New NIH policy on electronic submission of diversity supplements

Effective January 25, 2018, the NIH will require all single and multi-project diversity supplement requests to be submitted electronically. This is a change in NIH policy, which currently uses paper forms for these diversity supplements.

The diversity supplement funding opportunity announcement will be reissued with new FORMS-E application forms and instructions for supplement requests. For supplement requests prior to January 25, prepare requests using the current FOA.

Funds from diversity supplement requests are used to improve the diversity of the biomedical research workforce by recruiting and supporting students, postdocs, and eligible investigators from groups underrepresented in health-related research.

See the Dec. 28 Extramural Nexus blog post for more information on this new policy.

How to receive credit at OHSU for CITI Training modules from the VA or another institution

Have you completed CITI Training through the Portland VA or another institution? If so, you may be able to configure your CITI account in order to receive credit at OHSU for modules you’ve already completed in CITI.

One of the many benefits of OHSU transitioning research compliance training to the CITI Program is that courses completed elsewhere have the chance of transferring partial or full credit to other institutions that also use CITI. Each course on CITI is composed of a number of modules. When the individual modules from a course at one institution have the exact same Module ID number as that from another institution’s course, completion credit for that specific module will transfer to the new institution.

It is possible that the entire module list for a course will transfer credit, and you will show as completed for that course at OHSU. For example, the Portland VA Human Subjects Research (HSR) Basic Course and the Refreshers completed in the latter half of 2017 and onwards should match exactly to the corresponding OHSU course. However, each institution has the option to select the individual modules that compose their courses, so all the modules in a course may not match. If you receive credit for only some of the modules, you must complete any remaining modules to receive full credit for that course at OHSU.

To see if your modules will transfer credit to your OHSU CITI account, please follow the steps below.

Step 1: Affiliate your existing CITI account with your OHSU CITI account in one of two ways.

  • Log in to your CITI account associated with the external institution. On the Main Menu page, click on the blue bar near the bottom that says “Affiliate With Another Institution.”
  • Log in to your OHSU CITI account here. On the Main Menu page, click on the blue bar near the bottom that says “Affiliate With Another Institution.”
    • Note: If you have not logged in to your OHSU CITI account before, by logging in through this link you will be guided to create your OHSU CITI account. You can affiliate any existing CITI accounts with your OHSU CITI account during this process.

Step 2: Add the corresponding OHSU CITI course to see which modules transfer.

  • A course must be added to your OHSU CITI account in order for previously completed modules to transfer. This can be done by clicking the “Add a Course” link on the Main Menu page of your OHSU CITI account.
  • Start by selecting the OHSU course with the name most closely corresponding to the course you completed at another institution. For most courses, there are multiple versions, such as the Basic Course and different Refresher Courses. If you look at the list of modules you’ve completed, sometimes the module titles will include “Refresher” or “Basic” in parenthesis to help you identify what version of the course these modules are likely to transfer to. You can use “Add a Course” to change the version of your course until you find the one that offers the most transfer credit for a particular course.

 

If you have any questions about OHSU CITI Training, please contact Research Integrity at integrity@ohsu.edu.

New NIH policy on Certificates of Confidentiality

On Sep. 7, 2017, the National Institutes of Health issued a notice of changes for their policy regarding the issuing of Certificates of Confidentiality (CoC). This change comes as a result of the implementation of Section 2012 of the 21st Century Cures Act. A CoC is a privacy provision that will prevent “compelled disclosure” (a subpoena) of research data.

PadlockPreviously, a researcher had to apply for a CoC. With this new policy, any NIH-funded research involving identifiable, sensitive information, identifiable biospecimens or generating individual level genomic data that was active on Dec. 13, 2016, has retroactively been issued a CoC as of Oct. 1, 2017. For all new grant submissions, the CoC will be issued automatically as part of the NIH grant application process. Studies that are not NIH funded can still apply for a CoC through the usual process.

So what do you need to do now? If your NIH-funded study fits these criteria and, therefore, has a retroactively issued CoC:

  • If you are still seeing subjects, you should inform the subjects of this new privacy protection by modifying consent forms to include CoC language — see new, simplified CoC boilerplate language in the latest consent form template on the IRB Policies and Forms page. Include any limitations on the CoC, such as mandatory public health or child abuse reporting.
  • Update the IRQ CoC question (Study Details page, Q12) at the time of the consent form revision.
  • For NIH-funded studies under a Waiver of Consent, the change to the IRQ can be made in the next Modification or Continuing Review.

If your study is subpoenaed and you have a CoC, contact OHSU Legal (Legal@ohsu.edu) for assistance. If you are unsure if your study meets the criteria for having a CoC, or you have questions about the necessary changes, please contact Research Integrity at irb@ohsu.edu.

Recognizing OHSU innovation at the 2018 TTBD Awards ceremony, Feb. 8

The annual Technology Transfer and Business Development awards ceremony recognizes OHSU community members who have contributed in the areas of innovation, entrepreneurship, industry partnership, patenting and technology commercialization.

