Ethical Aspects in Health

Research
Dr. Godfrey G. Mendoza, LPT
Maestro
Background
 The ethical aspects of a proposed research study take
precedence over any other areas of the study. The rights of
study participants must be protected in all research studies
at all times.
 Why then, recall hearing about some unethical research?
(See examples presented).
 The need for ethical guidelines becomes clear after reading
these accounts of unethical research projects. The
development of appropriate guidelines is not simple. Ethics
is concerned with rules and principles of human behavior.
Because human behavior is very complex, rules to govern
the actions of human beings are difficult to formulate.
 Ethical principles frequently change with time and the
development of new knowledge.
Example #1: Jewish Experiment
 Between June and September 1944,
photographs and body measurements were
taken of 112 Jewish prisoners. They were
then killed, and their skeletons defleshed.
 One purpose of this study was to determine if

photographs from live human beings could

be used to predict skeletal size. The skeleton
collection was to be displayed at the Reich
University of Strasbourg (Nuremberg Military
Tribunals, 1949).
Example #2: Germany, World War II

1. Infecting women prisoners with syphilis,

having them impregnated by male
prisoners, then dissecting the live babies
and mothers.
2. Draining the blood from prisoners’ veins
and substituting horse blood.
3. Exploding gas gangrene bombs next to
prisoners tied to stakes.
4. ViVisecting prisoners to compile data on the
human endurance of pain.
Example #3: Syphilis
 One of the most widely known unethical studies was
carried out in 1932 in Macon County, Alabama by the
US Public Health Service. The study was titled
“Tuskegee Study of Untreated Syphilis in the Negro
Male.” Of the 600 black male subjects, 399 had
syphilis, and 201 did not have the disease. Subjects
with active cases were given no treatment. All subjects
were given free medical exams, free meals, and burial
expenses (Centers for Disease Control and Prevention,
2010). Even after penicillin was accepted as the
treatment of choice for syphilis in 1945, subjects were
still given no treatment. This unethical study became
common knowledge 40 years after it was begun. On
May 16, 1997, President Bill Clinton made a public
apology on behalf of the nation.
Example #4: Smallpox Vaccine
 Itis common knowledge that smallpox is no
longer a threat to the world. Few people
remember, or even know, that Edward Jenner
deliberately exposed an 8-year-old child to
cowpox to try out his new vaccine for
smallpox (Hayler, 1979).
Example #5: Cancer Clinical Trial
 Hundreds of women died for the sake of research in
cancer clinical trial (Bhatt, Feb. 13, 2017).
 The loss of lives at the expense of clinical research
raises many ethical questions that demand
consideration.

Example #6: Dengvaxia - ABS-CBN News 2018

 843, 890 - Vaccinated

 138 - Hospitalized

 8 - Died

Example #7: nCoV 2019?

 History
Code of Ethics
Codes of Ethics
Nuremberg Code – developed after Nazi Atrocities.
 The present ethical standards used in nursing research, and in

research conducted by other disciplines, are based on the

guidelines developed after World War II. The atrocities committed in
the German prison camps led to the Nuremberg Trials after the
war.
 The 1947 Nuremberg Code resulted from the revelations of

unethical human behavior that occurred during the war. This code
seeks to ensure that several criteria for research are met including
the following:
1. Potential subjects must be informed about the study .
2. The research must be for the good of society.
3. Animal research should precede research on humans, if possible.
4. An attempt must be made by the researcher to avoid injury to
research subjects.
5. The researcher must be qualified to conduct research.
6. Subjects or the researcher can stop the study if problems occurs.
 Many other ethical codes have been
developed since the Nuremberg Code. On
December 10, 1948, the General Assembly of
the United Nations adopted the Universal
Declaration of Human Rights (
http://www.un.org/en/documents/udhr).
 The World Medical Association adopted the
Declaration of Helsinki in 1964. Revised
several times, the sixth revision came in 2008
(http://wma.net/en/30publications/10policie
s/b3/index/html).
 In 1978 the National Commission for the Protection of
Human Subjects of Biomedical and Behavioral Research was
formed. The goals of this commission were to (a) identify
basic ethical principles that should guide the conduct of
research involving human subjects and (b) develop
guidelines based on principles that had been identified.
 The report titled “Ethical Principles and Guidelines for the
Protection of Human Subjects of Research,” published by
this commission in 1979, was titled “The Belmont Report,”
named after the Belmont Conference Center where the
document was drafted. It identified three basic principles
related to research subjects:
1. Respect for Persons – research subjects should have
autonomy and self-determination.
2. Beneficence – research subjects should be protected from
harm.
3. Justice – research subjects should receive fair and equal
treatment.
Philippines
Philippine National Health Research System
(PNHRS)

