Boston University Medical Campus
Sponsored Programs

BU will no longer submit new applications to FAMRI in support of sponsored research projects (Oct 30, 2009): The Flight Attendant Medical Research Institute (FAMRI) recently decided to use a standard non-negotiable contract for all new agreements. Previously FAMRI was amenable to making contract modifications during award negotiations. The template agreement imposes terms that are either very broad or hard to enforce, or potentially impact BU’s ability to collect payment for work completed. It also requires BU to accept restrictions on receiving funds from, or working with, certain entities. No changes to agreements for active, funded awards from FAMRI are anticipated. OSP-MED will inform the research community if a change in FAMRI’s position changes BU’s decision.

Major changes in application forms! (Oct 13, 2009)

ARRA reporting requirements (Sept 16, 2009): To date, Boston University Medical Campus has received 44 awards totaling more than $15.2 million funded by the American Recovery and Reinvestment Act (ARRA) of 2009. As outlined in the notice of award, all ARRA funded projects are subject to special quarterly reporting requirements.

To ensure consistency in reporting and minimize the additional administrative burden on award recipients, all ARRA related quarterly reporting will be handled centrally by OSP-MED with PIs and/or departmental administrators being asked to verify limited information (including an estimate of the number of jobs created and/or retained, and the completion status of the project or activity). Each quarter, OSP plans to be in touch with the PI to update information on these items.

OSP-MED will be holding a training/information session soon to discuss reporting process responsibilities and answer any questions related to this topic. At least one person associated with each award (PI and/or departmental administrator) is requested to attend this session. In some cases, one departmental administrator or PI may represent multiple awards. ARRA FAQ.

Restructured paper PHS398 and electronic SF424 applications announced by NIH (Sept 16, 2009):
The new versions of the PHS398 and electronic SF424 (R&R) application packages and instructions will be available by December 2009. Applicants must download and use the new application packages for submissions targeting due dates on or after January 25, 2010 (funding for FY 2011 and beyond). Applications that mix old and new paper application forms will be delayed and may not be reviewed. Please closely follow the instructions detailed in the application package. Contact OSP-MED if you have any questions about this announcement, NOT-OD-09-149. NIH guidance on the changes.

Key changes include:

1. Shortened page limits, 6 or 12 pages, for the newly-retitled Research Strategy section, depending on the FOA. One additional page will be allowed for Specific Aims. As always, if the FOA requires page limits that differ from the application instructions, the FOA page limits should be followed. For resubmission and revision applications for most programs, the Introduction will be limited to one page. For individual Career Development (K) applications, the Research Strategy includes Candidate Information, and will be limited to 12 pages.
2. Alignment of application with enhanced peer review criteria. To coordinate with enhanced peer review criteria, changes will be made to the Research Plan, Resources, and Biographical Sketch sections of the application forms and instructions, as follows:
   • Research Plan. Three sections of the current Research Plan (Background and Significance, Preliminary Studies/Progress Report, and Research Design and Methods) will be consolidated into a new single section entitled ‘Research Strategy.’ The new Research Strategy section (a single PDF upload in the PHS 398 Research Plan Component of the SF 424 (R&R)), will be sub-divided into three parts: Significance, Innovation, and Approach. The Approach sub-section will include both Preliminary Studies for New Applications and Progress Report for Renewal/Revision Applications.
   • Resources. The Facilities and Other Resources section will be changed to require a description of how the scientific environment will contribute to the probability of success of the project, unique features of the environment, and for Early Stage Investigators, the institutional investment in the success of the investigator (e.g. resources, classes, etc.). The Facilities and Other Resources section is part of the R&R Other Project Information in the SF 424 (R&R) application, and part of the Resources Format Page in the paper PHS 398 application.
   • Biographical Sketch. A new Personal Statement will be incorporated as Part A, changing the parts formerly called A, B, and C to Parts B, C, and D. Applicants will limit the list of selected peer-reviewed publications to no more than 15, chosen on the basis of recency, importance to the field, and relevance to the proposed research.

Manuscript number no longer to be used as proof of compliance with NIH Public Access Policy (8/17/09): Effective August 21, 2009, NIH will not allow an NIH Manuscript Submission Reference Number (NIHMSID) to be used as proof of compliance with the NIH Public Access Policy three months after paper is published. This number is used as a temporary substitute for the Pub Med Central reference number and is intended to be used only in cases where an awardee needs to cite a paper soon after its acceptance by a journal, when there is not enough time to complete every step of the NIH manuscript submission process. At issue is the fact that many months after publication of the paper, the temporary number still is being used, an unacceptable use of the NIHMSID.

Delayed electronic submission (6/26/09): The following mechanisms, originally scheduled to transition to electronic submission for applications due on/after September 25, 2009, have been rescheduled to electronic transition beginning with submissions on/after January 25, 2010:
• Institutional National Research Service Awards (T32, T34, T35, T36, T90, TU2)
• Other institutional training grants (T&D Series, D43, D71, T14, T15, T37, U2R and K30)
• Institutional career development programs (K12)

Please continue to submit these applications using the paper PHS398 application forms until then. NOT-OD-09-113

Cannot charge admin support under ARRA…(5/15/09): OMB considered a request to allow charging administrative salary costs directly to research grants funded under the American Recovery and Reinvestment Act (ARRA) and determined that no, ARRA’s reporting requirements are not sufficiently burdensome to justify this departure from usual policy.

