UNIVERSITY CHECKING D.A.R.E. INSTITUTE'S RESEARCH PROTOCOL

The Texas D.A.R.E. Institute is the target of an internal
investigation launched by Southwest Texas State University to
determine whether the organization violated research protocol by
carrying out studies in Texas high schools without university approval.

Since Texas D.A.R.E. (Drug Abuse Resistance Education) was established
at SWT in 1990 and designated the nerve center for program training
and coordination in Texas, it has expanded its prevention program from
300 officers in 150 school districts to 1,200 officers in more than
500 school districts, now reaching some 800,000 Texas students each
year.

And while the institute has met most of its quantifiable goals here,
an objective and scientific evaluation of the effectiveness of the
statewide program has remained illusive.

Despite years of high profile endorsements and visible campaigning,
mounting data on increased rates of drug and alcohol abuse among
teenagers throughout the 1990's has pressured D.A.R.E. programs
nationwide to bear out claims of their impact.

Finally, a statewide study contracted by Texas D.A.R.E. and completed
last June, appeared to be the touchstone the organization needed.

D.A.R.E. proponents claim the research - carried out in 18 school
districts throughout Texas on nearly 3,000 ninth graders, some exposed
to D.A.R.E. programs in the fifth grade - showed lowered "risk
factors" among the D.A.R.E. students, including more involvement in
church and scouts, positive perceptions of police and authority
figures, and lower rates of truancy, drug use and gang involvement
than their non-D.A.R.E. peers.

The results of the federally funded study may be marred however, due
to the project's failure to seek the approval of SWT's Institutional
Review Board (IRB) - a five member committee charged with reviewing
such projects for compliance with federal human subjects research
laws. The project was neither approved nor rejected - it simply was
never submitted.

Another study by D.A.R.E., conducted this time in the Houston
Independent School District, but yet to be released publicly, was
submitted to the IRB this June, eight months after it was first
requested and one month after the study had already been completed.

Though both studies, because they were conducted in established
educational settings, would likely have been exempted from full IRB
review, only the IRB can make that final determination after a written
proposal is received, according to SWT's guidelines for research on
human subjects.

Because the U.S. Department of Health and Human Services (HHS) does
not take human subjects research lightly - the agency has the
authority to suspend assurance and effectively freeze federally funded
research at universities that violate its codes - SWT can't afford to
take it lightly either.

The fact that at least two studies were carried out by Texas D.A.R.E.
without the university's knowledge or approval - a central criteria to
assure research conducted in SWT's name meets federal standards - is
of grave concern to IRB Acting Chairman Rick Archer.

Archer who held the IRB chairmanship from 1997 to 1999 and recently
took over for retiring chairman Donald Matlock this May, said, though
he doubts D.A.R.E.'s procedural missteps were intentional, the fact
that research projects may be slipping through the university's safety
net - meeting or not meeting federal guidelines in the field - has
initiated an overhaul of IRB procedures and a clarification of the
often confusing relationship between IRB, state and federal research
exemption policies.

"It concerns me if investigators are not submitting projects to the
IRB in any sense," Archer said, "but I have no impression at all there
was any attempt to avoid scrutiny. Our policy is it's better to be
safe than sorry. An investigator is welcome to allege there is an
exemption, but we nevertheless want to see a proposal."

With some 70 to 80 projects submitted to the IRB each year, Archer
said most of them fall under one of six exemption categories and do
not warrant a full board review, but because the IRB lacks a policing
function it is incapable of tracking studies not formally submitted
for exemption approval, but conducted nonetheless.

Principal investigator and project director for Texas D.A.R.E., Dave
Williams, said he was surprised at the IRB request for a proposal for
a study already exempted under federal guidelines that used an
established evaluation survey tested in thousands of schools across
the country.

Though Williams has not read the university's IRB handbook, he said
because the studies were funded through a U.S. Department of Education
grant, guidelines for protection of human subjects were already met,
and therefore a proposal through the IRB was not necessary.

"We were unaware we needed to file that, but our interpretation of the
law was this was not research," Williams said. "This is not research,
this is an evaluation and the technique is already approved by the
federal government. This issue was put to bed 15 years ago that this
does not fall under human subjects research."

Regardless, the Office of Human Research Protections (OHRP) - an
interagency body of HHS responsible for uniform implementation of
federal human subjects research rules across the 16 federal
departments that use them - draws no demarcation between research,
survey or evaluation work when human subjects, especially minors, are
involved.

Though an OHRP spokesperson said the agency could not determine
whether D.A.R.E.'s failure to comply with SWT's policies and
procedures regarding IRB approvals constituted a violation of federal
law without a full investigation, sanctions, including suspension of
research assurance, were never based on one violation.

Full out investigations by OHRP, prompted by specific complaints, are
rare, the spokesperson said, though the department is currently
reviewing 180 alleged violations. The agency prefers problems to be
handled at a university level, the spokesperson said.

Though specific statements of federal level exemptions granted to the
Texas D.A.R.E. studies could not be confirmed by press time, Ira
Prichard, a director at the U.S. Department of Education - the agency
that funded D.A.R.E.'s work - said such surveys, whether granted
federal exemption or not, still must go through the IRB.

"If it's a survey and it involves minors and it's used in research,
then it can't be exempt," Prichard said, "it must be reviewed by an
IRB to make sure there are adequate protections for research subjects.
I'm not aware of any circumstance where a principal investigator can
decide whether they are exempt or not when using federal money to
carry out a research project."

A recommendation is soon expected from Archer - who will conclude the
internal investigation this week - and by SWT Associate Vice President
of Research Bill Covington, who heads the university's Office of
Research and Sponsored Programs.

The recommendation, which could include sanctions against Texas
D.A.R.E., will then be presented to Vice President of Academic Affairs
Robert Gratz, at which point Covington and Williams will respond.

While Archer insists Texas D.A.R.E. will be subject to more intensive
scrutiny by the IRB, he fell short of characterizing the
organization's failure to submit its research proposals as
"violations," or endorsing outright restrictions on further research.

Covington also believes the procedural oversights were made out of
regulatory confusion, but made clear that protection of human subjects
is the driving principal behind what may be perceived as procedural
nit-picking.

"SWT takes the IRB approval process very seriously," Covington said.
"It always bothers me if we haven't done everything we can to make
sure we protect subjects involved in research. A lot of times we get
sidetracked by the bureaucracy."