TTBD reception and awards ceremony

Thursday, Feb. 8, 2018
4 p.m. Reception; 5 p.m. Ceremony
Doernbecher Children’s Hospital, Vey Auditorium
Registration is requested for this free event.

Top honors of the night will be awarded in the categories of New Inventor of the Year, Business Development Partnership, Technology Transfer Achievement and TTBD Appreciation. Also recognized will be the recipients of the NIH New Innovator Award, the Biomedical Innovation Program Award and the M.J. Murdock Charitable Trust Award.

The keynote address will be given by Phillip Marucha, D.M.D., Ph.D., dean, School of Dentistry. Opening remarks will be delivered by Peter Barr-Gillespie, Ph.D., interim senior vice president for research and Brendan Rauw, M.B.A., C.L.P., vice president of TTBD.

Join us for an evening of celebration

The event is free and open to the public. The reception includes complimentary drinks and hors d’oeuvres. Learn more and register. Contact Karen Boren with questions.

NIH under continuing resolution: What does it mean to you?

The NIH released a notice on December 19 indicating that all Department of Health and Human Services agencies will be acting under a continuing resolution through Jan. 19, 2018. (Note that Congress extended funding after the NIH notice was released.)

NIH logoThis means that until at least mid-January, grants will be funded up to 90% of the previously committed level. Adjustments may be made later, but there are no guarantees. So be cautious of spending ahead on your award.

For more information, refer to NIH notice number NOT-OD-18-120.

Ev McClendon, Ph.D., neuroscientist (and sheep OBGYN), featured in OHSU In the Lab

Premature babies are at risk for disabilities that can last a lifetime. With sheep from a local farmer, Ev McClendon, Ph.D., has made some groundbreaking discoveries about what causes these cognitive and learning problems — and what might be done to prevent them. A neuroanatomist working in the lab of Stephen Back, M.D., Ph.D., McClendon was the lead author on a recent paper that demonstrated low oxygen, more than low blood flow, causes major disturbances in brain development.

Ev McClendon, Ph.D., and Stephen Back, M.D., Ph.D.

Ev McClendon, Ph.D., and Stephen Back, M.D., Ph.D.

What are you studying and why is it important?

If we can understand what causes brain damage in premature infants, we can do something to prevent it. I look at the development of brains in newborns. In just the last decade, our understanding of early birth and brain development has come a long way. We knew that premature infants have smaller brains than full-term babies and we thought that this was because they were missing neurons. Indeed, with severe brain injury, it was easy to see that portions of the brain were missing. Consequently, it was logical to assume that in brains with milder, less obviously injuries, smaller brain volumes equated with fewer neurons. The previous dogma was that the neurons had died because there wasn’t enough blood flowing to the brain. Although limited blood flow can certainly contribute to maturational changes in the developing brain, it isn’t the only factor. One of the important discoveries in Dr. Back’s lab a few years ago was that the neurons in these small brains weren’t missing, they were underdeveloped. When I learned that all the players — the neurons you expect to find — were there, the next step was to find out why the brain was so small.

What’s been your most exciting moment of discovery?

When I started looking at the anatomy of the neurons in those small brains, I found that the dendritic arbors — the branches on the tree of the brain — weren’t as complex as the branches in normal brains. That was a pretty exciting outcome because it opened the door to possible therapies. All of our discoveries are exciting, since each have clinical implications. Our most recent finding, that low oxygen states alone are sufficient to cause maturational changes, can help provide clinical strategies for treating newborns. Our next step is to find out when and how much oxygen infants need so that we can provide the proper amounts. Too much oxygen can cause other kinds of damage to the infant’s body.

What’s your day-to-day life as a researcher like?

I like to joke that, in addition to being a neuroscientist, I’m a sheep OBGYN. We use a fetal sheep model in our research. The cool thing is that a lot of the sheep breeds have a high incidence of twin pregnancies. That allows us to take advantage of an internal control as far as the mom is concerned. One fetus can act as a control and the other can be the experimental animal. We don’t have just an animal to animal comparison, but an in utero comparison. We have a local farmer who time breeds her sheep on a particular schedule for us. When the ewes are two thirds of the way through their gestational period, I bring the ewes into surgery and place instruments on the fetuses so that I can take measurements later in the gestation period, and manipulate fetal blood flow and oxygenation. After recovery from the surgery, I connect the fetal lines to equipment that lets me monitor blood pressure, heart rate, and changes in arterial blood gases and electrolytes in response to the experimental manipulations. Eventually the brains are harvested to examine the impact of the experiment on neuroanatomy and physiology. Then? I crunch a lot of data.

About In the Lab

OHSU In the Lab publishes every third Thursday on O2 (login required). The series looks at the people in the laboratories who help make OHSU such a vibrant research institution. In each post, researchers describe their current work and answer the same three questions.

