Mid-Career/Senior Clinical Scientist Bridge Funding Award Details

This is a two-year award supporting 50% protected time as bridge funding for mid-career and senior investigators.

Grant Overview

The ACG Institute for Clinical Research and Education and the American College of Gastroenterology (ACG) are proud to support established clinical gastroenterology or hepatology researchers, who have experienced a lapse in federal funding which requires bridge support to sustain their robust research programs, and invite eligible applicants to apply for a $300,000, two-year bridge funding award, to be funded from July 1, 2021–June 30, 2023. This award provides short-term bridge funding to sustain an investigator’s independent research program between federal grants and is only available to ACG members.

All applications must be submitted online. The grant site will open to submissions in early September 2020, and close on Friday, December 4, 2020, at 11:59pm (Eastern time).

The goal of the Mid-Career / Senior Clinical Scientist Bridge Funding Award is to provide short-term (up to two-year) funding to mid-career and senior clinical scientists with a proven track record of funding in innovative and impactful clinical research in gastroenterology or hepatology. With the paucity of federal agencies willing to fund GI and hepatology clinical research and federal funding levels at less than 15%, intermittent gaps in federal funding are a reality in the research career of an independent clinical investigator. This bridge funding grant is designed to support researchers principally focused on digestive or liver diseases, and to sustain their competitive, patient-oriented research programs during such a gap in federal funding.

This grant is designed to support research that is principally focused on digestive or liver diseases. The patient population or disease target should be principally related to the gastrointestinal tract, liver, biliary system, pancreas, or neuroenteric science, including any translational, clinical, social science, or health services research studies that pertain to managing such patients or conditions. For example, a study about microbiota would be appropriate if it pertains to a digestive disease. In contrast, a study that is principally about HIV would likely not be appropriate unless it directly relates to how HIV affects digestive health. (For questions on study relevancy, contact the grant administrator at research@gi.org.) Since its inception in 1994, the ACG Institute for Clinical Research and Education has provided over $22 Million in funding to over 660 recipients.

A key mission of the ACG and its Institute for Clinical Research and Education is to fund innovative patient-oriented research awards. For the purposes of these awards, patient-oriented research is defined as:

1. Research conducted with human subjects
2. Research on new diagnostic and therapeutic interventions
3. Research on material of human origin, such as tissues and specimens While research that explores mechanisms of human disease is highly encouraged, the research projects should be translational in nature; i.e., have direct applicability to clinical care.
   Note: Studies involving animals will not be considered unless the work cannot be done in humans.

	The ACG Clinical Research Awards are a project of the ACG Institute and are supported by charitable contributions to the G.U.T. Fund.

Eligibility

Applicants must meet all the following criteria:

• ACG Member* (Required at time of application)
• U.S. or Canadian-based physician (MD or DO)
• Mid-Career or Senior Clinician
  • At least 8 years out of fellowship or terminal training program at time of application
  • Full-time faculty position at a university, medical school or other healthcare institution at time of application
• Evidence of recently concluded or newly anticipated funding (one of the following):
  1. Recipient of a recently concluded (within 2 years) NIH R01, VA Merit Award, or National Science Award
  2. Evidence of ongoing application for renewal for federal funding, or
  3. Evidence of new federal funding (scored but not funded research grant) to be re-submitted
• Able to guarantee 50% protected research time for entirety of the grant period. Candidates must devote at least 50% of their effort to clinical research related to gastroenterology or hepatology. A letter from the division chief or department chair must certify that the award will provide 50% protected time to the recipient, regardless of the amount budgeted for salary, in accordance with the terms of the award.

The following are not eligible for this award:

• Individuals who have only received career development funding (federal or non-federal) are not eligible.
• Fellows-in-training.
• Early career faculty.
• Projects that support laboratory or animal research projects.
• Award overlap: ACG does not provide duplicate funding.

*Important! Please note you must be an ACG member to apply for this grant. All member applications must be submitted by September 25, 2020 in order to be eligible for review at the October Credentials Committee meeting, which is the last opportunity to be approved for full membership prior to the grant application deadline. To Join ACG, click here. For questions on ACG membership, please email membership@gi.org or call 301-263-9000.

Preparing the Research Proposal

A complete application consists of two separate components:

1. A single Adobe PDF document comprising (but not limited to) the following: research proposal (limited to 8 pages), budget, biosketches for candidate and other investigators involved in the proposed research, other support funding details, IRB forms, COI statement (if applicable), and letters of support.
2. Completion of required tasks via the online grant system: upload the completed research proposal PDF; provide confirmation of ACG membership; provide full contact information for all investigators; submit a 350-word abstract of the proposed research; indicate IRB approval status; list all investigators and any potential conflicts of interest. See “Submitting the Application” below for instructions and requirements.

