Ethical Considerations in Clinical Research

Corey Jones, Ph.D., M.B.A., C.C.R.P.Research Subject Advocate

Dept. of Surgery /Clinical Research CenterMeharry Medical College

April 23, 2009

Outline

1. Defining Ethics2. historical events that led to the

current level of human subject’s protection.

3. Clinical Trial Volunteer’s Bill of Rights

Ethics

• Ethics - general beliefs, attitudes, values, or standards that guide behavior.

(Desjardins, 2006)Microsoft ClipArt

• 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.”

Ethical Relativism

Microsoft ClipArt(Desjardins, 2006)

Utilitarianism

• 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.

Bentham Mill

Text (Desjardins, 2006)Bentham Photo (Darwall, 2007)Mill Photo (Dahl, 1997)

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)

History

1. The Nuremberg Code (1947)2. The Declaration of Helsinki (1964)3. U.S. Code of Federal Regulations (1974)4. The National Research Act and The IRB

System (1974)5. The Belmont Report (1979)

“Those who do not learn from history are doomed to repeat it.”

George Santayana

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.htmlPhoto Reference (Austin, 2008)

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.htmlPhoto (Austin, 2008)

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.htmlPhoto (Austin, 2008)

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.htmlPhoto http://www.flickr.com/photos/tk_five_0/2234458406/

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.htmlPhoto http://www.flickr.com/photos/83646071@N00/467780352/

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.htmlPhoto http://www.flickr.com/photos/12254940@N00/1458574434/

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

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

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/

The Belmont Report

• Identifies the difference between practice and research

• Three Basic Ethical Principles

1. Respect for Persons2. Beneficence3. Justice

Microsoft ClipArt

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

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/

The Belmont Report-Beneficence

• Do no harm• Maximize possible

benefits and minimize possible harm

Microsoft ClipArt

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

The Belmont Report - Justice

• Who should receive benefits of research?

• Who should bear the burdens of research?

http://www.clinicaltrials.gov/ct2/show/NCT00269620?term=ortho+evra&rank=3

Microsoft ClipArt

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

http://www.betterpills.com/ortho_evra_patch_price_compariso.htm

Clinical Trial Volunteer’s Bill of RightsFrom 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