When Must I Register My Trial?

1. 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.
2. 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.
3. 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.
4. 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.

Tips resulting from very-recent experience on use of the Adobe-based forms for NIH submissions:

• Adobe transition notices: Availability of forms (Dec 2008); Transition clarification (Nov 2008); and Transition schedule (Sept 2008).
• Fatal error messages ensue if applicants use PureEdge forms for grant mechanisms that already have transitioned. As long as the closing date has not occurred, applicants should re-enter their application onto the proper Adobe-based forms; this includes those applicants who have served on Study Section, who have an extended period to submit, who may receive a fatal error message stating that their funding opportunity closing date has expired although it has not.
• As long as all of their versions of Adobe are compatible with the Grants.gov versions, applicants may use any of their Adobe versions, even though there may be several types located on different computers. For purposes of Grants.gov submissions, Adobe compatibility is a must.
• NIH has begun to post the Adobe-based packages for those announcements, since September 2008, that were published without form or instruction attachments. NIH expects to post all by mid-December.

NIH is focussing ever more strongly on its policy to encourage independent research careers. Investigators within 10 years of their terminal degree may classify themselves not only as new investigators, not having received primary research funding, but as Early Stage Investigators whose grant applications will be clustered among other like applications and whose classification will be taken into account during peer review. NIH aims to establish parity between the success fate of research funding to new investigators as to established ones.

eRA Alert: E-mail addresses are not appearing on NIH Notices of Award. On October 28, 2008 eRA Commons alerted the research community of a bug on the NIH Notice of Award that doesn’t print the institutional email address associated with the application and consequently, prevents the award announcement from going out to that address. Not to worry: investigators still receive an email announcement of their award. All emails are still being sent on the Issue Date to the investigator’s email as well as to the institution’s policy email. And, NoAs continue to be posted on the eRA Commons. Further, a query is available in the Commons that will retrieve a list of Notices of Award by institution. The Commons expects to have the bug fixed by January 16, 2009 so that email addresses will appear again on Notices of Award as of that date. For further information, the best way to contact the Commons is by email to helpdesk@od.nih.gov, or call eRA Helpdesk at 301-402-7469.

The NIH Loan Repayment Program application cycle opened Sept 1, 2008 for extramural (due Dec 3) and intramural (due May 1, 2009) for new repayment applications. These awards can have a positive impact on the careers of biomedical and behavioral researchers, often making the difference in pursuing a research career.

BENEFITS: New extramural LRP contracts for Clinical Research, Pediatric Research, Health Disparities Research, Contraception and Infertility Research, and Clinical Research for Individuals from Disadvantaged Backgrounds are awarded for two-year periods and repay up to $35,000 of qualified educational debt annually. An NIH grant or other NIH funding is not required to apply for or participate in the LRP.

ELIGIBILITY: Applicants must possess a doctoral-level degree (except for the Contraception and Infertility Research LRP); be a U.S. citizen, national, or permanent resident; devote 20 hours or more per week to conducting qualified research funded by a university, domestic nonprofit organization, or federal, state, or local government entity; and have qualified educational loan debt equal to or exceeding 20 percent of their institutional base salary.

Revised NIH Policy on Resubmissions….Attempts to resubmit a grant application that has been unsuccessful on its first try and first resubmission will no longer be allowed, according to new policy.

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. Go to Grants.gov Adobe version test to check your file formats and to download the proper Adobe version configured for NIH purposes.

Exceptionally innovative, high risk, original and/or unconventional research projects that have the potential to profoundly impact a broad area of biomedical or behavioral research are supported under the Transformative R01 Program, a new program of the NIH Roadmap. According to the funding announcement, the broad topics to be highlighted include: Understanding and Incenting Behavior Change; 3-D Tissue Models; Functional Variation in Mitochondria;Transition from Acute to Chronic Pain; Formulation of Novel Protein Capture Reagents; and Evidence for Pharmacogenomics Clinical Studies.

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. Resources for FY 2009.

Notice of Legislative Mandates in Effect for FY 2008 (Feb 2008)

Salary Limitation on Grants, Cooperative Agreements, and Contracts (Jan 2008)

NIH Public Access Policy and related clarifications of policy (Jan, Sept 2008)

Revised PHS 2590 (DHHS Public Health Service Noncompeting Continuation Progress Report) Now Available (Jan 2008)

Revised PHS 2271, PHS 3734, and HHS 568 Forms Now Available (Jan 2008)

Revised PHS 398 (DHHS Public Health Service Grant Application) Now Available (Jan 2008)

Modified Application Submission, Referral and Review for Appointed NIH Study Section Members (Jan 2008)

NIH Policy on Late Submission of Grant Applications (Jan 2008)

NIH Reduces Temporary “Error Correction Window” for Electronic Grant Applications from Five Business Days to Two (Nov 2007)

Full Implementation to Shorten the Review Cycle for New Investigator R01 Applications Reviewed in Center for Scientific Review (CSR) Recurring Study Sections (Aug 2007)

Extended Comment Period for the Request for Information on the NIH System to Support Biomedical and Behavioral Research and Peer Review (Aug 2007)

Revision: Streamlined Review Process to be used for Ruth L. Kirschstein National Research Service Awards (NRSA) Postdoctoral Fellowship Applications (F32) (Aug 2007)