November 28, 2017
Dear Purdue colleagues,
As you are no doubt aware, in late July, the university ordered the early closure of the research study referred to as Camp DASH — not quite two weeks into its second scheduled 25-day session. The DASH study was part of a five-year federally funded research study investigating the effects of diet and sodium reduction on blood pressure in adolescents. The study participants were youth, ages 11 to 15, who are at risk for hypertension and who were living on campus for purposes of the study. The decision to close the study was based on concerns regarding the safety of the study participants.
Shortly after the camp closure, I commissioned Vice President for Ethics and Compliance Alysa Christmas Rollock to conduct an institutional review and assessment of Purdue’s actions in connection with the DASH study. That assessment has been completed, and I have reviewed its findings, conclusions and recommendations. A link to the related report is provided below. In addition, the Purdue Biomedical Institutional Review Board (IRB) has separately deliberated and made determinations with regard to the DASH study.
As a result of these findings and determinations, the IRB made the following determinations:
- The DASH study has been terminated.
- Any new research protocols filed by or for Connie Weaver, the principal investigator for the DASH study, must include an approved comprehensive remediation plan and will be subjected to a heightened degree of scrutiny to ensure that the research team is keenly aware of its obligations to protect the participants and has established appropriate internal and external protocols to manage and monitor its fulfillment of those obligations.
The care with which the IRB approached its deliberations cannot be overstated. The questions that were to be answered by the DASH study are tremendously important to the health of our nation’s youth, and our loss of the opportunity to steward this transformative research disappoints us all.
I have spoken with Dr. Weaver, who understands the IRB’s findings and fully accepts its decisions.
At Purdue, we consider the safety of our entire community — faculty, staff, students and visitors — to be our highest priority. Over the past eight summers, more than 34,000 youth have attended over 300 camps organized through Purdue Conferences, and nearly an additional 18,000 youth have attended sports camps at Purdue Intercollegiate Athletics facilities since 2013 without any incident approaching those that occurred during the study.
Camp DASH was not a typical “camp” of the kind held routinely on Purdue’s campus. It was unique in that it was a research study, which required the adolescent subjects to be in residence and to be monitored several times daily for diet and physiological response during a total of 10 weeks.
The institutional assessment, as well as the IRB's findings and determinations, clearly show that, in this case, those who oversaw this particular study did not meet the high standards that are the hallmark of Purdue's otherwise excellent track record in hosting youth programming on campus. As the report indicates, there were serious flaws in the study’s implementation, which led to the discipline and management issues that ultimately led to its closure.
In the future, if any residential research study with the unique characteristics of the DASH study is proposed, the University will require the study protocol to include the following stipulations:
- The adoption of and adherence to standards established by the American Camp Association, the Association of Camp Nursing and the Higher Education Protection Network.
- The identification of a qualified camp administrator who will be tasked with the following:
- all aspects of camp operations — including screening and hiring of staff; scheduling and supervision of programs and activities; and managing living accommodations — are designed to meet the highest standards of care for the health and safety of participants.
- managing day-to-day aspects of camp activities and overseeing participants and counselors independent of the study’s principal investigator.
Our compliance office will develop and enforce specific standards related to residential research studies in partnership with our office of research and partnerships.
As one of our distinguished professors, Dr. Weaver has long been an esteemed researcher, and this outcome does nothing to alter our high estimation of the importance of her contributions to Purdue.
Dr. Weaver has asked that we provide this statement on her behalf: “I am deeply saddened by the instances that caused Camp DASH to end early. As the principal investigator, I accept responsibility for events that occurred at Camp DASH. The safety and security of research participants always comes first. I have dedicated my career to nutrition science research, and our team’s work has led to better health and wellness for millions of people across the world. We will continue these important efforts to find solutions to the nation’s top health concerns for at-risk, diverse adolescents.”
We sincerely thank those who have worked diligently over the past months to review and assess this issue and to those who continue to work to ensure that Purdue remains a safe place to live and work.
Mitchell E. Daniels, Jr.
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