Ethical Aspects of Nursing Research
WEEK 2
Ethics
• Study of moral behavior
• What is right and wrong
• What is good and bad
Research Ethics
• Application of ethics in the research process
• Involves being sensitive to person’s rights (study participants)
• Concerned on how a particular research abides by the ethical
standards
• Protect the rights and welfare of participants
• Protect intellectual property rights
EXAMPLES OF UNETHICAL MEDICAL RESEARCHES
• Tuskegee Syphilis Experiment (1932-1972)
o A clinical study conducted between 1932-1972 in
Tuskegee, Alabama by the Unites States Public Health
Service
o 400 Afro-American farmers, most were illiterate, were
studies to observe the natural progression of untreated
syphilis up to there eventual death by the disease
o Subjects did not give their informed consent
o They were not informed of their diagnosis and were told
that they were treated for “bad blood”
o They were told that if they participate, they would be
given free medical care, free transport to a medical clinic,
free meals, and free burial assistance in case of death.
o Subjects were also warned TO AVOID PENECILLIN
TREATMENT which at that time was already used with
other patients in nearby places in the treatment of
syphilis.
o The Tuskegee incident led to the creation of Belmont
Reports in 1979 which placed emphasis that health
researches must abide the following principles:
§ Principle of respect for human
dignity/autonomy
§ Principle of beneficence (to do good)
§ Principle of justice (fairness/ equality)
o Violations?
§ Respect for human dignity: The were not fully-
informed in order to make autonomous
decision. They were blinded of having syphilis
and were told just to have “bad blood” that
can be treated if they participate in the study
§ Beneficence: participants were harmed
because treatment was withheld; they were
told not to use penicillin)
§ Justice: only the blacks were selected to
participate in the study; discrimination and
malfeasance among persons of authority
§ It also led to the establishment of National
Human Investigation Board as well as the
request for the creation of IRBs or Institutional
Review Boards / Ethics Review Committee
(ERC)
• Nazi Human Experiments (1940s)
o Series of medical experiments on large numbers of
prisoners including children, by Nazi Germany in the
concentration camps in the early to mid 1940s during the
World War and the Holocaust
o Nazi physicians forced prisoners into participating (they
did not willingly volunteer and no consent was given for
the procedures)
o Experiments were conducted without anesthesia and
resulted to death, trauma, disfigurement, and permanent
disability.
o Such experiments were examples of medical torture
Summary of experiments
• Malaria Experiment: inmates were infected by mosquitoes or
by injection of extracts of the mucous glands of female
mosquitoes. Then the subjects were treated with various drugs
to test their efficacy.
• Immunization experiments: scientists tested immunization
compounds and serums to prisoners for the prevention and
treatment of contagious diseases including malaria, typhus,
tuberculosis, typhoid fever, yellow fever, and infectious
hepatitis
• Mustard gas experiment: Test subjects were deliberately
exposed to mustard gas and other chemicals which inflicted
severe chemical burns. The victims’ wounds were tested to find
the most effective treatment for mustard gas burns.
• Sulfonamide experiments: Wounds inflicted on the subjects
were infected with bacteria such as streptococcus and
clostridium tetani. The infection was treated with sulfonamide
to determine effectiveness.
• Sea water experiment: Victims were deprived of food and were
forced to drink filtered sea water.
• Sterilization and fertility experiments: The purpose of the
experiment was to develop method of sterilization which would
be suitable for sterilizing millions of people with a minimum
time and effort. The targets obviously were the Jewish people.
They were exposed to radiation, underwent surgery and was
forced to take various drugs.
• Experiments with poison: poison was secretly placed to the
subjects food. The victim dies as a result of the poison or were
killed immediately in order to permit autopsies.
• Electroshock experiments: women were electrocuted when
