DISCLOSURE

This lecture was prepared using some slides from

previous lectures/presentations on the subject.
“Experimenting on human beings is morally
necessary and necessarily immoral”
Jean Bernard
“Research is useful and necessary but pose a
moral problem:
scientific gain vs ethical pain.”
The Ethical Researcher
Qualified (education and training)
Of unquestionable moral values
Competent and diligent
Follows rules and regulations
Honest and trustworthy
Commands respect and is respectful himself
Humble
The ethical researcher avoids /refuses to commit
any form of scientific misconduct even under
duress or promise of financial, professional, or
social gains
Milestones in Health Research Ethics
William Beaumont
First code that focused on human experimentation
(1833)
“the voluntary consent of the subject is
necessary…
the experiment is to be discontinued when it
causes distress to the subject…
The project must be abandoned when the
subject becomes dissatisfied”
Nuremberg Code for Ethical Research (1947)
Properly formulated scientific experiments with
previous animal experimentation
Protection of human subjects: voluntary
consent, absence of coercion, beneficence, no
unnecessary suffering and injury
Required scientifically qualified researchers.
World Medical Association Declaration of Helsinki
1964 (amended the latest in 2008)
Subject autonomy with informed consent
Importance to individual subject welfare more
than the interests of science or society
Ethical over legal considerations
Basic Ethical Principles:
Beneficence, Non-maleficence, Autonomy,
Justice
Research committee approval, informed and
proxy consent and standard of care.
William Beaumont Nuremberg Code Declaration of Helsinki

Focus: Human
experimentation
“the voluntary Properly formulated Subject autonomy with informed
consent of the scientific experiments consent
subject is with previous animal
necessary… experimentation Importance to individual subject
welfare more than the interests of
the experiment is to Protection of human science or society
be discontinued subjects: voluntary
when it causes consent, absence of Ethical over legal considerations
distress to the coercion, beneficence,
subject… no unnecessary Basic Ethical Principles:
suffering and injury Beneficence, Non-maleficence,
The project must be Autonomy, Justice
abandoned when the Required scientifically
subject becomes qualified researchers. Research committee approval,
dissatisfied” informed and proxy consent and
standard of care.
International Guidelines for Biomedical Research
Involving Human Subjects drafted by
Council for International Organization of Medical
Sciences (CIOMS) in 1982, updated 2008
Identified the general principles of Beneficence,
Respect for person and Justice
Specified guidelines for ethical review, informed
consent, vulnerable groups and women
Special circumstances in developing countries were
addressed with special considerations:
Cannot be carried out in developed countries
Responsive to health needs and priorities of the
community
Approved by Ethics Review Committee in both
initiating and host countries
Detailed accounts of responsibilities of sponsors
and institutions
BENEFICENCE

Valuing the Person as an End

Respect for person
One of the principles embodied in the Belmont
report of 1979 for the protection of human
participants in research:
Protecting the person from harm
(non- maleficence) and
Making efforts to secure the person’s well being
Spells out boundaries between practice and
research in both social sciences and medical
science research
“Act in such a way that you treat human humanity
both in your own person and in the person of all
others, never as a means only but always equally
as an end.”

Kant
Valuing the Person as someone to Protect from
Harm and Wrong

NON-MALEFICENCE
Defined as “doing no harm” .. “doing no wrong”
(to present participant and/or future user; to
community, environment, science)

In research, it means making sure that no

intentional harm/wrong may be caused by doing
the research
Types of Harm
Harm to participants and others
Harm to the environment
Harm to community and society
Harm to science
Quantification of risk
Minimal.. Probability is not greater than those
experienced in ordinary daily life (ex. surveys)

More than minimal .. Probability is greater than

those experienced in ordinary life but will not
result in any serious/prolonged/permanent harm
to participant (usually anticipated and prepared for
by ordinary safeguards)
Ex. repeated blood extractions in children
Moderate.. Harm is highly probable, the
consequences may be prolonged and sometimes
unavoidable/uncontrollable; thus more than
ordinary monitoring and safeguards are needed)
ex. new medical device
More than moderate.. Probability of serious harm
is so apparent that a serious review of benefits
should be done if study is to be approved at all.
Ex. behavioral studies that have far reaching life-
style consequences
Weighing risks against benefits
Benefits are greater than risks….. Ideal

