Research Ethics

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Which side will you take?
Drug Protector?
Human Rights?
From the Greek word
ETHOS which means
behavior or conduct
A Glimpse of the PAST…
“unethical studies”
• Nazi Medical Experiments
• Tuskegee Syphilis Study
• Willowbrook Study
• Jewish Chronic Disease Hospital Study
Ethical Codes and Regulations
Nazi Medical Experiments
Nazi human experimentation was a series
of medical experiments on large numbers of
prisoners, including children
Programs included:
Sterilization
Euthanasia
to produce a population of pure Germans &
Aryans
Tuskegee Syphilis Study
• 1932 – US Public Health Service initiated a
study of syphilis in black men in the small rural
town of Tuskegee, Alabama
• Cont’d for 40 years
• To determine the course of syphilis in the
adult black male
• 2 groups:
n = 400 untreated syphilis (treatment group)
n = 200 without syphilis (control group)
• participants were not informed about the
purpose and procedures
• Subjects were kept from receiving treatment
• No effort to stop the study
Willowbrook Hepatitis Study
• mid 1950’s to early 1970’s – research on hepatitis at an
institution for the mentally retarded
• Subjects were children
• Parents were forced to give permission for
their child in order to gain their child’s
admission to the institution
• Subjects were deliberately infected with
Hepatitis virus
• 20 year study
Jewish Chronic Disease Hospital Study
• In 1960’s – purpose to determine
the patients’ rejection responses
to live cancer cells
• N = 22 – injected with a
suspension containing live cancer
cells that had been generated
from human cancer tissue
• Rights of patients not protected,
not informed, study was never
presented to the research
committee of the Jewish Hospital
What Happened?
• NUREMBURG CODE
The Belmont Report summarizes
ethical principles and guidelines for
research involving human subjects.
Three core principles are identified:
respect for persons, beneficence, and
justice.
Nuremberg Code
-focused on the importance of informed
consent.
• 1st internationally recognized set of ethical
standards
•Of course, while it’s
essential to have codes,
the responsibility for
ethical research
ultimately lies with the
individual researcher.
for Persons
Research endeavors uphold
respect for life, dignity and
reputation of both researchers
and participants/subjects,
with special and appropriate
protection for vulnerable
groups.
Philippine Normal University
Code of Research Ethics and Guidelines for Review
Youth, cognitively
impaired, mentally
challenged or people with
health issues
As researchers, we should respect the Rights
of Subject
• Right to informed consent
• Right to privacy and confidentiality
• Right to no harm
Informed Consent
• Tell participants who is
conducting study
• Why was subject singled out for
participation?
e.g. random sample
e.g. recently given
birth to 1st child
etc.
• What is the time commitment?
e.g. 45 minutes to
complete the
survey
Any benefits for the
participant to be expected?
Realistically, there are
often few direct benefits.
Any potential risks, and how
have these been managed?
Different forms of (informed) consent
(informed) consent:
• Presumed consent
• presumed consent may be ethical when the benefits of the
research outweigh any potential physical or social risks
• Verbal consent of consent**
• Written consent
** it may be impossible to obtain written consent in some
types of studies (such as telephone interviews) but
wherever possible the consent process should be
recorded
Sometimes Consent is not Possible
• Fake an assault in the street to gauge reaction of
bystanders
• Who will intervene and who will do nothing?
• Problem with the preceding:
• witnessing such an attack may be very disturbing to
some.
• Those who do not intervene may be upset and suffer
feelings of low worth.
• Those who do intervene may be injured.
• Debriefing is mandatory.
Informed Consent
• Special Populations
Difficult for some to give true
voluntary informed consent
They might lack necessary competency
--children
--mentally challenged
Informed Consent
•Others May be Indirectly Coerced
(persuade an unwilling person to do something by
using force or threats.) —This is WRONG
•
•
•
•
•
•
Students
Prison Inmates
Employees
Military Personnel
The Homeless
Welfare Recipients
Key components of informed consent
 Name and contact details
of researcher and
participant
 Aims and objectives of the
research project
 Role of the participant
 Treatment of material/
information collected
 Potential risks to the
participant
Voluntary participation
and freedom to withdraw
Option of receiving
summary of research
findings
Signature and date of
researcher and participant
Privacy and Confidentiality
• Invasion of privacy occurs when private
information is shared without an individual’s
knowledge or against his/her will
The subject has the right to
• Anonymity – exists only if the subjects
identity cannot be linked
even by the researcher
• Confidentiality- exists if the researcher can
manage the private information
shared by the subject.
