AYII UNIVERSITY

Lecture 1: UNDERSTANDING RESEARCH ETHICS

Lecturer: Dr. Stephenson – PhD
(Senior Medical laboratory scientist/Medical Educationalist and
Researcher)
CNS,CMLS, DMLS,BMLS,BMED,MVP
+211922181810-email:snkurimana2014@gmail.com
 Lecture 3: RESEARCH ETHICS

•What are ethics? Refers to the rules of

conduct of carrying out research.
•Ethical issues are present at all stages of
research Essential part of the research
process.
 What Are Research Ethics?
What Are Research Ethics?
• Research ethics refers to a set of principles, guidelines, and
standards designed to ensure that research is conducted
responsibly, ethically, and with respect for all involved. These
ethics govern the behavior of researchers to protect the
rights, dignity, and welfare of research participants, maintain
the integrity of the research process, and ensure the
credibility and trustworthiness of scientific findings.
 Importance Ethics in Research
• Protects Human and Animal Rights: Ethics ensures that the dignity, rights,
and welfare of human participants and animals involved in research are
safeguarded.
• Promotes Integrity and Honesty: Ethical research fosters transparency,
honesty, and accountability in data collection, analysis, and reporting.
• Prevents Harm: Adhering to ethical guidelines minimizes the risk of
physical, psychological, or emotional harm to participants.
• Ensures Informed Consent: Ethics require that participants are fully
informed about the research and voluntarily agree to participate, ensuring
their autonomy is respected.
• Encourages Trust: Ethical practices build trust between researchers,
participants, and the public, enhancing the reputation of the research and
its findings.
 Cont.
• Facilitates Fairness: Ethics promote fairness by ensuring that all participants are
treated equally and that vulnerable groups are not exploited.
• Supports Scientific Credibility: Ethical research enhances the validity, reliability,
and acceptance of results, contributing to the credibility of scientific findings.
• Prevents Misconduct: Ethics help avoid unethical practices such as plagiarism,
falsification, and data manipulation.
• Promotes Social Responsibility: Research ethics ensure that studies contribute
positively to society and avoid causing harm to individuals, communities, or the
environment.
• Complies with Legal Standards: Ethics ensure adherence to legal and regulatory
frameworks, protecting researchers and institutions from legal consequences.
 The
Nuremberg
Code - Ethical
Principles in
Research-
1947
 The Nuremberg Code
• The Nuremberg Code is a foundational set of ethical principles for
conducting research involving human participants. It was developed
in 1947 in response to unethical medical experiments conducted
during World War II, particularly by Nazi physicians. These principles
were established during the Nuremberg Trials, where individuals
involved in these experiments were prosecuted.
• The Nuremberg Code laid the groundwork for modern ethical
standards in human research and emphasizes the protection of
participants' rights, dignity, and welfare.
 Principles of Research according
to the Nuremberg Code
1. Voluntary Consent is Essential
• Participation in research must be voluntary and based on the
informed consent of the participant.
• Participants should have the capacity to give consent and should not
be coerced or deceived.
2. The Research Must Have Social Value
• The study should aim to produce beneficial results for society, such as
advancing scientific knowledge or improving medical practices.
• It should not be conducted without a clear and meaningful purpose
 Cont.
3. Risk-Benefit Assessment
• The research must be designed to minimize risks and maximize
benefits to participants and society.
• Unnecessary physical and mental suffering or harm should be
avoided.
4. Avoidance of Unnecessary Suffering
• Experiments should not cause harm or unnecessary suffering to
participants.
• If the risk is deemed too great or unnecessary, the study must not
proceed
 Cont.
5. If Harm is Likely, the Study Should Stop
• Researchers must terminate the experiment if there is any indication
of significant harm or injury to participants
6. Proper Preparation and Conduct
• The study must be based on prior animal research or other
established scientific methods to justify the experiment.
• Experiments should be designed and conducted in accordance with
established scientific standards
 Cont.
7. Qualified Researchers
• Research must be conducted by scientifically qualified
individuals.
• Proper supervision and skill are required to ensure
participant safety
8. Right to Withdraw
• Participants must have the right to withdraw from the
study at any time without penalty or consequence.
 Cont.
9. Minimization of Risk
• Researchers must ensure that the degree of risk does
not outweigh the potential benefits of the research.
10. Research Must be Justified
• The research must contribute to knowledge that could
not be otherwise obtained without conducting the
study.
Significance of the Nuremberg Code

