wp.cune.orgwp.cune.org/.../09/The-Tuskegee-Syphilis-Study.docx  Web viewChapter 1. Introduction: The

  • View
    212

  • Download
    0

Embed Size (px)

Text of wp.cune.orgwp.cune.org/.../09/The-Tuskegee-Syphilis-Study.docx  Web viewChapter 1....

2

The Tuskegee Syphilis Study: What It Means To Conduct Unethical Research On Human

Beings

Dr. Joseph Costa, D.H.Sc., PA-C

Health Policy and Management

MPH 525

Diana Pinney

April 2013

Table of Contents

Chapter Page

1. Introduction: The Tuskegee Syphilis Study.........3

2. How to Study Humans and Current Policies.......5

The Nuremburg Code......5

The Belmont Report.........6

Respect for Persons and Individual Autonomy.......6

Beneficence.........7

Justice......8

Informed Consent...........9

3. The Tuskegee Study from and Ethical Perspective...10

Why did the Medical Profession Pursue this Study?.10

What Went Wrong?...............................................................................................11

Scenarios in Which Informed Consent is Not Needed..........................................13

Waiving Consent for Some Areas of Clinical Investigation..........................14

4. Summary....17

Recommendations..17

References..20

Chapter 1

Introduction: The Tuskegee Syphilis Study

The Tuskegee Syphilis Study is named after the town and institution in Macon County, Alabama in which this United States Public Health Service (USPHS) research took place (Tuskegee University, 2013). The actual name given the study when it began in 1932 was the Tuskegee Study of Untreated Syphilis in the Negro Male (Centers for Disease Control [CDC], 2011). Six hundred African American men enrolled in the study. Of the 600, 399 had syphilis, and 201 controls did not (CDC, 2011).

Syphilis, the disease this study was designed to observe, is a sexually transmitted infection that is passed from contact with sores the bacterial infection causes (US Department of Health and Human Services [HHS] 2013). Syphilis is easily cured with a dose of penicillin, an antibiotic that was not in use when this study started (Tuskegee University, 2013).

Alexander Fleming discovered the antibacterial agents of the penicillin mold in 1928 (PBS, 1998). It would not be until 1938 that Fleming would publish his findings (PBS, 1998). Having seen the effects of bacterial infections during his experience in World War I, it was Flemings goal to allay this danger for the young men on the fronts of World War II (PBS, 1998). United States chemical manufacturers started the mass production and distribution of penicillin in 1943 (PBS, 1998). Penicillin was discovered to be a curative agent for the disease in 1948 (Tuskegee University, 2013).

Perhaps the most egregious aspect of the Tuskegee Syphilis Study is the fact that it continued until November of 1972. The participants were not informed of the benefits of penicillin, nor were they offered the opportunity to leave the study (Tuskegee University, 2013). Jean Heller, a reporter for the Associated Press released a story about a study on African American males in Alabama that was not treating their syphilis, but instead letting them languish with the symptoms and continue to sexually transmit it (Tuskegee University, 2013). The backlash was great. Six months later and after a federal interagency review, the Tuskegee Syphilis Study was declared ethically unjustified and was shut down by Assistant Secretary for Health and Scientific Affairs (Tuskegee University, 2013).

This perpetration of human rights violations by academic researchers continued without internal censure until it was forcibly ended by the federal government and only after being revealed by the press.

Chapter 2

How To Study Humans and Current Policies

There are very specific designs for the use of humans as research participants. These designs are intended to protect individual rights, and preserve the ethics of science (National Institutes of Health [NIH], 2011). The overarching idea that encompasses the policies surrounding the use of people as research participants is that humans shall never be used as means to an end (NIH, 2011).

This form of study and its governing policies are necessary because human subjects are essential for the progress of science, medicine, and our health. It is for this reason that the relationship between researchers and their participants should be based on honesty, trust, and respect (NIH, 2011, p. 3). It is also for this reason that conventions have been put in place governing studies using human subjects.

