Winter 2011-2012

Winter 2011-2012

Share this:

Latest News from the Office of Sponsored Projects

Office of Sponsored Projects (OSP) Listserv Announcement

Carilion Clinic OSP distributes a list of new and current grant opportunities. This list includes new opportunities from federal agencies, as well as grant announcements from foundations and other organizations. Notices from federal agencies on e-submission, compliance or other subjects are also included in the e-mail.

If you are interested in subscribing to funding opportunities and announcement e-mail list, please e-mail research@carilionclinic.org with "subscribe to OSP listserv" in the subject line.

Required W-9 Information for Research Subject

Carilion Clinic's accounts payable requires a W-9 for all patients who will be receiving stipends regardless of the amount. This applies to patients who are already active in studies as well as new enrollees. For the future, you may want to make this a standard form to get signed upon enrollment or current patients' next visit.

View the most current W-9.

The Integration and Analytics Department of Carilion Clinic

Under the direction of Mattie Tenzer, this department includes one full time and two part time biostatisticians who have over 50 years of combined experience, and they stand ready to support the growing research needs of the Clinic and its affiliates.

Though many people perceive biostatisticians as the number-crunchers whose work begins once the study is over and the data are in hand, the Carilion Clinic biostatisticians encourage researchers to engage their services as soon as a research question is formulated. The biostatistician can aid the researcher by:

  • Helping to create a valid experimental design
  • Helping to determine measurable outcome variables
  • Ensuring appropriate statistical methodology is chosen for the analysis
  • Calculating power and sample size
  • Identifying data sources and building secure databases
  • Preparing data for analysis (including data management and derivation of new variables from existing data)
  • Analyzing data using SAS, SPSS, Microsoft Excel, and other statistical software
  • Interpreting results
  • Optimizing presentation of results
  • Helping to write methods and results sections of a document, including producing graphs and charts

The biostatisticians and director are frequently involved in meetings with investigators throughout the study process. They also have extensive experience serving on committees of the IRB and can assist with the IRB application and approval process. Finally, the biostatisticians are involved in teaching activities through the Office of Professional Staff Affairs and are available to give classes to other audiences as needed.

For more information, please contact Mattie Tenzer at 540-224-5192 or mmtenzer@carilionclinic.org.

RAP8 Grant Awardees

Carilion Clinic's Research Acceleration Program (RAP) offers funding resources for Carilion employees interested in pursuing clinical, biomedical or behavioral research projects. Projects were selected for RAP funding based on their ability to contribute to Carilion's mission of clinical, education and research excellence as well as strengthen Carilion's collaborative relationships with research institutions within the region. We are delighted to announce the following proposals have been selected for RAP funding:

Timothy Ball, M.D.: "The VTCSOM Post Mortem Coronary Stent Registry: The natural history of the stented coronary artery with insights from Micro Computed Tomography and Histopathology"

Apostolos ÔPaul' Dallas, M.D.: "Medical student education of ultrasound guided injections in the lumbar facet joints"

Muhtab ÔMattie' Foroozesh, M.D.: "Role of education and continued support in smoke cessation (RECS in Smoke Cessation)"

Tim Fortuna, M.D.: 'Examining the variability amongst residents at different levels of training in their decision to terminate care during a cardiac arrest resuscitation using high fidelity human stimulation"

Roger Glick: “Planning decision support tools for large-scale pediatric emergencies”

David Hartman, M.D.: “Sexual functioning and quality of life of female patients maintained on buprenorphine/naloxone”

Ellen Harvey, MS.N.: “Impact of In Situ TeamSTEPPS® Simulation-based training on progressive care nurse and patient outcomes related to Failure-to-Rescue”

Susanti Ie, M.D.: ”Nocturnal Automatic Positive Airway Pressure (APAP) in the Treatment of Asthma: A pilot study”

Kinga Powers, M.D.: “Categorization of Latent Errors in the Operating Room and evaluation of the effectiveness of Virtual Operating Room Team Training on reducing Latent OR Errors”

George Steer, Ph.D.: “Pulmonary physiological parameters as an indicator of cardiovascular status in patients with chronic heart failure”

Grant awarded to Dr. Jayasimha Rao by the Jeffress Memorial Trust

Jayasimha Rao, Ph.D., has been awarded a research grant from the Thomas F. and Kate Jeffress Memorial Trust of Richmond for his study, "Mutational Analysis of RsmA Binding Sites and Regulatory Targets in Pseudomonas aeruginosa". The 2012-13 grant will underwrite this research for Dr. Rao, a molecular microbiologist who works for the Section of Infectious Diseases, Department of Medicine, at Carilion Clinic and also teaches at the Virginia Tech Carilion School of Medicine. Thomas M. Kerkering, M.D., Section Chief of Infectious Diseases, and Dorothy C. Garner, M.D., and Rahul Kulkarni Ph.D., in the Department of Physics, Virginia Tech., will provide clinical insight and bioinformatics’ approaches for the study.

The Jeffress Memorial Trust was established through the estate of Mr. Robert M. Jeffress, a business executive and philanthropist from Richmond. Mr. Jeffress had a deep interest in his native state, and he made large contributions during his life in support of scientific research in the Commonwealth of Virginia.

