December Update from the RI
Greetings, research community. I want to wish the entire research community a safe and joyous holiday season. Happy New Year!
January 1, 2017 is the deadline for completion of the new Good Clinical Practice and Responsible Conduct of Research training requirements for faculty and staff involved in research. You will be unable to submit applications to the IRB for approval without completion of the requirements detailed here https://kumed.sharepoint.com/sites/mykumc/kumcri-training/Pages/default.aspx.
KUMC now requires CITI Good Clinical Practice training for all faculty and staff engaged in research (for this purpose defined as all investigators and other research personnel, regardless of title or position, who are involved in the design, conduct or reporting of research, regardless of funding). The new Responsible Conduct of Research (RCR) training requirements are as follows:
- Complete the designated RCR modules in CITI by January 1, 2017, and once every four years after that.
- Attend or view two live seminars or conferences on RCR every four years.
If you have any questions about this program, please email Mary Hindle, Research Institute education and training manager, at email@example.com.
The HHS released a final rule on clinicaltrials.gov registration, and the NIH released a complimentary policy to this rule in September. Changes based in the final rule and complimentary policy are taking effect January 18, 2017. FDA/NIH will begin enforcement of the changes, in addition to longstanding requirements for the site, on April 18, 2017. It is critical that all applicable studies are registered to remain compliant with site requirements and to avoid enforcement actions.
Starting January 18, 2017, all clinical trials funded by the NIH (regardless of intervention type and phase) will be required to be registered and report results on clinicaltrials.gov. Studies not funded by the NIH require registration based on criteria established by either FDAAA or ICMJE.
If you have a clinical trial funded by the NIH which is currently active OR will be active after January 18, 2017, that may meet the new registration criteria, contact Kevin Smilor (firstname.lastname@example.org) in the Research Institute. If you have a clinical trial that you are interested in registering on clinicaltrials.gov, contact Kevin Smilor to understand the process and options available. For more information, see our guide posted at: http://www.kumc.edu/Documents/ri/cra/CT.gov%20Info%20Sheet_CURRENT%202016_v13_CLEAN.pdf.
NIH has released its implementation of the Final Research Performance Progress Report (RPPR) under NOT-OD-17-022 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-022.html. In short, a Final RPPR will be completed at the end of each funding segment regardless of whether or not a competitive renewal is being submitted. The Final RPPR replaces the Final Progress Report, effective January 2017, and will follow the format of the RPPR.
Steps to follow when contacted by clinical trials industry sponsors
Has an industry sponsor of clinical trials inquired about your interest in serving as a clinical investigator with KU as a clinical trial site? The Office of Legal Affairs at the KUMC Research Institute handles all inbound requests from industry sponsors of clinical trials for confidential disclosure agreements (CDAs). Negotiating and signing CDAs with industry sponsors is the first step KU and its clinical investigators must take before considering and starting a clinical trial agreement at KU.
Research Institute officials are authorized to approve CDAs. Individual investigators sign and acknowledge that they have read and understand CDAs but cannot approve the agreements for KUMC. Individual investigators should also closely scrutinize the contents of any click-through email inquiries seeking the investigator’s interest in clinical trials. Beware of language in the inquiry emails that purports to require the investigator or KU to maintain sponsor information in confidence; we prefer that you do not click through those emails but rather refer them to our office.
If you’re an investigator or study coordinator, please forward your CDAs to the Office of Legal Affairs: We prefer that you please click the “Request for Legal Support” button on the right side of the RI website page at http://www.kumc.edu/kumcri/office-of-legal-affairs.html and fill out the form identifying that you need a CDA with an industry sponsor of a clinical trial. You may also email your request to email@example.com. If you have any questions about CDAs, please contact Peter Griffith at firstname.lastname@example.org or 913-588-3082 or Morgan Smotherman at email@example.com or 913-588-5362.
The Clinical Research Administration Division is now fully staffed in both Regulatory and Budgets and Contracts.
With the addition of Jennifer Keyser (Clinical Trials Contracts Associate), the Budgets and Contracts group has become a well-rounded and fully staffed group. Jennifer brings nearly 10 years of industry and professional experience, with regulatory, budgetary/contract and IRB experience. She earned an MBA and is a Certified IRB Professional. For more information, contact Ecy M. Bullock, MBA, Director Budgets and Contracts at (913)588-5763.
What’s new? Clinical Trial Start-up Kick-off Meeting
Our Division of Clinical Research Administration has implemented a new pre-site start-up process. This process is designed to ensure that at the earliest stage of study start-up, the principal investigator, study team, project managers and Budgets and Contracts associates gather to review and address the key elements for all eligible studies.