Two of the most significant and predominant collections of ethics pertaining to biomedical research are the Nuremberg Code and the Belmont Report.

The Nuremberg Code

The unfortunate need for the creation of the Nuremberg Code was instigated by countless human rights violations perpetrated upon individuals residing in Nazi concentration camps during World War II (NIH, 2011). The War Crimes Tribunal at Nuremberg of December 1946 found that, medical experiments were performed on thousands of concentration camp prisoners and included deadly studies and tortures such as injecting people with gasoline and live viruses, immersing people in ice water, and forcing people to ingest poisons (NIH, 2011, p. 4).

The judges of this trial wrote the verdict in August of 1947. In a section of their decision called permissible medical experiments they created 10 directives for human experimentation. These directives are collectively called the Nuremberg Code (NIH, 2011). The Nuremberg Code represents the basic principles that must be observed in order to satisfy moral, ethical, and legal concepts in the conduct of human subject research (NIH, 2011, p. 5). It is still used today as a model for numerous institutions, projects, and as an internationally shared foundation. The Nuremberg Code also influenced the United States first federal policy regarding testing human subjects created at the Clinical Center of the National Institutes of Health (NIH, 2011).

The Belmont Report

The Belmont Report is the HHSs form of ethics relating to human subjects compiled in the tenuous time following the end of the Tuskegee Syphilis Study (NIH, 2011). In 1974, the National Research Act established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (HHS, 2013). This commission was given the task of highlighting ethical ideals that would form a standard of behavior surrounding human research subjects (HHS, 2013). This compilation of bioethics would come to be known as the Belmont Report and officially included in HHSs policy.

The Belmont report made official and commonplace the bioethical ideas of respect for persons, beneficence, and justice. The final report also references the importance of informed consent and assessment of risks and benefits (HHS, 2013).

Respect For Persons and Individual Autonomy

According to the Belmont Report, there are two aspects of ethics involved when considering respect of persons. These are first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection (HHS, 2013).

The concept of individual autonomy was born of Enlightenment humanism and has highly influenced contemporary liberal political philosophy (Stanford Encyclopedia of Philosophy, 2009). In our modern, western tradition, individual autonomy is the basis of ethical considerations. To be autonomous is to be one's own person, to be directed by considerations, desires, conditions, and characteristics that are not simply imposed externally upon one, but are part of what can somehow be considered one's authentic self (Stanford Encyclopedia of Philosophy, 2009).

Not all people are able to grasp the concept of individual autonomy. Some individuals may experience diminished autonomy depending on ones cognitive, emotional, physical, or mental state (HHS, 2013). It is for this reason that, out of respect for persons, individuals with diminished autonomy are in need of extensive protection which may mean discounting them from research involving human subjects (HHS, 2013). A necessary component of ethical human subject research is that participation is informed and voluntary, because of the requirement for respect and autonomy. Researchers must confirm the subjects understand the risks and benefits of the study while not influencing their decision to participate in any way (NIH, 2011).

Essentially, the basis of the Belmont Reports ethical ideal regarding respect for persons is not based simply on the presence of individual autonomy, but also on the absence of oppression.

Beneficence

The root word of beneficence, benefit, assists in its definition because beneficent behavior is displayed with the intent to benefit others (Stanford Encyclopedia of Philosophy, 2008). This definition links beneficent behavior to understanding the potential risks and benefits to a set of planned actions (NIH, 2011). Principles of beneficence codified by many philosophers can potentially provide a basis for decisions made on what is right, or what is wrong (Stanford Encyclopedia of Philosophy, 2008). The Belmont Report conveys two ways in which beneficence shall be utilized in scientific studies. The first is do not harm, and the second, maximize possible benefits and minimize possible harms (NIH, 2011, p. 19).

Beneficence comes into play during the construction of a therapeutic study as members of the scientific community consider what they hope to learn, how they hope to learn it, and how it will potentially benefit their subjects health and the health of the greater population. This must all be considered with the great responsibility of upholding individual rights and avoiding unnecessary risks.

Justice

The concept of justice in its applic