• Foundation of Modern Research Ethics

• The Nuremberg Code was one of the first documents to formally outline the
importance of informed consent and the ethical treatment of research participants.
• Influence on Later Guidelines
• It served as the basis for subsequent ethical codes, such as the Declaration of
Helsinki (1964), the Belmont Report (1979), and Good Clinical Practice (GCP)
standards.
• Focus on Human Rights
• The Code emphasizes the protection of human dignity, autonomy, and rights in
research contexts

N.B: The principles outlined in the Nuremberg Code remain relevant today
and continue to influence ethical guidelines for human research globally.
Declaration of
Helsinki –
Ethical
principles in
Research on
Human
Subjects
 Declaration of Helsinki – Human Subjects
• The Declaration of Helsinki was first adopted in 1964 by the
World Medical Association (WMA). It has undergone several
revisions since then, with the most recent version being
updated in 2013.
• This declaration provides ethical guidelines for medical
researchers, particularly those conducting research involving
human participants, and emphasizes the importance of
informed consent, safety, and the well-being of participants.
History and Development-Declaration of Helsinki

• First Adopted: 1964, Helsinki, Finland, by the World Medical

Association.
• Revisions:
• 1975 (Tokyo): Addressed the need for ethical review by independent
committees.
• 1983 (Venice), 1989 (Hong Kong), 1996 (Somerset West): Focused on
clarifying guidelines for informed consent and research conduct.
• 2000 (Edinburgh): Emphasized the use of placebo and standards of care.
• 2008 (Seoul): Highlighted the ethical concerns regarding vulnerable
populations.
• 2013 (Fortaleza): Updated provisions for compensation in case of research-
related harm.
 Principles of the Declaration of Helsinki
1. Respect for Individuals
• Researchers must respect the dignity, rights, and autonomy of all
participants.
• Informed consent is essential, and participants must voluntarily agree
to take part in research.
2. Well-being of Participants
• The health, safety, and welfare of participants take precedence over
the interests of science and society.
 Cont.
3. Scientific Validity
• Research must be scientifically sound and based on a
thorough understanding of scientific literature,
evidence, and relevant experimentation.
4. Ethical Review
• All research involving humans must be reviewed and
approved by an independent ethics committee before
it begins.
 Cont.
5. Informed Consent
• Participants must be fully informed about the research, its purpose,
procedures, risks, and benefits.
• Consent must be obtained freely, without coercion or undue
influence.
6. Vulnerable Populations
• Additional care and safeguards must be in place when research
involves individuals who are unable to give informed consent or are at
greater risk of exploitation.
 Cont.
7. Risk-Benefit Assessment
• The potential benefits of research must outweigh the risks, and all
efforts should be made to minimize harm to participants.
8. Use of Placebo
• The use of placebo is acceptable only when no proven intervention
exists, or under specific, scientifically justified circumstances.
9. Compensation for Harm
• Participants must be compensated for any harm resulting from their
participation in research.
 Cont.
10. Transparency and Reporting
• Researchers must publish their findings accurately,
ensuring that both positive and negative results are
disclosed.
10. Post-Trial Access
• After the trial, participants should have access to the
best proven intervention arising from the study.
Significance of the Declaration of Helsinki

• Global Impact
• The Declaration has influenced national laws, guidelines, and regulations concerning
research ethics.
• Standardization
• Provides a global ethical framework for conducting medical research involving
human participants.
• Emphasis on Participant Rights
• Reinforces the importance of human dignity, autonomy, and protection from
exploitation

N.B: The Declaration of Helsinki continues to serve as a cornerstone in medical

research ethics, promoting the rights, safety, and well-being of participants while
advancing scientific inquiry.
Belmont Report
– Ethical
principles
 Belmont Report – Human Subjects
The Belmont Report, published in 1979 by the National
Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research, is a foundational
document that outlines ethical principles and guidelines for
research involving human subjects. The report emphasizes the
need for ethics in research to protect participants' rights and
well-being. It identifies three core ethical principles: Respect
for Persons, Beneficence & Justice.
.
 Belmont report - Ethical principles
1. Respect for Persons
• Core Ideas:
• Individuals should be treated as autonomous agents, capable of making their
own decisions.
• Persons with diminished autonomy (e.g., children, prisoners, or individuals
with cognitive impairments) are entitled to additional protections.
• Application:
• Obtain informed consent, ensuring participants have a clear understanding of
the research, its risks, benefits, and their right to withdraw.
• Respect participants' decisions and privacy
 Cont.
2. Beneficence
• Core Ideas:
• Researchers must strive to maximize potential benefits and minimize
possible harms to participants.
• This principle emphasizes the welfare and well-being of the research subjects.
• Application:
• Conduct a thorough risk-benefit assessment to ensure the study is ethically
justified.
• Implement safeguards to protect participants from harm
 Cont.
3. Justice
• Core Ideas:
• Ensure fairness in the distribution of the benefits and burdens of research.
• Avoid exploiting vulnerable populations and ensure equitable selection of
participants.
• Application:
• The selection of research participants must be based on scientific objectives,
not convenience or vulnerability.
• Benefits of the research should be accessible to all groups, especially those
who bear the burdens of participation
Additional Ethical
principles
 Cont.

