What you understand by this???
Ethics in Nursing Research
Nasreen Ghani
Prof INS SUIT
Objectives
• Define Ethic
• Evaluate the ethical dimensions of a research
report.
• Describe the ethical principles that direct the
conduct of research with human subjects
• Describe the role of the institutional review
board in the review of research proposals
What is Ethics
• The word is derived form the Greek word “ethos”
meaning; “the set of moral principles”
principles
• Ethics are ways of understanding and examining the
moral life, or of right and wrong human conduct.
• Bioethics is a way of understanding and examining
the moral aspects of biomedical research and
practice
What do we mean by ethics
• Morality or ethics represents a code of conduct that
governs how people treat each other.
•
• In essence, it is concerned with the way people act
or behave.
• The term ‘ethics’ usually refers to the moral
principles, guiding conduct, which are held by a
group or even a profession” (Wellington, 2000: 54)
Ethics
• Ethics, also known as moral philosophy,
philosophy is a branch
of philosophy that involves systematizing,
defending, and recommending concepts of right and
wrong behavior.
• Research Ethics Involves the application of
fundamental ethical principles to planning,
conducting & publishing of research
Why Worry About Research Ethics
•The science itself
• Other scientists
• The research participant
• The public
• The future
• Ourselves
Ethics
• Ethics covers the following dilemmas:
• How to live a good life
• Our rights and responsibilities
• The language of right and wrong
• Moral decisions - what is good and bad?
What is Research Ethics
• Ethics are the set of rules that govern our
expectations of our own and others’ behavior
• Research ethics are the set of ethical guidelines that
guides us on how scientific research should be
conducted and disseminated.
• Research ethics govern the standards of conduct for
scientific researchers
• It is the guideline for responsibly conducting the
research.
Objectives of Research
Ethics
• The first and comprehensive objective to guard/protect
human participants, their dignity, rights and welfare
• To make sure that research is directed in a manner that
assists welfares of persons, groups and/or civilization as
a whole.
• To inspect particular research events and schemes for
their ethical reliability, considering issues such as the
controlling risk, protection of privacy and the
progression of informed consent
Historical Background
• During The Islamic Era
• Islamic Rules included all the basic ethical principles known
in modern history which include:
• Respect for persons Non-maleficence Beneficence Justice
• History of Research Ethics Codes, guidelines & regulations
developed to guide research involving human participants.
Guidelines were created in response to:
• An ethical lapses in research.
• Provide answers to new problems and challenges in
research.
Historical Background
• Nazi Medical experience
• Tuskegee Syphilis study
• Willow brook Study
• Nuremberg Code (1949)
• Declaration of Helsinki(19640
• National Commission For the protection of
Human and medical Research(1978)
Historical events Influencing the
development of Ethical codes and
regulation
• Nazi Medical experience.
experience
• Goal of this type of experiments was to determine how long
German pilots would survive after parachuting into the cold sea.
A prisoner is submerged in a tank filled with cold water.
• High Altitude Experiments •
• High altitude experiments were performed to test how long pilots
would survive after being ejected from their planes. Prisoners
were put into low-pressure tanks with little oxygen.
• Many of those who did not die immediately were put under water
until they died.
Tuskegee Syphilis study
• Tuskegee, Alabama
• High prevalence of syphilis
• Although treatment existed, blacks in the rural
southern town were not receiving treatment
• Lack of funds/Lack of doctors
• Study natural course of syphilis
• Enrolled 400 black males infected with syphilis
• Not an experiment but rather a “study in nature”
Tuskegee Syphilis study
• Tuskegee Syphilis Study (1932 - 1972) Ethical
Issues
• Inadequate disclosure of information
• Subjects believed they were getting free treatment
Told that spinal taps was therapy
• US Gov’t actively prevented men from receiving
penicillin
• 1972 press reports caused the U.S. Gov’t to stop the
study
Willow brook Study
• Research done at a state school of mentally
handicapped children
• Deliberate infection with live Hepatitis virus
• Institution could only take in those accepting to
participate in the study
• Poor public had no other institutional choice
• Parents were not completely told what study
involved
Nuremberg Code
•.How Could This Happen? German physicians had
sworn to “DO NO HARM”
• First Codification of Research Guidelines Human
Rights and Welfare of Subjects.
• The first and longest principle Subjects have the
right to withdraw at any time “The voluntary
consent of the human subject is absolutely
essential.”
Declaration of Helsinki
• Helsinki Developed by the World Medical Association in
Finland in 1964.
• Provide guidance for physicians and participants in medical
research.
• Many updates were introduced in 1975, 1983, 1989, 1996,
2000 and in 2008.
• The Declaration of Helsinki It indicates: The well-being of
the subject should take precedence over the interests of
science and society.
• Physician should obtain the subject’s freely given informed
consent in writing. Ethical review committee approval is a
must.