 Risks are greater than benefits…..

is not necessarily a non-justifiable research

However, risks and benefits are often non-

quantifiable
Harms/risks … while can be foreseen, can never
be completely avoided when doing research

But to intentionally cause them against no

foreseen benefit at all is what the principle of
NON-MALEFICENCE is all about.
Valuing the Person as one with Dignity

AUTONOMY
Respecting the person
As one with feelings
As one with previous experiences
As one with his own values and beliefs
As one with dignity and self-worth
That make him
Capable of deciding for himself, unless that
capability has been taken away from him
Autonomy.. freedom of each individual to control
his or her own life
Informed consent document
basically explaining the reason for recruiting the
participant,
written in a language that the participant can
understand and
has a section for signatures and
dates when signatures were taken
Purpose of informed consent document
(ICD)
Primarily
To protect research participants (from possible
injustice, exploitation, misinformation, doubts)
and to promote their welfare and interests.
Secondarily,
The IC is taken to protect the researcher,
institution, or sponsor from undue claims and
expectations of participants

The IC takes the form of a socio-legal as well

as a moral document.
Thirdly,
The IC is taken to help protect quality of
research..

… tends to increase participants’ adherence to

protocol.
Informed consent process

Element of full disclosure begins when initial

contact is made with a prospective participant to
inform him
 WHY he is being recruited
 WHAT the study is all about
 HOW the study will proceed
 WHO is recruiting him
Minimum Information in ICD:
That this is a research
That the procedure/drug being tested is not yet
used as a standard of care (if applicable)
That participation is voluntary
That there will be confidentiality of data/record
That compensation for joining the study will be
(or will not be) available
That injuries related to or sustained during the
study will be treated without expense to the
participants (and shouldered by
investigator/sponsor)
That participant can withdraw from study anytime
without prejudice to receiving further
treatment
That the participants’ responsibility includes
disclosure of past medical history, follow-up
visits, disclosure of non-compliance, etc;
injuries sustained while under the study.
Element of Adequate Comprehension necessitates
that
the person is of sound mind, not in a situation
where his understanding or mental faculty is
compromised
the person has adequate education, and is old
enough, to understand the disclosures.
a language to which the person is most
comfortable must be used.
the participant is given enough time to digest
what is being dished out to him.
the participant is encouraged to ask questions
(which should be answered honestly, promptly
and completely)
the participant is encouraged to give feedback
(return information) and is corrected promptly
Element of Voluntary Choice necessitates that
1. the first two elements have been complied with
satisfactorily
(full disclosure and adequate comprehension)
2. the person is so situated that he is able to
exercise free power of choice without the
intervention of any element of force, fraud,
deceit, or other ulterior form of constraint.
(an offer one cannot refuse is essentially
coercive or “undue” )
In research involving Children
The consent of parents or immediate
guardian/legally responsible person will have to
be obtained.
The child who has reached the age of reason*
must also be explained to and asked to sign the
consent.

*differs from country to country

Rule of 7s (below 7, 7 to 13, 14 to 21)
Rule of 7s

Before 7 children are said to lack the cognitive

development necessary for autonomous decision

7 – 13 children are considered able to

distinguish right from wrong

14 and above are legally and socially

accountable
for their action
The child’s negative attitude or expression of
distress to any procedure must be respected as a
sign of dissent.
In summary, respect for the dignity of a
research participant is best shown while getting
his consent to participate in a research study. .
Equal to others
JUSTICE
The principle of justice
Rightness of people’s interactions and
relationships.
Contract with fair principles to guide actions
Give or not deprive what is deserved:
 rights,
 equal distribution of benefits/harms
Unfortunate vs. unfair

“Inequalities are permissible only insofar as

they maximize the lot of the minimally
advantaged.”

(Rawls)
In research, do not increase but reduce health
inequalities.
“After all is said and done, the best safeguard for
ethical research is the ethical researcher.”

Angeles Tan Alora, MD

Thank you!