Research Institute Newsletter -- February 2016
Greetings Research Community:
Activities at the University of Kansas Medical Center Research Institute have been very busy. All our divisions continue to serve the research community from Clinical Research Administration, Sponsored Projects Administration, Accounting and Legal Services. The KUMC-RI Annual Report was disseminated to the research community. Hopefully, you received the electronic version and have had a chance to read about the important work being done at the Medical Center.
As mentioned in a previous newsletter, there are several developing initiatives still taking shape.
Jamie Caldwell, MBA
The following University of Kansas Medical Center investigators have received external funding. This list includes funding awards for new projects and competing renewals that were received as July, 2015 through January 2016.The following University of Kansas Medical Center investigators have received external funding. This list includes funding awards for new projects and competing renewals that were received as July, 2015 through January 2016.
- $21,385 to Thomas Yankee from The Children's Mercy Hospital & Clinic for the proposal "The Influence of IL-33 Signaling in Type 2 Innate Lymphoid Cells, Regulatory T Cells and Hepatic Fibrosis in Pediatric Liver Transplant Recipients."
- $35,000 to Linda Heitzman-Powell from The University of Alaska Anchorage for the proposal "Capacity Building for Autism Intervention FY16."
- $318,494 to Michael Artman from Kansas Department of Health and Environment for the proposal "Outreach Peds FY16."
- $50,048 to E. Morris Matthew from American Heart Association Midwest for the proposal "Hepatic PGC1alpha Regulates TAG Secretion."
- $33,522 to Devin Koestler from Tufts University for the proposal "Microbiomes in Human Pancreatic Cancer."
- $102,071 to Laura Martin from University of Kansas Center for Research, Inc., for the proposal "Psychosocial Stress as a Vulnerability Factor for Problem Gambling."
- $30,000 to Kelly Dalton Kreisler from Children's Cancer Center for the proposal "Improving ADHD Care Coordination Using a Nurse Led Patient Centered Medical Home Model."
- $33,000 to Eve-Lynn Nelson from Children's Mercy Hospital & Clinics for the proposal "A Pediatric Obesity Treatment Pilot for Rural Primary Care Providers Using a Project ECHO Approach."
- $20,000 to Lisette Jacobson from Kearney County Health Care Foundation for the proposal "Pioneer Baby: A Focus Group Study Leading to Improved Pregnancy and Birth Outcomes."
- $799,298 to Heather Schrotberger from Kansas Department for Children and Families for the proposal "Kansas Early Head Start FY2016."
- $15,000 to Kim Kimminau from Johnson County, Kansas for the proposal "Assessment and Mapping of Food Sandbars in Johnson County."
- $52,500 to Jed Lampe from University of Kansas Center for Research, Inc. for the proposal "Defining the Hydrophobic and Electrostatic Interactions between CYP3A and CYPb5."
- #25,000 to Darren Wallace from Kidney Institute for the proposal "Targeting the LKB1-AMPK Pathway in Polycystic Kidney Disease."
- $40,500 to Hao Zhu from University of Kansas Center for Research, Inc. for the proposal "Atomic Structure of a Multi-Domain Redox Enzyme Ncb5or Implicated in Diseases."
- $46,500 to Farbia Behbod from University of Kansas Center for Research, Inc. for the proposal "Role of BCL9 in STAT3 Signaling and DCIS Invasive Progression."
- $78,395 to Russ Waitman from Patient-Center Outcomes Research Institute for the proposal "The Greater Plains Collaborative (Phase 1 Supplement) - Health Systems Demonstration Project."
- $247,866 to Roy Jensen from National Institutes of Health for the proposal "E-Decidete: Mobile Cessation Support for Latino Smokers in Mexico."
- $78,000 to Czarina Sanchez from American Association for the Study of Liver Diseases for the proposal "AASLD 2015 NP/PA fellowship."
- $342,615 to Carolyn Schmidt from Kansas Department of Health and Environment for the proposal "Community Collaborative Prenatal Care Program."
- $67,365 to Pamela Barnes from Department of Health and Human Services for the proposal "Nurse Faculty Loan Program."
