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Printable Handouts
Navigable Slide Index
- Introduction
- Children as property
- Children as patients
- Growth of pediatric care and teaching
- First reactions to research that invoked ethical principles
- 20th Century regulatory activities as a reaction to harm to children (1)
- 20th Century regulatory activities as a reaction to harm to children (2)
- Origins of oversight of clinical research
- 20th Century regulatory activities as a reaction to harm to children (3)
- Addressing asymmetry in research activity
- Principles of the United States 1977 National Commission Report
- Principles of 1977 National Commission Report
- National commission risk categories and ethical principles
- Who is a child?
- Subsequent federal regulation
- Authorization to participate in research
- Extension of regulatory content of 45CFR46
- Assent documentation
- Dissent and other circumstances
- Child who are wards require an advocate
- Summary
Topics Covered
- Growth of pediatric care and teaching
- 20th Century regulatory activities as a reaction to harm to children
- Principles of the United States 1977 National Commission Report
- 45CFR46
- Assent and dissent documentation
Talk Citation
Hirschfeld, S. (2025, January 30). Pediatric research: history and ethics [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved February 5, 2025, from https://doi.org/10.69645/KUYI4312.Export Citation (RIS)
Publication History
Financial Disclosures
- Dr. Steven Hirschfeld has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.
Pediatric research: history and ethics
Published on January 30, 2025
28 min
A selection of talks on Pharmaceutical Sciences
Transcript
Please wait while the transcript is being prepared...
0:00
Hello. This is Dr.
Steven Hirschfeld at
the Uniformed Services University
of the Health Sciences.
I'm going to share with you
some of the highlights of
the history and some of
the ethical principles
around pediatric research.
0:18
For most of history,
children had been regarded as
property and children
were regarded as
the property of adults
and didn't have any
independent rights.
This began to shift around
the time of the Age
of Enlightenment in Europe
in the 18th century.
In particular, Lady
Mary Montague went
to visit Turkey, the
city of Constantinople
and she observed some practices
of the inoculation
against smallpox.
So, she decided to have
her son inoculated.
She returned to the UK and
taught others about
her experience.
Three years later, the
Reverend Cotton Mather
and the physician
Doctor Boylston started
what was probably the
first clinical trial
in the United States, in
Boston, and they
selected 280 people,
including 65 children and
inoculated them in a case
control study where they
had 2% mortality in
the inoculated group and
in their comparison group,
which was the
general population,
there was a 14% mortality.
So, they thought they
were successful, but
the 2% mortality caused
not only a public
outcry, but riots and
an attempt on the
Reverend Mather's life
when someone threw a
bomb into his house.
Toward the end of the
18th century in 1796,
Edward Jenner observed
that milkmaids were using
cowpox to protect themselves
against the disease
and he decided to apply
the same principle
to protect children.
So, he took some
cowpox and inoculated
several children aged
11 months to 8 years
using the cowpox and they
indeed were protected
against smallpox by virtue
of not coming down
with the disease.
So, based on this level of
evidence compulsory
inoculations which were
renamed vaccinations
after the latin word
for cow were instituted
in parts of England.