1. Non-Maleficence
•Avoid causing harm to participants, whether
physical, emotional, social, or psychological.
•Risk assessment must be a priority, ensuring
no undue harm occurs.
 Cont.
2. Confidentiality and Privacy
• Protect the privacy of participants and ensure their
data is kept confidential.
• Use secure methods to store and handle sensitive
data.
• Anonymity should be maintained unless explicit
consent is given otherwise.
 Cont.
3. Independent Ethical Oversight
• All research protocols must be reviewed and approved
by an independent ethics committee or institutional
review board (IRB).
• The ethical review ensures that studies adhere to
principles of fairness, safety, and respect.
 Cont.
4. Post-Trial Access
• Participants should have access to interventions
identified as beneficial during the research.
• Researchers must ensure that the findings of the
study are shared in ways that benefit the wider
community.
 Cont.
6. Social Responsibility
• Research must contribute to the advancement of
health, knowledge, or public good.
• Studies should not proceed if they lack potential
social or scientific value.
 Cont.
14. Ongoing Monitoring
• Researchers must monitor participants
throughout the study for adverse events and
respond appropriately.
• Studies must be terminated if the risks to
participants become unjustifiable.
Good Clinical
Practice (GCP)
standards
 Good Clinical Practice (GCP) standards

• Good Clinical Practice (GCP) standards are internationally recognized

ethical and scientific quality requirements for designing, conducting,
recording, and reporting clinical trials involving human subjects.
These standards ensure the rights, safety, and well-being of
participants are protected and that the clinical trial data are credible
and accurate.
• GCP standards are outlined in the International Council for
Harmonization of Technical Requirements for Pharmaceuticals for
Human Use (ICH) guidelines, particularly in ICH E6(R2).
 Principles of Good Clinical Practice
1. Ethical Conduct
• Clinical trials must adhere to the ethical principles outlined in the
Declaration of Helsinki.
• The well-being of trial participants must take precedence over the
interests of science or society.
2. Informed Consent
• Participants must voluntarily provide informed consent before
enrollment.
• Consent must be based on clear, comprehensive information about
the trial’s purpose, procedures, risks, benefits, and alternatives.
 Cont.
3. Risk and Benefit
• The anticipated benefits of the research must outweigh the risks to
participants.
• Researchers must continuously assess and minimize risks
4. Scientific Soundness
• Trials must be scientifically valid and based on prior laboratory and
preclinical research.
• A clear and detailed protocol must guide the study
 Cont.
5. Independent Review
• Ethics committees or Institutional Review Boards (IRBs) must review
and approve the trial protocol to ensure ethical and scientific
compliance.
6. Participant Safety
• The rights, safety, and confidentiality of participants must be
protected at all times.
• Adverse events must be promptly identified, recorded, and reported.
 Cont.
7. Qualified Personnel
• Researchers and trial staff must have appropriate education, training,
and experience to perform their roles.
• Adequate supervision and resources must be provided throughout
the trial.
8. Protocol Adherence
• The study must be conducted in strict compliance with the approved
protocol.
• Deviations from the protocol should be minimized and documented
 Cont.
9. Data Integrity
• All trial data must be accurately recorded, handled, and stored.
• Records should be complete, verifiable, and available for auditing.
10. Confidentiality
• Participant data must be kept confidential and protected in
accordance with applicable regulations.
• Identifiable information should only be accessible to authorized
personnel.
 Cont.

11. Product Quality

• Investigational products must be manufactured,
handled, and stored according to Good
Manufacturing Practice (GMP) standards.
• Their use must comply with the study protocol.
 Cont.
12. Transparency and Reporting
• All trial findings, including negative results, must be
accurately and transparently reported.
• The results should contribute to scientific
knowledge and public health.