- $10,000 to Joseph Tash from Burroughs Wellcome Fund for the proposal "Effects of Novel Non-hormonal Male Contraceptive Agents on Ovarian Function."
- $143,000 to Jason Stubbs from American Heart Association Midwest for the proposal "Intestinal Microbiota and Atherosclerosis Risk in Chronic Kidney Disease."
- $635,619 to Sarah Kessler from National Institutes of Health for the proposal "Adapting the HITSystem to Support PMTCT Retention and ART Adherence."
- $450,000 to Priyanka Sharma from Conquer Cancer Foundation of ASCO for the proposal "Evaluation of BRCAness phenotype as prognostic marker in triple-negative breast cancer utilizing specimens from SWOG 9313."
- $65,000 to Scott Belliston from National Multiple Sclerosis Society for the proposal "Clinical Care Physician Multiple Sclerosis Fellowship."
- $407,700 to Peter Smith from National Institutes of Health for the proposal "Role of a BHLHB9 Polymorphism in the Etiology of a Developmental Disorder."
- $39,409 to Colin McCoin from Veteran Affairs Medical Center for the proposal "Mitochondrial Mitophagy in the Development and Treatment of NAFLD."
- $10,000 to Lisette Jacobson from Kansas Department of Health and Environment for the proposal "Pioneer Baby-Moving Toward a Health Promotion Program via Focus Groups."
- $50,000 to Steven Levine from Kansas City Area Life Sciences Institute for the proposal "AAV Gene Therapy for Krabbe Disease."
- $762,782 to John Miles from National Institutes of Health for the proposal "FFA Production from Triglyceride-rich Lipoproteins."
- $89,722 to Edward Ellerbeck from Agile Health for the proposal "Kick Butts: Mobile Engagement and Cessation Support for Latino Smokers."
- $226,500 to Irfan Saadi from University of Delaware for the proposal "A Web-based Craniofacial Disease Gene Discovery Tool SysCLFT."
- $1,651,565 to Douglas Wright from National Institutes of Health for the proposal "Painful Versus Insensate Diabetic Neuropathy."
- $1,359,000 to Darren Wallace from National Institutes of Health for the proposal "Role of Periostin in Polycystic Kidney Disease."
- $405,000 to Christine Daley from S.G. Komen Breast Cancer Foundation for the proposal "Continuing an American Indian Breast Cancer Disparities Training Program."
- $831,402 to Sue Min Lai from Kansas Department of Health and Environment for the proposal "Kansas Cancer Registry."
- $337,500 to T.R. Kumar from University of Colorado Denver for the proposal "FSH and Inhibin B Dysregulation in Obesity: Functional and Statistical Analysis."
- $62,593 to Hope Krebill from Health Communication Impact LLC for the proposal "Recruiting Underserved Populations into Clinical Trials with Customizable Media."
- $100,000 to Andrew Godwin from Braden's Hope Foundation for the proposal "The Achilles' Heel and Novel Targeted Therapies of Ewing Sarcoma."
- $975,000 to Eve-Lynn Nelson from Department of Health and Human Services for the proposal "Telehealth Rural Outreach to Children of Kansas (Telehealth ROCKS)."
- $44,556 to Neekum Sharma from American Association of Immunologists for the proposal "Understanding the Role of NKG2D Signaling in Autoimmune Diabetes."
- $488,562 to Navneet Dhillon from National Institutes of Health for the proposal "Impact of Opiate Abuse on HIV-mediated Pulmonary Vascular Remodeling."
- $1,223,588 to Ana Paula Cupertino from National Institutes of Health for the proposal "S.C.O.R.E: Students for Community-Oriented Research and Education."
- $7,550 to Nicole Nollen from Association of Schools and Programs of Public Health for the proposal "Access to Healthy Food and Neighborhood Walkability: Insights Through Inter-professional Curricula."
- $415,250 to Alan Yu from National Institutes of Health for the proposal "Randomized, Controlled Pilot Study of Nicotinamide in Polycystic Kidney Disease."
- $25,300 to Mark Fisher from University of Kansas Center for Research, Inc. for the proposal "Stability and dynamics of Immunoglobulins."
