cannabisnews.com: University Checking D.A.R.E. Institute's Research University Checking D.A.R.E. Institute's Research Posted by FoM on July 09, 2000 at 19:08:32 PT By Murlin Evans, Staff Reporter Source: San Marcos Daily Record 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."NewsHawk: Harvey GinsbergPublished: July 9, 2000E-Mail: smdrnews centuryinter.net Copyright: 2000 San Marcos Daily RecordCannabisNews DARE Archives:http://cannabisnews.com/news/list/DARE.shtml Home Comment Email Register Recent Comments Help Comment #1 posted by kaptinemo on July 10, 2000 at 05:11:36 PT: They're all missing the point! The point being that DARE is nothing more than a propaganda machine wedded to an intellligence-gathering organ that seeks to collect information in the only way it could; surreptitiously. Operating under the concept that 'little pitchers have big ears', the cops are seeking to end-run Constitutional guarantees of privacy by utilizing children as spies. It's as simple as that.And as to DARE's 'efficacy': picture a room full of little kids, awed and at the same time more than a little scared of the 'pleecmin' in their classroom. They know from their own upbringing at home and their socialization process in the classroom that 'wrong' answers elicit punishment and 'right' answers rewards. So, *of course* they're going to tell the 'pleecmin' what they think he wants to hear. They aren't dumb. Using the responses of cowed children to gauge the effectiveness of multi-million dollar projects is hardly good science. But the DrugWarriors have never been concerned with intellectual integrity, or they would have acknowledged cannabis's relative saftey compared to tobacco and alcohol long ago. Their continued feeding at the public trough depends upon the maintenance of a lie. So, lie they will. [ Post Comment ] Post Comment Name: Optional Password: E-Mail: Subject: Comment: [Please refrain from using profanity in your message] Link URL: Link Title: