Oregon daily emerald., January 16, 1978, Page 3, Image 3

Researchers cutting down the risks
University paperwork
makes projects safer
By CAROLYN BEAVER
Of the Emerald
Any participant in a University
research project can be assured
there will be no risks involved, or
that the benefits outweigh the
risks, says Fred Wilhelm, of the
Committee for the Protection of
Human Subjects.
All grant applications come
through the Graduate School’s Of
fice of Scientific and Scholarly
Research. If the grant involves
“human subjects,” Wilhelm sends
the researcher a form asking for
the project’s specifics.
The form asks for a description
of the research, the number of
subjects to be used, the kinds of
groups to be involved, the poten
tial benefits to the subjects and to
humanity and a detailed descrip
tion of the “known or forseeable
risks.” tt also requires a list of
planned safeguards employed
and an example of an informed
consent form.
“The University has always
taken a look at this issue,” says
Wilhelm, but before 1971, it was
on an informal basis. The commit
tee was formed in 1971, and in
1975 it became even more
specific when the Department of
Health, Education and Welfare is
sued new, stricter regulations that
required everyone applying for
federal money to establish a
board or committee.
A cross-section of the commun
ity makes up the University's
committee.
When a project form is returned,
Wilhelm picks two committee
members to initially review it.
The full committee meets
monthly to discuss the grants.
Wilhelm estimates they consider
seven or eight projects monthly.
“The major problem investigators
have is in identifying the risks and
preparing an appropriate in
formed consent form," Wilhelm
says. The consent form allows the
subject complete information
about the project.
The form should outline the
risks and benefits, if a treatment is
involved, should lay out an alter
native which signifies the treat
ment is not a "cure-all,” and
should note the participation is
voluntary.
Parental or legal guardian con
sent is necessary when working
with children or those who would
not understand the consent form,
says Wilhelm.
Problems may arise with the
consent form, Wilhelm says.
Many times “researchers feel if a
subject is informed completely, it
ruins the project.”
If no risk is involved to the sub
ject, sometimes the consent form
can be modified.
Researchers must also identify
risks involved for the subject, in
cluding invasion of privacy, and
physical and psychological risks.
When there are risks, safeguards
must be provided them.
"A lot of the information inves
tigators require is highly sensitive
Prof receives biology grant
A University chemistry profes
sor has received a $750,000.
five-year federal grant extension
for the continuation of a study
begun at the University 10 years
ago.
Peter von Hippel, director of the
University’s Institute of Molecular
Biology, is heading the research
project.
The director was the ‘principle
investigator” when the study was
first started at the University 10
years ago. He says the study will
continue to look at how protein
molecules recognize specific se
quences of DNA and “turn them
on.”
According to von Hippel, 10
post-doctoral research as
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He points out that the U.S. Pub
lic Health Service and the Nationa
Institute of Health are financing
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and could cause embarassment if
it were to get out. Researchers are
in a bind because knowledge
must be pursued, but in a bal
anced way to protect those in
volved,” says Wilhelm.
Wilhelm stresses not every risk
has to have a corresponding
safeguard, but the total
risk/benefit ratio should be equal.
‘‘If there was a great deal of risk,
and not much benefit, the commit
tee would probably say no," says
Wilhelm.” If the benefits far ex
ceeded the risks, that would be
another story.”
He says cases rest on “their
own merits."
“Some researchers feel the
committee is an infringement on
their integrity,” Wilhelm says. It
the research because it may have
medical applications.
Von Hippel says, “If we can un
derstand the process, we may be
able to manipulate the process.
This manipulation might be ap
plicable to the treatment of cellular
diseases such as cancer."
Pointing out the value of study
ing the recognition process, von
Hippel says, “The best applied re
search is based on basic re
search."
sets up a barrier because they
have to go through a process.”
‘‘The forms have had a lot more
positive benefits because of the
awareness it has instilled in re
searchers, Wilhelms says.
“They’re more aware of things
that would be considered a breach
of ethics now."
A few years ago, if a professor
Si
wanted to find out what effects
stress had on students, he or she
could have given the students a
test back marked ‘F,’ just to see
what the reaction would be. Be
cause of the committee, the pro
fessor would now have to take
many other factors into considera
tion before this could be done,
says Wilhelm.
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