- $743,228 to Madhulika Sharma from National Institutes of Health for the proposal "Implication of Notch Signaling Pathway in HIV Associated Nephropathy."
- $5,389,445 to James Calvet from National Institutes of Health for the proposal "Kansas PKD Research and Translation Core Center."
- $315,202 to Darren Wallace from a NovaTarg for the proposal "Synthesize and Evaluate Novel, Potent and OCT2-selective Biguanides for Lead Optimization."
- $734,211 to Brenda Salley from National Institutes of Health for the proposal "Visual Attention, Joint Attention and Emergent Language in Infancy."
- $101,279 to Jinxi Wang from University of Kansas Center for Research, Inc. for the proposal "Noninvasively Relieving Joint Contracture by Using Ultrasound-assisted Laser Technique to Remove Scar Tissues in the Knee Joint."
- $734,394 to Alexey Ladokhin from National Institutes of Health for the proposal "Low Cost Electronic Detection of Molecular Aggregation for Rapid Drug Development."
- $412,384 to Jason Stubbs from Spectradyne LLC for the proposal "Low Cost Electronic Detection of Molecular Aggregation for Rapid Drug Development."
- $537,627 to Mei Liu from Northwestern University for the proposal "Effect of ACA Medicaid Expansion on Diabetes: Diagnosis, Treatment, Patient Compliance, and Health Outcomes."
- $1,908,712 to Hiroshi Nishimune from National Institutes of Health for the proposal "Exercise-activated Mechanisms Reduce Degeneration of Aged Neuromuscular Junctions."
- $759,334 to Tracie Collins from National Institutes of Health for the proposal "Text Messaging to Promote Walking in Latinos with Peripheral Arterial Disease."
- $15,000 to Cheryl Gibson from the Hartwig Legacy Foundation for the proposal "KC Healthy Starts."
- $85,800 to E. Matthew Morris from Veteran Affairs Medical Center for the proposal "Mitochondrial Mitophagy in the Development and Treatment of NAFLD".
- $596,826 to Russell Swerdlow from Alzheimer's Association for the proposal "Trial of Oxaloacetate in Alzheimer's Disease (TOAD) Study."
- $1,019,273 to Susana Patton from National Institutes of Health for the proposal "An Interactive mHealth App for Better Glycemic Control in Families of Young Kids with T1D."
- $35,000 to Eugene Lee from National Institutes of Health for the proposal "Tablet-based Application to Improve Perioperative Outcomes in Radical Cystectomy."
- $35,000 to Rekha Rao Manepalli from National Institutes of Health for the proposal "Role of HSF1 in Regulating BCR and NF-kB Signaling in CLL."
- $35,000 to Dan Dixon from National Institutes of Health for the proposal "Implementation of the Depression and Anxiety Guidelines: Award for a Mental Health Coordinator."
- $162,000 to Joel Mermis from Cystic Fibrosis Foundation for the proposal "Implementation of the Depression and Anxiety Guidelines: Award for a Mental Health Coordinator."
- $166,296 to Nteeba Jackson from American Diabetes Association National for the proposal "Role of the Prolactin Receptor in Maternal Glucose Homeostasis and Islet Function."
- $80,000 to Ranjan Preet from Prevent Cancer Foundation for the proposal "The RNA Binding Protein HuR as a Novel Exosome Biomarker in Colon Cancer."
- $4,500 to Lisa Mische-Lawson from Vantage for the proposal "Promoting Physical Activity and Nutrition through Sensory Enhanced Aquatics."
- $3,411,635 to Susan Carlson and Byron Gajewski from National Institutes of Health for the proposal "Docosahexaenoic Acid (DHA) Supplementation in Pregnancy to Reduce Early Preterm Birth."
- $3,379,626 to Kimber Richter from National Institutes of Health for the proposal "Changing the Default for Tobacco Treatment."
- $74,998 to Jill Madden from Ovarian Cancer Research Fund for the proposal "Targeting FoxM1 to Enhance Sensitivity to Carboplatin in Ovarian Cancer."
- $80,000 to Eugene Lee from Urology Care Foundation for the proposal "A Carbohydrate Restricted Diet in Patients with Diabetes and Non-muscle Invasive Bladder Cancer."
