Davao Medical School Foundation

Department of Community and Family Medicine

Epidemiology Section

Notes on Ethics in Research

Alvin S. Concha, MD

1. Research
• Asking questions
• Generating answers through a rigorous process
• Communicating the new information
• Knowledge/information production
• Advancement of medicine through research

2. The thing about research

Research participants may be unduly harmed
 1796: Edward Jenner inoculated healthy 8-year-old James Phipps with cowpox,
then 3 months later with smallpox, and was hailed as the discoverer of smallpox
vaccine (From lecture of Prof Edlyn Jimenez)
 1900: Walter Reed infected 22 Spanish immigrants in Cuba with the agent for
yellow fever, paying them $100 if they survive and $200 if they contract the
disease; first “informed consent” (From lecture of Prof Edlyn Jimenez)
 1906: Richard Pearson Strong, then head of the Philippine Biological Laboratory,
inoculated 24 men--inmates of Manila's Bilibid Prison--with a cholera vaccine
that somehow had been contaminated with plague organisms; 13 men died.
 1970: Laud Humphreys published Tearoom Trade, a study on “deviant behavior”;
the book described how he pretended to be a lookout for men who had fellatio in
public restrooms. Humphreys copied their car plate numbers to get their
addresses, and interviewed the men by pretending to be a market researcher.
 -Nazi medical experiments
 Tuskegee Syphilis Study

3. Ethical guidelines
(From lecture of Prof Edlyn Jimenez)

Nuremberg code (1947)

− Principles resulting from the Nuremberg Trials (the Doctors’ Trial) (1945-49)
− 23 leading German physicians and administrators – for conspiracy, war
crimes, crimes against humanity, membership in criminal organization
− principles
 informed consent (autonomy)
 absence of coercion (autonomy)
 properly formulated scientific experimentation
 beneficence towards experiment participants

Declaration of Helsinki (1964)

− By World Medical Association, amended several times
− First significant effort of the medical community to regulate itself
− Principles
 respect for the individual
 right to self determination (autonomy)
 research should be based on a thorough knowledge of the scientific
background
 research must have a reasonable likelihood of benefit to the population
studied (beneficence)
  research must be conducted by suitably trained investigators using
approved protocols, subject to independent ethical review and
oversight by a properly convened committee

CIOMS Guidelines
− International Ethical Guidelines for Biomedical Research Involving Human
Subjects
− By the Council for International Organizations of Medical Sciences
− 1993; revised 2002
− “To indicate how the ethical principles that should guide the conduct of
biomedical research involving human subjects, as set forth in the Declaration
of Helsinki, could be effectively applied, particularly in developing countries,
given their socioeconomic circumstances, laws and regulations, and executive
and administrative arrangements.”
− Principles
 Respect for persons
 Beneficence
 Justice
− Guidelines
 Scientific validity
 Ethical review committee
 Individual informed consent
 Undue inducement
 Benefits/risks to participation
 Populations/communities with limited resources
 Equitable distribution of burdens and benefits
 Vulnerable persons
 Children
 Mental/behavioral incapacitated to consent
 Women
 Pregnant women
 Confidentiality
 Right of injured to treatment and compensation
 Strengthening capacity for review
 Obligations of sponsors

National Ethical Guidelines for Health Research (2006) (Philippines)

− Research Ethics Review Process
− General Ethical Guidelines for Health Research
− Special Guidelines
 Ethical Guidelines for Clinical Trials on Drugs, Devices, and
Diagnostics
 Ethical Guidelines for Herbal Research
  Ethical Guidelines for Complementary and Alternative Medicine
Research
 Ethical Guidelines for Epidemiologic Research
 Ethical Guidelines for Social and Behavioral Research
 Ethical Guidelines for the Conduct of Research on Populations
Traumatized in Emergencies and Disasters
 Ethical Guidelines for HIV/AIDS Research
 Ethical Guidelines for Research on Assisted Reproductive Technology
 Ethical Guidelines for Genetic Research with a Section on Stem Cell
Research
 Ethical Guidelines for International Collaborative Research
− Guidelines on Authorship and Publication

4. Ethical principles
Non-maleficence
Research must not cause harm to the participants in particular and to people in general.

