn about study
procedures, risks, benefits, and their rights.
• Individuals sign an informed consent
document to authorize their agreement to
participate in a study.

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
By:8/13/2020
Ms. Gulshan Umbreen
31
Elements of Informed Consent
• Informed consent includes four elements:

(1) Disclosure of essential study information to
the study participant
(2) Comprehension of this information by
the participant
(3) Competence of the participant to give
consent; and
(4) Voluntary consent of the participant to take part
in the study.

Element 1. Essential study information
• Information that the study involves Research
• Risks or discomforts
• Benefits
• Alternatives
• Confidentiality
• Compensation/treatment offered
• Contact information for research subject rights
• Statement that participation is voluntary
• Option to withdraw.
1: Information that the study involves research
• Explain the purpose of the research, expected
duration of the subject’s participation and
identify any procedures that are
experimental or done solely for research
purposes.

2: Risks or discomforts
• Include a clear description of the
risks/discomforts
• Review any risks related to procedures and
tests relating solely to the research
• Inform subjects about previously reported
adverse event

3: Benefits
• Explain any benefits to the subjects or others
4: Alternative Procedures
• Describe any alternative treatments that may
be beneficial to the subject so that they can
consider the full range of options.
• When appropriate, include a statement that
supportive care with no additional treatment is
an alternative

5: Confidentiality
• Explain how the researchers will maintain
confidentiality of study records and include any
agencies, institutions, or individuals who will have
access to the records
6: Compensation and Available Treatment
• Describe any compensation that will be offered
• State whether any medical treatment will be offered
in case of research related injury and describe the
conditions and extent of the payment/treatment.
Include contact information for questions.

7: Subject Rights
• Include contact information (name and phone
number) for questions relating to subject rights and
research related injury.
8: Participation is Voluntary
• State that participation is voluntary, that refusal to
participate will not incur a penalty or loss of
benefits and that the subject may discontinue at
any time.
9. Option to withdraw. Subjects are informed that
they may discontinue participation (withdraw from a
study) at any time, without penalty or loss of benefits
Element 2. Comprehension
• Informed consent implies not only that the
researcher has imparted information to the subjects,
but also that the prospective subjects have
comprehended that information.
• The researcher must take the time to teach the
subjects about the study.
• The amount of information to be taught depends on
the subjects’ knowledge of research and the specific
research topic.

• Researchers need to discuss the benefits and
risks of a study in detail, with examples that the
potential subjects or participants can understand

Element 3. Competence to Give
Consent
• Autonomous persons, who are capable of
understanding the benefits and risks of a proposed
study, are competent to give consent.
• Persons with diminished autonomy because of legal
or mental incompetence or confinement to an
institution frequently are not legally competent to
consent to participate in research

VULNERABLE SUBJECTS
Children
Legally and ethically, children do not have the
competence to give informed consent. Usually,
the informed consent of children’s parents or
legal guardians should be obtained.

Mentally or emotionally disabled people.
• Individuals whose disability makes it
impossible for them to weigh the risks and
benefits of participation and make an informed
decision (e.g., people affected by mental
retardation, senility, mental illness, or
unconsciousness) also cannot legally or
ethically provide informed consent.
• In such cases, researchers should obtain the
written consent of a legal guardian.

Severely ill or physically disabled people
• For patients who are very ill or undergoing
certain treatments, it might be necessary to
assess their ability to make reasoned decisions
about study participation.

• Certain disabilities, special procedures for
obtaining consent may be required.
• For example, with deaf participants, the entire
consent process may need to be in writing.
• For people who have a physical impairment
preventing them from writing or for
participants who cannot read and write,
alternative procedures for documenting
informed consent (such as audiotaping or
videotaping consent proceedings) should be
used

• Pregnant women.
The U.S. government has issued stringent
additional requirements governing research with
pregnant women and fetuses.
These requirements reflect a desire to safeguard
both the pregnant woman, who may be at
heightened physical and psychological risk, and
the fetus, who cannot give informed consent.

• The regulations stipulate that a pregnant
woman cannot be involved in a study unless
the purpose of the research is to meet the
health needs of the pregnant woman and risks
to her and the fetus are minimized or there is
only a minimal risk to the fetus.

Element 4. Voluntary consent
• Researchers obtain voluntary consent after the
prospective subject receives the essential
information about the study and has
demonstrated comprehension of this
information

Informed Consent

THERAPEUTIC
MISCONCEPTION
• Research subject misinterpret and enrol in the

study thinking it to be routine medical care
• Misinterpret the information and believes that

research directly benefits him

CODE OF ETHICS FOR
DIFFERENT DISCIPLINES

• Important Code of ethics adopted by National
Commission for the Protection of Human
Subjects of Biomedical and Behavioural
1978 Research (U. S)
• Guidelines for psychologists published by the

American Psychological Association in Ethical
principles of Psychologists and Code of Conduct
1992
• The American Nurses’Association put forth a

document entitled Ethical guidelines in the
Conduct, Dissemination and Implementation of
1995 Nursing Research

External Reviews and Protection of
Human Rights
• An institutional review board (IRB), also known

as an independent ethics committee (IEC),
ethical review board (ERB), or research ethics
board (REB), is a type of committee that
applies research ethics by reviewing
the methods proposed for research to ensure that
they are ethical.

• Such boards are formally designated to approve
(or reject), monitor, and review biomedical
and behavioral research involving humans. They
often conduct some form of risk-benefit
analysis in an attempt to determine whether or
not research should be conducted.

Common Role of the IRB
• Review of research.
• Informed consent.
• Do the benefits outweigh the risks?
• What constitutes an adequate informed consent?

