1. Ethical Considerations in Clinical Research
Corey Jones, Ph.D., M.B.A., C.C.R.P.
Research Subject Advocate
Dept. of Surgery /Clinical Research Center
Meharry Medical College
April 23, 2009

2. Outline Defining Ethics
historical events that led to the current level of human subject’s protection.
Clinical Trial Volunteer’s Bill of Rights

3. Ethics
Ethics - general beliefs, attitudes, values, or standards that guide behavior.
(Desjardins, 2006)
Microsoft ClipArt

4. Ethical Relativism
A view that it is not possible to make objective ethical judgments.
“Who is to say what is right or wrong?”
“Anyone who can offer good reasons to support a judgment of right or wrong.”
(Desjardins, 2006)
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5. Utilitarianism
Bentham
Mill
Defined By Jeremy Bentham and John Stuart Mill in the nineteenth century.
Maximize the greater overall good for the greatest number.
Often seen in public policy, economics, government regulation.
Text (Desjardins, 2006)
Bentham Photo (Darwall, 2007)
Mill Photo (Dahl, 1997)

6. Deontology/Kantian Ethics
Immanuel Kant – Requires that we treat people as ends and never simply as means or as subjects, and never simply as objects.
Text (Desjardins, 2006)
Photo (Buller, 2004)

7. History The Nuremberg Code (1947) The Declaration of Helsinki (1964)
“Those who do not learn from history are doomed to repeat it.” George Santayana
The Nuremberg Code (1947)
The Declaration of Helsinki (1964)
U.S. Code of Federal Regulations (1974)
The National Research Act and The IRB System (1974)
The Belmont Report (1979)

8. The Nuremberg Code
Developed due to Nazi atrocities during World War II
Human experimentation is justified when the results are for the good of society and cannot be procured by other methods.
Bullet 1 (Amdur, 2003)
Bullet 2
Photo Reference (Austin, 2008)

9. Nuremberg Code
The research must satisfy moral, ethical, and legal concepts
Voluntary consent of the human subject is absolutely essential
Text
Photo (Austin, 2008)

10. Nuremberg Code
Experiments should yield fruitful results for the good of society, unprocurable by other methods of study, and not random in nature.
Text
Photo (Austin, 2008)

11. The Nuremberg Code
Experiments should be designed and based on results of animal experimentation and a knowledge of the natural history of disease or problem under study that the anticipated results will justify the performance of the experiment.
Text
Photo

12. Nuremberg Code
Unnecessary physical and mental suffering and injury should be avoided.
If there is a prior reason to believe death or disabling injury will occur the experiment should not be conducted.
Risk should not be greater than humanitarian importance.
Text
Photo

13. The Nuremberg Code
Preparations and facilities should protect subjects against injury, disability, and death.
Experiments should only be conducted by scientifically qualified persons with the highest degree of skill and care.
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14. Nuremberg Code
The subject should be at liberty to end the experiment when continuation seems to be impossible.
The scientist must be prepared to terminate the experiment if the experiment is likely to result in injury, disability, or death.

15. Declaration of Helsinki (1964)
World Medical Association declaration
Recommendations for physicians involved in research with human subjects
A minimum standard, individual countries may have stricter standards of research
Interest of science should never take precedence over well-being of the subject
An independent review of research should be conducted

16. The Belmont Report
The National Research Act (1974) created a commission for the protection of research subjects
The Belmont Report Summarizes the basic ethical principals identified by the commission.
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17. The Belmont Report
Identifies the difference between practice and research
Three Basic Ethical Principles
Respect for Persons
Beneficence
Justice
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18. The Belmont Report – Respect for Persons
Individuals should be treated as autonomous agents
Persons with diminished autonomy are entitled to protection
Subjects must enter research voluntarily with adequate information
Some subjects require protection due to illness, mental disability, or circumstances that restrict their liberty
The extent of protection should depend on risk of harm and likelihood of benefit
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19. The Belmont Report-Beneficence
Do no harm
Maximize possible benefits and minimize possible harm
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20. The Belmont Report - Justice
Who should receive benefits of research?
Who should bear the burdens of research?
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21. Clinical Trial Volunteer’s Bill of Rights From Informed Consent By Kenneth Getz and Deborah Borfitz
To be told the purpose of the clinical trial
To be told about all risks, side effects, or discomforts that might be reasonably expected
 To be told of any benefits that can be reasonably expected
To be told what will happen in the study and whether any procedures, drugs, or devices are different than those that are used as standard medical treatment
To be told about options available and how they may be better or worse than being in a clinical trial
To be allowed to ask any questions about the trial before giving consent and at any time during the course of the study
To be allowed ample time, without pressure, to decide whether to consent or not to consent to participate
To refuse to participate, for any reason, before and after the trial has started
To receive a signed and dated copy of the informed consent form
To be told of any medical treatment(s) available if complications occur during the trial