2. Defining Research Ethics Principles.pptx.pdf

DEPARTMENT OF SCIENCE AND TECHNOLOGY
PHILIPPINE COUNCIL FOR HEALTH RESEARCH AND DEVELOPMENT
PHILIPPINE HEALTH RESEARCH ETHICS BOARD
Deﬁning
RESEARCH ETHICS PRINCIPLES

Committee on Information Dissemination, Training, and Advocacy
INTRODUCTION
• In ethics, a common basis is the use of
principles
• In research ethics most codes are based on
ethical principles

OBJECTIVES
• Justify the need for knowledge of principles
• Enumerate the most common ethical principles
cited in research
• Explain their meaning
• Apply to research

OUTLINE
• Why Principles?
• List of principles
• Principle
Meaning, Importance, Application
• Summary

WHY PRINCIPLES?
• “Language” of ethics
• Basis of most codes
• Easy to state and understand
• Provide direction and predictable answers
• Stress individual rights and duties

ETHICAL PRINCIPLES IN RESEARCH
PRINCIPLES
Generalizations accepted as true and serving as
tools for analysis
▪ Beneficence
▪ Non-maleficence
▪ Respect for Person
▪ Justice

BENEFICENCE
• Act for the benefit of others
Benefit: a desired outcome, an advantage
• Promote Good (active)
Prevent or remove harm, (or risk of harm
or unnecessary burden)
Do good (improve situation by use of
outcomes)
• Act in such a way that you treat
humanity, whether in your own person
or in the person of any other, never
merely as a means to an end, but
always at the same time as an end.” -
Kant
• Benevolence (intention, virtue)
Beneﬁcence statue at
the campus of Ball
State University, IN

TYPES OF BENEFITS
• Direct and indirect (collateral)
• Intended or Unintended
• Potential or Actual
• Character

IMPORTANCE OF
BENEFICENCE IN RESEARCH
• Research is an extraordinary activity
• Society gains useful knowledge
• Those who choose to join (participants, community)
should benefit from joining
• Researcher and sponsor may have secondary gainers

MAXIMIZING BENEFITS
Beneficence in research should be MAXIMIZED
1. Motive: for Good of Human (Benefit to
Society)
– Scientific, Ethical and Social Good {Humanitarian
Value}
– Topic: Relevant to the needs of participants,
community, country

MAXIMIZING BENEFITS
National Unified Health Research Agenda (NUHRA}
Research priorities of 4 core Philippine National
Health Research System (PNHRS) agencies:
– Department of Health (DOH)
– Department of Science and Technology – Philippine
Council for Health Research and Development
(DOST-PCHRD)
– Commission on Higher Education (CHED)
– National Institute of Health (NIH)

MAXIMIZING BENEFITS
2. Participants (conduct)
– Become better by joining research
“At the conclusion of the study, patients entered into the
study are entitled to be informed about the outcome of the
study and to share any benefit that result from it. For
example, access to the best proven prophylactic,
diagnostic or therapeutic method identified by the study.”
(Helsinki Declaration)
– Non-therapeutic research, social research, surveys

MAXIMIZING BENEFITS
3. Community
• Innovative/Creative sustained
healthcare/structure
• Improved local structure:
‒ Capacity Building:
(resources and expertise influx)
‒ Shared Benefits/Results:
(helpful information, affordable
products)
• Value of community consultation

NON-MALEFICENCE
• Do not harm and do not put at risk of harm
• Protect, preserve and defend life, health,
integrity and dignity of participants, fetus and
future generations and others (community,
environment).
• Independent of consent
• Harm vs wrong
• Harm vs risk
• Usually directed to participants, community and
researcher

TYPES OF HARM
• Direct and indirect (collateral)
• Intended or unintended
• Potential or Actual
• Character

IMPORTANCE OF
HARM IN RESEARCH
• Primary principle do no harm
• Research is an extraordinary
activity
• No one should be harmed
• Those who choose to join
(participants, community) must
not be worse off by joining

APPLICATION
1. Society
wasteful use of resources
misinformation/harmful information
2. Participants
unavoidable, minimal, reasonable,
proportionate harm/risk/burden
comply with beneficence, respect and justice
3. Community
wasteful use of resources
disrespect of values

Reasonable Risks:
POSITIVE BENEFIT/HARM RATIO
Positive Benefit/harm or risk or
burden
– to participants, society,
researcher and all
stakeholders
– separately or collectively
When can benefits to one
(society) outweigh harm to
another (participants)?
Role of individual preferences;
free and informed consent

RESPECT FOR PERSON
“A recognition of the personal dignity
and autonomy of individuals, and
special protection for those with
diminished autonomy”
- National Ethical Guidelines -

IMPORTANCE OF
RESPECT FOR PERSON
• Recognize nature of person
-- can (rationality) and should (stewardship)
decide what is best for and can be done to
him (right).
• Expression of how one values another:
– as one with inherent dignity self-worth,
experiences, values and beliefs
– as one who volunteers to help in the research

APPLICATION
1. Society
Consider values
Protect the vulnerable
2. Participants
Obey all principles
Respect rights
Treat with respectful manner
Honor choices (free and informed consent)
Protect the vulnerable
3. Community
Consider values/cultures
Involve in decision making