Philippine Health Research Ethics Board

(PHREB)

Developed the
 National Ethical Guidelines for Health and

Health-Related Research 2017

Cordillera Administrative Region (CAR) and
University Ethics Board/Committee
Cordillera Regional Health Research Development Consortium
(CRHRDC) – Accredited Level 1

National Commission for Indigenous People (NCIP) -

Accredited

Baguio General Hospital and Medical Center – Research Ethics

Board/Committee (BGHMC – REB / REC) – Accredited Level 2

Saint Louis University, Research Ethics Board/Committee (SLU

- REB/REC) – Accredited Level 1

University of the Cordilleras – Research Ethics

Board/Committee (UC – REB / REC) – for Accreditation Level 1
Ethical Principles for Protecting Study
Participants: 3 Broad Principles
1. Beneficence – imposes a duty on researchers
to “minimize harm” and “maximize benefits”.
a. The Right to Freedom from Harm and
Discomfort:
 The obligation of the researcher to avoid,

prevent, or “minimize harm” (non-maleficence).

 Must not be subjected to unnecessary risks for

harm or discomfort.
 Participation must be essential to achieving

scientifically and societally important.

2. Respect for Human Dignity:

2 Principles
a. Right to Self-determination – prospective
participants can voluntarily decide whether to take
part in a study, without risk or prejudicial treatment.
1. People have the right to ask questions.
2. Refuse to give information.
3. To withdraw from the study.
Inclusions:
a.1 Freedom from “Coercion” – involves threats of
penalty from failing to participate in a study.
 Excessive rewards from agreeing to participate.

a.2 “Stipend” – generous monetary incentive.

b. The Right to Full Disclosure – people’s right
to make informed, voluntary decisions about
study participants.
 Means that the researcher has fully described

the nature of the study, the person’s right to

refuse participation, the researcher’s
responsibilities, and likely risks and benefits.
 The Right to Self-determination and the Right

to Full Disclosure are the “Two Main Elements

on which Informed Consent is Based”.
3. Justice
a. The Right to Fair Treatment – means that
researchers must treat people who decline to
participate / who withdraw from the study in a
non-prejudicial manner; that they must honor
all agreements made with participants.
 Demonstrate respect for the beliefs, habits, and

lifestyles of people from different backgrounds

or cultures.

b. The Right to Privacy – participants have the

right to expect that their data will be kept in
“Strictest Confidence”.
Procedures for Protecting
Study Participants
1. Risk and Benefit Assessment
 Design to examine whether the benefits of
participating in a study are in line with the
costs, be they financial, physical, emotional, or
social – “RISK AND BENEFIT RATIO IS
ACCEPTABLE”.
 “Minimal Risk” – defined as risks no greater

than those ordinarily encountered in daily life

or during routine tests or procedures.
Note: Proceed with caution – taking every step
possible to diminish risks and maximize benefits
- risks to participants outweigh the anticipated
benefits – research should be “Redesigned”.
2. Informed Consent and Participant
Authorization
 The principal means for ensuring that the rights
of research subjects are protected.
 Important procedure for safeguarding study
participants.

