The Inadequacy of Increased Disclosure  July 16, 2009
 By Brian Hanley <[log in to unmask]>

In recent years there has been a strong push to attempt to regulate science
by increasing disclosure of financial conflicts of interest (FCOI). As
well-intentioned as this regulatory approach might be, it is based on flawed
assumptions, poses the risk of becoming a self-perpetuating end in itself,
and is a distraction from the underlying serious problem.”

It is hard to see how it could be possible that strengthened FCOI
disclosures could have a significant effect since we know from the very
reports from Sen. Charles Grassley’s Finance Committee that there is next to
no enforcement. If the dog is all but toothless now, will someone
unscrupulous hesitate much to game the system by simply not reporting? A
clever operator will get a lawyer to guide such behavior. But this is hardly
the extent of what we should be thinking about.

Conflict of interest rules are supposed to control corruption by recusing
those with a financial stake. Corruption is the rational response in
systems, so the mythical “rational players” will be corrupt. In political
culture corruption is a given and conflict of interest rules have had some
effect in legislatures of the USA. But science is not politics.

Scientific culture presumes honesty, but the data says that scientific fraud
is large and growing<>.
A recent study <>quite
boggles the mind when one considers that some 9,000 papers were
flagged for possible plagiarism with 212 of the first 212 being probable
plagiarism on full examination, and to get into the running required
substantial matches in the abstracts. It recently came to light that
virtually an entire
subfield<>in medicine
was a fraud, though it is not clear if it was harmful. I will
not belabor this, but basic sense tells us that if the dumbest kind of fraud
is so widespread, we doubtless have serious problems elsewhere.

There is little punishment if one is caught in those rare cases when it is
discovered. Looking at cases of scientific fraud, one finds that usually no
charges are filed and authors don’t necessarily even withdraw their papers.
When they do withdraw them, there is little facility for recording that
fact, and papers can remain available in NIH databases and others without so
much as a warning flag.

There is a European pilot project
<>attempting to make a stab at the
problem to mixed review. There is a
Scifraud Web site <> as well that is
similarly mixed. At worst, research privileges may be taken away. In one of
the few cases I am aware of where charges were filed, the South Korea
case, Hwang
Woo-Suk <> was given a prestigious
award despite currently standing trial for
being unable to attend the ceremony for that reason. In other words,
science, a life of crime is easy -- at worst one gets a slap on the wrist.
For those who commit frauds of various kinds, mostly one wins --
publications generate promotions, grants, etc.

Look at the situation objectively, and one must ask the question. Why bother
doing real research if you can scout out what is probably true from some
hard-working researchers with real data, then submit a paper that looks
perfect "proving the hypothesis" with "all the latest techniques"? As we
saw, simple plagiarism of the dumbest kind is probably endemic. There is
software that can fake a gel, that can fake flow cytometry data, and one
must assume that it is used. Call it “theft by perfection." We have no data
at all on such fraud, but anecdotal evidence forming semi-random samples of
significant size certainly suggests it occurs in certain areas of
bioscience. So if there is great upside in science fraud – where’s the

Perhaps one might be exposed, but even then, unless it’s really high
profile, few people will know. Is the chance of being caught even as high as
one in 5,000? Those thousands of fake papers say no, and instead suggest the
chance of being caught may be less than one in 10,000 or more.

Given all of this, the rational response would be to face the scientific
fraud problem head on rather than enact window dressing regulations, and I
have a few proposals for how to do that.

The first regulatory change we need is to throw out the statute of
limitations regulation that is set at six years. Folks, under current
National Institutes of Health rules the case of the midwife toad would not
have been exposed! Isn't that ridiculous? Scientists are (or should be) some
of the better records keepers on the planet. Yes, records aren’t perfect,
nor are memories, but mostly we have them around somewhere, or at least
enough of them. We should remember also that scientists have been selected
for superior memories and analytic abilities. In the context of science,
graduate students are the people who usually find out about fraud first
because they see exactly what is going on. The median time for a graduate
student to awarding of a Ph.D. is six years; this is a time when they are
extremely vulnerable to retaliation.

