Guidelines For EthicalClinicalResearch

Nagwa El-Badri M.D., Ph.D.

Professor and Founding Chair
Biomedical Sciences Programs
https://www.youtube.com/watch?v=ZV7RzS8QRXE
 The Tuskegee Timeline

In 1932, the USPHS, working with the Tuskegee Institute, began

a study to record the natural history of syphilis. It was originally
called the “Tuskegee Study of Untreated Syphilis in the Negro
Male” (now referred to as the “USPHS Syphilis Study at
Tuskegee”). The study initially involved 600 Black men – 399
with syphilis, 201 who did not have the disease. Participants’
informed consent was not collected. Researchers told the men
they were being treated for “bad blood,” a local term used to
describe several ailments, including syphilis, anemia, and
fatigue. In exchange for taking part in the study, the men
received free medical exams, free meals, and burial insurance.
 The Tuskegee Timeline
• Participants’ informed consent was not collected.
Researchers told the men they were being treated for
“bad blood,” a local term used to describe several
ailments, including syphilis, anemia, and fatigue. In
exchange for taking part in the study, the men
received free medical exams, free meals, and burial
insurance.
• By 1943, penicillin was the treatment of choice for
syphilis and become widely available, but the
participants in the study were not offered treatment.
 The Tuskegee Timeline

In 1972, an Associated Press story about the study was

published. As a result, the Assistant Secretary for Health
and Scientific Affairs appointed an Ad Hoc Advisory
Panel to review the study. The advisory panel that the
study was “ethically unjustified”; that is, the “results
[were] disproportionately meager compared with known
risks to human subjects involved.” In October 1972, the
panel advised stopping the study. A month later, the
Assistant Secretary for Health and Scientific
Affairs announced the end of the study.
 The Tuskegee Timeline

• In March 1973, the panel also advised the Secretary of the Department
of Health, Education, and Welfare (HEW) (now known as the Department
of Health and Human Services) to instruct the USPHS to provide all
necessary medical care for the survivors of the study.

• The Tuskegee Health Benefit Program (THBP) was established to

provide these services. In 1975, participants’ wives, widows and children
were added to the program. In 1995, the program was expanded to
include health, as well as medical, benefits. The last study participant
died in January 2004. The last widow receiving THBP benefits died in
January 2009. Participants’ children (10 at present) continue to receive
medical and health benefits.
 The Tuskegee Timeline

• Later in 1973, a class-action lawsuit was filed on

behalf of the study participants and their families,
resulting in a $10 million, out-of-court settlement in
1974.

• On May 16, 1997, President Bill Clinton issued a

formal presidential apology for the study .
https://www.cdc.gov/tuskegee/timeline.htm
 The National Institute of Health (NIH)
NIH published 7 main principles to guide the conduct of ethical research:

• Social and clinicalvalue

• Scientificvalidity

• Fair subjectselection

• Favorable risk-benefit ratio

• Independent review

• Informedconsent

• Respect for potentialand enrolled subjects

 Social and ClinicalValue

• The answer to a scientific question should be important enough to

justify

• Asking people to accept some risk or inconvenience for others.

• It should contribute to the scientific understanding ofhealth and

disease.

• It should improve our ways ofprevention and treatment of a disease

to Justify exposing participantstothe risk and burden of research.

 Scientific Validity

• Careful scientific design of the study with proper

control cohorts.

• Is the question answerable to begin with?

• Can itbe done?
 Fair SubjectSelection

• No bias in subject selection.

• Participants, if they accept, should gain benefits

from the outcome of this research as a group.
 Favorable Risk-BenefitRatio
• Research risks may be trivialor serious, transient or long-term. They can be

physical, psychological, economic, or social.

• Tryto minimize therisks and maximize thebenefits so they outweigh the risks.
 IndependentReview
The role of the institutional review boards (IRB)

• An independent review panel known in institutes as the

institutional review board or IRB should review the
proposal and ask important questions, including:

– Are those conducting the trialsufficiently freeof bias?

– Is the study doing allitcan to protect researchparticipants?

– Ha s the trial been ethically designed and is the risk–benefit ratio

favorable?

– The panel also monitors a study whileitis ongoing.

The role of the institutional review boards
 InformedConsent

Potential participantsshould decide whether or not to take partin a

research study:

– The informed consent process which inwhich participants are:

– Accuratelyinformed of the purpose, methods, risks, benefits, and

alternativesto the research.

– Understand this informationand how itrelatestotheirown clinical

situation or interests.

– M a k e a voluntary decision about whether to participate

 Respect for Potential andEnrolled Subjects

Individuals should be treatedwith respect as they are being approached to

participate in a study, even ifthey refuse enrollment.This includes:

• Respecting their privacy and keeping their private information confidential

• Respecting their right to change their mind, to decide that the research does not
match their interests, and to withdraw without a penalty

• Informing them of new information that might emerge in the course of research,
which might change their assessment of the risks and benefitsof participating

• Monitoring their welfare and, ifthey experience adverse reactions, unexpected effects,
or changes in clinical status, ensuring appropriate treatment and, when necessary,
removal from the study

• Informing them about what was learned from the research

 References

https://www.cc.nih.gov/recruit/ethics
.html