Required elements for the full research proposal document (i.e., the PDF that will be uploaded to the online grant system):

A. FORMATTING—Format all pages with ½" margins and use a font no smaller than 11 point. All pages must include a page number in the left header. All pages must include the PI name and grant type in the right header, in the following format:

Last name, First name
Award Type

B. RESEARCH PROPOSAL—Limit to 8 pages (excluding references). Outline the proposed research. In general, this should be a series of linked projects developed around a common theme, and should include the following sections:

• Specific Aims—Provide a clear description of the study objectives. What is the hypothesis to be addressed? What are the immediate objectives? What are the ultimate objectives? How does the proposed research fit into an overall research program?
• Background/Significance—State how the proposed work bears on prior work and indicate how it will extend the boundaries of current knowledge.
• Pilot Data/Previous Work—This award type does not require pilot data. However, if the applicant has prior data pertinent to the present application, it should be briefly presented here. References to published work are preferred to detailed descriptions of published manuscripts.
• Research Plan—Provide a detailed research plan, including the inclusion/exclusion criteria for enrollment, methods to be used, the kinds of data that are to be collected, and how these data will be analyzed. Provide detailed sample size estimates. Grants without a statistical analysis section or sample size justification are unlikely to be successful.
• Current Funding Status—Indicate to which funding agency the initial grant application was submitted, and the outcome of this submission. Further indicate plans for re-submission. Also, address how the additional funding provided by this award will help address shortcomings in the initial research submission, as identified by the study section or review committee who assessed the initial grant.

C. REFERENCES—Include a separate section for references. Be judicious in the use of references.

D. BUDGET AND JUSTIFICATION—Include a separate section for the budget and justification. The budget should be listed as a table, indicating all expenses for each year of the award, with quantity and units for each item (ex: number of hours, and rate for salary and fringes). The budget justification should be listed after the budget table, with an explanation for each budget item (ex: justification for number of hours supported by the grant, how statistical support will be utilized, etc.). Funding for this award will provide salary support for the PI and co-investigators, and salary support for other personnel (research nurse, computer programmer, statistician) if adequately justified. Expenses for supplies and equipment are allowed, and facility fees are allowed if adequately justified. Costs not supported: major equipment acquisitions; travel and manuscript preparation; indirect costs (i.e., university overhead).

E. INSTITUTIONAL REVIEW BOARD (IRB) STATUS—Include the IRB approval letter, or indicate if IRB approval is pending. If IRB approval is pending at the time of submission and the grant proposal is subsequently approved for funding, funds will not be released until the IRB approval letter is received by the ACG. If the proposal is requesting funds for reimbursement of human subjects, a copy of the IRB-approved consent form is required prior to funding as well.

F. CONFLICT OF INTEREST STATEMENT—Include, if applicable.

G. BIOSKETCHES—Provide these for the primary investigator, co-investigator(s), and anyone critical to completion of the project. Use the NIH format and adhere to the NIH 5-page limit. (For sample format see the NIH webpage at grants.nih.gov/grants/forms/biosketch.htm.)

H. OTHER RESEARCH SUPPORT—List this information on separate pages. List the title, funding agency, total direct costs, dates, including expected dates of notification of pending applications for all current and pending funding for the Primary Investigator and Co-Investigators. (Use NIH format: grants.nih.gov/grants/forms/othersupport.htm.)

I. INSTITUTIONAL SUPPORT—This letter from either the Division Chief or Department Chair should indicate strong commitment from the division to support the candidate by protecting time for research and for providing adequate research facilities. The letter must certify that the award will provide 50% protected time to the recipient, reserved for the proposed research, in accordance with the terms of the award, regardless of the support budgeted in the application for the recipient’s salary. Limit to 2 pages.

J. OTHER LETTERS OF SUPPORT (optional)—Provide letters from any other collaborators, such as those supplying patient referrals, if applicable. These may be included to demonstrate the other investigators’ involvement and support of the project (example: other research sites providing patients, or collaborator who will provide a unique set of skills required for the project).

K. APPENDICES—Use (if needed) for data collection forms. Do not use to expand project description.

Submitting the Application

All applications must be submitted online. The online grant application site will open in early September; a link to the site will be available at gi.org/acg-institute/research-awards. The submission deadline is Friday, December 4, 2020 at 11:59 pm Eastern Time. This deadline will be strictly enforced, and no exceptions will be made.

Once you begin the online application process, you will be able to save your work and return to complete it until the submission deadline. As part of the online application process, applicants are required to provide information about others, such as institutional addresses and potential conflicts of interest for co-investigators, etc. We encourage applicants to gather all the necessary information early, and to not wait until the last minute.

The following tasks must be completed via the online grant system in order to successfully submit an application for grant consideration:

A. INDICATE PROPOSAL TITLE AND SELECT GRANT TYPE—The title should be concise and clearly reflect the proposed research. Select the “Bridge Funding” grant type. (Please note, the same project should not be submitted for multiple ACG grant types, and will not be considered if this occurs, i.e., do not submit the same proposal for a Bridge Award and a Clinical Research Award.)