they get sick; they underwent this experimentation before
being sent to gas chambers and killed.
• Blood coagulation experiments: Subjects were forced to take
Polygal (substance made from beet and apple pectin which aid
in blood clotting); this was done to reduce bleeding from
gunshot wounds sustained during combat or surgery.
• Head injury experiment: a young boy of eleven or twelve was
strapped and couldn’t move. Above him was a mechanized
hammer that every few seconds came down upon his head.
• Experiments on twins: attempt to create a conjoined twins by
sewing twins together, causing gangrene and eventual death.
• Bone, muscle, and nerve transplantation: subjects had their
bones, muscles and nerves removed without anesthesia. The
result of this operation include intense agony, mutilation, and
permanent disability.
Something to ponder:
“Unethical research persists; so do efforts to eliminate or at least limit it.
Ultimately, the best safeguard for ethical research is the ethical
researcher.” -PHREB, 2012
True or false?
• Research ethics is applied exclusively during implementation
of the research.
• A research, although not that scientifically-grounded, may still
be ethical under certain circumstances.
Important point
• “An ethical piece of research must demonstrate rigor in the
design, conduct, analysis, and reporting of the
research.”(Morrison,1996);
• THUS, researches that are not scientifically sound are NEVER
deemed ethical.
 Ethical Aspects of Nursing Research
WEEK 2
KEY COMPONENTS OF ETHICAL RESEARCH • RESPECT FOR HUMAN DIGNITY
o Right to self-determination
1. SCIENTIFIC SOUNDNESS - Concerns the scientific merit of the § autonomy (informed consent)
research: “Will the data be valid or credible? § freedom from coercion (not forced to
participate)
o Right to full disclosure
Requisites: § nature of the study (what is it about), the
person’s right to refuse
a. Qualified and suitable researcher participation (assurance that one’s
b. Clear, attainable objectives refusal will not be taken against him),
c. Prior literature and studies and likely risks and benefits (risk: benefit
d. Feasible, adequate study site, and resources ratio)
e. Rigorous reproducible design and conditions of the study § covert data collection (concealment)
1. Adequate representative sample § deception (false incomplete information
2. Valid, reliable, and objective research tools/ to mislead research subjects)
instruments - Application of appropriate research
tool to meet the stated objective of the research/ • JUSTICE
investigation o Right to fair treatment
3. Appropriate statistics - equitable distribution of benefits and burdens of
4. Meticulous data gathering research
f. Honest reporting of results - participants selection
g. Objective interpretation, well-founded conclusions - non-prejudicial manner (feeling of dislike or pre-
judge a matter) - respect
True or false? It is justifiable to sacrifice a life, if in the process, it saves - keeping promises
the lives of millions. o Right to privacy and confidentiality
§ right to expect that their data will be kept
in strictest confidence
Important points to ponder § Data Privacy Act of 2012 (Protect the
fundamental human right of privacy, of
“The rights, safety and well-being of study participants are the most communication while ensuring free flow
important considerations and should prevail over the interests of science of information to promote innovation
and society.” (International Council for Harmonization – Good Clinical and growth)
Practice [ICH-GCP], 2006)
PROCEDURES FOR PROTECTING STUDY PARTICIPANTS
2. ETHICAL SOUNDNESS
• Concerns the research being rooted on the overarching 1. INFORMED CONSENT
principle of research ethics- the principle of “the person as an 2. CONFIDENTIALITY PROCEDURES
end and not as means to an end”. 3. DEBRIEFING AND REFERRAL
• Guide questions: 4. TREATMENT OF VULNERABLE GROUPS 5. INSTITIONAL REVIEW
i. Will man benefit as an end? BOARDS (IRBs)
ii. Is the research topic relevant to the needs of the
participants, the institution and the wider community,
given the current state of knowledge? 1. INFORMED CONSENT
iii. Does the research abide the ethical principles? a. Content “Were all information about the study
communicated to the participants?”