In general the purpose of the Clinical Trial Start-up Kick-off Meeting is to:
(i) determine whether or not previously‐executed agreement(s) with sponsor and negotiated terms therein may be applicable for the new study.
(ii) determine appropriate timelines for completing certain deliverables related to the contracts for the study, potentially:
- when the draft CTA will be available for PI review.
- when the draft CTA will be available for sponsor review.
- when an approved, negotiated agreement will be in place for the study.
But most importantly, these meetings will identify potential red flags on study (administrative, legal, fiscal, IRB) which could delay start-up times.
Complete details will be forthcoming.
Sponsored Programs Administration has been restructured to ensure better internal controls and stronger customer service. The division has identified two assistant directors to provide direct oversight in their specific areas of expertise: Lorelei Sells is now Assistant Director, Pre Award; and Diana Weber is now Assistant Director, Post Award. The Grants and Contracts Specialists report directly to the Division Director, Deborah Maloney.
A new Grant Administrator, Pre Award, started work at the RI December 5. Kaycie Bennett comes to us from UMKC with pre award experience.
Faculty Travel Award Application – January 6th
The Research Institute and the KUMC Faculty Assembly Research Committee is pleased to announce applications are now being taken for the January 6th deadline, for qualified faculty members of the University of Kansas Medical Center Kansas City, Wichita and Salina campuses, to provide support for transportation only.
REVISED CRITERIA - The Faculty Assembly Research Committee has reviewed the funding mechanism and has shortened the time between the awards.It is now 12 months.
Clinical Pilot Research Program and Frontiers Pilot and Collaborative Studies Funding Program
Proposal Due Date: Letter of Intent due, February 1, 2017, via REDCap.
KUMC Research Institute: Lied Basic Science Grant Program
Proposal Due Date: Letter of Intent due, February 1, 2017, via REDCap.
Multidisciplinary Pilot Research Grant
Proposal Due Date: Letter of Intent due, February 1, 2017, via REDCap.
The Kansas City Consortium on Musculoskeletal Diseases has a funding opportunity for Research Neuromuscular/Musculoskeletal Disorders.
Application Due Date: March 1, 2017, via REDCap.
The following University of Kansas Medical Center projects have received external funding. This list includes funding awards for new projects that have been received in FY17 (7/1/2016 – 11/30/2016).
- $60,791.00 to Shellie D Ellis from Brown Performance Group for the proposal "Increasing the Offer of Urological Cancer Trials in Kansas: The Learn-Inform-Recruit Pilot"
- $270,000.00 to Bruce F Kimler from American Cancer Society for the proposal "Institutional Research Grant"
- $163,500.00 to Christa A Manton from American Cancer Society for the proposal "Function and Regulation of the Metastasis Suppressor Domain of BRMS1"
- $1,721,250.00 to Luciano Ditacchio from National Institutes of Health for the proposal "JARID1a in Circadian Control of Hepatic Energy Metabolism"
- $1,860,314.00 to Carol E Smith from National Institutes of Health for the proposal "TEEN Connections for Support from Multidisciplinary Professionals & Peers"
- $384,638.00 to Animesh Dhar from Genzada for the proposal "Targeting Super Enhancers in PDAC using GZ17-6.02 and 562 Compounds"
- $100,364.00 to Subhrajit Saha from BCN Biosciences [National Institute of Health] for the proposal "Mechanism of Action of 512 in Mitigation of Radiation Induced Pulmonary Injury"
- $46,798.00 to Hope M Krebill from Kansas Dept. of Health and Environment [Centers for Disease Control and Prevent] for the proposal "Kansas Cancer Partnership"
- $80,110.00 to Elizabeth A Ablah from Kansas Dept. of Health and Environment for the proposal "Worksite Wellness Assessment And Programming"
- $50,489.00 to Elizabeth A Ablah from ASPPH for the proposal "ASPPH Global Health Competency Assessment and Updating Project"
- $6,410.00 to Russell Howard Swerdlow from University of Kansas Center for Research [KU Endowment Association] for the proposal "Bioenergetic Manipulation For The Treatment Of Alzheimer’s Disease"
- $250,000.00 to Carol J Fabian from Breast Cancer Research Foundation for the proposal "Effect of Duavee on Benign Breast Cell Proliferation in Women at Risk for Breast Cancer"
