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University of Santo Tomas

Senior High School
Grade 12- Practical Research 2

Ethics in Research

Jerry V. Manlapaz, RN, PhD, EdD, LPT

Ethics
- Derives from a Greek word “ethikos”. It refers to the rules of conduct
recognized in certain associations or departments of human life.
- A system of thinking and adoption of moral principles, rules and
perspective that becomes standards for professional conducts
- Ethical guidelines are developed consistent with the rules and norms of
human based on Christian Morality and Ethics. The code of ethics of the
University of Santo Tomas states that “the professional conduct and
relations of the researcher shall be based on respect for human rights and
dignity, honor, justice, truthfulness, freedom, solidarity and personal
integrity.
Bioethics- application of ethics in the conduct of biological and medical research.
Principles must be universal

Basis for Ethical Standards

1. Nuremberg Code
- it was developed in 1949 borne out of Nuremberg trials
- the code stipulated the following as essential requirements of ethical
research which are, voluntary consent , withdrawal of subjects from the
study, protection of subjects from physical and mental suffering, injury,
disability and dearth, balance of benefits and risk.
Sections of the Nuremberg Code

1. The voluntary consent of the human subject is absolutely essential…

2. The experiment should be such as to yield fruitful result… and not random and
unnecessary in nature.
3. The experiment should be so designed and based on… knowledge that
anticipated results will justify the performance of the experiment.
4. The experiment should… avoid all unnecessary physical and mental suffering
and injury.
5. No experiment should be conducted where there is an a priori reason to believe
that death or disabling injury will occur; except… where the experimental
physicians also serve as subjects.
6. The degree of risk to be taken should never exceed… the importance of the
problem to be solved by the experiment.
7. Proper preparations should be made and adequate facilities provided to protect
the experimental subject against even remote possibilities
8. The experiment should be conducted only by scientifically qualified persons.
9. During the course of the experiment, the human subject should be (able) to bring
the experimental to an end….
10. During the course of the experiment, the scientist… must be prepared to
terminate the experiment… if he (or she) has probable cause.... that a
continuation of the experiment is likely to result in injury, disability, or death to the
experimental subject.
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2. Declaration of Helsinki
- adopted by the World Medical Association in 1964
- it was last updated in 2000
- the main contribution of this document was the introduction of the
distinction between therapeutic and non -therapeutic research.
- in therapeutic research the patient could benefit from experimental
treatment that might have beneficial results. In non-therapeutic research,
the main goal is the generation of new knowledge which might produce
beneficial results to future patients but less likely to the actual research.
3. CIOMS ( Council for International Organizations of Medical Science )
- created in 1993 by CIOMS and was updated in 2002
- formally known as International Ethical Guidelines for Biomedical
Research Involving Human Subjects
- is a set of medical experimentation
- the 21 guidelines, fifteen of which were in the original report, addressed
issues including informed consent, standards for external review,
recruitment of participants, etc.
- the guidelines are general instructions and principles of ethical biomedical
research
4. Belmont Report
- on July 12, 1974, the National Research Act was signed into law thereby
creating the National Commission for the Protection of human Subjects of
Biomedical and Behavioural Research
- the commission was to identify the basic ethical principles that should
underlie the conduct of biomedical and behavioural research involving
human subjects and to develop guidelines tom assure that such research
of this sort is conducted in accordance with those principles.
- The report was published by the commission in 1979 was titled “The
Belmont Report”. The report has the following considerations:
a. The boundaries between biomedical and behavioural research and the
accepted and routine practice of medicine
b. The role of assessment of risk-benefit criteria in the determination of
the appropriateness of research involving human subjects;
c. Appropriate guidelines for the selection of human subjects for the
participation in such research;
d. The nature and definition of informed consent in various research
settings

Why Should There Be Ethical Consideration in Research?

Since research studies deal primarily with human subjects, there is a concern for
protecting individuals from any harmful effects that might result from their
participation in a study. Thus, ethical guidelines are needed. Specific guidelines also
apply to those who involved in research whether as respondents, participants, or
investigators.

The Basic Human Rights

1. Right to self-determination (Autonomy)

- autos meaning self and monos meaning rule governance or law
- able to see, judge and decide what is logical and best for the person to
survive and enjoy living.
- it involves self determination and freedom to choose and implement ones
decision free from deceit, constraint and coercion.
- autonomous person has the ability to; understand, reason out, deliberate
and make and independent choice.
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The researcher should obtain voluntary consent from the research participant.
Informed consent must include the following elements.

Six elements of informed consent

a. Explanation of the purpose of the study

b. Explanation of potential risks and discomfort
c. Explanation of potential benefits
d. An acknowledgement that researchers will answer any questions that the
subject may have concerning the study
e. An acknowledgement that subjects can withdraw at any time
f. An assurance of anonymity and confidentiality

2. Right to privacy and dignity

The type of date collected may be highly sensitive with respect to the subjects’
privacy and dignity; information may be of income, marital status, personal
activities, opinions, beliefs, and attitudes. Thus, the researcher must handle
information discretely so as to keep the privacy of the subject intact. In
addition, the use of cameras, tape recorders, diaries, and patient records may
easily be construed as an invasion of privacy.

The researcher is obligated to make sure that the subjects clearly understand all
procedures so that they can make an information decision about participating in a
study.
individual control over access to himself or herself extending to physical or
informational inaccessibility.

3. Right to anonymity and confidentiality

Anonymity refers to keeping individuals nameless and limiting access to

information collected about a subject. Confidentiality refers to protecting data by
not divulging without permission any information obtained while caring for a
patient, such as when the information may carry stigma - diagnosis of mental
illness, evidence of domestic violence, or a prison record.

4. Right to fair treatment

The researcher must observe the principle of justice when dealing with research
participants. The participants need to be informed about the purpose of the
study, the procedure in the study, and the description of compensation for
medical treatment, if any.

5. Right to freedom from injury (Nonmaleficence)

- an obligation not to inflict harm intentionally

- primun non nocere maxim of medical ethics which means above all do
no harm to anyone
- researcher should protect subjects from physical and/or emotional injuries
that may result from participating in the research study.
- If there is potential harm, the subjects must be informed of it before their
consent is obtained.
6. Beneficence- actions done for the good and benefit of others
7. Veracity- in its basic meaning is truthfulness.
8. Fidelity- the act in good faith and to keep vows and promises, fulfil agreements ,
maintain relationships
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How to Ensure Protection of Human Rights

1. Obtainment of informed consent from respondent/participant.

2. Review of study protocols by an ethics committee, which is often referred to as

an Institutional Review Board (IRB).

What is an Institutional Review Board?

An Institutional Review Board is a group responsible for ensuring that

researchers do not engage in unethical behavior or conduct poorly designed research
studies.The major responsibility of an IRB is to review research proposals at convened
meetings to ensure that established guidelines are followed. The IRB ensures that the
researcher is not violating the rights of the human subjects. The board also reviews the
procedure in selecting subjects, thus, ensuring voluntary informed consent and
confidentiality.

Scope and Coverage of Bioethics

1. Clinical trials
2. Experimental research involving human subjects
3. Gene cloning, genetic screening, and genetic engineering
4. Human reproductive studies and in vitro fertilization
5. Stem cell research
6. Trials involving laboratory animals
7. Euthanasia

Vulnerable subjects for research

1. Pregnant women
2. Children
3. Elderly
4. Mentally ill patients
5. Terminally ill patients
6. Endangered species

Dr. Jerry V. Manlapaz