FUNDAMENTAL ETHICAL PRINCIPLES

The ICF must include the ff. information (PHREB, 2011):

• Beneficence - Making efforts to secure their well-being

o Do not harm; maximize possible benefits and • That the individual is invited to participate in the research.
minimize possible harms • The reason for considering the individual suitable for the study
• Respect for Human Dignity (inclusion criteria)
o individuals should be treated as autonomous agents • The number of participants invited in the research
o persons with diminished autonomy are entitled to • The participation is voluntary
protection
The ICF must include the ff. information (PHREB, 2011):
• Justice - fairness in distribution and that equals to be treated
fairly • That the individual is free to refuse to participate and is free
to withdraw from the research at any time without penalty or
ETHICAL DILEMMAS - Situations in which participants’ rights and study loss of benefits to which he or she is entitled.
demands are in direct conflict. • The purpose of research
• The procedures to be carried out by the investigator
• The expected duration of the individual’s participation
Ethical Principles for Protecting Study Participants
(including number and duration of visits and the total time
involved)- nature of commitment
• BENEFICENCE • The possibility of termination of the individual’s participation
o Right to freedom from harm or discomfort in the study
§ Physical (injury, fatigue) • Any foreseeable risks, pain or discomfort, or inconvenience to
§ Emotional (stress, fear) the individual associated with participation in the research
§ Social (loss of social support) (SAE)
§ Financial (loss of wages) • The direct benefits, if any, expected to manifest to individuals
o Right to protection from exploitation from participating in the research.
§ not placing participants at a disadvantage
or expose them to damages.
 Ethical Aspects of Nursing Research
WEEK 2
• The expected benefits of the research to the community at
large, or contribution to scientific knowledge (in line with the
significance of the study)
• Compensation for participation (money or kind)
That after the completion of the study, the individual will be
informed of the findings, if he desires. (disclosure of results)
• That the research will be published or presented before a
scientific community
• The possible use of participants’ data by other researchers
(meta- analysis and meta synthesis, systematic reviews)
• The ICF must include the ff. information (PHREB, 2011):
• Measures to ensure the privacy of the participants and the
confidentiality of records in which they are identified
• The limits, legal or other, to the investigator’s ability to
safeguard confidentiality, and the possible consequences of
breaches of confidentiality.
• The sponsor of the research, the institutional affiliation of the
researchers, and the nature and sources of funding. (mention
if the research is a school requirement)
• That treatment will be provided free of charge for specified
types of research-related injury or for complications associated
with the research, the nature and duration of such care, the
name of the organization or individual that will provide
treatment, and whether there is any uncertainty regarding the
funding of such treatment
• In what way and by what organization the research participants
or the family (or dependents) will be compensated for disability
or death resulting from such injury (or, when indicated, that
there are no plans to provide such compensation).
• Name and contact details of the researchers, affiliated
institution and pertinent individuals (research director, clinical
psychologist, physician)
True or false? Once the participant has volunteered to join the study,
he/she could not anymore retract consent.
PROCEDURES FOR PROTECTING STUDY PARTICIPANTS
3. DEBRIEFING AND REFERRAL
• process of receiving an explanation of a study or investigation
after participation is complete
• making referrals to appropriate health, social, or
psychological services.
• NOTE: debriefing is mandatory most especially when the
research study involves deception. It provides participants
with a full explanation of the hypothesis being tested,
procedures to deceive participants and the reasons why it
was necessary to deceive them. Researchers learn how the
participants viewed the procedures.
4. TREATMENT OF VULNERABLE GROUPS
• Children
• Mentally Ill
• Those with sensory deficits or impairments - Terminally Ill
• Institutionalized people
• Pregnant women
• Members of the LGBTQ Community
• Indigenous people
• Special guidelines
A. CHILDREN/ MINORS
o Informed consent from a parent or LAR
(Legally Authorized Representative)
o Legally capacitated third party: additional
permission required if child’s parents are
minors; EMANCIPATED MINORS
o In the absence of parents or judicially
declared guardians (in order): grandparents,
oldest sibling over 21 yo, actual custodian
over 21 yo, and duly appointed officials of
the DSWD (state) in case of orphan street
children.
o Teachers: may give consent in loco parentis
for educational research with minimal risk
(Cohen, et al, 2007)
o Assent: a child’s affirmative agreement to
participate in research; must be obtained if
the child is 7-17 yo (PHREB, 2011)