EXAMINING THE BENEFIT-RISK
RATIO OF A STUDY
• Nurses who serve on an IRB for their agency,

serve as patient advocates when research is
conducted in their agency, or are asked to
collect data for a study should examine the
balance of benefits and risks in studies.
• To determine this balance, or benefit-risk ratio,
the benefits and risks associated with the
sampling method, consent process, procedures,
and potential outcomes of the study are
assessed

LEVELS OF REVIEW
• The functions and operations of an IRB involve

the review of research at three different levels:
• (1) exempt from review,
• (2) expedited review, and
• (3) complete review.

Exempt from Review
• Studies usually are exempt from review if they

pose no apparent risks for the research subjects.
A common type of exempt study is when de-
identified data from patient charts are analyzed.

Expedited Review
• Studies that carry some risks, which are viewed as

minimal, qualify for an expedited review.
Minimal risk means that “the probability and
magnitude of harm or discomfort anticipated in
the research are not greater in and of themselves
than those ordinarily encountered in daily life or
during the performance of routine physical or
psychological examinations or tests.
• Descriptive studies, in which subjects are asked to
respond to questionnaires, commonly need only
expedited review

Full Review
• Any proposed research not qualifying for
Exempt status or Expedited review requires a
Full Review, in which a majority of IRB
members review and vote on the proposal.
• These typically involve projects that place
human subjects at more than minimal risk, or
that involve sensitive topics or vulnerable
populations such as prisoners, terminally ill
patients, children, veterans, or cognitively
impaired persons.

Time Duration
• Review of Exempt or Expedited

protocols takes about two to three
weeks.
• The review process for protocols submitted

for Full Review can take up to a month or
longer to complete

RESEARCH
MISCONDUCT
GUIDELINES FOR
CRITIQUING ETHICAL
ASPECTS OF STUDY
• Was the study approved and
monitored by IRB?
• Were participants subjected to
any physical harm or
psychological distress?
• Did the benefits outweigh
potential risks?

• Were the participants
deceived in any way?
• Were appropriate
informed consent
procedures used?
• Were adequate steps
taken to safeguard
participant’s privacy?
• Were vulnerable
groups involved in
research?

ETHICAL CONCERNS IN QUALITATIVE
RESEARCH
• Distress
• Misinterpretation
• Identification
• Inconvenience

• ETHICAL CONCERNS
IN QUANTITATIVE
RESEARCH
Related to the stage of
research
• Formulating the research
questions
• Designing the study
• Collecting data
• Analysis
• Reporting

ETHICAL CONCERNS IN MIXED
METHOD RESEARCH
• Identify and describe issues
related to the protection of
human subjects
• Understand the ethical issues
associated with quantitative and
qualitative research
• Be prepared to educate IRB
reviewers about mixed method
research

CONCLUSION
• If research is based on
a robust design and in
a safe and ethical
manner, it can be of
benefit to all

Reference
• Polit, D. F., & Beck, C. T. (2017). Nursing
research: Generating and Assessing Evidence
for Nursing Practice (10th ed.). Philadelphia:
Lippincott Williams & Wilkins.


Lect 6.7.8. Code of Ethics in Research

Uploaded by

Document Information

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Lect 6.7.8. Code of Ethics in Research

Uploaded by

Copyright:

Available Formats

ETHICS & ETHICAL

By: Ms. Gulshan Umbreen

By: Ms. Gulshan Umbreen

By: Ms. Gulshan Umbreen

• The branch of philosophy that deals with morality.

By: Ms. Gulshan Umbreen

By: Ms. Gulshan Umbreen

By: Ms. Gulshan Umbreen

By: Ms. Gulshan Umbreen

By: Ms. Gulshan Umbreen

• Selection of subjects was racially based

• The studies were unethical not only because

By: Ms. Gulshan Umbreen

By: Ms. Gulshan Umbreen

By: Ms. Gulshan Umbreen

By: Ms. Gulshan Umbreen

By: Ms. Gulshan Umbreen

By: Ms. Gulshan Umbreen

By: Ms. Gulshan Umbreen

By: Ms. Gulshan Umbreen

By: Ms. Gulshan Umbreen

1. Voluntary consent is essential

By: Ms. Gulshan Umbreen

By: Ms. Gulshan Umbreen

• Investigators must protect life

By: Ms. Gulshan Umbreen

By: Ms. Gulshan Umbreen

By: Ms. Gulshan Umbreen

By: Ms. Gulshan Umbreen

By: Ms. Gulshan Umbreen

• Access to an intervention that • Physical harm

By: Ms. Gulshan Umbreen

By: Ms. Gulshan Umbreen

By: Ms. Gulshan Umbreen

By: Ms. Gulshan Umbreen

• The right to fair

• The right to privacy

By: Ms. Gulshan Umbreen

By: Ms. Gulshan Umbreen

By: Ms. Gulshan Umbreen

By: Ms. Gulshan Umbreen

• Researchers should ensure that their research is

By: Ms. Gulshan Umbreen

By: Ms. Gulshan Umbreen

By: Ms. Gulshan Umbreen

By: Ms. Gulshan Umbreen

By: Ms. Gulshan Umbreen

By: Ms. Gulshan Umbreen

• Informed consent is process of ensuring that

By: Ms. Gulshan Umbreen

• The right to self-determination and the right to

• Informed consent includes four elements:

By: Ms. Gulshan Umbreen

By: Ms. Gulshan Umbreen

By: Ms. Gulshan Umbreen

By: Ms. Gulshan Umbreen

By: Ms. Gulshan Umbreen

By: Ms. Gulshan Umbreen

By: Ms. Gulshan Umbreen

By: Ms. Gulshan Umbreen

By: Ms. Gulshan Umbreen

By: Ms. Gulshan Umbreen

By: Ms. Gulshan Umbreen

By: Ms. Gulshan Umbreen