INFORMED CONSENT – participants have adequate

information about the research, comprehend that
information, and have the ability to consent to or
decline participation voluntarily.
- Concerns subjects’ participation in research in
which they have full understanding of the study
before the study begins.
The Elements of Informed Consent:
1. Researcher is identified and credentials
presented.
2. Subject selection process is described.
3. Participant status.
4. Study goals or Purpose of the study is
described.
5. Type of data.
6. Study procedures are discussed.
7. Nature of the commitment.
8. Sponsorship.
9. Participant selection.
10. Potential risks are described.
11. Potential benefits are described.
12. Alternative procedures, if any, are disclosed.
13. Compensation, if any, is discussed.
14. Anonymity or confidentiality pledge is assured.
15. Voluntary consent (Right to refuse to
participate).
16. Right to withdraw and withheld information
from the study without penalty is assured.
17. Offer to answer all questions is made.
18. Means of obtaining study results is presented.
19. Contact Information (Researcher and
Participant).
3. Confidentiality Procedures
 Kept in “Strict Confidence”.
a. Anonymity – cannot link participants to their
data.
 Means that no one can identify the subjects in

a study.

b. Confidentiality – pledge that any information

participants provide will not be publicly
reported in a manner that identifies them, and
will not be accessible to others.
- Means that the researcher will protect the
subjects’ identities.
4. Treatment of Vulnerable Groups
Vulnerable Populations – may be incapable of
giving fully informed consent.
a. Children – when children are younger than 7
years, parental consent is sufficient. If a child
is older than 7 years, not only must the parent
consent to the child’s participation, but the
child must also agree to be in the study by
giving assent to participate.

“ASSENT” – means that an underage child or

adolescent freely chooses to participate in a
study.
b. Mentally or Emotionally Disabled People –
obtain written consent from the person’s legal
guardian.
c. Severely ill or Physically Disabled People (Ex:
Deaf – writing).
d. The Terminally ill – health care and comfort
are not compromised.
e. Institutionalized People / Hospitalized
People / Inmates in Prisons.
f. Pregnant Women – safeguard both the
pregnant woman and fetus; cannot involved in
a study unless risks to them and the fetus are
minimal and must meet women’s health needs.
Vulnerable Groups and Individuals
Guidelines:
 Some groups and individuals are particularly
vulnerable and may have an increased likelihood
of being wronged or of incurring additional harm.
 All vulnerable groups and individuals should

receive specifically considered protection.

 Medical research with a vulnerable group is only

justified if the research is responsive to the

health needs or priorities of this group and the
research cannot be carried out in a non-
vulnerable group. In addition, this group should
stand to benefit from the knowledge, practices or
interventions that result from the research.
5. External Reviews and the
Protection of Human Rights
 Formal Committees – responsible in reviewing
proposed research plans.
a. Human Subjects Committees.
b. Ethical Advisory Boards.
c. Research Ethics Committees.
c.1. Institutional Review Board (IRB).
c.2. Research Ethics Board (REB) or Research
Ethics Committee.
6. Other Ethical Issues
a. Ethical Issues in Using Animals in Research
 For Biomedical and Behavioral Research.
 Physiologic mechanisms and to test
interventions that could pose risks to
humans.
Ex: Animal Research Ethics by Gilbert, et.al.,
2009; and The Ethics of Research Involving
Animals by Nuffield Council on Bioethics, 2005

b. Ethical Issues in Using Plants in Research

Ex: PHREB and PNHRS
7. Research Misconduct (Scientific
Misconduct)
 The US Public Health Service Regulation (2005).
a. Fabrication – involves making up data or study
results.
b. Falsification – involves manipulating research
materials, equipment, or process; it also
involves changing or omitting data or
distorting results.
c. Plagiarism – appropriation of someone’s ideas,
results, or words without giving credit,
including information obtained through the
confidential review of research proposals or
manuscripts.
Data Privacy Act of 2012
Data Privacy Act of 2012
 Provisions of this law have clear implications
on how human research data are collected,
stored, accessed, and used.
 Serves to concretize the ethical practice of

research thru:
a. Transparency – “Openness”
b. Legitimate purpose – “Consent”
c. Proportionality – “Only what is necessary”
End of the topic…next topic…
Components of Research
Process