- $241,247.00 to Priyanka Sharma from Southwest Oncology Group (SWOG) for the proposal "Phase II Randomized Placebo-Controlled Trial of Cisplatin with or without ABT-888 (Veliparib) in Metastatic triple-negative breast cancer and BRCA mutation-associated breast cancer"
- $11,778.00 to Neil Alan Segal from Brigham and Women's Hospital, Harvard Medical School [National Institutes of Health] for the proposal "Studying Physical Activity Rewards and Telephonic Active Coaching"
- $49,526.00 to Jean P Hall from University of Kansas Center for Research [Centers for Disease Control and Prevent] for the proposal "Kansas Program to Improve the Health of People with Mobility Limitations and Intellectual Disabilities"
- $21,835.00 to Jennifer Rose Klemp from Kansas Dept. of Health and Environment [Centers for Disease Control and Prevent] for the proposal "Kansas Cancer Partnership - Kansas Survivor Care Quality Initiative"
- $18,397.00 to Natabhona Marianne Mabachi from University of Kansas Center for Research [Dept. of Health and Human Services] for the proposal "The Heartland Sexual Assault Policies & Prevention on Campuses Project"
- $12,705.00 to Jean P Hall from University of Kansas Center for Research [Health Care Foundation of Greater Kansas City] for the proposal "Kansas Medicaid: Evaluating Program Satisfaction, Access to Care, and Unmet Needs of Adults with Serious Mental Illness"
- $75,000.00 to Elizabeth A Ablah from Blue Cross Blue Shield of Kansas City for the proposal "WorkWell KS - Pathways to a Healthy Kansas Grant Deliverables"
- $50,000.00 to Hiroshi Nishimune from Kansas City Area Life Sciences Institute for the proposal "Effect of Oxaloacetate for the Lifespan of Amyotrophic Lateral Sclerosis (ALS) Model Mice"
- $50,000.00 to John P Thyfault from Arkansas Children's Hospital Research Inc. for the proposal "Fitness and Bile Acid Metabolism"
- $6,000.00 to Carolyn Rose Schmidt from March of Dimes for the proposal "Kansas Healthy Babies are Worth the Wait Program"
- $0.00 to Andrew Kent Godwin from Leidos Biomedical Research Inc. for the proposal "Clinical Proteomic Technology Assessment for Cancer Program"
- $1,802,593.60 to Sally Louise Maliski from National Institutes of Health for the proposal "Staying Strong and Healthy during Androgen Deprivation Therapy for Latino Men"
- $46,440.00 to Abeer Walid Rafiq Anabtawi from Cystic Fibrosis Foundation for the proposal "Cystic Fibrosis Related Diabetes, Nutrition and Bone Disease"
- $171,320.00 to Milind Arvind Phadnis from University of Arkansas for Medical Science [Am Heart Assn Natl] for the proposal "Effectiveness and Safety of Clopidogrel, Prasugrel and Ticagrelor in Patients with End Stage Renal Disease (ESCALATE)"
- $50,000.00 to Hannes Devos from American Parkinson Disease Association for the proposal "Pupillary Response to Cognitive Workload in Parkinson's Disease"
- $199,894.00 to Andrew Kent Godwin from Braden's Hope Foundation for the proposal "Exosome miRNAs as Biomarkers and Targets for Chemoresistance in Ewing Sarcoma"
- $300,000.00 to Shrikant Anant from Braden's Hope Foundation for the proposal "Sarcoma in a Dish: A Novel Approach for Precision Medicine"
- $9,374.00 to Liskin Swint Kruse from University of Kansas Center for Research [National Institutes of Health] for the proposal "Leadership Committee Member for COBRE Protein Structure and Function"
- $932,239.00 to Eric Dennis Vidoni from Department of Health and Human Services for the proposal "Kansas City Collaborative to Enhance Access to Behavior and Physical Activity Supports for Individuals with Alzheimer's Disease and Related Dementias"
- $22,956.00 to Linda S Heitzman-Powell from Integrated Behavioral Technologies, Inc. [National Institute on Disability and Re] for the proposal "Development of a Learning Management System for Supervision and Experience Standards for Becoming a Board Certified Analyst"
- $17,500.00 to Subhrajit Saha from National Institutes of Health for the proposal "Mitigation of Radiation Induced Pulmonary Syndrome by Modulating Myeloid Derived Stromal Niche"
- $35,000.00 to Lane K Christenson from National Institutes of Health for the proposal "Role of Follicular Fluid Exosomes on Induction of Ovarian/Fallopian Carcinogenesis"
- $35,000.00 to Jeremy Richard Chien from National Institutes of Health for the proposal "Exploiting Vulnerabilities in Ovarian Cancer by Targeting ER-stress Pathway"