Issues Relating to the
Principle of Respect
Justice
Research
intentions and
processes adhere
to generally
accepted scientific
principles.
Philippine Normal University Code of Research Ethics and Guidelines for Review
“fairness and equity”
• Obligation to treat
people fairly &
equitably
• Equal access to
benefits/equal share of
burdens
• Avoid underprotection
& overprotection
Justice
Beneficence
Harms and Benefits
•One should do good and above
all do no harm
•Freedom from harm and
freedom from exploitation
Maximizing Benefits & Minimizing Harms
• duty to maximize benefits
• To produce benefits to society as a whole, subjects
themselves, other individuals in society,
advancement of knowledge
• Apply principle of “Nonmaleficence” – the duty to
avoid, prevent, or minimize harm to others
Maximizing Benefits & Minimizing Harms
• Participants should not be subjected to
unecessary risks of harms
• no consequences if the participant withdraws
• Debriefing sessions can be used
• Freedom from exploitation
Key Principles
Principle
1.Respect for
persons
2.Beneficence
3.Justice
Application
1.Informed consent
2.Assessment of risks/benefits
3.Fair selection of subjects
Other ethical standards
Laboratory Research Animals
REPUBLIC ACT NO. 8485 (RA 10631 amendments)
AN ACT TO PROMOTE ANIMAL WELFARE IN THE PHILIPPINES, OTHERWISE
KNOWN AS “THE ANIMAL WELFARE ACT OF 1998”
• SECTION 6. It shall be unlawful for any person to torture any animal, to
neglect to provide adequate care, sustenance or shelter, or maltreat any
animals or to subject any dog or horse to dogfights or horse fights, kill or
cause or procure to be tortured or deprived of adequate care sustenance or
use the same in research or
experiments not expressly authorized by the
Committee on Animal welfare.
shelter, or maltreat or
The killing of any animal other than cattle, pigs, goats, sheep, poultry, rabbits,
carabao, horse, (deer and crocodiles) is likewise hereby declared unlawful except in
the following instances:
animal is killed after it has been used in authorized
research or experiments; and
• 6. When
• In all the above mentioned cases, including those of cattle, pigs, goats, sheep, poultry, rabbits, carabao,
killing of the animals shall be done
through humane procedures at all times.
hones, (deer and crocodiles), the
• For this purpose, humane
procedures shall means the use of the most
scientific methods available as may be determined and approved by
the Committee.
The Philippine Animal Welfare Society (PAWS)
•PAWS opposes to the use of
animals in experimentation
PAWS encourages the researchers to apply
Three Rs
• Reduction – reduce the number of animals being used
• Refinement – animals should not feel pain while being
experimented on and should be euthanized
immediately after the experiment if the can
no longer be rehabilitated
• Replacement – will promote the use of alternative
methods of research and dissection (virtual
dissection)
Laboratory Research Animals
• To approve animal use:
• Procedures must avoid pain or discomfort and have
sound research design
• Procedures involving minor discomfort or pain
must include sedation, analgesia, or anesthesia
• Animals that would experience chronic pain must
be euthanized at the end of the procedure
Laboratory Research Animals
• To approve animal use:
• Living conditions must be appropriate for species
• Medical care must be available from veterinarian
• Personnel conducting procedures must be qualified
• Methods of euthanasia must abide by Committee
on Animal Welfare or Bureau of Animal Industry
(BAI) rules
Other Ethical Issues
•One should not cheat, falsify data
•One should not plagiarize.
Plagiarism
• Plagiarism is taking another’s work and passing it
off as your own.
• When we talk about the decline and fall of the
Roman Empire or say, “To be or not to be, that is
the question” in normal conversation, we rarely
attribute the words to Gibbon and Shakespeare
respectively.
Useful Definitions:
Plagiarism and Self-Plagiarism
• Plagiarism:
using the ideas or words of another
person without giving appropriate credit
(Nat. Acad. Press document)
• Self-Plagiarism:
The verbatim copying or reuse of
one’s own research (IEEE Policy statement)
Both types of plagiarism are considered to be
unacceptable practice by most scientific publications
Plagiarism Extends to More than Words
• One should always provide references for any
• statistics
• graphs
• tables
• numbers, etc.
Copy Direct Quotations Exactly
• Make sure that you write it precisely, word-forword as in the original.
