1. A brief history of modern research ethics and the IRB
Zoltan Boka
Director of Research Compliance and Bioethics
Lehman College

2.  Testing ideas and hypotheses by performing
experiments involving people has a long
history but much of that time has been marred
by abuse
 For example, in 1718, King George I of England
offered a pardon to any prisoner in Newgate
Prison who agreed to be injected with the
smallpox virus as part of an experiment to find
a vaccine. (Huth, 2006)

3.  You’re a prisoner in England in 1718: The King offers
you a choice- get out now and be infected with the
smallpox virus, or be free of the virus but remain in
jail.
 Is that really a choice?
 The first task of IRB is to ensure that consent is freely
given. This is more complicated than it sounds.

4.  The Nuremberg Code was developed in the
aftermath of the discovery that Nazis
conducted human experimentation on
prisoners in concentration camps.
 The Code has three requirements for consent:
That one have a) the capacity to consent, b) a
freedom from coercion, and c) comprehension
of the risks and benefits involved

5.  King George has an idea: He would like to try out
the vaccine for smallpox on prisoners and gives
you two scenarios:
 1) A prisoner who consents to a trial gets a pardon
and one who does not consent stays in jail.
 2) Every prisoner gets an injection and will be told
that it is to help advance science but not told what
it is.
 What do you think?

6.  Between 1932 and 1972, the U.S. Health Service
told poor African-American men in Alabama
that they were receiving free medical care
when in actuality, they were not being treated
at all as physicians watched the disease
progress and individuals infect others.
 In 1974, Congress established 45 CFR Part 46,
which discusses the process by which
institutions obtain informed consent.

7.  First, you need to ask yourself whether what
you’re doing is human research:
 Are you conducting human research or clinical
investigations on human participants?
 Scenario: You are interested in how life expectancy
has grown between 1800 and 1900. You look up
death records to compile a list of how long people
in Bronx County lived before dying between 1800
and 1900. Is this human research?

8.  Once you know that you need IRB approval for
human research, you need certification.
 A certificate is generally good for up to three
years. Anyone who wants to work on human
subject research must have one.
 Once you are armed with a certificate, you
have to think about the design of your study.

9.  “The third experiment…took such an extraordinary
course that I called an SS physician of the camp as
witness, since I had worked on these experiments all
by myself. It was a continuous experiment without
oxygen at a height of 12 kilometers conducted on a
37year–old Jew in good general condition. Breathing
continued up to 30 minutes. After 4 minutes the
experimental subject began to perspire and wiggle his
head, after 5 minutes cramps occurred, between 6 and
10 minutes breathing increased in speed and the
experimental subject became unconscious; from 11 to
30 minutes breathing slowed down to three breaths per
minute, finally stopping altogether.” (Katz, 1992)

10.  These slides are just a primer. As you do
research, you will find yourself in many
situations where you have questions: The IRB
office can answer most of these issues.
 Once you’ve decided that a) you are going to
do research and b) involving human beings,
you must ask yourself: What, who and why?

11.  What procedures will you use?
 What equipment will you need?
 What space will you conduct your experiments
in? (If you are use more than one space,
sometimes you will need more than one
approval.)

12.  Who are you? What makes you qualified?
 Who will you be working with? (Even assistants
who are students will need to be certified.)
 Who is the population you’ll be studying? If you
are working with sick people, children, prisoners
or a specific vulnerable segment of the population,
you’ll face more scrutiny.
 Ask yourself who will be participating in your
study.

13.  For IRB this is the most important question and
it permeates everything:
 Why will you be performing this test instead of
something else?
 Why will you be looking at this population?
 Why do you need a certain number of
participants?

14.  Are you someone who “thought out
beforehand any accident or situation that might
occur, so that you know the right thing to do at
the right moment, and are willing to do it”?
 Spend twice as much time planning and
thinking as you do writing.
 Never assume that something can’t happen.

15.  I’m studying stress in athletes. I’m looking at how
their heart rate changes as they undergo more
difficult exercises.
 What should I do?
 I’m considering studying a disease and how it
effects the spine. The disease can show up in rats
and people and effect the spine the same way.
 What is your advice?

16.  It is always a good idea to get input from
another person; Even better if s/he from
outside your field or department.

17.  Huth, E. (2006). Quantitative evidence for
judgments on the efficacy of inoculation for the
prevention of smallpox: England and New
England in the 1700s. Journal of the Royal Society
of Medicine, 99(5), 262-266.
 Katz, J. (1992). Abuse of human beings for the
sake of science. In When medicine went mad (pp.
233-270). Humana Press.