ORA e-Blasts
Criteria for Clinical Trial Registration with NIH
When Must I Register My Trial?
- Trials initiated after 9/27/2007 must be registered in full not later than 21 days after the first patient is enrolled, or by 12/26/2007, whichever is later.
- Trials that were initiated on or before 9/27/2007 and “ongoing” as of 12/26/2007 and do involve a “serious or life threatening disease or condition” must be registered in full by 12/26/2007.
- Trials that were “ongoing” as of 9/27/2007 and do not involve a “serious or life threatening disease or condition” must be registered in full by 9/27/2008.
- Trials that were “ongoing” as of 9/27/2007, do involve a “serious or life threatening disease or condition,” and are completed (meaning, not “ongoing”) by 12/26/2007 are not subject to these requirements, though they may be subject to pre-existing registration requirements. (“Ongoing” in this context means a trial had one or more patients enrolled, but had not examined the final subject or provided the final subject an intervention for the purposes of final collection of data for the primary outcome.)
Three NIH notices have been published on this topic, all can be seen at this link.
K-series Now Electronic
The NIH has announced new business processes for individual career development applications (K-series, except K12) for the February 12, 2009 submission date and beyond (NOT-OD-09-029):
- Applications must be submitted electronically; and
- Applicants will be required to provide additional information.
NIH is transitioning to electronic submission of all Research Career Development Award Programs (Ks) with the exception of K12s. Funding Opportunity Announcements (FOAs) for individual K programs have been updated and will also be announced in the NIH Guide for Grants and Contracts. The SF 424 (R&R) Application Guide for NIH and Other PHS Agencies, now includes Part 1.7 Supplemental Instructions to the SF 424 (R&R) for Preparing an Application for the K series, and should be used with all Adobe application packages.
Grant Writing Workshops
Date: Thursday, December 18, 2008
WRITING SUCCESSFUL GRANTS, will take place from 9 am to 4:30 pm.
FINDING FUNDING, 1:30-4:30 pm.
Location: Pending (Medical Campus)
GrantWinners Seminars, led by Dr Robert Porter, is returning to present its popular workshops on grant writing, each lasting about three hours, sponsored by BUMC’s Office of Research Administration and BMC’s Grant Administration Office.
Writing Successful Grants covers the basic principles of good grant writing for researchers in all disciplines, starting with the phrasing of a compelling research theme to the actual construction of the proposal itself. Major differences between acceptable “academic prose” and persuasive grant writing are highlighted. Common pitfalls that can lead to early rejection of good ideas are reviewed and matched with practical strategies for better writing.
- Ten killer mistakes in grant writing and how to avoid them;
- Two critical steps that will double your chances for success;
- How to win over the grant reviewer;
- Simple keys to a more powerful writing style;
- Visualization: Using illustrations to “sell” your project.
Finding Funding addresses the search for funding, which can be both time consuming and frustrating. Online databases are becoming increasingly important in helping scholars to quickly identify potential sponsors for their research. This “hands on” workshop will focus on the use of powerful tools such as Community of Science, the Foundation Center, and Grants.gov. Search techniques for web sites of federal agencies will also be covered, with plenty of time for participants to practice their skills. (Note: This workshop requires a laptop computer with wireless capability.)
Robert Porter, PhD, has more than thirty years’ experience as a tenured professor, healthcare consultant and research administrator. His proposals have won more than $5 million in awards from government agencies and private foundations. He has presented papers and workshops on grant writing at national conferences and has published award-winning articles on this subject in the Journal of Research Administration. Now working with the Faculty Development Institute at Virginia Tech, Dr. Porter has previously taught at Swarthmore College, Susquehanna University, and Eastern Washington University. He holds graduate degrees in Speech Communications from the University of Michigan.
TO REGISTER, complete the Registration Form 2009 and fax it to 617-414-2834 or e-mail Ellen Jamieson at BMC Grants Administration by Dec 4, 2008. Because of seating limitations, registration is on a “first come, first served” basis. Once registered, additional information regarding the location of the seminars will be sent. If you are unable to attend, please contact Ellen Jamieson to release your spot to a stand-by registrant.
Continuing Resolution Funds DHHS
DHHS continues to operate on a continuing resolution (CR) [Public Law 110-329 Consolidated Security, Disaster Assistance, and Continuing Appropriations Act, 2009] that extends through March 6, 2009. The CR applies the terms of the FY 2008 appropriations for the period covered by the CR. Until the final FY 2009 appropriation is enacted, NIH will issue non-competing research grant awards at a level below that indicated on the most recent Notice of Award (generally up to 90% of the previously committed level). This is consistent with previous three years’ practice. NIH may consider upward adjustments to these levels after the final appropriation is enacted. Additional details to be posted at: Resources for FY 2009. Note that the CR appropriates funds for VA research at a 6% increase, however.
Recent Funding Opportunities
2008 Breast Cancer Research Program (BCRP) Funding Opportunities
FY08 BCRP Program Announcements are expected to be released mid-October 2008. The announcements will describe opportunities for funding by the following award mechanisms:
1. Concept Award
2. Postdoctoral Traineeship Award
Brief descriptions of each of these mechanisms are being released in the News Release on the CDMRP website.
CDMRP opportunities provide another funding mechanism outside of the NIH funding streams and generally are open to researchers at all institutions, foreign and domestic, public and private. Check the eligibility instructions for each award for specific eligibility for each program.
Requests for e-mail notification when Program Announcements are released may be sent to Help@CDMRP.org.
Summer 2008
As NIH gears up to convert all electronic applications to Adobe format, it has provided a test page where investigators may check whether their current versions of Adobe meet the requirements. Note that it is NOT recommended to obtain Adobe from the Adobe website in the usual way. NIH and Adobe, as partners in this electronic applications initiative, recommend that all members of the research community go to Grants.gov Adobe version test to check their file formats and download the proper Adobe version configured for NIH purposes.
June 2008
ORA’s new application review policy was piloted during the recent March cycle and took effect June 1, 2008, giving investigators the option of taking extra time to devote to the science writing of their applications. ORA announced that investigators may choose between two options for review of grant applications: prepare and submit the budget, assurances and research components in one package five business days ahead of the grant deadline, or submit these components separately. Under the second option, budgets, assurances, and a draft abstract must arrive at ORA’s doorstep eight business days prior to the deadline but investigators have an added week to devote to writing the research plan. The finished science must be uploaded into the electronic application three days prior to the deadline, with ORA submitting the entire package without further review. Go to institutional forms for the application forms. See the 
Application Submission Planner.
