The document discusses ethical principles in research, highlighting the significance of conducting trustworthy and socially responsible studies. It reviews historical instances of unethical research practices, such as the Tuskegee syphilis study and the Nuremberg Code guidelines, which emphasize informed consent and the protection of vulnerable populations. The importance of maintaining integrity, avoiding research misconduct, and ensuring participants' rights, including privacy and fair treatment, is also underscored.

1. Ethics in Research
Bashir Institute of Health Sciences
(BIHS)
Islamabad
3/10/2023 1

2. EXAMPLE
A general practitioner in a small rural town, is approached by a contract
research organization (C.R.O.) to participate in a clinical trial of a new
non-steroidal anti inflammatory drug (NSAID) for osteoarthritis. She is
offered a sum of money for each patient that she enrolls in the trial. The
C.R.O. representative assures her that the trial has received all the
necessary approvals, including one from an ethics review committee. The
doctor has never participated in a trial before and is pleased to have this
opportunity, especially with the extra money. She accepts without inquiring
further about the scientific or ethical aspects of the trial.
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3. What is Ethics?
• A branch of philosophy
• A set of principles of right
conduct.
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4. Why Ethics in Research?
• Research is a public trust that must be
ethically conducted, trustworthy, and socially
responsible if the results are to be valuable.
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5. Historical Events Influencing Ethics in
Research
Nazi Trial (1935-1945)
• 23 German Nazi physicians tortured,
brutalized and murdered thousands of
victims in the name of research
• Exposing human bodies to extreme
temperatures and altitudes
• To see how quickly a human could be
euthanatized (Painless Death)
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6. Historical Events Influencing Ethics in
Research
 Tuskegee Syphilis study for 40 years
• By the U.S. Public Health Service to study the natural
progression of untreated syphilis in poor, rural black
men who thought they were receiving free health care
from the U.S. government.
• They were never told they had syphilis, nor were they
ever treated for it.
• Over one hundred of the infected men died and others
suffered from serious syphilis related conditions.
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7. Historical Events Influencing Ethics in
Research
Willowbrook Study (1963-1966)
• Mentally retarded children were deliberately infected with hepatitis
virus to invent the vaccine for specific strains of hepatitis
Jewish Chronic Disease Hospital Study (1960)
• Research undertaken at New York City's Jewish Chronic Disease Hospital
to understand the human cell transplant rejection process.
• These studies involved the injection of live cancer cells into patients who
were hospitalized with various chronic debilitating diseases.
• Patients were not informed and no written informed consent was obtained
• Researchers thought that this research will bring upon extremely important
knowledge, and they felt they had strong reasons that these cells will be
rejected
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8. 10 Guidelines from Nuremberg Code
1. Research participants must voluntarily consent to research
participation
2. Research aims should contribute to the good of society
3. Research must be based on sound theory and prior animal
testing
4. Research must avoid unnecessary physical and mental
suffering
5. No research projects can go forward where serious injury
and/or death are potential outcomes
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9. 10 Guidelines from Nuremberg Code
6. The degree of risk taken with research participants cannot exceed
anticipated benefits of results
7. Proper environment and protection for participants is necessary
8. Experiments can be conducted only by scientifically qualified
persons
9. Human subjects must be allowed to discontinue their participation
at any time
10. Scientists must be prepared to terminate the experiment if there is
cause to believe that continuation will be harmful or result in injury
or death
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10. Research Misconduct
 Coercion
 Occurs when an overt threat of harm or an excessive reward is intentionally
presented by the researcher to the participant, so as to obtain compliance
(participation)
 Covert data collection
 Subjects are unaware that research data are being collected
 Deception
 Misinforming the subjects for the research purposes
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11. Research Misconduct
Fabrication
• Making up data or results and reporting them
Falsification
• Manipulating research materials or processes such that the
research is not accurately presented
 Plagiarism
• Owning others’ ideas
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12. Vulnerable Populations
• Old, very young (age extremes)
• Mentally or physically disabled
• Institutionalized persons (hospitalized, in old age
homes etc.)
• Pregnant women
• Terminally ill patient
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13. Protecting Human Rights
 Right to self-determination
◦ Humans should be treated as Autonomous agents
 Researchers must have informed them about the study
 Must have allowed them to choose to participate or not participate
 Must have allowed them to withdraw from the study at any time with
out penalty
Informed Consent:
 Participants must know that they are getting involved before they commit
 Should not be coerced or manipulated in any way to participate
 Must consent to participate in the study as a participant
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14. Informed Consent
• Who signs for whom?
• Can language be understood?
• Written Vs. oral?
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16. Protecting Human Rights
Right to Privacy
 Right to Anonymity
• When data is not linked with the personal references; using IDs
for participants; no identity revealing information sought
 Right to Confidentiality
• Keeping the information confidential by not sharing it with unrelated
people; keeping the data under lock and key and in password
protected files
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18. Protecting Human Rights
• Right to Fair Treatment
– Avoid injustice in selection
• Selecting the ones especially suitable for getting
favorable research results e.g. poor
• favorite patients receive the intervention
• No injustice to those who don’t agree to participate
• Right to Protection from Discomfort and Harm
– Beneficence
• Freedom from harm or exploitation
• Assessing risk/benefit ratio
• High anticipated benefit versus high risk
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20. Understanding the process
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Predict the outcome of the study
Assess benefits
Assess risks
Benefit versus risk ratio
Benefits are greater or equal to risk
Approved study
Risks outweigh benefits
Reject study

21. What are the points of Ethics Involved
in these Research Questions?
• What are the coping mechanisms of parents
whose children have a terminal illness?
• Does a new medication prolong life in patients
with cancer?
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22. Back to the Example
• Should not have accepted so quickly
• Should first find out more about the project and ensure that it
meets all the requirements for ethical research
• Should ask to see the protocol that was submitted to the
ethics review committee and any comments or conditions
that the committee puts on the project.
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23. Back to the Example
• Should only participate in projects in her area of practice
• Should seek the advice of colleagues in larger centers, if she is not
comfortable
• Should not agree to enroll a fixed number of patients as subjects since this
could lead her to pressure patients to agree
• Should carefully monitor the patients in the study for unexpected adverse
events and be prepared to adopt rapid corrective action
• Should communicate to her patients the results of the research as they
become available.
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24. Integrity is doing right when no one is
watching.
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25. References
Polit, D. F., & Beck, C. T. (2008). Nursing research: generating and assessing evidence for nursing
practice (8th ed.). Williams and Wilkins: Philadelphia
University of Minnesota, Center for Bioethics. (2003). A guide to research ethics.
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26. THANK YOU
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