• Also essential that you enclose the quoted text in
quotation marks.
• Failing to put someone else’s direct text in
quotation marks and crediting the author, may
lead to accusations of plagiarism.
“Plagiarism” Sometimes Not
Intentional
• Many instances of plagiarism stem from sloppy
research rather than through a deliberate desire to
cheat.
• Many students during the research process take bad
notes, e.g. they write down someone else’s text
verbatim but forget to include the quotation marks.
“Plagiarism” Sometimes Not
Intentional
• Later when they are writing the actual paper
and they refer to their notes, they fail to
remember that the text is another author’s and
not their own.
• So, the golden rule is to take excellent notes,
write your whole paper yourself and to
document your sources as well and as honestly
as possible.
“Common Knowledge” and Plagiarism
• It is not necessary to document every single statement.
• One need not give a reference for stating that President
John F. Kennedy was assassinated in 1963.
• This fact is common knowledge and belongs in the
public domain.
• However, if you are referring to Historian X’s thesis that
Kennedy was killed by a crime syndicate and not by Lee
Harvey Oswald, proper citation to such a theory is
requisite.
Other Types of Ethical Violations
• Duplicate publication/submission of research
findings
• Unrevealed conflicts of interest that could affect
the interpretation of the findings
• Misrepresentation of research findings - use of
selective or fraudulent data to support a
hypothesis or claim
SAMPLE
Let’s study some researches and
the ethical issues that happened
or may happen.
• The Zika vaccine, with the clinicalsounding name GLS-5700, will first be
tested in 40 healthy volunteers. The first
tests in humans should start in the next
few weeks, Inovio said in a news release.
- CNN, June 21, 2016
(http://cnnphilippines.com/world/2016/06/21/First-Zika-vaccine-to-be-tested-in-humans.html)
•Study on embryonic
stem cells
Case study
In a class, a teacher notices that male students have
performed much better than women students
The teacher decided to introduce a new design to the
module to provide an experimental context in which
he can evaluate differential performance by student
gender
His research design will involve:
•ongoing (process) evaluation of the module
•review of marks allocated to male and female
students
•interviews with students to gauge their
perceptions*
* interviews conducted before the course ends to
ensure that all students are available to participate
What are the ethical issues?
How might these issues be resolved
Case study – ethical issues
 informed consent must be obtained before
students sign up for module
 it must be an optional not a compulsory
 the students should not be linked to their work
 To achieve confidentiality it may be good
practice to ask a colleague to conduct the
interviews
Case study – ethical issues
 address any fears students may have of being
penalised for not taking part or that their
participation may positively or negatively
prejudice their performance
 possibility of positive bias
 Hawthorne effect influencing students’
evaluation of the module
Key ethical concerns
Research involving a researcher’s students/pupils as
research participants raises a number of ethical
concerns, including:
• Consent
• Confidentiality
• Competence
Potential solutions
1. Minimize risks
A. research students/pupils elsewhere
B. research other’s students/pupils in your setting
C. research but do not assess your own students/pupils
D. research your own students/pupils using methods that
generate anonymous data unlink-able to assessment
E. research your own students/pupils but use anonymous
assessment techniques unlink-able to research data
F. research and assess your own students/pupils buthave
assessments independently moderated/second-marked
Summary
We live in a fast changing world
with the scientific knowledge and
new technologies continuously
challenge our values.
We have to make decisions based on
the fundamental values of human
dignity.
We, the teachers, have more
information and more basic
knowledge about the very issues that
generate these ethical dilemmas.
So why not,
PRACTICE IT …
SHARE IT…
and INSPIRE MORE TO DO
THE SAME…
References
• http://www.nasw-michigan.org/?page=Ethics
• http://www.asasa.ca/images/services/ethics.png
• http://www.asbpe.org/blog/2013/10/15/ithenticate-study-ids-10-plagiarism-formats-worthy-of-attention/
• https://en.wikipedia.org/wiki/Research_ethics
• http://www.niehs.nih.gov/research/resources/bioethics/whatis/
• http://www.apa.org/monitor/jan03/principles.aspx
• https://researchethics.ca/what-is-research-ethics/
• http://www.socialresearchmethods.net/kb/ethics.php
• http://www.admu.edu.ph/code-ethics-research
• http://www.ahc.umn.edu/img/assets/26104/Research_Ethics.pdf
• Philippine Normal University Code of Research Ethics and Guidelines for Review (1Approved by the Board of
Regents on June 11, 2015)
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