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Ethical Considerations in Clinical Research

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. Outline. Defining Ethics

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Ethical Considerations in Clinical Research

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

  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 http://ohsr.od.nih.gov/guidelines/nuremberg.html 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 http://ohsr.od.nih.gov/guidelines/nuremberg.html 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 http://ohsr.od.nih.gov/guidelines/nuremberg.html 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 http://ohsr.od.nih.gov/guidelines/nuremberg.html Photo http://www.flickr.com/photos/tk_five_0/2234458406/

  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 http://ohsr.od.nih.gov/guidelines/nuremberg.html Photo http://www.flickr.com/photos/83646071@N00/467780352/

  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 http://ohsr.od.nih.gov/guidelines/nuremberg.html Photo http://www.flickr.com/photos/12254940@N00/1458574434 /

  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. http://ohsr.od.nih.gov/guidelines/nuremberg.html

  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 http://www.wma.net/e/policy/17-c_e.html

  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 http://www.hhs.gov/ohrp/

  17. The Belmont Report • Identifies the difference between practice and research • Three Basic Ethical Principles • Respect for Persons • Beneficence • Justice Microsoft ClipArt http://www.hhs.gov/ohrp/

  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 http://www.hhs.gov/ohrp/

  19. The Belmont Report-Beneficence • Do no harm • Maximize possible benefits and minimize possible harm Microsoft ClipArt http://www.hhs.gov/ohrp/

  20. The Belmont Report - Justice • Who should receive benefits of research? • Who should bear the burdens of research? Microsoft ClipArt http://www.clinicaltrials.gov/ct2/show/NCT00269620?term=ortho+evra&rank=3 http://www.betterpills.com/ortho_evra_patch_price_compariso.htm http://www.hhs.gov/ohrp/

  21. Clinical Trial Volunteer’s Bill of RightsFrom Informed ConsentBy 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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