This document discusses key principles of research ethics including guidelines for authorship, the Nuremberg Code, Declaration of Helsinki, Belmont Report, and Philippine laws and guidelines. Ethical research requires voluntary informed consent, favorable risk-benefit ratio, scientific validity, fair subject selection, and independent review. Research ethics aims to protect human subjects and ensure scientific integrity by applying principles like respect for persons, beneficence, and justice.

1. RESEARCH ETHICS
Helen V. Madamba, MD MPH-TM

2. Ethical Guidelines on
Authorship and Publication
Who is an author?
1. Substantial contributions to the conception or
design of the work; or the acquisition, analysis, or
interpretation of data for the work; AND
2. Drafting the work or revising it critically for
important intellectual content; AND
3. Final approval of the version to be published; AND
4. Agreement to be accountable for all aspects of the
work in ensuring that questions related to the
accuracy or integrity of any part of the work are
appropriately investigated and resolved.
http://www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html

3. RESEARCH ETHICS
Research ethics is the
application of ethical
principles to provide
guidance in the responsible
conduct of scientific
research.

4. Nuremberg Code
10-point guideline
developed as a result of
subsequent Nuremburg
trials, the Doctors Trial of
1946-1947, that prosecuted
23 German Nazi physicians
who carried out torturous
experiments on
concentration camp
prisoners.

5. Nuremberg Code
1. Voluntary human consent is essential.
2. Experimental results should result in good for society.
3. Anticipated results should justify the experiment.
4. Avoid all necessary physical and mental suffering
5. No experiment if there is a chance of death/disability
6. Minimize risk of subjects
7. Proper preparations and facilities to protect subjects
8. Experiments conducted only by qualified persons
9. Subjects can withdraw at anytime
10. Terminate experiment if results are known or with
best judgment.
https://history.nih.gov/research/downloads/nuremberg.pdf

6. Declaration of Helsinki 1964
• a set of ethical principles regarding human
experimentation developed for the medical
community by the World Medical Association
(WMA)
• the cornerstone document on human research
ethics.
https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/

7. Belmont Report 1979
• Guidelines issued by the US National
Commission for the Protection of Human
Services of Biomedical and Behavioral Researc
in 1979 in response to the Tuskegee syphilis
experiments performed from 1932 to 1972.
• Three main principles:
• Respect for persons: participants know about and
consent to research
• Beneficence: do no harm, maximize benefits,
minimize risks
• Justice: fair distribution of costs/benefits to all
potential participants
https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html

8. Council for International Organizations of
Medical Sciences (CIOMS)
in collaboration with the World Health
Organization developed the International
Ethical Guidelines for Biomedical
Research Involving Human Subjects with
the intent to apply the provisions in the
Declaration of Helsinki in developing
countries.
https://cioms.ch/

9. DOST Administrative Order 001-2007
• Requires the review of all health researches
involving human subjects/participants
• Establish research ethics committees that will
evaluate and monitor researches involving
human subjects/participants
• In accordance with National Ethical Guidelines
for Health Research
http://www.ethics.healthresearch.ph/index.php/orders-and-memorandums/
10-orders-and-memos/219-dost-administrative-order-001-series-of-2007

10. Republic Act 10532
http://www.ethics.healthresearch.ph/index.php/orders-and-memorandums/
10-orders-and-memos/219-dost-administrative-order-001-series-of-2007
An act
institutionalizing the
Philippine National
Health Research
System

11. Medical research is subject
to ethical standards that
promote and ensure
respect for all human
subjects and protect their
health and rights.
Declaration of Helsinki

12. 1. Social or scientific value
2. Scientific validity
3. Fair subject selection
4. Favorable risk-benefit ratio
5. Independent review
6. Informed consent
7. Respect for potential and enrolled subjects
https://www.ncbi.nlm.nih.gov/pubmed/10819955

13. Social or scientific value
• Responsible use of limited resources –
clinical, manpower, financial
• Avoidance of exploitation of human
participants
• Address and help resolve a health issue
which is relevant to the subject population
and community
• Justifications are stated in the significance
of the study
• Publication of results in scientific journals
or presentation in scientific meetings
• To teach and train the next generation of
researchers to learn the scientific method
DR Benavides. Clinical Practice Guidelines for Ethics Review in POGS Research Handbook: The Essentials.