1. INFORMED CONSENT Guiding principle of assent:

• Comprehension - “Is it written and verbally explained in a
medium or language understandable to the participants?”
• 15-17 years old: child co-signs on the informed consent form of
• Documentation
parents
A. “Was a personal copy given to the participant?”
• 12-15 years old: child signs on a simplified assent form
B. “Was ample time given to the participant in
different from the ICF which the parent or guardian signs
reviewing the form before signing?”
• 7-12 years old: verbal assent
C. “Were vulnerable participants afforded alternative
means of documenting consent?” • < 7 years old: no assent needed
2. CONFIDENTIALITY PROCEDURES
• Anonymity True or false?
A. most secure means of ensuring confidentiality
B. measures: Using fictitious names, not disclosing
• The parents of a 12-year-old boy consented to have their child
identifying information, using ID nos., placing
join the research but the boy refused to join & does not want
identifying information to a locked file
to sign the assent form. Because the parents have consented,
C. not encoding identifying information onto computer
the researchers could still insist on the child joining.
files - password protection of research data
• The parents of a 6-year-old girl agreed to have their child join
D. destroying identifying information as quickly as
a research on the effects of giving daily iron supplements on
possible - making research personnel sign
students’ school grades. But the girl clearly refused to join and
confidentiality pledges
cried. In this case, the researchers may still insist on her
E. reporting research information in the aggregate
joining.

Examples of personal identifiers:

Important point - “In the absence of assent, a child’s dissent must always
be respected unless they directly benefit from the study and the parents
• name have consented”(PCHRD,2012)
• birth date
• social security number
B. COGNITIVELY INCAPACITATED ADULTS
• home address
o decisional capacity is determined by
• phone number cognitive assessment (PHREB, 2011)
• e-mail address 1. Folstein’s Mini-Mental State
• Photographs (blur) Examination (27/30 or higher)
• other ‘leading’ information 2. Rapid assessment (understanding of
info given and justifying reason for
decision)
 Ethical Aspects of Nursing Research
WEEK 2
o Surrogate decision-makers (next of kin & in
order): spouse, children of legal age, parents,
brothers and sisters, court- appointed
guardian

True or false? - Consent was sought from the spouse of a participant with
dementia. She agreed to have her husband be part of the research which
involves observing his household behaviors. The researcher could still
push through with the study even though the participant is agitated and
restless with the researcher present in their home

Important point - “The surrogate decision maker and/ or researcher must

be sensitive to signs of dissent from the participant and must be
respected.” (PHREB, 2011)

5. INSTITUTIONAL REVIEW BOARDS (IRBs) - formal committees for

reviewing proposed research plans in terms of its ethical dimensions

Types of research misconduct

1. Fabrication - making up data results

2. Falsification - manipulating research materials, equipment, or
the process - changing or omitting data, or distorting results
3. Plagiarism - appropriation of someone’s ideas, results, or words
without giving due credit

In summary...

• Research has to scientifically sound and has to adhere with

ethical principles to be truly ethical.
• The researcher has an ethical obligation to the participants, to
the institution, and to the larger society and scientific
community.
• A person has an inherent dignity and is
• Self-determining (autonomous)
• Equal to other persons
• Protected against harm and wrong
• Treated with respectful manner
• An END and not a means

In summary...

“While truth is good, respect for human dignity is better.” (Cavan, 1977)

“Have the courage to do what’s right not because you have to but
because it’s the right thing to do. After all what is said & done,
remember that ETHICS is doing the right thing ... even if nobody is
watching.”