- $170,191.00 to Michael Artman from Kansas Department of Education for the proposal "KS-SHCN"
- $49,940.00 to Kathy L Layton from Paul J Patton Trust for the proposal "UBQLN2 Mutations in a Pediatric Neurodegenerative Disorder: Animal and Pluripotent Stem Cell Models"
- $1,200,000.00 to Eve-Lynn Nelson from Department of Health and Human Services for the proposal "Telehealth Network Grant Program"
- $1,728,302.00 to Russell J McCulloh from National Institutes of Health for the proposal "SPeCTRe: The Sunflower Pediatric Clinical Trials Research Extension"
- $382,500.00 to Indranil Biswas from National Institutes of Health for the proposal "Mechanistic Understanding of Quorum Sensing in Streptococcus Mutans"
- $23,376.00 to Thomas M Yankee from American Association of Immunologists for the proposal "Development of a Novel Chimeric Antigen Receptor for Use against Solid Tumors"
- $30,000.00 to Katherine F Roby from National Institutes of Health for the proposal "Gilbert S. Greenwald Symposium on Reproduction and Regenerative Medicine"
- $332,862.00 to Heather Dawn Schrotberger from Kansas Department for Children and Families [Department of Health and Human Services] for the proposal "Project Eagle Kansas Early Head Start Home Visiting"
- $320,827.00 to Heather Dawn Schrotberger from Kansas Department for Children and Families [Department of Health and Human Services] for the proposal "Project Eagle Kansas Early Head Start Child Care Partnership"
- $107,960.00 to Deepika Polineni from Cystic Fibrosis Foundation for the proposal "Methylthioadenosine is a Biomarker of Cystic Fibrosis Lung Disease Severity"
- $1,625,625.00 to Irfan Saadi from National Institutes of Health for the proposal "Role of SPECC1L Cytoskeletal Protein in Craniofacial Development and Malformation"
- $449,871.00 to Linda S Heitzman-Powell from Department of Health and Human Services for the proposal "Online and Applied System for Intervention Skills (OASIS) Parent Training Program: Translating Research to Practice"
- $2,000.00 to Sandra Anne Billinger from Am Heart Assn Heartland for the proposal "Student Scholarship in Cerebrovascular Disease and Stroke"
- $325,000.00 to Eve-Lynn Nelson from Department of Health and Human Services for the proposal "Heartland Telehealth Resource Center"
- $189,102.00 to Keith A Greiner Jr from Kansas State University [Department of Health and Human Services] for the proposal "Covering Kids of Kansas"
- $2,205,108.00 to Navneet Kaur Dhillon from National Institutes of Health for the proposal "Extracellular Vesicles and and HIV/Cocaine Associated Cardiopulmonary Dysfunction"
- $136,500.00 to Kenneth E McCarson from Tourette Association of America for the proposal "Modeling a Tourette's-Related Human Developmental Disorder in Mice with Nerve Growth Factor-Related Gene Mutations"
- $22,145.00 to Dan A Dixon from Bayer for the proposal "Targeting HuR in Colon Cancer"
- $10,000.00 to Sufi Mary Thomas from American Head and Neck Society for the proposal "Role of Tumor-associated Fibroblasts in Head and Neck Cancer Metabolism"
- $154,000.00 to Sandra Anne Billinger from Am Heart Assn Natl for the proposal "Understanding Cardiovascular Risk and Cerebrovascular Regulation in Older Adults"
- $154,000.00 to Reena Rao from Am Heart Assn Natl for the proposal "GSK3 - A Potential Drug Target to Prevent Renal Fibrosis Following Acute Kidney Injury"
- $154,000.00 to Rajasingh Johnson from Am Heart Assn Natl for the proposal "Molecular Recapitulation of Noonan Syndrome in iPSC-Derived Cardiomyocytes"
- $154,000.00 to Andras Czirok from Am Heart Assn Natl for the proposal "The Interplay between Cardiomyocyte Differentiation, ECM Organization and Cardiac Tissue Morphogenesis during Embryonic Development"
- $214,200.00 to Maria Kalamvokis from University of Kansas [National Institutes of Health] for the proposal "Developing Chemical Inhibitors of Essential ICP0 Functions in Herpes Viruses"
- $2,033,954.00 to Navneet Kaur Dhillon from National Institutes of Health for the proposal "Impact of Opiate abuse on HIV-mediated Pulmonary Vascular Remodeling"
- $154,000.00 to Brenda Jean Rongish from Am Heart Assn Heartland for the proposal "Vascular Endothelial Growth Factor regulation of early cardiovascular structure and function"
- $16,000.00 to Richard Joel Barohn from National Institutes of Health for the proposal "Experimental Therapeutics across the Spectrum of Neuromuscular Disease"
