Research Institute Newsletter -- June 2015
Greetings Research Community:Spring is in full swing and summer is almost here! For you Royals baseball fans, they are also off to a great start. Activities at the University of Kansas Medical Center Research Institute are also very busy. All our divisions continue to serve the research community from Clinical Research Administration, Sponsored Projects Administration, and Legal Services to our Human Resources Division.
Stay tuned, and we will keep you up to date on these developing initiatives.
Jamie Caldwell, MBA
The following University of Kansas Medical Center projects have received external funding. This list includes funding awards for new projects and competing renewals that were received since the last edition of the Research Institute's newsletter.
- $65,000 to Scott Belliston from the National Multiple Sclerosis Society for the proposal "Clinical Care Physician Multiple Sclerosis Fellowship."
- $50,000 to Pavla Brachova from Lalor Foundation, Inc., for the proposal "The Role of CD81 in Follicular Exosome Biogenesis."
- $20,000 to Mark Chertoff from Research Institute, Inc., for the proposal "Developing a Clinical Test of Auditory Nerve Survival."
- $20,000 to Wenxing Ding from Research Institute, Inc., for the proposal "Mechanisms of Autophagy in Protecting Against Alcohol-Induced Pancreatitis."
- $30,000 to Luciano Ditacchio from Research Institute, Inc., for the proposal "Regulation of Bile Acid Homeostasis by Histone Demethylase Jmjd5."
- $388,259 to Melissa Filippi from the NIH for the proposal "Development of a Tobacco Health Literacy Instrument."
- $35,000 to Paige Geiger from K-INBRE for the proposal "Estrogenic control of mitochondrial function in skeletal muscle."
- $747,000 to Christy R. Hagan from the NIH for the proposal "ck2-dependent Phosphorylation of Progesterone Receptors Mediates Proliferative Signaling in Breast Cancer."
- $35,000 to Janna L. Harris from Research Institute, Inc., for the proposal "Taurine Treatment for Traumatic Brain Injury in Aging."
- $20,000 to Leslie L. Heckert from Research Institute, Inc., for the proposal "In vivo Function of a 3' Distal Regulatory Element of Fshr."
- $15,333 to Judy A. Johnston from the Kansas Department of Health and Environment for the proposal "Technical assistance for regional Bureau of Health Promotion staff."
- $8,471 to Judy A. Johnston from the Kansas Department of Health and Environment for the proposal "Regional Early-Detection Works-Research and technical assistance."
- $30,000 to Partha Kasturi from Research Institute, Inc., for the proposal "Organelle Specific DNA Damage Response."
- $30,000 to T. Rajendra Kumar from Research Institute, Inc., for the proposal "Re-routing of Luteinizing Hormone (LH) and Ovarian Function."
- $30,000 to Alexey Ladokhin from Research Institute, Inc., for the proposal "Membrane-mediated Interactions of Bcl-2 Protein Family in Regulation of Apoptosis."
- $35,000 to Jed Lampe from K-INBRE for the proposal "Toxic reactive metabolites for nevirapine in the neonate."
- $5,000 to Asona Lui from the American Medical Association Foundation for the proposal "The Impact of IFN-stimulated Gene Expression on Patient Response to Aromatase Inhibitor Therapy for ER+ Breast Cancer."
- $30,000 to Hiroshi Nishimune from Research Institute, Inc., for the proposal "Exercise-regulated genes ameliorate NMJ denervation in aging."
- $125,000 to Randolph J. Nudo from the Kansas Board of Regents for the proposal "Advanced Neuroprosthetics for Functional Restoration after Acquired Brain Injuries."
- $425,809 to Susana Patton from the NIH for the proposal "Reducing hypoglecemia fear in parents of young kids with video-based telemedicine."
- $35,000 to Brenda Rongish from Research Institute, Inc., for the proposal "VEGF Role in Early Heart Morphogenesis."
- $15,000 to Carolyn Schmidt from Wichita Medical Research and Education for the proposal "Interpregnancy Interval Pilot Study to Improve Maternal and Infant Health."
- $619,231 to Heather Schrotberger from the Kansas Department of Health and Environment for the proposal "Early Head Start: 2015-2017 - Kansas Maternal, Infant and Early Childhood Home Visiting Program."
- $560,608 to Heather Schrotberger from the Kansas Department of Health and Environment for the proposal "Connections 2015-2017 - Kansas Maternal, Infant and Early Childhood Home Visiting Program (MIECHV)."
- $10,000 to Heather Schrotberger from the Junior League of Wyandotte and Johnson for the proposal "Project EAGLE Family Wellness Initiative."
- $3,493 to Neil Segal from the University of Iowa Foundation for the proposal "Discovering the Effect of a Realigning Brace on Tibiofemoral Contact Stress."