15. Scientific validity
• For a research to be ethically sound, it must
be technically sound
Declaration of Helsinki, Principle 21:
Medical research involving human subjects
must conform to generally accepted scientific
principles, be based on a thorough knowledge
of the scientific literature, other relevant
sources of information, and adequate
laboratory and, as appropriate, animal
experimentation.
DR Benavides. Clinical Practice Guidelines for Ethics Review in POGS Research Handbook: The Essentials.

16. Scientific validity
• A research must be conducted in a
methodologically rigorous manner and
contain the following elements:
1. Clear scientific objective
2. Research design based on accepted
principles
3. Reproducible and feasible methodology
4. Sufficient power and sufficient number of
subjects to definitely test the objective
5. Plausible data analysis plan
DR Benavides. Clinical Practice Guidelines for Ethics Review in POGS Research Handbook: The Essentials.

17. Fair subject selection
JUSTICE – there is an ideal distribution of risks and
benefits when recruiting participants in clinical
trials
• Scientific objective should be the basis for
selection of study sites and subject population
• Clear description of the inclusion and exclusion
criteria
• Probability sampling
• Higher probability of risk and severity of harm
that should be the reasons why certain groups
are to be excluded
DR Benavides. Clinical Practice Guidelines for Ethics Review in POGS Research Handbook: The Essentials.

18. Favorable risk-benefit ratio
• Benefit is defined as a valued or desired
outcome: an advantage.
• Risk is the probability of harm or injury
occurring as a result of participation in the
study
DR Benavides. Clinical Practice Guidelines for Ethics Review in POGS Research Handbook: The Essentials.

19. Favorable risk-benefit ratio
• Risk justified only if consistent with scientific
aims of the study, and the relevant standards
of clinical practice, three conditions are
fulfilled:
1. The potential risks to individual subjects
are minimized
2. The potential benefits to individual
subjects are enhanced
3. The potential benefits to individual
subjects and society are proportionate to
or outweigh the risks
DR Benavides. Clinical Practice Guidelines for Ethics Review in POGS Research Handbook: The Essentials.

20. Favorable risk-benefit ratio
• Declaration of Helsinki, Principle 16:
Medical research involving human
subjects may only be conducted if
the importance of the objective
outweighs the risks and burdens to
the research subjects.
DR Benavides. Clinical Practice Guidelines for Ethics Review in POGS Research Handbook: The Essentials.

21. Favorable risk-benefit ratio

22. Favorable risk-benefit ratio
Risk- benefit assessment can be achieved
using these steps
1. Identifying and minimizing risks
2. Enhancement of potential benefits
3. Weighing in and comparing the risks
and potential benefits of the clinical
research interventions to individual
subjects
DR Benavides. Clinical Practice Guidelines for Ethics Review in POGS Research Handbook: The Essentials.

23. Independent review
• Declaration of Helsinki, Principle 23
The research protocol must be submitted for
consideration, comment, guidance and approval
to the concerned research ethics committee
before the study begins. This committee must be
transparent in its functioning, must be
independent of the researcher, the sponsor and
any other undue influence and must be duly
qualified. It must take into consideration the laws
and regulations of the country or countries in
which the research is to be performed as well as
applicable international norms and standards.
DR Benavides. Clinical Practice Guidelines for Ethics Review in POGS Research Handbook: The Essentials.

24. Informed consent
• Respect for persons is based on the fundamental
ethical principle of AUTONOMY, which states
that each person has the right to self-
determination, the right of a competent person
to decide and choose what is in his/her best
interest.
• Process by which a person voluntarily confirms
his or her willingness to participate in a
particular trial, after having been adequately
informed of all aspects of the trial that are
relevant to the decision to enroll or to continue
participation.
DR Benavides. Clinical Practice Guidelines for Ethics Review in POGS Research Handbook: The Essentials.

25. Informed consent
https://www.who.int/rpc/research_ethics/informed_consent/en/

26. Respect for potential and
enrolled subjects
• Participants must be treated with respect
throughout and even after the participation
in the study
1. Respect for privacy and confidentiality
2. Permitting withdrawal
3. Providing new information
4. Monitoring welfare
5. Informing subjects of results of clinical
research
DR Benavides. Clinical Practice Guidelines for Ethics Review in POGS Research Handbook: The Essentials.

30. RESEARCH ETHICS
Helen V. Madamba, MD MPH-TM