IRB Notes eIRB Helpdesk: Top Tips for IRB Submissions

1. I need to add or remove a staff member on my eIRB study. What’s the best way to do this?

You should submit staff changes independent of other changes to your study. Normally, staff-only modifications can be turned around within 24 hours, allowing your change to take effect quickly. If you pair this change with other items, the staff has to wait for the approval of the entire modification.

2. I am trying to add someone to my eIRB study, but I am not finding them in the search. What gives?

Chances are one of two things has happened. First, double check that the person has registered for the eIRB. Simply taking the Big Brain courses doesn’t create an eIRB account. If someone needs to register, they can find the “Registration” link at the bottom left of the eIRB login page. If they’ve already registered for the eIRB, check that you are spelling their name correctly. The eIRB is connected to the HR database, so you must use the person’s name as it appears in HR’s records.

3. I am adding someone to my eIRB study, and I am getting an error message that they are not compliant with the required Big Brain trainings and / or Conflict of Interest. I think they have two Big Brain accounts; what do I do?

You can handle this one of two ways. First, you can email your request, and the person’s full name, to oioeduc@ohsu.edu. Second, you can call us to have the person’s account updated. Once the multiple accounts are merged, the system updates overnight, and you’ll be ready to submit!

IRB Brown Bag: STudents As ResearcherS: STARS in the IRB Sky

Brown BagSTudents As ResearcherS: STARS in the IRB Sky
Student Research
Lynn Marshall – IRB Vice Chair
Thursday September 25th, 2014
11:30 AM – 12:30 PM
UHS 8B60
 
IRB Vice Chair Lynn Marshall will lead a space walk through of the basics of submitting your research to the Institutional Review Board (IRB) for review. She will cover our online submission system, the documents you need to prepare, what elements should be in the documents, and how to avoid common omissions that delay approval.

Deadline extended: Graduate Research Fellowship applications for Neurobiology of Disease due Sept. 26

The OHSU Brain Institute announces the 2014 Neurobiology of Disease Fellowship Award Program (this award includes base stipend plus $2,000) that can support graduate students (Ph.D. or M.D./Ph.D.) pursuing research relevant to the neurobiology of disease. Applications will be judged on the basis of scientific merit, novelty, relevance of the research to the neurobiology of disease, the commitment of the student to ongoing research on the neurobiology of disease, and the mentor’s qualifications.

The deadline to apply is September 26, 2014

Eligibility requirements:

  • Student must have completed at least one year of Ph.D. training at OHSU and be enrolled full-time as a Ph.D. student during the proposed year of fellowship support.  Preference will be given to 3rd and 4th year graduate students and students who have not previously received an OHSU Brain Institute Graduate Student Fellowship.
  • The student’s research interests must be relevant to the neurobiology of disease.
  • Student must have identified a mentor who has agreed to supervise the dissertation and provide support for the student’s research.
  • Student must be in good academic standing with a GPA ≥ 3.0.

Graduate students interested in applying for these fellowships should submit the following as a single PDF document:

  • A brief description of the proposed research (three pages maximum, not including references). This should include a clearly stated hypothesis, specific aims, impact, significance, preliminary data and experimental design. Font should be Arial or New Times and be no smaller than 11 point. Margins should be 1”. Applications using smaller fonts or margins will not be considered.
  • A description (1/2 page) of student’s long term career goals
  • Student’s curriculum vitae
  • A letter from the mentor indicating the support available for the graduate student and the proposed research
  • Mentor’s biographical sketch and research support (NIH format)

To submit applications, email applicaiton materials to Ashley Uchtman, Program Coordinator, OHSU Brain Institute.

Gates Foundation Grand Challenges Explorations proposals due Nov. 12

The Bill & Melinda Gates Foundation has announced its research topics for the 14th round of its Grand Challenges Explorations grant program. This program is intended to foster unconventional ideas that could transform health and agricultural development in the world’s poorest countries. Grants of up to $100,000 are available to applicants at any experience level; in any discipline; and from any organization, including colleges and universities, government laboratories, research institutions, non-profit organizations and for-profit companies. Projects will have one opportunity to apply for a follow-on Phase II grant of up to $1 million. The topics in this round are:

Applications are due November 12, 2014.

See other active funding opportunities in this week’s Funding Alerts.

Fall Vollum Writing Program starts Sept. 24

The Vollum Writing Program is a 6-week professional science writing course open to OHSU graduate students, postdoctoral fellows, and junior faculty.

This class uses short lectures, class discussion, and workshop-style writing assignments to help researchers learn to write better papers and grants. Topics include:

  • The basic elements of good scientific writing style, including sentence and document structure;
  • Insight into scientific conventions regarding grammar, punctuation, and usage;
  • Strategies for revising;
  • Dealing with writer’s block and time management;
  • Best practices for writing introductions, results, discussions, and grant proposals.