• Balancing Two Goals Without an Adequate Framework of Research
Ethics Advancement of Science Protection of Subject Welfare/Rights
General Ethical Principles
• All research involving human participants should be conducted
in accordance with four basic ethical principles:
• Respect for persons,
• Beneficence,
• Non-maleficence, and
• Justice.
• Honesty
• Integrity
• Objectivity
• Informed consent
General Ethical Principles: Respect for
Persons
• Respect for persons incorporates at least two other
fundamental ethical considerations:
1. Autonomy,
Autonomy which requires that those who are
capable of deliberation about their personal goals
should be treated with respect for their capacity for
self determination.
2. Protection of persons with impaired or
diminished autonomy, which requires that those who
are dependent or vulnerable be afforded security
against harm or abuse.
General Ethical Principles: Beneficence
• Beneficence is the ethical obligation to
maximize possible benefits and to minimize
possible harms and wrongs. OR
• Beneficence Maximize the benefits of the
participants. to maximize possible benefits
and to minimize possible harms to the
respondents.
General Ethical Principles: Non-Maleficence
• Non-maleficence (do no harm) holds a central
position in the tradition of medical ethics, and
guards against avoidable harm to research
participants.
General Ethical Principles: Justice
• Justice requires that cases considered to be alike
be treated alike, and that cases considered to be
different be treated in ways that acknowledge the
difference.
General Ethical Principles: Honesty
• Honest with the beneficiaries and respondents.
• Honest about the findings and methodology of the
research.
• Honest with other direct and indirect stakeholders .
General Ethical Principles: Integrity
• Integrity Ensuring honesty and sincerity.
• Fulfilling agreements and promises
.
• Do not create false expectations or make false
promises.
General Ethical Principles: Objectivity
• Objectivity Avoiding bias in experimental
design,
• Data analysis, data interpretation, peer
review, and
• Other aspects of research Informed consent
General Ethical Principles Informed consent
• Informed consent means that a person knowingly,
voluntarily and intelligently gives consent to
participate in a research
• Informed consent is related to the autonomous right
of the individual to participate in the research
•.
• Informing the participant about the research
objective, their role, benefits/harms (if any)
Advantages of Research Ethics
• Research ethics promote the aims of research
• It increases trust among the researcher and the
respondent.
• It is important to adhere to ethical principles in
order to protect the dignity, rights and welfare of
research participants.
• Researchers can be held accountable and
answerable for their actions.
• Ethics promote social and moral values.
.
Ethical vs. Unethical Research
• Ethical studies protect subjects and are carried out
using scientific principles.
• Unethical research includes:
• Scientific misconduct
• Fraud, research protocol violations
• Fabrication, falsification, forging of data
• Plagiarism
• Putting subjects at risk without consent
Limitations of Research Ethics
• .Possibilities to physical integrity, containing those linked
with experimental drugs and dealings and with other
involvements that will be used in the study (e.g. measures used
to observe research participants, such as blood sampling, X-rays or
lumbar punctures).
• Psychological risks: for example, a questionnaire may
perhaps signify a risk if it fears traumatic events or
happenings that are especially traumatic.
• Social, legal and economic risks: for example, if personal
information collected during a study is unintentionally
released, participants might face a threat of judgment and
stigmatization.
Elements of Ethical Research
• Protecting human rights
• Understanding informed consent
• Understanding institutional review of
research
• Balancing benefits and risks in a study
Ethical Codes and Regulations
• Nuremberg Code (1949)
• Declaration of Helsinki (1964)
• Department of Health, Education and
Welfare regulations (1973)
• National Commission for the Protection of
Human Subjects of Biomedical and
Behavioral Research (1978)
Nuremberg Code (1949)
1. The voluntary consent of the human subject is
absolutely essential...
1. The experiment should be such as to yield fruitful
results for the good of society, (Levine 1986, pp.
425-426)
Nuremberg Code (1949) (cont’d)
3. The experiment should be so designed and based
on the results of animal experimentation and a
knowledge of the natural history of the disease or
other problem under study that the anticipated
results will justify the performance of the
experiment.
(Levine 1986, pp. 425-426)
Nuremberg Code (1949) (cont’d)
4. The experiment should be conducted as to avoid
all unnecessary physical and mental suffering and
injury.
5. No experiment should be conducted where there
is an a priori reason to believe that death or
disabling injury will occur, except, perhaps, in
those experiments where the experimental
physicians also serve as subjects.
(Levine 1986, pp. 425-426)
Nuremberg Code (1949) (cont’d)
6. The degree of risk to be taken should never
exceed that determined by the humanitarian
importance of the problem to be solved by the
experiment.
7. Proper preparations should be made and adequate
facilities provided to protect the experimental
subject against even remote possibilities of
injury, disability, or death.