Coming Changes to NIH Clinical Trials and How They Affect Your Research

Beginning in 2018, NIH is changing the definition of a clinical trial—expanding it beyond its current scope. If you work with human subjects, your research may be affected, including the indirect cost rates you can put on your grants. But not all NIH institutes are following the same guidelines. You’re invited to hear the latest on these changes and what they may mean for you from our experts in OPAM.

Session 1
Date: Thursday, December 21st, 2017
Time: 1:30pm – 2:30pm
Room: MRB 634

Session 2
Date: Thursday, January 4th, 2018
Time: 1pm – 2pm
Room: MRB 634

Questions? Contact funding@ohsu.edu.

 

Three researchers receive 2018 Biomedical Innovation Program awards

The Oregon Clinical & Translational Research Institute and Technology Transfer and Business Development have awarded three grants to investigators through the Biomedical Innovation Program. The awards provide funds, project management, and mentorship to facilitate the development of innovative technologies at OHSU and accelerate their translation to the marketplace.

This track of funding supports translational projects that develop new biomedical devices, diagnostics, and software.

Luiz-Bertassoni-DDSLuiz Bertassoni, D.D.S., Ph.D., assistant professor of restorative dentistry, was awarded a grant to support product development and commercialization of a material system for regenerative dental applications.

Basic science developments of the material, EndoGel, are supported by National Institutes of Health RO1 funding. The Biomedical Innovation Program award will help the team move toward launching the commercial product, which promises to be a feasible solution for an unmet need in dental and craniofacial therapies.

Kim Hutchison, M.D.Kimberly Hutchison, M.D., associate professor of neurology, was funded for the project “Novel mouth sealer to decrease oral leaking and improve compliance with nasal CPAP for the treatment of obstructive sleep apnea.”

The project brings the technical expertise of bioengineers to the project of a sleep medicine physician in order to develop a prototype that is ready to be tested in clinical trials. The concept is a device that will vastly improve the current 55 to 60 percent sub-optimal compliance with the CPAP.

David SheridanDavid Sheridan, M.D., assistant professor of emergency medicine, was awarded funding to commercially develop a simple, non-invasive dehydration monitoring device, HydraSense. The team will focus on two markets. In developed countries, the device can reduce costs of unnecessary medical visits.

In developing countries, there is a significant impact on true morbidity and mortality, and the device can help providers with limited medical training in resource-limited settings determine whether to treat with IV fluids or transfer to higher levels of care.

“The Biomedical Innovation Program meets a critical need at OHSU by funding promising early stage and potentially marketable technologies,” said OCTRI Director David Ellison, M.D. “This funding, along with project management and mentorship, helps move the needle substantially, to put these technologies in the best possible position for commercialization where they can ultimately improve patient outcomes. We are very excited to fund these new technologies for 2018, and look forward to working closely with the investigators.”

Detailed information on all three awards, including project abstracts, is provided on the OCTRI website. Visit the OCTRI website for information on OCTRI’s resource services.

 

The Biomedical Innovation Program awards are also supported by the Office of the Senior Vice President for Research, with additional funding and support from industry partners Welch-Allyn and GE Healthcare. 

OCTRI is supported by the National Center for Advancing Translational Science at the National Institutes of Health (UL1TR002369).

Impact notification: Water system shutdown in Richard Jones Hall, Dec. 12-13

Impact notification: Richard Jones Hall

Impact notification: Richard Jones Hall

As part of the project to improve the OHSU Auditorium cooling system, crews will relocate a water line impacted by chilled water piping installation.

The water line relocation will impact the Richard Jones Hall North (old Basic Science sector) from Tuesday, Dec. 12, 4 p.m., to Wednesday, Dec. 13, 7:30 a.m.

Questions or concerns? Email David Keyser (keyser@ohsu.edu)

New RATE online learning: Brief, convenient, informative

Classroom training is still available but now there’s a more convenient way to launch into learning about select research administration topics from Research Administration Training and Education.

These modules enable new supervisors, investigators, researchers and research administrators to learn about the core components of each topic anytime with their OHSU network credentials. Those with more direct job responsibilities can follow links to further learning at the close of each module.

Effort Concepts

  • Understand the importance of tracking effort and labor distribution
  • Discern the difference between effort reporting and effort certification
  • Identify resources that support effort compliance

To launch Effort Concepts, login to Compass.

OGA Overview ModuleOracle Grants Accounting (OGA) Overview

  • Understand how OGA serves departments’ needs
  • Prepare to request user access
  • Locate guidance to find award information and attachments, run reports, and check encumbrances

To launch OGA Overview, login to Compass.

InfoEd Overview (coming soon!)

  • Understand how InfoEd serves departments’ needs
  • Prepare to request user access
  • Locate guidance and training for InfoEd

RATE expects to complete development of this module in January 2018. Meanwhile, hands-on classroom training for InfoEd is open to enrollment via Compass.

Learners may complete any of these brief modules through Compass and then revisit them anytime to review ideas, guidance, and useful links.

Welcome to the Research News Blog

Welcome to the Research News Blog

OHSU Research News is your portal to information about all things research at OHSU. Find updates on events, discoveries, and important funding information.

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