Harms that research can cause

 psychological harm
 social harm
 legal harm
 harm to dignity

Deception
 non-disclosure of adequate information
 giving of incorrect information about the research
 An ethics committee might allow non-disclosure of all information, provided:
 detailed justification that there is no alternative means
 harm is “minimal”
 respect of participants’ rights and welfare
 disclosure about aspects that would affect willingness to participate
 rest of information, especially of risks involved, are revealed
 debriefing will be made available

Beneficence
Research should also make a positive contribution towards the welfare of people.

Researcher’s responsibility
− Ensure that the research is consistent with
− protection of life
 − improvement of human existence
− protection and improvement of the environment
− advancement of the science profession
− Give back the results of the research to the community

Autonomy
Research must respect and protect the rights and dignity of participants.

Informed consent
• Consent given by a competent individual who has received the necessary
information, who has adequately understood the information, and who after
considering the information, arrived at a decision without having been subjected
to coercion, undue influence or intimidation.

Voluntariness
 Contracts are voidable when consent is obtained by:
− mistake: substance of or conditions in the contract
− violence: irresistible force
− intimidation: reasonable fear of imminent danger
− undue influence: taking improper advantage of power
− fraud: insidious words or machinations
 Non-written consent must be documented
 For a minor child (below 18 years), insane, deaf-mutes or those who cannot write,
consent of a legally authorized representative PLUS assent of the mentally
competent participant are required
 A man’s supplemental consent may be accepted, but in no case may a competent
adult woman be enrolled in research solely upon the consent of another person.
Her individual consent is always required
 If the community consents to participate, individuals may still refuse to
participate; if the community does not consent, individual members of the
community should not be approached for study enrollment

Inducement
• excessive or inappropriate reward or other overtures to obtain compliance
− payment
− offers of subject credits to students
− promises of leniency to prisoners

Contents of the informed consent

 Title, aims and duration of the study
 What you will do to the participants and what their participation will be
 Risks in joining the study
 Benefits in joining the study, including fees for participation
  Declaration of the following participant rights:
 Right to refuse consent
 Right to withdraw from the study anytime
 Right to confidentiality of personal information
 Right to access of information of study results and anything pertinent to
participation
 A statement, below which the participant signs that he or she has understood all
the provisions in the form and has given voluntary consent to join the study.

Justice
The benefits and risks of research should be fairly distributed among people.

When involving communities

 Understand, appreciate and respect historical, cultural and social values and
beliefs of the community
 Do courtesy calls
 Acquire permission from the mayor, barangay captain, village chief or community
leader
 Ensure that recruited participants and communities benefit from the conduct and
results of the research
 Ensure equal representation of all sectors (women, indigenous people, prisoners)
 Share fairly the benefits and rewards of the research

5. Privacy and confidentiality

Privacy is the right of persons not to share information about themselves. (Dunn and
Chadwick 2004)

Confidentiality is the obligation to keep private information that has been collected from
being shared with others. (Dunn and Chadwick 2004)

Identifiers (From lecture of Dr Vicente Belizario)

• Names
• all geographic information
• all elements of dates (except year), including birth, death, admission and
discharge dates
• Telephone numbers
• Fax numbers
• Email addresses
• Social security numbers
• Medical record numbers
• Health plan beneficiary numbers
• Account numbers
• Certificate/license numbers
• Vehicle identifiers and serial numbers including license plate numbers
 • Device identifiers and serial numbers
• Web URL
• IP address
• Biometric identifiers, including finger and voice prints
• Full face photographic images and any comparable images
• Any other unique identifying number, characteristic or code

