3. THEM
• …The subjects
• …The respondents
• …The participants
• …The people
• …Have the RIGHT
4. RESEARCH AND PEOPLE
• Nursing research focus on people
• Humans are almost always involved
• Every person has basic human rights
• Human rights are to be respected
• PNA Code of Ethics recognize that “health is a
fundamental right of every individual”
• Nurses’ responsibility: to protect these rights
6. CHARACTERISTICS OF SCIENTIFIC
RESEARCH
• SCIENTIFIC OBJECTIVITY
– Being aware of personal values and biases
• COOPERATION (W/ Institutional Review Boards, IRB)
– IRB reviewed and approved
• INTEGRITY
– Benefits and risks of research are made aware
• EQUITABLENESS
– Acknowledging contributions of others
7. CHARACTERISTICS OF SCIENTIFIC
RESEARCH
• NOBILITY
– Researcher assumes responsibility of protecting the
participants from harm, deceit, coercion, or invasion of
right to privacy
• TRUTHFULNESS
– Reflected in the study’s purpose, procedures, methods,
and findings
• IMPECCABILITY
– Observance of anonymity and confidentiality of data
8. CHARACTERISTICS OF SCIENTIFIC
RESEARCH
• HONESTY
– Disclosure of all funding resources
• ILLUMINATION
– Research should yield or produce fruitful or beneficial
results
• COURAGE
– Needed to clarify publicly any distortion that others may
make of the research findings
9. Code of Research Ethics
• Several documents served as guidelines for
conducting ethical research, examples are:
• NUREMBERG CODE
– Developed because of Nazi’s abuses
– Consent became necessary
• HELSINKI DECLARATION OF 1964
– Participants must be informed
• ANA’s Human Rights Guidelines for Nurses in
Clinical and other Research
– Detailed guidelines
11. AUTONOMY
• Right to self determination
• Research subjects have independence
• They must be fully informed by the
researchers
12. BENEFICENCE
• “doing good”
• Subjects must “benefit”
• Dimensions include:
– Freedom from harm
– Freedom from exploitation
– Benefits from research
– Risk-benefit Ratio
13. Non-maleficence
• “do no harm”
• Researchers must not inflict direct harm
• Avoiding unnecessary pain or injury
• Harm may be physical, mental, psychological,
social, emotional, spiritual
• Although harm may happen accidentally,
researcher must put an effort to prevent harm
14. Justice
• To be just, to be fair
• Giving one what is due
• Non-discriminatory selection of subjects
• Fair share in benefits and risks
• Vulnerable groups (infants, elderly, etc.) must
be treated with fairness, respect, courtesy
15. Rights of Human Subjects (ANA 2011 and APA 2010)
• Right to Self Determination
• Right to Privacy and Dignity
• Right to Anonymity and Confidentiality
• Right to Fair Treatment or Justice
• Right to Protection from Discomfort and
Harm
16. How about in our Country?
• The constitution upholds human rights
• It must be respected and not violated
• Autonomy- we are a democratic country
• Beneficence- we are a country concerned with
our citizens
• Non-maleficence- we are a country who cares
• Justice- we are a country that believes in
equality
17. Balancing Benefits and Risks for a Study
• Researchers must:
1. Predict the outcome of study
2. Assess the actual and potential benefits
and risks on the basis of this outcome
3. Maximize the benefits and minimize the
risks
18. Balancing risks and benefits
• Benefits must outweigh the risks
• The more the benefit, the better
• The lesser the risk, the better
19. Benefit-Risk ratio
• Determined on the basis of the maximized
benefits and the minimized risks
• Changes in study purpose or procedure or
both can affect this ratio
• Thus it is changed by the researcher before
actually conducting the study
20. Example: “Effects of Exercise and Diet to
Serum Lipid Levels: A One Year Study”
• Benefit: instruction of exercise and diet
• Potential benefit: improved lipid values,
better habits
• Risk: temporary discomfort during blood
tests
• Assessment: better benefits than risks
23. Obtaining the informed Consent
• INFORMING- the transmission of essential ideas
and content to subjects
(must be understood/ comprehended)
• CONSENT- the prospective subjects “agreement”
to participate (after being informed)
• Legal and ethical requirement
• Formally defined in the first principle of the
Nuremberg Code
24. 4 elements of consent
1. Disclosure
2. Comprehension
3. Competence
4. Voluntarism
25. Information Essential for Consent
(Grove, Burns, and Gray, 2013)
• Introduction of Research Activities
• Description of Risks and Discomforts
• Description of Benefits
• Disclosure of Alternatives
• Assurance of Anonymity and
Confidentiality
26. Information Essential for Consent
(Grove, Burns, and Gray, 2013)
• Compensation for Participation in
Research
• Offer to Answer Questions
• Non-coercive Disclaimer
• Option to Withdraw
• Consent to incomplete disclosure
(participants must know also if it is
incomplete disclosure)
27. Comprehending the Consent Information
• Use lay terminology
• Simple words, not jargons
• In the document use headings, upper case and
lower case, proper spacing
• Introduce purpose of study
• Outline the process/treatment
• Written clearly
• Address the participant directly, “you are being…”
• Estimate the reading level of the document
28. Remember
• Participants who give consent must be legally, mentally, and
physically competent
• Consents must be voluntary, there should be no coercion
• Informed consent must be well documented
29. Waived Written consent
• May be waived if there is no more than minimal
risk present
• Example: giving a harmless questionnaire
• Completion of the questionnaire by the respondent
may already serve as a consent
• Thus some questionnaires has this on top” “The
completion of this questionnaire serves as your
consent”
30. Waived Written consent
• May also be waived when the only record linking the subject and
the study would be the consent document and that the risk of the
study is the potential breach in confidentiality
• The subject still needs to be given an option whether to sign or not
• However, the 4 elements of consent are still essential in all studies
(whether with waived consent or none)
32. Institutional Review Board (IRB)
• Committee that reviews and ensures that
researcher is doing the study ethically
• Schools, hospitals, and other institutions may have
IRB’s
• US have guidelines on who must be IRB members
• *UP has an IRB
• In our case, your proposals will be reviewed by the
panel
• Sometimes it is called an Ethics Committee (EC)
33. 3 levels of IRB Review
1. EXEMPT FROM REVIEW
– If study pose no apparent risk
2. EXPEDITED REVIEW
– If study may have minimal risk
3. COMPLETE REVIEW
– If study may have greater than minimal risk
