Ethics of Research
History of Regulation of
Research

A history of scandals
– Nazi experiments, WWII
– Beecher expose of US research without
consent, 1966
– Tuskegee syphilis study exposed, 1972
– US radiation experiments exposed, 1990s
– Japanese WWII experiments on Chinese
exposed, 1990s
Results
Focus on informed consent
 Focus on initial research design
 Assume harm comes by being
included in experiments
 Focus on vulnerable populations of
subjects

Research in US Today
Some
good news
Some bad news
Good News
There is a set of Federal guidelines to
protect subjects of research
 The guidelines have real teeth
 The guidelines apply uniformly no
matter who funds the research (govt
agencies or private)

Bad News
This
is true only of
research involving
animals, not
humans
 “We
will not allow human
beings to be made into guinea
pigs.”

President Clinton
 “We

should all be so lucky.”
Alta Charo, NBAC
The Research Regulation
Mess
Private industry
Federally funded research
(17 agencies)
A New Scandal
Penn gene therapy experiment
 Healthy 20-year-old subject dies as a
result of gene transfer therapy
 Adverse outcomes in earlier trials
concealed
 Financial interest of investigators,
university in company concealed

Lessons from Penn
Focus on initiation of study may lead to
inadequate follow-up of actual results
 Present system may be inadequate to
deal with serious conflicts of interest
 Mere existence of review board and
regulations did not prevent major
problems with informed consent

Conflicts of Interest

Genomics industry report to
Federal Recombinant DNA Advisory
Committee on why reports of
adverse events during human trials
should be regarded as proprietary
secret information--
Conflicts of Interest-- II
Reporting adverse event makes our
stock go down
 Open reporting would allow our
competitors to avoid same mistake
 Adverse events are rich sources of
unanticipated new data


Assess these in light of ethics of
protecting human subjects
Conclusion
 The
current heavy reliance on
private industry funds to support
medical research creates a serious
risk to both the values of scientific
inquiry and the protection of
human subjects
 How?
Back to Basics
The research enterprise is
fundamentally different from the
enterprise of treating individual patients
 The relationship between health care
professional and patient is
fundamentally different from the
relationship between investigator and
subject

The Therapy Context
 The
principal, overriding goal is
the benefit to the individual
patient
 If new knowledge emerges, it is
a secondary good, not the aim
The Research Context
 The
principal, overriding goal is
generating new knowledge that
can be generalized
 Any improvement in the health
of an individual subject is a
secondary good, not the aim
“Therapeutic
Misconception”
Research subjects encounter people
who look like doctors and nurses in a
setting that looks like a clinic or hospital
 Therefore they assume (despite
explicit informed consent) that the
overriding goal of the research context
is to improve their personal health

Ideal Research Subject
Fully informed
 High level of understanding
 Least vulnerable to outside pressures
 Most highly motivated to make the
research a success for its own sake
 Senses self to be a true partner in the
research enterprise


Who is this?
Emanuel et al.
The basic ethical question in research
on humans is exploitation
 The process of informed consent is
neither necessary nor sufficient to
prevent exploitation
 Need detailed list of safeguards based
on real ways subjects may be exploited

Future?
NBAC draft report on regulation of
research (due in 12/00)
 Very likely to recommend major
overhaul of present regulatory system
 More focus on substance of protection
and less on paperwork
 More focus on ongoing conduct of trial
