PRINCIPLES THAT GUIDE RESEARCH

ON HUMAN SUBJECTS
(WEEK – 13)
PROF. IMELDA ARCEO-DE LEON, RMT, MPA
CAHP-UERMMMCI

TOP OF THE LINE

MEDICAL SERVICE
PROVIDER
LEARNING OUTCOMES
1.Determine the rights of human research subjects and the concept of ethical
soundness

2.Interrelate critically historical events and their social and temporal contexts to
the establishment of ethical guidelines and standards in conducting research

3.Understand the Code of Nuremberg and Declaration of Helsinki

4.Articulate a critical understanding about Good Research Practices the

principles that Guide Research on Human Subjects

5.Discuss the composition and functions of the Bioethics Committee

 HUMAN RIGHTS,
RESEARCH AND CONCEPT
OF ETHICAL SOUNDNESS
 Historical Atrocities

a. Tuskegee Syphilis Research

b.  Willowbrook Research
c. Nazi Experiments
 Tuskegee Syphilis Experiments
• conducted by the US Public
Health Service
• Involved 600 black men, 399
with syphilis
• No informed consent
• Participants were denied with
information and treatment
Willowbrook Research (Hepatitis)

Mentally retarded children housed at the Willowbrook State

School in Staten Island, New York, were intentionally given
hepatitis in an attempt to track the development of the viral
infection. The study began in 1956 and lasted for 14 years.
Nazi Experiment (Jewish in concentration camp)

23 German physicians who participated in the Nazi program to

euthanize prisoners or who conducted experiments without consent
were tried.  16 of the doctors charged were found guilty.  7 were
executed.
BASIC CONCEPT ON ETHICS
•ETHICS - study of ideal human behavior
Eudaimonia - doing well & living well

Kantianism - set of universal moral principle for all human beings

irregardless of context or situation

•Moral philosophy
critical reflection about morality

•Microethics vs. Macroethics

Micro refers to moral dilemmas and issues -individual
researches, practitioners
Macro –collectively confronts scientific enterprise, profession
societal decision
•Pluralistic
several values that may be correct and fundamental
 The Code of Nuremberg and the
Declaration of Helsinki

The Declaration of Helsinki is designed to protect

human subjects participating in medical research. It
was developed from the Nuremberg Code, the
Declaration of Geneva, and the International Code
of Ethics.
Difference between Helsinki & Belmont Report

The Declaration of Helsinki of 1964 stressed the

importance of written consent forms.

The 1974 Belmont Report highlighted the 3

fundamental principles of respect for persons,
beneficence, and justice.
Principles that Guide Research on
Human Subjects
 PATIENTS RIGHT
Categories/Modes of Patients’ right
1. The right to preservation of Bodily Integrity& totality
2. The right to adequate health care
3. Right to Information
4. The right to confidentiality and Privacy
5. The right to self- determination (autonomy)
INSTITUTIONAL REVIEW BOARD must be established in every Academic/Research Institution
.     Good Research Practices
Composition of Bioethics Committee
• Representative from:
Specialty group
Bioethicist
Medico-legal (doctor-lawyer)
Chaplain with training on bioethics
Member of the community or a nursing staff or medical social service
Member of the administration(support)
 Fundamental Functions of
Bioethics Committee

1. Act as a consultative body

2. Educate and source of knowledge and enlightenment
3. Help or guide in policy formulation
4. Function as a recommendatory team
5. Craft, ethical guidelines or policies that will govern the
medical practice of health professionals.
The Bioethics Committee in Research for Healthcare
I. International Body
(WHO, COHRED, UNESCO)
COUNCIL FOR INTERNATIONAL ORGANIZATIONS OF
MEDICAL SCIENCES (CIOMS)

II. Local Body

(DOH, DOST-PCHRD, CHED, UP-NIH)
PHILIPPINE HEALTH RESEARCH ETHICS BOARD (PHREB)
IMPORTANCE OF BIOETHICS
• framework within which dilemmas can be analyzed and
decisions made
• resolve conflicts in basic values and identify alternatives that
best meet the patient’s needs
• clarify situations that extend beyond the scope of daily
practice
• advocate the rights of patients
• promote fair policies and procedures that lead to favorable,
patient-centered outcomes
SUBDISCIPLINES OF BIOETHICS (GOOD TO KNOW)

Medical Ethics aka healthcare ethics or

biomedical ethics
BIOETHICS
Public Health population level rather than
Ethics
patient-centered
Research Ethics standards of conduct for
scientific researches
Animal ethics animal rights, animal welfare,
use of animals
Environmental moral relationship of man to
Ethics the environment
BIOETHICS TIMELINE (Milestone)
ETHICAL/BIOETHICAL ISSUES IN THE PHILIPPINES

• Dengvaxia
• ActRx Triact Trials
• Reproductive Health Law
• In vitro Fertilization
• HIV/AIDS Law
• Bt Talong
• Planned Construction of Kaliwa Dam
• Garbage shipment from Canada, Hongkong
Scope of
 PRINCIPLES THAT GUIDE RESEARCH
ON HUMAN SUBJECTS

Ethical
Soundness FORMATIVE
LEARNING Historical
Define & know the
concept.

OUTCOMES
Events
2
Nuremberg Code
Articulate critical
understanding
Declaration of
Helsinki SUMMATIVE
Resolve ethical
Good dilemmas.
Research
Practice