ARRA Update…(5/13/09): BUMC submitted 366 applications in response to funding opportunity announcements under the American Recovery and Reinvestment Act, 102 of those for the Research Challenge Grant (RC1) deadline alone. In just a few weeks NIH received roughly the total number of applications it receives in a four-month submission round. Regarding RC1 only, NIH received approximately 20,000 applications. Those applications are now working their way through submission to assignment, and with such volume, eRA Commons reminds the research community that it may take staff longer to respond to support and status inquiries.

Currently, NIH Center for Scientific Review (CSR) is making logical groupings for the review process. While these efforts are underway, investigators may receive multiple automated emails alerting them to check eRA Commons when changes are made to an application assignment. CSR expects that most assignment changes will be final by May 21.

All RC1 applications will be reviewed in Special Emphasis Panels. Special efforts are being made to convene Special Emphasis Panels of reviewers with appropriate expertise. Investigators may find that the panels are being coordinated by Initial Review Groups (IRG) with which they are not familiar. CSR will not consider requests to move applications between panels.

Automated notifications also are being generated for Institute/Center (IC) assignment changes. Although these messages give contact information, questions about IC assignments are best directed to the assigned primary IC or the IC that the investigator feels is more appropriate. IC contacts can be found on the IC-specific Challenge Grant Web sites.

BUMC’s new DHHS rate agreement (FY2010)… BU letter annoucing fringe benefit rate and DHHS rate agreement, Feb 10, 2009

Recent NIH-approved, unfunded applications may be funded!…(4/6/09): Under ARRA’s unprecedented $8.2 billion bolus of extramural grant funds, NIH will make grant awards from existing peer-reviewed, meritorious grant applications that can be accomplished in two years or less, meet the goals of the ARRA, and meet the mission priorities of NIH Institutes/Centers (I/C). If your application was submitted for FY2008/2009 funding and you received:

• a meritorious priority score from the initial peer review process;
• Advisory Council or Board approval prior to 9/30/2009; and
• a score that could not otherwise be paid in FY 2008 or 2009

then consider contacting your program director. Program directors now are contacting applicant PD/PIs to discuss potential modifications of the Abstract, Specific Aims, Public Health Relevance, and budget. Individual NIH ICs have more detailed information on their websites regarding this and other specific ARRA funding opportunities. Find the NOT-OD-09-078 announcement.

RC1 deadline (Memo to the Research Community from Jane F. Kinsel, ORA Director)… (4/2/09): The BUMC Office of Research Administration (ORA) is trying to staff appropriately to meet the needs of BUMC researchers who are preparing applications related to the Recovery Act (Stimulus) funds. Thanks to those of you who have already completed the on-line survey regarding your upcoming planned submissions. If you haven’t had an opportunity to respond yet to the survey or if you plan to submit additional applications based on the funding opportunities posted recently, we encourage you to provide this information. By April 6th, please ensure that you have completed the survey form for applications, including supplements, that you plan to submit over the next four months.

Because grants.gov (the federal centralized submission portal for applications) might not be capable of handling the number of applications being submitted at the next deadline(s), we are requesting the deadline date of no later than close of business, April 15th, 2009, for the RC-1 applications in order to ensure they will process through the pipeline. Any applications received by ORA after that date will require ORA to obtain approval from the Provost for submission and may jeopardize error-free acceptance through grants.gov.

Find guidance and information about funding opportunities on: Recovery Act 2009.

NIH Revision Applications and Challenge Grants, new from the Recovery Act… (2/25/09): NIH has announced solicitations for new funds received for Fiscal Years 2009 and 2010 as part of the American Recovery and Reinvestment Act of 2009 (ARRA, or the Stimulus Package). NIH has designated $1 billion for supplements and $200 million for a new initiative called the NIH Challenge Grants in Health and Science Research (RC1). See ORA guidance on supplements and the RC1 expedited process. The Challenge Grants use the RC1 mechanism, and will support research on topic areas which address specific scientific and health research challenges that would benefit from significant 2-year jumpstart funds and for which NIH Institutes and Centers have selected specific Challenge Topics within each Challenge Area. Research in Challenge Areas should have a high impact in biomedical or behavioral science and/or public health. See RFA-0D-09-003 for the complete announcement.

