Transcript Ethical Consideration for Research

University College of Nursing
Ethical Consideration for Research
Prof (Mrs. Bhupinder Kaur)
Professor
University College of Nursing
Faridkot-151203, Punjab
University College of Nursing
Agenda for Discussion
After completing this, participants should be able to know
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What is Ethics, Need for Ethical
Guidelines
Ethical Dilemma’s in Conducting Research
Plagiarism
Designing Consent Form
Building Ethics into design of the Study
Consent Form
Guidelines
Nursing Research
and Ethics
Building Ethics
Ethical Committee
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What is Ethics?
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Ethics are-- Study of right and wrong
 From Ethos, meaning cultural customs or
habit
 System of moral principles and values
 Principles of conduct that help govern
human behaviors, determine which acts
are right and which are wrong, and are
used by society for evaluating the
behavior of individuals and groups.
 Means of regulating and setting limits on
behavior.
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Ethics at all levels of life
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Normative ethics---practical guidelines or norms
Personal ethics---cultivating a virtuous character
and develop proper self-esteem
Interpersonal ethics---moral obligations toward
others and ourselves
Environment ethics—moral obligation toward the
environment
Classroom ethics---how to behave in the
classroom
Professional ethics---moral guide of profession
Clinical ethics---day-to-day moral decision making
or those caring for clients
Theoretical ethics---or theoretical morality—
argues everyone already knows what is right and
wrong
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Ethics- Definitions
Ethics is
“the study of standards of right
and wrong; that part of science
and philosophy dealing with moral
conduct, duty and judgment”
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Need of Ethical Guidelines
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For the Protection of Rights of
Human under study
Ethical Conduct need to be
Mandatory in all discipline of
research
Always Ethical Consideration have
not been given adequate importance
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Historical Background
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Nazi Germany
Experimentation
Historical Background
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Charges brought against 23 German
physicians in the Nuremberg War Crime
Trials for their medical experiments –
included:
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Freezing Experiments
Malaria Experiments
High-Altitude Experiments
Led to the development of
Code
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Nuremberg
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Historical Background
Jewish Chronic Disease
Studies were conducted at the Jewish Chronic
Disease Hospital in New York City to
develop information on the nature of the
human transplant rejection process.
Chronically ill patients who did not have
cancer were injected with live human
cancer cells.
The physicians did not inform the patients as
to what they were doing. The physicians’
rationalization for their actions was as
follows:
(i) they did not want to scare the patients
and
(ii) (ii) they thought the cells would be
rejected
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Historical Standards of Ethics
CIHR (2001)
Historical Background
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Nuremberg Code (1947): principles to satisfy moral,
ethical, and legal concepts in human experimentation, with
voluntary consent being absolutely essential.
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Universal Declaration of Human Rights (1948): is
a recognition of and pledge to basic human rights for the
international community; human rights are protected by law
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Declaration of Geneva (1948): is a physician’s oath to
devote life to the service of humanity
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Declarations of Helsinki (1964, 1975, 2000):
Ethical Principles for Medical Research Involving Human
Subjects(research procedures, risk assessment duties, issues
of informed consent)
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Historical Background
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Historical Background
Belmont Report
National Commission for the Protection of Human Subjects
of Biomedical and Behavioral Research published
report (1978) under National Research Act affecting
government research.
Three principles became pillar of ethics standards:
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Beneficence,
• Respect persons’ decisions and protect from
harm
• maximize possible benefits and minimize
possible harms
Respect for human dignity, and
• Autonomy of individuals
• Persons with diminished autonomy are entitled
to protection
Justice.