Dr. Rao’s research work is focused on bacterial infections such as Pseudomonas aeruginosa, which is an opportunistic human pathogen that can cause infections in hospitalized and/or immuno-compromised patients. The potential impact of this study will provide new insights into the molecular mechanisms affecting the switch from colonization to acute/ or chronic infections. The study will also define the role of a Regulator of Secondary Metabolites (RsmA), a global regulator and a RNA binding protein which controls the expression of various virulence genes during P. aeruginosa infections.

Innovation Advisors Program Recipient – Colleen Kraft, M.D.

In January 2012, Dr. Colleen Kraft, Department of Pediatrics, was selected into the Center for Medicare and Medicaid Innovation’s (CMMI) inaugural Innovation Advisors Program. Of the more than 900 healthcare professionals around the country who applied, only 73 were chosen by CMMI to join this initiative.

This prestigious group includes clinicians, allied health professionals and health administrators who will work with the CMMI Innovation Center to test new care models aimed at improving quality and lowering costs. Dr. Kraft’s focus will be on efforts to improve the health of at-risk children in the Roanoke area.

She is assessing the question, “What if Medicaid Managed Care hired Nurse Home Visitors to provide in-home, ‘high touch’ care management to pregnant women instead of traditional phone-based case management?” She will study if this intervention will impact prematurity and low birth weight, and if the mothers will be more likely to establish and sustain a responsive relationship with their infants, preventing toxic stress and promoting brain development.

CMMI’s Innovation Center was created as part of the Patient Protection and Affordable Care Act, and this program is aimed at and improving the delivery of healthcare while reducing the costs. As part of this program, Dr, Kraft will cultivate partnerships with other advisors with the aim of developing new ideas and implementing them both regionally and nationwide. Dr. Kraft’s activities are supported by a stipend award from CMMI that covers her activities while serving in the program.

Carilion IRB Information

What is required to be submitted to Carilion IRB for Western IRB (WIRB) studies after authorization to submit to WIRB is given?

The Carilion Clinic IRB requires investigators to submit copies of all local protocol violations and local unanticipated problems/serious adverse events. Remember that an unanticipated problem is defined as an incident, experience or outcome that is
  1. unexpected in terms of nature, severity or frequency
  2. related or possibly related to the research
  3. suggests the research places subjects or others at a greater risk of harm than was previously known

All three criteria must be met in order to meet the criteria of an unanticipated problem/serious adverse event. See the Carilion Clinic Standard Operating Guideline 2.9 for further information.

The CC IRB also requires submission of copies of reports or letters from monitors or auditors concerning the local site.

In addition, any change in local research personnel also must be submitted to the CC IRB. New personnel must email a CV to CC IRB and must have completed a Research Financial Disclosure Questionnaire and required on-line education and training. Any reports involving local issues or study personnel should be submitted on CC IRB forms.

Carilion IRB Update - Effective March 1, 2012

For first time submissions, we ask that documents are emailed to the IRB Office. This includes the IRB application, protocol, consent, data collection tool, recruitment, and CV's. Documents larger than 50 pages should be sent hard-copy to the IRB Office. When adding new study personnel, please always email the CV.

Signature pages may be faxed to 540-985-5323 or scanned and emailed.

Always visit the IRB website for applications and forms to make sure you are using the most updated version.

This update is posted under New Submissions on the IRB website. Please read on for further submission details.

Carilion Institutional Review Board

IRB Research Application Instructions

This application is for use by researchers proposing to conduct human subjects research at Carilion Clinic, including the Jefferson College of Health Sciences, or who will use Carilion services as part of the research process. The application is for use by the Carilion Institutional Review Board, a committee charged with protecting the rights and welfare of human subjects in research. The entire application must be completed if the proposed research involves Carilion faculty, employees, students, facilities or patients.

Research protocols may be reviewed at convened meetings of the IRB or through a single reviewer process involving the IRB chair and staff. The type of review is determined by the nature of the project, the level of potential risk to research subjects and the characteristics of the subject population. The final determination of the type of review applicable to a study is made by the IRB.

  • Full Board Reviews: Research that would require review at a convened meeting of the IRB would include but is not limited to research that involves: 1)more than minimal risk, 2)vulnerable populations, 3)experimental drugs or devices 4)invasive procedures, or 5)deception (e.g., in behavioral research). A schedule of IRB meetings can be found on the Carilion IRB website.
  • Expedited or Exempt Reviews: Some studies may not require review by the convened IRB, but may be eligible for “Expedited review” or “Exempt status” after review by one or more IRB members. Expedited studies involve no more than minimal risk to subjects. Federal regulations define minimal risk as the probability that the magnitude of harm or discomfort anticipated in the research are not greater in of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. Some research may be Exempt from further review once this initial determination is made. The Carilion IRB must determine whether proposed studies meet the criteria for Expedited or Exempt review.

Submission Instructions

All Full Board, Expedited, and Exempt study submissions to the IRB should be submitted using this application. Investigators should send the completed application to the IRB electronically.

For Expedited or Exempt submissions please send the application to Julie Wimmer at jkwimmer@carilionclinic.org. For Full Board submissions, please send the application to Meredith Talmadge at mttalmadge@carilionclinic.org. Signature pages may be sent electronically or faxed to 540-985-5323. For further information call 540-853-0728.