N.B: GCP is essential for maintaining trust in clinical research and

ensuring that investigational therapies are safe and effective.
 free Good Clinical
Practice (GCP)
certification courses
 Cont.
1. National Institutes of Health (NIH) - Office of
Extramural Research
• Course: GCP for Clinical Trials
• Details: The NIH offers free online training in
GCP, designed to provide foundational
knowledge of clinical trials.
• Website: NIH GCP Course
 Cont.
2. CITI Program (Collaborative Institutional Training
Initiative)
• Course: Good Clinical Practice (GCP)
• Details: CITI Program offers free GCP certification for
those who work with clinical trials and human
research.
• Website: CITI Program
 Cont.
3. World Health Organization (WHO)
• Course: Good Clinical Practice (GCP)
• Details: WHO offers free online training that adheres
to international GCP standards. This course is aimed at
helping participants understand how to maintain
quality standards in clinical research.
• Website: WHO GCP Training
 Cont.
4. Clinical Research International (CRI)
• Course: GCP Certification
• Details: CRI offers a free GCP certification program
that includes important topics related to conducting
clinical trials.
• Website: Clinical Research International
 Cont.
5. Coursera (Occasionally offers free courses)
• Course: Various courses related to clinical
research and GCP
• Details: While not always free, Coursera offers
financial aid for several courses, including GCP-
related ones from recognized universities.
• Website: Coursera GCP Courses
 Cont.
6. Udemy (Free and Paid Courses)
• Course: GCP for Clinical Trials (free or discounted
options)
• Details: Some free or discounted courses related
to GCP and clinical research may be available on
Udemy.
• Website: Udemy GCP Courses
Importance of
Adhering to
ethical
principles
ensures
 Importance of Adhering to ethical
principles ensures
• Protection of participants' dignity, rights, and
welfare.
• Scientific validity and credibility.
• Trust between researchers, participants, and
society.
• Compliance with legal and institutional
requirements.
Applications
of the
Principles of
Ethics in
Research
 Applications of the Principles
1. Informed Consent
• Researchers must provide participants with
comprehensive information about the study, including
its purpose, risks, benefits, and procedures.
• Consent must be obtained voluntarily, without
coercion, and with the participant fully understanding
the information.
 Cont.
2. Assessment of Risks and Benefits
•A systematic evaluation to ensure the
research design minimizes harm and
maximizes potential benefits.
•Researchers and ethics review boards
are responsible for this assessment.
 Cont.
3. Selection of Subjects
• Ensures that participant selection is equitable
and not based on convenience, bias, or
discrimination.
• Special consideration is given to including and
protecting vulnerable populations.
Subjects/participants
Right’s in Research
 Subjects/participants Right in Research
1. Right to Informed Consent
Subjects have the right to be fully informed about the purpose,
procedures, risks, benefits, and alternatives of the research before
agreeing to participate. They must voluntarily consent without coercion
or undue influence.
2. Right to Privacy and Confidentiality
Subjects' personal information and identity must be protected. Data
collected from participants should be anonymized or securely stored to
prevent unauthorized access.
 Cont.
3. Right to Voluntary Participation
Participation must always be voluntary. Subjects can refuse to participate or
withdraw from the study at any time without penalty or loss of benefits.
4. Right to Be Protected from Harm
Subjects have the right to be shielded from physical, psychological,
emotional, or social harm during and after the research. Risks must be
minimized, and benefits must outweigh any potential harm.
5. Right to Fair Treatment
Subjects must be treated with fairness and respect, regardless of their
background, beliefs, or circumstances. Special care should be taken to avoid
exploitation, particularly for vulnerable populations.
 Cont.
6. Right to Access Information
Subjects have the right to access relevant information about the study,
including updates, findings, and how their participation contributes to the
research. If the study involves clinical trials, participants should be informed
of any new risks or findings that arise.
7. Right to Compensation
If a subject suffers harm or incurs expenses as a result of participating in the
research, they may have the right to compensation or reimbursement.
8. Right to Ask Questions
Subjects have the right to ask questions about the research at any time, both
before and during their participation, and to receive clear, honest answers.
 Cont.
9. Right to Be Heard
Subjects can express concerns or complaints regarding
the study and expect those concerns to be addressed
promptly and appropriately.
10. Right to Withdrawal Without Repercussions
Subjects can opt out of the study at any stage without
facing any negative consequences or loss of benefits
they were entitled to.
THANKS