• Benefits and risks of research must be distributed
fairly
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Code of Ethics
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Professional Ethics
Medical Ethics
Nursing Ethics
International Council of Nurses Code
Others Ethical responsibilities toward
state licensing laws
Statuary Laws
Common Law
Professional Code of Ethics
Law of Privacy
Protection Act about Fundamental right
of every Citizen
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Nurses’ Codes for
Practice & Research
American Nurses Association (1995) – Ethical Guidelines in the
Conduct, Dissemination, & Implementation of Nursing Research
. Nurse researcher must
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respect autonomous research participants’ capacity to consent to
participate… without negative consequences
- prevent or minimize harm, & promote good to all participants
- respect personhood or diversity of participants
- ensure burdens and benefits of research are equitably distributed
amongst participants
- protect privacy of participants to maximum degree
- ensure ethical integrity of research process
- report suspected, alleged or known scientific misconduct
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Canadian Nurses’ Codes
for Practice and Research
CNA – www.cna-
nurses.ca/CNA/practice/ethics/guidelines
Nursing Values & Research, Safe, competent &
ethical research & practice
health & well-being
choice
dignity
confidentiality
justice
accountability
and quality research environments.
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Indian Nurses’ Codes for
Practice and Research
Code of ethics
 Uniqueness of individual
 Rights of individuals
 Rights to privacy
 Quality nursing care
 Practice with in boundaries
 Work harmoniously with health
team.
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Risk/Benefit Ratio
Predict the Outcome of the study
Assess the risks
Assess the benefits
Benefit- Risk Ratio
Benefits are greater than the
risks
Approve the Study
Risks outweigh the benefits
Reject the Study
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Potential Risks/Benefits
RISKS:
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Physical harm; side effects
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Physical discomfort, fatigue,
etc
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Psychological or emotional
distress
 Social risks – stigma, loss of
status, effect on personal
relationships, etc.
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Loss of privacy
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Loss of time
 Monetary costs (e.g. child
care, transportation, time lost
from work or family, etc).
BENEFITS:
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Access to intervention(s)
otherwise unavailable
Comfort in discussing issues
with objective person
interested in area of concern
Increased knowledge about
themselves & their condition
Escape from normal routine –
exciting to be part of groundbreaking initiative
Satisfaction that information
from study may help others
Direct monetary or material
gains through stipends,
incentives, or products
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Why Nurse Researcher Need to be
Particularly Vigilant about Ethics
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Dealing with vulnerable populations
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Very young, Very Old and Mentally ill
Safety from physical & Psychological Harm
Trust and Nurse-Patient Relationship
Risk of Monocultural Approach and issues are
bi-cultural and multicultural
Recognized code of ethical Practice and it
should be Clear to Public
Ethics and Quality are inextricably linked
Social Scientists have paid for more attention
to Ethical aspects in compare to Health
Professionals
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Ethical Dilemmas in
Conducting Research
Ethical Dilemmas in Conducting Research
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How Emphatic are Nurses in
Their Treatment of Patients in
the Coronary Care Unit?
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Ethical Dilemma
Participant be aware of their role
If researcher inform nurses
participating in this study that their
degree of empathy in treating CCU
patient will be under screening
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Will there behavior be “Normal”?
Here lies the dilemmas that usual behavior
of nurse is altered because of the known
presence of research observer.
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Ethical Dilemmas in Conducting Research
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Does a new medication prolong life
in patient?
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Ethical Dilemma
http://mentalhealthcartoons.com/cartoons/MHH_cartoon-a-thon_31_500.jpg
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Ethical Principles in
Research
Freedom from Harm
 Freedom from Exploitation
 Benefit from Research
 The Risk/Benefit ratio
 Respect for human dignity
 Right to self determination
 Right to full disclosure
 Justice
 Anonymity and confidentiality
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Need to maintain Confidentiality at
all Cost by the following
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Obtain identification (ID) information
Assign an ID Number
Maintain ID information in a locked file
Restricted Access
Do not enter ID information into
computer files
Destroy ID information as quickly as
possible
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Plagiarism
•Plagiarism
is the "wrongful appropriation" and
"stealing and publication" of another author's
"language, thoughts, ideas, or expressions" and
the representation of them as one's own original
work.
It is derived from Latin
word plagiarius (literally kidnapper) to
denote stealing someone else‘s work.
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Plagiarism contd….
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The modern concept of plagiarism is immoral.
Plagiarism is considered academic dishonesty and a
breach of journalistic ethics.
It is subject to sanctions like penalties, suspension,
and even expulsion.
Plagiarism is not a crime but in academia and
industry, it is a serious ethical offense, and cases of
plagiarism can constitute copyright infringement.
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Plagiarism contd….
