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Ethical Considerations in Clinical Research

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Presentation on theme: "Ethical Considerations in Clinical Research"— Presentation transcript:

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) Microsoft ClipArt

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. Text Photo /

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. Microsoft ClipArt

17 The Belmont Report Identifies the difference between practice and research Three Basic Ethical Principles Respect for Persons Beneficence Justice Microsoft ClipArt

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 Microsoft ClipArt

19 The Belmont Report-Beneficence
Do no harm Maximize possible benefits and minimize possible harm Microsoft ClipArt

20 The Belmont Report - Justice
Who should receive benefits of research? Who should bear the burdens of research? Microsoft ClipArt

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

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