Ethical Considerations

in Research
Marishiel Mejia-Samonte, MD, DFM

Ethical Principles
Established by many national and international
bodies:
1. World Medical Association Declaration of
Helsinski
2. Council for International Organizations of
Medical Sciences (CIOMS) International
Ethical Guidelines for Biomedical Research
Involving Human Subjects

World Health Organization

Principles of Good Clinical Practice
Principle 1: ETHICAL CONDUCT
Research involving humans should be
scientifically sound and conducted in
accordance with basic ethical principles:
a. respect for persons
b. beneficence
c. justice

Respect for Persons

Incorporates two ethical convictions:
Individuals should be treated as autonomous
agents
Persons with diminished autonomy are entitled to
protection

Directly implemented within the GCP through

the process of Informed Consent

Beneficience
Ethical obligation to maximize benefit and to
minimize harm
Directly implemented through risk / benefit
assessment during design and review

Justice
Gives rise to moral requirements that there be
fair procedures and outcomes in the selection
of research subjects
Requires attention in two respects:
Individual fairness in research so NO, NO, NO
Potentially beneficial research only to some patients
who are in favor
Select only undesirable persons for risky research

Social no group should bear more than its fair

share of risks or benefits

Informed Consent
Purpose of the study
Study treatments and probability of random
assignments
Study procedures including all invasive
procedures
Responsibilities of the participants
Expected duration of participation in the study
Approximate number of participants

Informed Consent
Study aspects that are experimental
Foreseeable risks
Risks from allowable use of placebo
Reasonably expected benefits
Expected benefits to the community or society
or contribution to scientific knowledge
Description of post study access to the study
product or intervention

Informed Consent
Alternative procedures or treatment available to
the participant
Compensation or insurance or treatment
entitlements of the participant in case of study
related injury
Anticipated payment, if any, to the participant in
the course of the study
Compensation (or no plans of compensation) for
the participant or participants dependents in
case of disability or death

Informed Consent
Anticipated expenses to the participant during
the course of the study
Statement that it is voluntary and participant
may withdraw anytime without penalty or loss
of benefit to which the participant is entitled
Statement on who will have access to the
participants medical records for purposes
only of verification of clinical trial data/
procedures

Informed Consent
Statement that records identifying the participant
will be kept confidential and will not be made
publicly available; identity of the participant will
be kept confidential in case of publication
Description of policy regarding the use of genetic
tests and familial genetic information;
precautions to prevent disclosure to immediate
family members without consent from
participant

Informed Consent
Possible direct or secondary use of
participants medical records and biological
specimens taken in the course of clinical care
or in the course of this study
Plans to destroy collected biological specimen
at the end of the study OR details of storage
(duration, type of facility, location, access
information) and possible future use

Informed Consent
Plans to develop commercial products from
biological specimens and if participant will
receive monetary or other benefit from such
development
Participant will be informed in a timely
manner if information relevant to willingness
of the participant to continue to participation
is available
Access of the participant to the study data

Informed Consent
Extent of participants right to access his / her records
Foreseeable circumstances and reasons under which
participation in the study may be terminated
Sponsor, institutional affiliation of the investigators
If investigator is both PI and healthcare provider or
only as PI
Persons to contact in the study team for further
information regarding the study and whom to contact
in the event of study-related injury