Ethics in Health Research

By: Gizachew Abdissa (MSc, Assist. Prof.)

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Session outline
✓Introduction to Ethics in health research

✓Ethical principles

✓Informed consent

✓Ethical issues in selected health researches

✓Research Misconducts

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 Session objectives
By the end of this session you have to be able to:

• Explain the different ethical principles

• Describe Content of the informed consent

• Describe different research misconduct

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 Ethics in health research
• Scientifically rationalized, substantiated and supported code of moral
principles and practices with respect to design (formulation),
implementation, and dissemination of any health research undertaking.

• No one shall be subjected to torture or to cruel, inhuman or degrading

treatment or punishment.

• In particular, no one shall be subjected without his/her free consent to

medical or scientific experimentation
(International Covenant on Civil and Political Rights, Article 7, 1966)

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 Ethics in health research…
• Before you embark on research with human subjects, you are likely to require
ethical approval.
• Prior to the development of ethical and human rights patients’ rights were
often ignored and many individuals were seriously harmed by medical
experimentation.
• Atrocities committed during World War II in the Nazi Germany
• Tuskegee Syphilis Study in USA (1932-1970s) to study the long-term
effects of untreated syphilis
• …..
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 Ethics in health research…
• Internationally recognized bodies and guidelines of research ethics:
• The Nuremberg Code (1947)
• United Nations Declaration of Human Rights (1948)
• WMA’s Declaration of Helsinki (1964)
• World Health Organization (2000)
• Council for International Organizations of Medical Sciences (CIOMS)
(2002)
• Etc.
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 Ethics in health research…

• “Health research involving human participants be it biomedical, clinical or

epidemiological (survey, surveillance etc.,) should obtain ethics approval
prior to their commencement ” Belmont Report.

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 Ethics in health research
• Research ethics: involves the application of fundamental ethical
principles to a variety of topics involving scientific research.
• These include the design and implementation of research involving
human experimentation, animal experimentation, various aspects
of academic scandal, including scientific misconduct (such as fraud,
fabrication of data and plagiarism)

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 Ethics in health research…
• Studies should be judged ethically on three sets of criteria:
• Ethical principles,
• Ethical rules,
• Scientific criteria

• Scientific criteria is often neglected but is important since if a study is

poor then the study is not capable of demonstrating anything and
consequently could be regarded as unethical.

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 Common Violations of Researcher Integrity
• Abusing ethics for career interests
• Weak and non appealing research methodology – knowingly or
unknowingly!
• Lack of honesty
• Going beyond proposals
• Bypassing ethic committees
• Inappropriate consenting
• Using research for financial interests
• Community or patient overlooking
• Conflict of interest

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 Basic ethical principles
• Respect for persons autonomy-the right to govern oneself
• Beneficence: the act of doing good
• Non-Maleficence: not doing harm
• Justice: fairness or moral rightness
• Informed consent

• They are considered universal regardless of geographic, economic,

legal and political boundaries.
• Researchers are obliged to assure that these principles are followed
while conducting research involving human participants.

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 1. Respect For Persons:
a) Autonomy: incorporates at least two fundamental ethical
considerations, namely:
• Respect for autonomy, which requires that those who are capable of
deliberation about their personal choices should be treated with respect
for their capacity for self-determination;
• Protection of persons with impaired or diminished autonomy, which
requires that those who are dependent or vulnerable be afforded
security against harm or abuse.

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 Respect For Persons…
B. Voluntary participation
• An agreement to participate in research constitutes a valid consent
only if voluntarily given after adequate information.
• This requires freedom from coercion and undue influence.

C. Confidentiality:
• The need to respect the implied or expressed wishes of the research
participant providing information that is not to be disseminated.

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 Confidentiality and privacy
Confidentiality: The use of information for any purpose other than that to which
participants consented is unethical to the participants.
• Certainly, no information obtained with the patient’s or subject’s permission
from their medical records should be disclosed to any third person without that
individual’s consent.
Privacy:
• Is the subjects personal right to authorize or decline access to personal (private)
information
• Incapacitated adults and children are unable to control access to their privacy,
they still have the right to privacy
• Informed consent process should disclose any risk to privacy
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 Informed consent
• “Involves providing a potential subject with adequate information to
allow for an informed decision about participation in the clinical
investigation facilitating the potential subject’s comprehension of the
information, providing adequate opportunity for the potential subject to
ask questions and to consider whether to participate, obtaining the
potential subject’s voluntary agreement to participate, and continuing to
provide information as the clinical investigation progresses or as the
subject or situation requires.” US Informed consent guidance, 2014.
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 Informed consent…
• Informed: everything should be revealed to the study subject or the
surrogate; No fact should be concealed

• They should be told about the purpose of the research, procedures and
interventions like possible therapeutic benefits, potential risks etc. Who
pays for undesired outcomes? Researchers? Insurance? Subjects?