- $450,000 to Priyanka Sharma from the Conquer Cancer Foundation of ASCO for the proposal "Evaluation of BRCAness phenotype as prognostic marker in triple-negative breast cancer using specimens from SWOG 9313."
- $20,000 to Chad E. Slawson from Research Institute, Inc., for the proposal "Regulation of PKD development O-GlcNAcylation and identification of early stage."
- $415,250 to Michael Soares from the NIH for the proposal "Natural Killer Cells and Hemochorial Placentation."
- $35,000 to Michael Soares from K-INBRE for the proposal "Prolactin signaling, gestational adaptations and glucose homeostasis."
- $100,000 to Russell Swerdlow from the Kansas Board of Regents for the proposal "Bioenergetic Manipulation for the Treatment of Alzheimer's Disease."
- $283,125 to John Thyfault from the NIH for the proposal "Aerobic fitness, mitochondrial dysfunction and fatty liver."
- $4,000 to Christopher Ward from the University of Kansas Center for Research for the proposal "Isolating and Purifying Polycystin Complex From Human Urinary Exosomes."
- $55,545 to Mary E. Warren from the Kansas Department of Health and Environment for the proposal "Kansas Quality of Care (KQOC) Conference."
- $30,000 to Steven Weinman from Research Institute, Inc., for the proposal "Mechanisms of viral control of vesicular trafficking and exosome secretion."
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 (firstname.lastname@example.org, 913-588-3230) for assistance.
The KU Medical Center Research Institute's Clinical Research Administration division is pleased to announce that its newest Regulatory Specialists have successfully completed their training and have received their disease group assignments. Audrey, Kaitlyn and Tiffany assumed full responsibility for their groups effective June 1.
Kaitlyn Gerwick assumes responsibility for General Surgery, Plastic Surgery, Urologic Surgery, Orthopedic Surgery, Headache & Stroke and ENT. She can be reached at email@example.com or at extension 8-6092.
Audrey King has been assigned to Dietetics & Nutrition, Emergency Medicine, Radiology, Pulmonary, Endocrinology Metabolism & Genetics, Pathology & Laboratory Medicine and the Hoglund Brain Imaging Center. Audrey can be reached at firstname.lastname@example.org or extension 8-5751.
Tiffany will be responsible for Breast Cancer Prevention, Pediatrics and Allergy/Immunology/Rheumatology. In addition, she will assist Lindsey Atchity in the administration of multi-site, foundation-sponsored neuromuscular trials. Tiffany can be reached at email@example.com or extension 8-5705.
Kaitlyn, Audrey and Tiffany are excited to begin their roles supporting these groups and providing exceptional service for both new and ongoing clinical trials.
The new Genomic Data Sharing (GDS) Policy promotes sharing of large scale genomic data generated by NIH research. This includes human, non-human and model organism data.
Investigators preparing grant applications should prepare now if the work proposed involves the generation or use of large-scale genomic data. The following highlights should be noted:
Applicants preparing such grant applications are expected to:
- State in the cover letter that the studies proposed will generate large-scale human and/or non-human genomic data, and
- Include a genomic data sharing plan in the application. If sharing of human data is not possible, applicants should provide a justification explaining why they cannot share these data and provide an alternative data sharing plan.
Applicants who plan to use controlled-access human genomic data from NIH-designated data repositories as a secondary user to achieve the specific aims in the application should:
- Briefly address their plans for requesting access to the data, and
- State their intention to abide by the NIH Genomic Data User Code of Conduct, in the Research Plan of the application.
Applicants preparing applications that involve research funded prior to the Policy's effective date should:
- Make every effort to include a genomic data sharing plan in the application that outlines plans to comply with the expectations outlined in the Policy, and
- Plan to transition to a consent for future research uses and broad sharing, if possible, if the studies involve human participants and were initiated before the Policy's effective date and used consents that do not meet the expectations of the GDS Policy.
With implementation of the GDS Policy, submission of the Institutional Certification for human genomic data will become part of the standard Just-in-Time process. Additional guidance for researchers and institutions submitting grant applications and contract proposals involving large-scale genomic data is available on the Genomic Data Sharing website: (http://gds.nih.gov/).
The Sponsored Programs Administration Division of the KU Medical Center Research Institute welcomes three new hires to its team: Miranda Holloway, grant administrator in Pre-Award; Becky Tackett-McFarland, SPA coordinator who will be processing Greenphire ClinCards for SPA grants and provide overall assistance; and Jingwen Wei, grant administration in Pre-Award.
The division also announces a process change: Proposal and Progress Report (RPPR) intake will now be assigned to Pre-Award administrators as applications come in instead of by department.