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Plagiarism is also considered a moral
offense against anyone who has provided
the plagiarist with a benefit in exchange
for what is specifically supposed to be
original content (for example, the
plagiarist's publisher, employer, or
teacher).
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Plagiarism in academics
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Common forms of student plagiarism
•Submitting someone’s work as their own.
•Taking passages from their own previous work without adding
citations.
•Re-writing someone’s work without properly citing sources.
•Using quotations, but not citing the source.
•Interweaving various sources together in the work without citing.
•Citing some, but not all passages that should be cited.
•Melding together cited and uncited sections of the piece.
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Self-plagiarism
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Self-plagiarism (also known as "recycling fraud" is the
reuse of significant, identical, or nearly identical portions
of one's own work without acknowledging.
Articles of this nature are often referred to as duplicate or
multiple publications.
In addition there can be a copyright issue if copyright of
the prior work has been transferred to another entity.
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Informed Consent
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Informed Consent
What is informed consent?
 Informed consent means that participants are told
enough about the nature of surveillance to enable them
to make an informed decision about whether or not to
take part.
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The decision to participate should be voluntary.
Project staff should try to ensure that respondents are
not pressurized.
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Content of Informed Consent
Informed Consent
What information should be provided during informed consent?
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Participant Status
Study Goal: The nature of the survey (e.g., length of interview
and type of question)
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Types of Data
Procedures
Nature of Commitment
Sponsorship
Participant selection
The potential risks and benefits
Alternative
Compensation
Confidentiality
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How the information will be used
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How privacy will be protected
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That participation is voluntary
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That participants have the right to refuse to answer any
questions or stop the interview at any time
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Participants should also be given a chance to ask questions
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Building Ethics into the
Design of the Study
Reporting
Data Collection
Sample
Intervention
Research Design
Building Ethics into the Design of the Study
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Building Ethics into the
Design of the Study
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Before building ethics in the study
design researcher required to be
careful during planning of a research
project.
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Building Ethics into the Design of the Study
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Research Design
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Will participants get allocated to
different treatment groups fairly?
Will research control the risks
participants will incur?
Will the setting for the study be
selected to protect against participant
discomfort?
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Building Ethics into the Design of the Study
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Intervention
Is the intervention designed to
maximize good and minimize harm?
 Under what conditions might a
treatment be withdrawn or altered?
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Building Ethics into the Design of the Study
Sample
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Is the population unnecessarily exclude
important segments of people (e.g.
women, minorities)?
Is the population defined in such a way
that especially high-risk people (e.g.
unstable patients) could be excused
from the study?
Will potential participants be recruited
into the study equitably?
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Building Ethics into the Design of the Study
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Data Collection
Data should be collected in such a
way, to minimize respondents
burden.
 Data collection procedures should
maintain confidentiality.
 Data collection team should be
appropriately trained.
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Ethical Committee/ Ethical
Review Procedure
Ethical Committee/ Ethical Review Procedure
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Ethical Committee/
Ethical Review Procedure
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The need for evaluation of research proposals has
been emphasized under the Statement of Specific
Principles at item no. 5 of ICMR Ethical Guidelines
pertaining to precaution and risk minimisation.
It is mandatory that all proposals on biomedical
research involving human participants should be
cleared by an appropriately constituted Institutional
Ethics Committee (IEC).
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Ethical Committee/ Ethical Review Procedure
Composition of
Institutional Ethics Committees
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Chairperson
One - two persons from basic medical science
area
One - two clinicians from various Institutes
One legal expert or retired judge
One social scientist/ representative of nongovernmental voluntary agency
One philosopher/ ethicist/ theologian.
One lay person from the community
Member Secretary
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Ethical Committee/ Ethical Review Procedure
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Monitoring
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Once IEC gives a certificate of approval it is the
duty of the IEC to monitor.
Actual site visits can be made especially in the
event of reporting of adverse events or
violations of human rights.
Additionally, periodic status reports must be
asked for at appropriate intervals based on the
safety concerns
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Conclusion
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It is important that nursing research is
undertaken with a clear ethical concerns.
Ethical component is not enough to protect a
study.
A more overt and less immature approach to
access for fieldwork is required.
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Thanks………