• Do not give more hope than is justified

• The possibility to withdraw from the experiment at any time

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Informed consent…
• Types of informed consent: written or oral consent
• Elements of informed consent:
✓Disclosure of information
✓Understanding
✓Voluntariness
• Written consent form
• Study summary–explanation of what the study is about, the
procedures, related risks and possible benefits, alternatives, rights;
• Elements required by regulations

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 Informed consent…
• Description of the research and the role of the participant, including an
explanation of all procedures relevant to the participant
• Description of reasonably foreseeable risks
• Description of expected benefits
• Alternatives to participation, such as other studies or services in the area
• Explanation of confidentiality
• Explanation of compensation for injuries or health problems resulting
from participation in the study
• Whom to contact about the research if the participant has questions or
concerns
• Explanation that participation is voluntary
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 Informed Consent:
Study Information Sheet
• Title of the project
• Background of the study (Summary)
• Objective
• Significance of the study
• Study site and period of the study
• Study procedures (e.g. amount of blood sample)
• Potential risks/Benefits associated
• Samples storage (if indicated)
• Compensation (if indicated)
• Confidentiality/Justice/Privacy
• Rights of participation (Voluntary Participation)
• Termination of the study (participants are free to withdraw from the study at
any time, and this will not have any impact on their subsequent management)
• Questions, rights and complaints (Specify the address of contact person)
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Surrogacy:
• In case of competent individual, decisions should be made by the person.
• When the person is not competent (minors, mentally handicapped),
decisions are made by a surrogate (legally authorized representative for
the subjects).

• Such a study is justified only if mentally competent adults are not suitable
subjects. (E.g. pediatric drugs, psychiatric medications)

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 Waiver of consent
• The research involves no more than minimal risks to the subjects

• The waiver or amendment will not adversely effect the rights and welfare
of the subjects

• The research could not practicably be carried out without the waiver or
amendment

• Whenever appropriate, the subjects will be provided with additional

pertinent information after participation
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Assent:
• Affirmative agreement of the potential participant to participate in the
research
• Usually required for research involving children and adults with limited
capacity to consent [ Diminished capacity to provide free & informed
consent]
• Assent means child’s agreement to participate in the research
• Permission means the agreement of parent or guardian to participation of
their child in the research

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 Beneficence and Nonmaleficence
Non-Maleficence (Inflict no harm):
• This principle states that we may not inflict harm on or expose people to
unnecessary risk as a result of our research project.
• This is particularly important if our subjects may not be competent in some way,
such as, the ability to give informed consent.
• Children, pregnant women, prisoners, mentally impaired/ill individuals
Beneficence – we ought to further others’ legitimate interests
• This is the principle that obliges us to take positive steps to help others pursue
their interests.
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 Justice
❖Ensuring fair entitlement to resources

❖There must be equitable distribution of both the burdens and benefits of

participation in research

• Equal treatment
• Different treatment requires justification (experience, Age, derivation,
competence, position, etc.)

• What is deserved – People should be treated fairly, and should be given

what they deserve in the sense of what they have earned.
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Veracity:

• All subjects in any research project should always be told the truth.

• There is no justification for lying, but this is not the same non-
disclosure of information should it, in particular, invalidate the
research.

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• Fidelity
• Fidelity means keeping our promises and avoiding negligence with
information.
• If we agree for example, to send a summary of our research
findings to participants in a study we should do so.

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 Research misconducts
• Research misconduct includes, but is not limited to:
• Conducting research involving humans without obtaining ethical
approval.
• Collecting data without obtaining voluntary informed consent except
in conditions where waiver is applicable.
• Failure to maintain the confidentiality of research participants’
information
• Fabricating or falsifying data, or knowingly plagiarizing others’ work.

• Plagiarism: is using and claiming the words or ideas of another person as

one’s own, without acknowledging their contribution.
• Is a major ethical offence
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