- $35,214.00 to Donna Susan Nyght from Department of Health and Human Services for the proposal "KU Nurse Anesthesia Program"
- $3,294,855.00 to Randolph J Nudo from National Institutes of Health for the proposal "Reorganization of Motor Cortex after Brain Injury"
- $535,740.00 to Xia Zhou from National Institutes of Health for the proposal "Crosstalk of DNMT1 and Sirt1 in Autosomal Dominant Polycystic Kidney Disease"
- $573,751.00 to Christy R Hagan from Department of Defense for the proposal "Novel Pro-Inflammatory Progesterone Receptor/STAT5 Gene Programs in Breast Cancer"
- $764,699.00 to Danny Ray Welch from Department of Defense for the proposal "Blocking Breast Cancer Metastasis by Modulating the RNA-binding Protein HuR"
- $79,471.00 to Pamela Kay Barnes from Department of Health and Human Services for the proposal "Nurse Faculty Loan Program"
- $118,790.00 to Pavla Brachova from National Institutes of Health for the proposal "Role of Follicular Fluid Exosomes on Ovarian/Fallopian carcinogenesis"
- $300,000.00 to Irina Tikhanovich from Am Assn for the Study of Liver Diseases for the proposal "The Role of PRMT1 in Innate Immunity"
- $8,745,363.00 to Russell Howard Swerdlow from National Institutes of Health for the proposal "University of Kansas Alzheimer's Disease Core Centers"
- $420,750.00 to Hao Zhu from National Institutes of Health for the proposal "Rescue of the mtDNA-derived Defects by Mitochondria-targeted mRNA Import and Translation"
- $1,724,884.00 to Christophe Pierre Nicot from National Institutes of Health for the proposal "How HTLV-I Tax and HBZ Control Telomerase Activity to Induce Adult T-cell Leukemia"
- $1,300,500.00 to Bruno Angelo Hagenbuch from National Institutes of Health for the proposal "Molecular Characterization of Hepatic Organic Anion Transporting Polypeptides"
- $688,500.00 to Xiaogang Li from National Institutes of Health for the proposal "ADPKD: Understanding Mechanisms, Discovering Treatments"
- $420,750.00 to Mark E Chertoff from National Institutes of Health for the proposal "Developing a Biomarker for Auditory Nerve Survival"
- $487,945.00 to Liskin Swint Kruse from Rice University [National Institutes of Health] for the proposal "Expanding the Utility of Transcriptional Bacterial Computing"
- $111,500.00 to Rebecca Joyce Wates from American Cancer Society for the proposal "Targeting the K1F11/K1F15/TPX2 Axis as a Treatment for Ovarian Cancer"
- $759,000.00 to Laura E Martin from American Cancer Society for the proposal "Smoking Cessation and Brain Activation: How Practice Changes the Brain"
- $420,750.00 to Edward B Stephens from National Institutes of Health for the proposal "The role of APOBEC3 proteins in innate immune responses in developing thymocytes"
- $120,333.85 to Devin Charles Koestler from Tufts University [National Institutes of Health] for the proposal "Prospective Immune Profiling Using Methylation Markers and Risk of Pancreatic Cancer"
- $160,540.00 to Joel Douglas Mermis from Cystic Fibrosis Foundation for the proposal "CF Center Support"
- $80,000.00 to Eugene K Lee from Urology Care Foundation for the proposal "A Carbohydrate Restricted Diet in Patients with Diabetes and Non-muscle Invasive Bladder Cancer"
- $366,053.00 to Qi Chen from National Institutes of Health for the proposal "New HuR Inhibitor against Pancreatic Cancer EMT and CSCs"
- $382,500.00 to Partha Kasturi from National Institutes of Health for the proposal "Organelle Specific Oxidative Stress Response in Environmental Toxin-Induced Cellular Dysfunction"
- $376,689.00 to Megha Ramaswamy from National Institutes of Health for the proposal "Correctional and Public Health Links to Bolster HPV Vaccine and Cancer Prevention"
- $5,509,448.00 to Hartmut W Jaeschke from National Institutes of Health for the proposal "Mechanisms of Liver Injury and Diseases"
- $762,769.00 to Randolph J Nudo from Case Western Reserve University [Department of Defense] for the proposal "A Closed-Loop Neural Prosthesis for Restoration of Function after Traumatic Brain Injury"
- $493,881.00 to Sarah Finocchario Kessler from National Institutes of Health for the proposal "Piloting At-birth Point of Care HIV Testing Strategies in Kenya"
- $124,999.00 to Roy A Jensen from National Institutes of Health for the proposal "Adaptive Intervention to Maximize Colorectal Screening in Safety Net Populations"