The second regulatory change concerns intra-university investigations. There
is institutional collusion that whitewashes intra-university investigations
unless a professor or dean takes up the cause. Flatly, these
intra-university procedures don't work for graduate students and post-docs,
and those who use them tend to find themselves pariahs. In this way our
biosciences system has been systematically eliminating some of the most
ethical and capable researchers in training who leave when subjected to
retaliation. Keep your head down and don't rock the boat is the watchword in
graduate school these days. I get the strong impression that those who went
through grad school 30 years ago have little clue how bad it is. Ad hoc
committees of arbitrarily chosen people who I believe are sometimes
interfered with backstage by chancellors can exhibit phenomenally poor
investigative skills when presented with claims. Those who serve on such
committees are in a lose-lose position, and have no incentive to be there.

The only way they win is to curry favor with the administration.

Consequently, responsibility for academic misconduct complaints and whistle
blower reports must be removed from the institutions in which they occur. I
propose that such investigations be turned over to the Justice Department
for investigation by an Office of Research Integrity moved into Justice for
special adjucation. Researchers should be held personally liable, and they
should be charged with criminal conduct, and efforts made to cut deals with
them for fingering others in their loose circle. I strongly suspect that
fraud appears in clusters linked by human networks in academia as it does
elsewhere. Scientific fraud should be a criminal matter at the federal level
if federal funds are used. Papers containing fraudulent data should be
removed from federally funded databases and replaced with an abstract of the
case and link to the case file.

Non-citizen students and post-docs are even more vulnerable to manipulation
and extortion than citizens because of their dependence on their professor
for a visa. This enables the unscrupulous to exert even more retaliatory
power. I suspect the only cure for that is to grant a 10-year visa that will
act like a time limited green card to deal with the problem. That way, at
least non-citizens can vote with their feet and have some leeway to get away
from an unscrupulous scientist.

But we can’t just improve what we do in response, although that is
important. We also have to work hard to find our problems, so the third
major area for improved regulation is to create scientific transparency.
This will make it possible for other scientists to more easily detect
fraudulent work. It should be required that data be made available within 12
months of collection to other researchers, on request. (There could be some
variation depending on the kind of research.)

The researchers running the study could be given an embargo period of two
years (or some other interval chosen by a reasonable formula) to publish
based on their data, but there is no reason why other scientists shouldn't
be able to see the data before publication during such an embargo. After
publication, other researchers should be given access. It is transparency at
the most fundamental level that is missing. Since court precedents have
given researchers who receive government funds control over their data,
because there was no other rule in place, the only way to improve data
transparency is to mandate it. At the very least, base data should be
released on demand after publication.

Dealing with these fundamentals will yield good results. Most researchers
are innocent; they are guilty of little more than reluctance to get involved
in the hard work of whistleblowing for no reward. Just tightening the
straitjacket on researchers by giving them more hoops to jump through, and
forcing them to recuse themselves from their own area of expertise because
of financial rewards they earned by hard work will not prevent the
unscrupulous from failing to report conflicts that nobody will find if they
don’t report them. It will, instead, punish the ethical and financially harm
them by taking away just rewards while having next to no impact on the

In its simplest restatement, science has a two-horned problem. On the one
hand, there is an enforcement problem that exists because there is little
chance of being caught in any 10-year period, and if one is caught the
penalty is barely a slap on the wrist. This is exaggerated by the setting of
statutes of limitations to coincide with the interval during which those
most likely to find out are ensconced in a feudal serfdom holdover. On the
other hand, sometimes huge rewards should legitimately accrue to people who
spend their lives working very hard. Protecting such rewards is the entire
purpose of our patent system which encourages innovation and the creation of
new economic value.

In summary, we cannot fix the enforcement problem in scientific fraud by
making it harder for the rewards to occur. We won't even raise the risk
premium for fraud by any of the current rule changes proposed. We will,
however, slow the pace of research by taking the best researchers off of
problems they know best because they are forced to recuse themselves due to
financial conflicts of interest.

Doing that, we will penalize researchers. We will also be penalizing top
institutions by forcing them to step aside from involvement with furthering
what has great economic value to the nation; because where there is conflict
of interest, that means that value has been created. We need to attack the
real problem head-on if we want to get good results and keep science
respectable and economically most productive. The problem is simply
scientific fraud.

*Brian Hanley is an entrepreneur and analyst who recently completed a Ph.D.
with honors at the University of California at Davis.*