(Levine 1986, pp. 425-426)
Nuremberg Code (1949) (cont’d)
8. The experiment should be conducted only by
scientifically qualified persons.
9. During the course of the experiment the human
subject should be at liberty to bring the
experiment to withdraw.
(Levine 1986, pp. 425-426)
Nuremberg Code (1949) (cont’d)
10. During the course of the experiment the
scientist in charge must be prepared to
terminate the experiment at any stage,
• The continuation of the experiment is
likely to result in injury, disability, or
death to the experimental subject...
(Levine 1986, pp. 425-426)
Declaration of Helsinki
• Therapeutic research
• Results might benefit participants
• Nontherapeutic research
• Results are not of benefit to participants, but
might be in the future
National Commission for the Protection
of Human Subjects
• Ethical principles:
• Principle of respect for persons
• Principles of beneficence
• Principle of justice
Principle of Respect for Persons
• Self-determination (participation and withdrawing)
• No coercion
• Full disclosure, no deception
• Voluntary consent
• Persons with diminished autonomy have special
protections
Principle of Beneficence
• Freedom from harm
• Freedom from exploitation
• Risk/benefit ratios
• High anticipated benefit may balance high risks
Principle of Justice
• Fair treatment
(even if choose not to participate)
• Right to privacy
• Anonymity
• Confidentiality
Human Rights
• Right to self-determination
• Right to privacy
• Right to anonymity and confidentiality
• Right to fair treatment
• Right to protection from discomfort and harm
Self-Determination
• Humans are autonomous agents with freedom to
conduct their lives as they choose.
• This principle would be violated by:
• Coercion: forcing someone to be in study
• Covert data collection: subjects are unaware study is
taking place
• Deception: misinforming subjects about the study
People with Diminished Autonomy
• Are given extra protection of right to self-
determination because of decreased ability or
inability to give informed consent. These people
include:
• Legally and mentally incompetent subjects
• Neonates and children
• Terminally ill subjects
• People confined to an institution
• Pregnant women and fetuses
Right to Privacy
• The freedom that an individual has to
determine the time, extent, and general
circumstances under which private
information will be shared with or withheld
from others
Right to Anonymity and
Confidentiality
• Confidentiality: researcher refrains from
sharing information with others
• Breach of confidentiality: unauthorized access to
raw data
• Anonymity: no one, not even the researcher,
knows the identity of the subjects
Right to Fair Treatment
• Based on the principle of justice
• Selection of subjects and their treatment during the
study are fair for all
• Prevents coercion of subjects (i.e., paying subjects
large sums of money to participate)
Right to Protection from Discomfort
and Harm
• No anticipated effects
• Temporary discomfort
• Unusual levels of temporary discomfort
• Risk of permanent damage
• Certainty of permanent damage
Informed Consent
• Essential information for consent
• Comprehension of consent information
• Competence to give consent
• Voluntary consent
Essential Information for Consent
1. Introduction of research activities
2. Statement of research purpose
3. Selection of research subjects
4. Explanation of procedures
5. Description of risks and discomforts
6. Description of benefits
7. Disclosure of alternatives
8. Assurance of anonymity and confidentiality
Understanding scientific misconduct
Predict the outcome of the study
Assess risks
Assess benefits
Benefit risk ratio
Risks outweigh benefits
Benefit are great or equal to risk
Reject study
Approved study
Authorship
• There is no universally agreed definition of
authorship, although attempts have been made
•.
• As a minimum, authors should take responsibility
for a particular section of the study.
Who qualifies for authorship?
• Substantial contributions to:
• conception and design, &/or
analysis and interpretation of
the data
• drafting the article or revising it
critically for important intellectual content
• final approval of the version to
be published
Who does not qualify?
• Participation solely in acquisition of funds
• Just collection of data
• General supervision
• Performing statistical tests
• No ‘gift’ authorship
Role of IRB in research
• Institutional review boards (IRBs) or research ethics
committees provide
• A core protection for human research participants
through advance and periodic independent review of
the ethical acceptability of proposals for human
research.
Role of IRB in research
• IRBs are charged with providing an independent
evaluation.
• That proposed research is ethically acceptable,
checking clinical investigators' potential biases,
• And evaluating compliance with regulations and
laws designed to protect human subjects.
Role of IRB in research
• The IRB is concerned with protecting the welfare,
rights, and privacy of human subjects.
• The IRB has the authority to approve, exempt,
disapprove, monitor, and require modifications in all
research activities that fall within its jurisdiction as
specified by both the federal regulations and
institutional policy.
Reference
Burns, N. & Grove, S. K. (2007). Understanding nursing research. (4th
ed.). Philadelphia: W.B. Saunders.
Parahoo, K. (2014). Nursing research, principles, process and issues.
(3rd ed.). London, Palgrave, Macmillan.