Ethically and legally valid disclosure of health information (From lecture of Dr Vicente
Belizario)
 De-identified (coded) health information
 Publicly available health information, e.g., those published in research
 Mandatory reporting laws
− RA 8504 – Philippine AIDS Prevention and Control Act of 1998
− RA 3573 – Law on Reporting of Communicable Diseases (e.g., SARS,
dengue)
 Judicial and administrative proceedings
 Law enforcement activities, e.g., compulsory HIV testing

6. Authorship
 “Authorship matters greatly: it is at the centre of academic life” (R Horton, R
Smith)
 An “author” is generally considered to be someone who has made substantive
intellectual contributions to a published study
 Can be power-driven
 "each author should have participated sufficiently in the work to take full
responsibility for the content." (International Committee of Medical Journal
Editors - Vancouver Group)

Basis for authorship (International Committee of Medical Journal Editors - Vancouver

Group)
 Substantial contributions to
A. Conception and design, or analysis and interpretation of data
B. Drafting the article or revising it critically for important intellectual content
C. Final approval of the version to be published
 "conditions (A), (B), and (C) must all be met"

Contributors
 Those who do not meet the criteria for authorship; listed in an acknowledgements
section and their contribution should be specified
− Provided purely technical help, writing assistance or general support
− Financial and material support
− Clinical investigators or participating investigators
− Scientific advisors, reviewers, collected data or cared for study patients
7. Animal Research
The dominant ethical position, world-wide, is that achievement of scientific and medical
goals using animal testing is desirable, provided that animal suffering and use is
minimized.

The British government has additionally required that the cost to animals in an
experiment be weighed against the gain in knowledge.

Arguments against animal research

− Tom Regan: animals have moral rights; animals are beings with beliefs, desires
and self-consciousness
− Bernard Rollin: any benefits to human beings cannot outweigh animal suffering,
and that human beings have no moral right to use an individual animal in ways
that do not benefit that individual
− Peter Singer: there is no convincing reason to include a being's species in
considerations of whether their suffering is important in utilitarian moral
considerations

R.A. 8485 (Animal Welfare Act of 1998

 aims to protect and promote the welfare of all animals in the Philippines

SECTION 6: It shall be unlawful for any person to torture any animal, or to neglect to
provide adequate care, sustenance or shelter, or maltreat any animal or to subject any
dog or horse to dogfights or horsefights, kill or cause or produce to be tortured or
deprived of adequate care sustenance or shelter, or maltreat or use the same in
research or experiments not expressly authorized by the Committee on Animal
Welfare.

The killing of any animal other than cattle, pigs, goats, sheep, poultry, rabbits,
carabaos, horses, deer and crocodiles is likewise hereby declared unlawful except in
the following instances:

1. When it is done as part of the religious rituals of an established religion or sect or a

ritual by tribal or ethnic custom of indigenous cultural communities. However,
leaders shall keep records in cooperation with the Committee on Animal Welfare;

2. When the pet animal is afflicted with an incurable communicable disease/s

determined and certified by a duly licensed veterinarian;

3. When the killing is deemed necessary to put an end to the misery suffered by the
animal as determined and certified by a duly licensed veterinarian;

4. When it is done to prevent an imminent danger to the life or limb of a human

being;
 5. When done for the purpose of animal population control;

6. When the animal is killed after it has been used in authorized research or
experiments; and

7. Any other ground analogous to the foregoing as determined and certified by a

licensed veterinarian.

In all the above mentioned cases, including those of cattle, pigs, goats, sheep, poultry,
rabbits, carabaos, horses, deer and crocodiles, the killing of the animals shall be done
through humane procedure at all times.

For this purpose, humane procedures shall mean the use of the most scientific methods
available as may be determined and approved by the committee.

Only those procedures approved by the Committee shall be used in the killing of animals.

8. Bottomlines
 Research is very important but it can be harmful to participants, communities or even
to the researchers

 Research processes must be ethically regulated

 There are international, national and local guidelines that follow widely-accepted
ethical principles; these guidelines can be used for reference in designing research
methods

 Screening by Ethics Review Boards allows proper weighing of risks and benefits of
certain research procedures; risks may not always be avoided, but they can be
managed