B. ACG MEMBERSHIP VERIFICATION—You must provide your ACG member ID. To look up your member ID number, log into gi.org/membership/my-acg-login then click “My Contact Information” from the menu on the left. Member ID is listed below Date of Birth.

C. ADD INVESTIGATORS—List the PI and any Co-Investigators. Enter their names, ACG member status (and year joined if available), titles, email address, role (PI, Co-investigator), and institution names and addresses.

D. ACKNOWLEDGEMENT OF PRINCIPAL INVESTIGATOR—Indicate agreement to abide by the grant requirements, if awarded grant funding.

E. INVESTIGATOR ADDITIONAL INFORMATION—Provide PI’s academic position, and state whether the principal investigator has received NIH R01, VA Merit Award, or a National Science Award within the last two years, or has evidence of ongoing application for renew or new federal funding in the form of a scored, but not funded, research grant, to be submitted with the support of this bridging mechanism.

F. RESEARCH PROPOSAL ABSTRACT—Provide an abstract of no more than 350 words that summarizes the proposed research. In this section, you will also be asked to enter the topic area for your application.

G. IRB STATUS—Verify current IRB status.

H. RESEARCH GRANT PROPOSAL PDF UPLOAD—Format the file as required in the “Preparing the Research Proposal” section, including all required elements, and upload the file as directed. The file name should include the candidate’s first and last name.

I. CONFLICT OF INTEREST—A potential conflict of interest (COI) exists when research involves a device from which any investigator(s) or a company may benefit. It also exists when research involves a pharmaceutical agent that is not FDA-approved for any indication. A conflict of interest exists if any investigator holds or has submitted a patent on a device or pharmaceutical agent or is a major shareholder in a company involved in the research. If applicable, select “Yes” and include a detailed explanation within the grant system, including names of each investigator and their potential COIs.

Application Review Process

Immediately following the application submission period, all applications are reviewed and scored by the ACG Research Committee, following its standardized process.

Reviewers consider the following when scoring applications: the feasibility, scientific and clinical significance of the research proposal, attributes of the candidate (previous publication and funding record) and qualifications to perform high-quality research, and strength of the institutional environment, including a letter of support for 50% protected time if the proposal is funded.

In evaluating the merits of an application, the Committee will consider two categories of criteria, each comprising 50% of the overall assessment: 1) Project Merit, and 2) Individual Merit

1. Project Merit—50% of score includes:

• Scientific and clinical significance (25%)
• Feasibility (including availability of adequate resources, such as personnel and facilities) (25%)
• Methods (50%)
  • Availability of preliminary data (25%)
  • Study design (50%)
  • Power, sample size, and statistical analysis (25%)

2. Individual Merit (Credentials / Institutional Support / Previous record of funding success)—50% of score includes:

• Applicant’s Credentials
• Previous success in attracting and sustaining independent research funding
• Institutional Environment (including a letter from institution’s Division Chief / Department Chair supporting 50% protected time)

Award Notification and Grant Requirements

Notification of Awards will be completed by April 1, 2021. Please do not contact ACG prior to this date to inquire about the status of your application.

• Funding:Awards consist of $150,000 per year for two years, for a total award of $300,000. Funds are to be used for related expenses of the proposed research, including salary, supplies, and equipment. Funds are not to be used for: major equipment acquisition; travel and manuscript preparation; indirect costs (i.e., university overhead).
• Required Progress Reports: Awardees must file a progress report, on completion of the first year, for review by the ACG Institute Director and Research Chair, prior to the release of year two funding. This report must include proof of ongoing application for renewal of federal funding or new federal funding. A final report is due at the completion of the funding period must include an update on notice of award for subsequent funding. A final financial statement indicating allocation of funds is required. All reports must also be submitted to research@gi.org.
• Abstract Presentation at an ACG Annual Scientific Meeting: ACG encourages the selected awardee to submit any abstracts to the ACG Annual Scientific Meeting for presentation.
• Publication: All publications arising from work funded by this award must acknowledge ACG support in any publications that result from the research.
• Award overlap: ACG does not provide duplicate funding. The aim of this award is to sustain the research until federal or other funding is obtained.

Questions or Assistance

For any questions about grant requirements, please refer to the FAQs.

Prior grant application submitters must create a new login for the grant system each year, even if you have applied for an ACG grant previously.

Technical support questions about the online submission system: Contact CadmiumCD Technical Support using the Technical Support link on the upper right corner of the submission site’s screen, via email at Help@ConferenceAbstracts.com, or via phone at (877) 426-6323.

For any questions not answered in the RFA or FAQs, or reporting questions, contact us via email at research@gi.org.

Important Dates