GENDER AND CULTURAL
SENSITIVITY
• Set of skills that enable us to learn about and
understand people who are different from ourselves
thereby becoming better able to serve them within
their own community
• Being aware that cultural differences and similarities
between people exist without assigning them a
value, positive or negative, better or worse, right or
wrong
• Be vigilant vs insensitivity
• Reduce cultural bar between professional and client

HONORED CHOICES:
Free and Informed Consent
• Permission given by a person
to act on him/her
• Given by one who knows
what will be done, freely and
voluntarily chooses to have it
done, and expresses that
choice
• Necessary before start of
research until the
dissemination of results
(separate activity on Informed
consent)

JUSTICE
“Rightness of person’s interactions and
relationships”
Golden rule:
“What one would have others do to
oneself” (natural law)
“Fair if I were in need; Fair if I were to
give”
• Give or not deprive others their due
(what they deserve)
• Refers to
– history and substance
– process > outcome
– unfair > unfortunate
• Equality vs equity

WHAT IS DUE...
• Fundamental rights and freedoms
• Share of benefits and burdens (egalitarian)
– from each according to ability, to each according
to need
– preference for poor and vulnerable (Christian)
– inequalities are permissible only insofar as they
maximize the lot of the minimally advantaged
(John Rawls)
• Treat equals equally, treat unequals unequally
proportionate to their unequal qualities (Aristotle)

IMPORTANCE
• Most important principle which relates to public’s
view of study credibility
• Permeates most aspects of research choice of
topic, site, investigator, participant, all
stakeholders
• Most difficult ethical requirement to comply with

JUSTICE IN RESEARCH
1. FOR ALL STAKEHOLDER
– Reduce inequalities or at least do not
increase
– Follow other principles; truth-telling
– No COI
– Share burdens and benefits fairly
2. SOCIETY
– Population benefit likely
– Compliance with law
– Timely and truthful peer reviewed
publication
– “whistle blow”

GUIDELINES FOR AUTHORSHIP
• Lead author (Guarantor)
– Responsible for integrity of whole paper.
• All Other Authors:
– Substantial input: responsible for appropriate portion of
content and final approval
▪ concept, designs, data acquisition, analysis,
interpretation;
▪ drafting or critical revision of article;
▪ not funding, provision of participants, general
supervision, inspiration, out of gratitude
• Contributors
– Facilitated study but could be placed under
Acknowledgement

JUSTICE IN RESEARCH
3. PARTICIPANTS
– fair selection and assignment of
participants (separate activity)
– just compensation
– benefit sharing

JUST COMPENSATION
• Not exploitative
• Not undue
• Consider:
– Full reimbursement of expenses related to participation:
lost earnings, transportation, food, companion
– If no direct benefit: positive for discomfort, inconvenience,
time
– If difficult to recruit: positive incentive provided not undue
– if harm/wrong/injury: positive correction
• Remunerations per visit not at end of study

JUSTICE IN RESEARCH
4. COMMUNITY
– Relevant topic, capacity to utilize
– Consultation and respect for values
5. RESEARCHER
– Compensation and autonomy
6. INSTITUTION
– Compensation and protection of reputation
7. SPONSOR
– Good work

SUMMARY
• Principles are basis for ethical soundness of
research
• Beneficence is maximizing good
• Non-maleficence is minimizing harm
• Beneficence should outweigh non-maleficence
• Respect for person is being courteous and
obtaining free and informed consent
• Justice is being fair and giving what is due

THANK YOU! ☺

INTERACTIVE SESSION:
• A researcher wants to know if children tutored by their
parents have higher school achievement than children
not tutored.
• At a PTA meeting for grades 2,3,4 students, parents were
asked to fill a survey regarding homework which included
the following question:
• “On the average how much time do you spend sitting with
your child going over his/her homework on school days?
• > 15 min < 15 min”
• Those who chose < 15 were categorized as not tutored
• Those who chose > 15 were categorized as tutored
• Corresponding grades were correlated

ANALYSIS:
Based on the given information:
1. Does the study have social value?
2. Is it scientifically valid?
3. What benefit can it provide?
4. What harm can it do?
5. Is the benefit/risk ratio +
6. Is there informed consent?
7. Is the study just?

SMALL GROUP WORK:
Applying Research Ethical Principle
Instructions:
• 4 scenarios are described
• As a group, choose one, then:
– List 2 important benefits and 2 important risks
– Balance the benefits and risks and determine if
positive
– Describe 2 expressions of respect
– Describe 2 possible injustices

SCENARIO 1
Prevalence of nits among grade 2
children in (public school):
At school clinic in groups of 5 are
fine combed to catch nits given
lollipop

SCENARIO 2
Factors which influence pregnant single women to
abort:
– In a government hospital pregnant women
with history of abortion made to answer
survey:
– Rank the following factors according to the
extent of their influence in your decision to
abort (1 most 5 least) spouse, family, church,
economic condition, work

Relationship of type of drinking water to
diarrhea:
Visit Urban poor community
households and observe drinking
water if bottled, boiled or direct from
tap, prevalence of diarrhea
SCENARIO 3

Effect of E-mail in learning
2 Student groups: one allowed
email access to teacher. Final
exam results to determine who
did better
SCENARIO 4

Effectiveness of Drug X in
metastatic cancer:
Private hospital metastatic cancer
patients not responsive to
standard drugs given drug X by
IV
SCENARIO 5

2. Defining Research Ethics Principles.pptx.pdf

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2. Defining Research Ethics Principles.pptx.pdf