The class runs for six weeks, from 9:30 a.m. to 12 p.m. on Wednesdays, beginning September 24, 2014. Six individual tutorials with the instructor are included. There are no prerequisites for this noncredit, professional development course, but you should not take the class unless you have enough data to write about.

The course carries a fee of $500 per student (unless you are in a Vollum lab or part of select graduate Ph.D. programs). Questions? Contact Taylor St. Clair.

Register for the Fall Vollum Writing Program.

OHSU startup Orexigen earns FDA approval

The office of Technology Transfer and Business Development is happy to announce that a drug from  Orexigen Therapeutics Inc., called Contrave, has been approved by the FDA. This drug helps with weight management, along with a reduced-calorie diet and increased physical activity, in adults with an initial body mass index of 30 kg/m2 or greater (obese), or 27 kg/m2 or greater (overweight) who also have at least one weight-related comorbid condition.

Contrave has two components: naltrexone, an opioid antagonist, and bupropion, a relatively weak inhibitor of the neuronal reuptake of dopamine and norepinephrine. Nonclinical studies suggest that naltrexone and bupropion have effects on two separate areas of the brain involved in the regulation of food intake: the hypothalamus, which regulates appetite, and the dopamine circuit,  which serves as a reward system.

Orexigen is an OHSU startup company.  The FDA’s approval of Contrave represents a significant milestone for both Orexigen and OHSU.  Sales through Orexigen’s North American partner, Takeda Pharmaceuticals, are set to begin this fall.

RAIN is back from summer break

The Research Administration Information Network (RAIN) is back from its summer hiatus, with the latest announcements, updates, and news from research administration at OHSU.

RAIN is a forum for research staff across the university who take part in aspects of research administration. At RAIN meetings, we deliver the latest information on NIH updates, award administration, learning opportunities, RDA staffing, and any other notable activity in research administration.

Meetings are held the third Thursday of each month at 9:30 a.m. All are welcome to attend either in person in UHS 8B60, via west campus videoconferencing, or through the live stream at the usual meeting time.

To join the RAIN distribution list, send your request to the meeting administrator.

IRB Notes From the Chair: A New Electronic IRB

 

eIRB Upgrade Coming summer 2015!

 

The new eIRB will help us support the rapidly growing research community at OHSU and maintain our high standards of compliance as a world-class research institution. We expect this new version will provide a much simpler, understandable and streamlined approach for submitting your studies for IRB Review.

 

The eIRB Upgrade project has been divided into two phases: Phase 1 –  Design & Phase 2 – Development and Implementation. Phase 1 was completed at the end of June and Phase 2 is underway. We have divided Phase 2 into Sprints which gives us the ability to do more frequent review and testing of key stages. This is important for us in order to identify any problem areas to resolve early on throughout.

 

At the end of each sprint we conduct User Acceptance Testing (UAT) sessions. We have completed UAT for Sprint 2 – Initial Submission Smart Form content. We had an outstanding response from the research community who volunteered to be testers and we received an amazing amount of feedback. We are doing our best to incorporate whatever suggestions possible into this upgrade.

 

We will need current and additional volunteers to test upcoming key upgrade components and provide feedback by alerting us to any bugs or identifying other possible areas that may require fixes or improvements for additional sprints. Sprint 3 – Initial Submission Workflow – is coming up toward the end of September so keep an eye out for more information coming soon.

 

If you are interested in signing up to participate in this testing, please contact Andrew Perluss and David Holmgren to sign up as a testing volunteer.

 

Volunteer

 

IRB Notes from the Manager: IRB Billing Tips

We have recently received a few questions about the billing for industry sponsored studies. Below is a reminder of the types of modifications that are “billable” and “not billable” on these studies.

Billing

As a reminder, including “no charge” or similar language in the title of your modification does not serve as a trigger for whether items are billed. If you have questions or concerns about IRB billing, please email Dave Holmgren, IRB Manager.

OCTRI Design Studio: Get feedback on your project from senior faculty

Are you submitting a Career Development K award?

Or your first R01? A similar major grant?

The Oregon Clinical and Translational Research Institute has an opportunity for basic and clinical scientists to present their research and get constructive feedback from OHSU scientists to improve their chances of success. The OCTRI Design Studio has helped many OHSU researchers improve their aims and identify important areas of improvement before submitting awards.

The Design Studio has openings at four scheduled meetings for this
winter and spring:

*   Friday, September 19, 11 am to 1 pm
*   Monday, October 20, 1 to 2 pm
*   Tuesday, November 18, noon to 2 pm
*   Monday, December 15, 1 to 3 pm

OCTRI’s Design Studio has been a great opportunity for basic scientists as well as clinical scientists at all levels of training. Learn more about Design Studio, or contact Karen McCracken about presenting.

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 Oregon Health & Science University. Visit often for updates on events, discoveries, and important funding information.

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