Clinicaltrials.gov requires regular review of study information to verify it is accurate and up-to-date. The "Responsible Party" (PI, Grant Awardee or Sponsor) is accountable for information posted about the study. To ensure trial information meets site requirements, the information must be reviewed/released at specific times during a study, including:
- Every six months for studies that are enrolling
- Annually for active but NOT enrolling studies
- When there is a change in the enrollment status
- When enrollment numbers need to be updated
- When there are changes in the protocol (e.g. eligibility criteria)
Some studies require results and adverse events to be posted. If your study is an “applicable” clinical trial, results need to be posted within 12 months of the study completion date (NOTE: this is independent from publishing status).
Clinicaltrials.gov recently emailed notifications to Investigators/Responsible Party that had one or more records on the site requiring attention. If you received this email, the notification relates to one or more of your study records that are non-compliant with site requirements. Issues that are common include: failure to keep records up to date, not releasing previous updates, and failure to review the record at required time points. Failure to update postings when required raises red flags with the FDA.
If you received one of these emails, then you need to take action. Login at register.clinicaltrials.gov (organization: UKansasMCRI) to review, edit (as needed) and release study information. If you do not know your login information, are unsure of what study needs attention, how to edit study information, need guidance navigating the clinicaltrials.gov system or have general questions about the site and site requirements, contact Kevin Smilor (email@example.com), (913) 588-3230 for assistance.
The Research Institute has received many questions related to our travel reimbursement policies.
While we realize some of our policies may be inconvenient, we are required to comply with federal guidelines under Uniform Guidance (i.e. OMB Circular A-21). Please be reminded of the following University travel policy: “Early Bird” check-in is considered an upgrade and not a requirement for the flight. Passengers may choose this option, but it is not reimbursable.
The mileage reimbursement rate the Research Institute uses is based on the IRS mileage reimbursement rate which has changed. Effective for travel beginning on or after January 1, 2016, the rate is $0.54 per mile. Per Diem rates are paid in accordance with the U.S. General Services Administration (GSA) rates. Domestic per diem rates changed effective October 1, 2015 http://www.gsa.gov/perdiem. For more detailed information on travel reimbursement and these rates, go to the RI website http://www.kumc.edu/Documents/ri/spa/TRAVEL-Policy2.pdf .
The Velos eResearch Clinical Trials Management System (CTMS) commonly referred to as CRIS at KUMC is used to manage and track clinical trials and study participants at KUMC. Additionally, CRIS is an integral part of the KU Hospital billing process. Study and participant data is exported to O2 on a daily basis. When all information is accurately entered into CRIS, it greatly improves clinical research billing compliance. For complete details or questions, please contact Kevin Smilor firstname.lastname@example.org, (913) 588-3230 for assistance. A PDF version of the CRIS User’s manual can be found on the RI website http://www.kumc.edu/Documents/ri/cra/CRIS_RTM_Users_Guide_FINAL_v11.pdf.
The University’s Semi-Annual Effort Certification period is now open. On February 8th, 2016 an email notification was sent out to university employees who participate in sponsored research activity. These individuals are required to certify their effort and have a maximum of 21 days to complete their certification. The deadline for the current effort certification period is February 29th, 2016. Any questions or concerns regarding the ECRT system should be emailed to email@example.com.
Please join us in welcoming the following new staff members:
Disha Jetani, Clinical Trial Project Manager
Jessica Cosby, Clinical Trial Project Manager
Shilo Artis, Grant Administrator (Pre Award)
Emily Swanger, Administrative Assistant
Lorelei Sells, Assistant Director
Matt Morgan, Grant Administrator (Post Award)
Katie Knight, Grant Administrator (Pre Award)
New certifications for Research Institute Staff
Three of our Clinical Trial Project Managers passed the Society of Clinical Research Associates (SOCRA) examination last December and have received their Certified Clinical Research Professional designation. Congratulations to Kaitlyn Gerwick, Audrey King, and Tiffany Robinson!
They join Jeanna Julo, Lindsey Atchity and Kevin Smilor as SOCRA certified.