A communication from Provost and Dean Karen H. Antman, M.D. on the Stimulus Package, NIH FY2009 appropriation, and whom to contact… (2/25/09): First, regarding NIH Appropriations, FY2009, $30.32 billion is budgeted, an increase of $937.5 million (3.2%) over FY2008. This is separate from the stimulus package.
In the Stimulus Package, NIH will fund:

• $300 million to NCRR for shared instrumentation, either SIGs or S10 shared instrumentation grants. The deadline is March 23rd. Contact David C. Seldin, M.D., Ph.D., 617-638-7027
• $1 billion to NCRR for renovation, improvement and construction of extramural research facilities. Several BUMC construction grants are planned.
• R01 and related mechanisms: in FY2008 approximately 14,000 applications were approved for funding but unfunded. These will be reviewed to see if two years of funding would be productive. If you just missed the funding range last year, call your program director to inquire about funding.
• Supplements to existing grants: some competitive, some administrative, and some theme oriented—e.g. training and equipment. Call your program director to inquire about a supplement for trainees, post-docs, equipment, and/or for funding an additional research aim.
• NIH Challenge Grants: $100-200 million available, based on quality of the responses, for two-year awards in priority research, public health, or cross-cutting initiatives. Guidance forthcoming on how to apply for awards (reportedly $500K/year, new RFA, short application form, expedited peer review).
• $400 million, transferred from the Agency for Healthcare Research and Technology (AHRQ) for comparative effectiveness research.

Key principles are: money must be obligated within two years; none of the funds (yet) have been added to the base; NIH will not restore prior cuts or under-funding; concern for new investigators integrated into all mechanisms.
Upcoming NIH deadlines (see NIH site for comprehensive list): March 16, R03, R21 (renewal, resubmission); March 23, S10 Shared instrumentation grants; April 8, all Fs; April 12, R13 (conference); April 13, F 31 (diversity); May 7, AIDS and related; June 16, R03, R21 (new).

H.R. 1 American Recovery and Reinvestment Act (aka Stimulus Package)…How will it affect BUMC? A communication from Provost and Dean Karen H. Antman, M.D. (2/15/09): The new Stimulus Package provides a major opportunity for BUMC to obtain funding for outstanding research and to obtain signficant levels of funding for grants already scored and reviewed. BUMC will be implementing several strategies aligned with the package. Please keep the following in mind as you contemplate your next application cycles:

• Construction grants for animal facilities, energy savings upgrades, and the K research building;
• Shared Instrumentation Grants for campus-wide core facilities;
• Hiring of grants administration personnel;
• Facilitation of grant applications.

The relevant biomedical funding in the final conference agreement on the H.R.1 Act, synthesized from a number of sources, provides:

$10 billion to NIH,over and above the Small Business Innovation Research and Small Business Technology Transfer programs’ set-aside requirements.

• $8.2 billion is appropriated to the Office of the Director (OD) to be transferred mostly to the Institutes, Centers, and the Common Fund with $800 million retained in the OD to “be used for purposes that can be completed within two years, with priority placed on short-term grants that focus on specific scientific challenges, new research that expands the scope of ongoing projects, and research on public and international health priorities.”
• $1.3 billion to NCRR, $1 billion for “competitive awards for the construction and renovation of extramural research facilities.” The conference agreement waives non-Federal match requirements for extramural facilities. NCRR will give priority to those applications that are expected to generate demonstrable energy-saving or beneficial environmental effects. An additional $300 million goes to “shared instrumentation and other capital equipment.”
• $0.5 billion for the NIH Buildings and Facilities account to be used for construction and renovation of NIH intramural buildings.

$3 billion to NSFfor basic research in science and engineering:

• $2.5 billion for research and related activities;
• $300 million for the major research instrumentation program;
• $200 million for academic research facilities’ modernization.

$1.6 to 2 billion for the Department of Energy for science and research programs.
$0.8 billion to AHRQ, $400 million to be transferred to the NIH Institutes, Centers, and the Common Fund, for comparative effectiveness research, with up to an additional $400 million to the Secretary of Health and Human Services for comparative effectiveness research.
$0.5 billion to HRSA for health professions workforce development (scholarships, loan repayment, and equipment grants to training programs).
$0.3 billion to the National Health Service Corps (NHSC), 20% of NHSC funds for field operations, $75 million to remain available through 9/30/2011 for extension of service contracts, and the remainder for “all the disciplines trained through the primary care medicine and dentistry program, the public health and preventive medicine program, the scholarship and loan repayment program, the scholarship and loan repayment programs authorized in Title VII (Health Professions) and Title VIII (Nurse Training) of the PHS Act, and grants to training programs for equipment.” The NHSC funds may be used to coordinate cross-state telemedicine activities.
Regarding student loans, $30 billion in new funds would flow to students and their families in 2009 and 2010:

• $17 billion in the form of increased Pell Grants;
• $13 billion in expanded higher education tax credits (now available to students from lower-income families that do not pay taxes);
• Dropped from the compromise legislation were increased limits for federal student loans and funds for Perkins Loans.

Criteria for Clinical Trial Registration with NIH…
When Must I Register My Trial? (12/11/08):

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 at this link.

K-series Now Electronic… (Dec 2008): NIH has announced new business process 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.

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… Thursday, December 18, 2008
WRITING SUCCESSFUL GRANTS, 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, 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, he has taught at Swarthmore College, Susquehanna University, and Eastern Washington University and 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. Seating is limited; 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.

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.

This entry was posted on Wednesday, November 4th, 2009 at 12:00 pm.