Ethical Considerations In Human

Subject Studies

Ewnetu Firdawek

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 Outline
• The foundation for Ethical Principles and rules
• Existing Ethical Guidelines
• Ethical Principles and Rules
• Informed Decision Making
• Ethical approval procedures

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 Foundation and Existing Guidelines
• The general conduct of biomedical studies is guided
by internationally recognized principles of human
rights, including the international ethical guidelines.
• The main source of guidance on the ethical conduct
of clinical research have been
– Nuremburg code
– Declaration of Helsinki
– Belmont Report
– International Ethical Guideline for Biomedical research
involving Human Subjects
– Operational Guidelines for Ethics Committees that
review Biomedical Research
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 Ethical Considerations
• In broader sense Research projects are
reviewed for three broad categories of Ethical
subjects
– Respect for Persons
– Beneficence
– Justice

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 Respect for Persons
• Participation in the research should be
completely voluntary and based on informed
consent
• Privacy should be protected by ensuring
confidentiality while data collection in
individuals
• Respect to the community means respecting
its values and having its approval for the
research
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 Respect for Persons…
• Respect for person addresses two main ethical
considerations
– Autonomy and
– Protection of persons with diminished or impaired
autonomy

• An autonomous person is that who is capable of

deliberation about personal goals and of acting
under the direction of such deliberations.
• Every person is not capable to self-decide.
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 Respect for Persons…
• Persons who are considered incapable or diminished autonomy
are

– Children due to lack of maturity

– Mental disability
– Circumstances that severely restrict liberty e.g. prisoners
– Decreased capacity of self-decision

• The extent of protection afforded depends on the risk of harm

and the likelihood of benefit.
• Respect for person also demands voluntary participation and
Confidentiality.
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• Voluntary Participation:
– An agreement to participate in research constitutes a
valid consent only if voluntarily given
– This requires free of coercion and undue influence.
– Coercion occurs when an overt threat of harm is
intentionally presented by one person to another to
obtain compliance.
– On the contrary, undue influence occurs through an
offer excessive, unwarranted, inappropriate or
improper reward to obtain compliance.

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• Confidentiality:
– The need to respect the response of the research
participant providing the information that is not to
be disseminated is obviously clear.
– The investigator must establish secured safeguards
of the confidentiality of research data, by using
codes.
– Disclosure may result in substantial costs for
participants, researchers and society.
– The use of information for any purpose other than
that to which participants consented is an unethical
to the dignity of the participants.

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 Beneficence

• When research involves experimentation on

human subjects, every effort should be made
to maximize the benefits to the
subjects(beneficence) and the subjects should
suffer no harm(non-maleficence)

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• Beneficence
– Participants are treated in an ethical manner not only by
respecting their decisions, but also protecting them from
harm and making efforts to secure their well-being.
– Two general rules have been formulated as complementary
expressions of beneficence:
a) Do no harm, and
b) Maximize possible benefits and minimize possible harms.

– Beneficence has two components: benefits and

risks

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• Benefits could have different components
– Beneficiaries: Research Participants, Community,
Country
– Forms of benefits: Monetary, Health care,
capacity building
– Magnitude of Benefits: compensation
– Duration of benefit: Short (only for the study
period) and long (extends beyond the study
period)term

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 Justice
• Participation in the research should correlate
with expected benefits
• No population group should carry an undue
burden of research for the benefit of another
group

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• Justice:
– The underlined principle of justice is to treat each person in
accordance with what is morally right and proper, i.e., fairness in
distribution
– This is to say that there must be equitable distribution of both the
burdens and benefits of participation in research.

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 Informed Decision Making
• The participant should be given clear
information on the research prior to giving
consent for participation, and hence the need
for informed consent.
• The roles of Informed Consent are:
– To respect individual rights
– To establish participatory research

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• Types of informed consent
– Written: written consent has to be obtained for
epidemiological research as much as possible. But
for clinical research, written consent is a must.
– Verbal: verbal consent may be opted in
communities where people are reluctant to put
their signature on official document for
epidemiological research. This, however, cannot be
an excuse for clinical studies.

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Individual informed consent is obtained from a
competent individual who
– Has received the necessary information
– Has adequately understood the information
– Has arrived at a decision without having been
subject to coercion, undue influence, inducement
or intimidation

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• The prospective research participant may have
a number of serious concerns including
– Why the research is being done
– Why to take part in the study
– What to be asked
– What to be provided
– Advantages of being a participant
– Disadvantages of being a participant
– Confidentiality
– Possibility of withdrawal

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• Hence the researcher needs to address the
concerns of the participants by providing
information's regarding
– Aims and Methods of the research
– Expected duration of participation
– Benefits to the participant and the society
– Any risk or discomfort as of participation
– Extent of maintaining confidentiality
– Free medical services for research related injury
– Any compensation
– Freedom of withdrawal
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• Investigators Obligation
– Aequately communicate to the participants
– Provide opportunity to participants to ask if any
– Avoid the possibility of unjustified deception
– Seek consent after due understanding
– Obtain a signed consent as an evidence
– Renew the informed consent if any changes on
procedure

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• Reading Assignment
– Informed consent in special circumstances
– The process of informed consent
– Informed consent form
– World medical association declaration of helsinki
ethical principles for medical research involving
human subjects
– International ethical guidelines for biomedical
research involving human subjects

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Thank you

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