Accelerating Breakthrough Discoveries into Medicines

Policies

Program Policies

Eligibility Criteria for Applicants

Harrington Discovery Institute requires that all applicants meet the following criteria:

  • Hold an MD or MD/PhD from an accredited institution
  • Hold a faculty position at an accredited academic medical center, university or research institution in the U.S. and conduct the majority of his/her research activities at that institution
  • A project may have only a single Principal Investigator (PI) who will be responsible for project oversight and financial management. The PI may engage collaborators, core labs, or commercial CROs to execute any fraction of the project.
  • Past recipients of the Harrington Scholar-Innovator Awards may submit new and distinct proposals but may not seek additional support for previously funded projects

Sponsoring Institution Requirements

Investigators may apply from accredited academic medical centers, research institutions or universities in the U.S. and U.S. territories. Institutions must provide the necessary facilities and infrastructure for the research, and accept the conditions of the award, including the Budget & Use of Funds. They must assure compliance with the prevailing national guidelines for animal and human studies and provide proper oversight of the Grant funds.

Sponsoring institutions must safeguard the rights and welfare of individuals who participate as subjects in research activities by reviewing proposed activities through an Institutional Review Board (IRB) as specified by the U.S. Department of Health and Human Services Office for Human Research Protections, HHS OHRP. Additionally, the Grantee’s institution must assure appropriate governance of animal studies. IRB approval and IACUC numbers are not required at the time of application, but must be provided for final signature of the Grant Agreement, which will be sent to Grantees shortly after they have been selected.

Additionally, sponsoring institutions must adhere to current U.S. Department of Health and Human Services guidelines regarding financial conflict of interest, recombinant DNA, and research misconduct.

Harrington Scholar-Innovator Project Types

The goal of the Harrington Scholar-Innovator Program is to advance physician-scientist-initiated projects aimed at clinical introduction of new medicines (drugs or biologics). The specific focus of eligible projects includes fundamental discovery (elucidation of novel targets and leads) or development of novel drugs or biologics or drug-device combinations.

The Harrington Scholar-Innovator Program Selection Process and Deadlines

Harrington Scholar-Innovators will be selected by a two-stage process. Interested applicants are asked to submit a Letter of Intent by 5:00 PM EDT May 1, 2015. Invitations to submit a full proposal will be sent to applicants via email by the end of June and proposals will be due on August 3, 2015.

Confidentiality in the Application Process

As a part of The Harrington Project, members of Harrington Discovery Institute’s review panel and Scientific Advisory Board are required to complete mutual Confidentiality & Disclosure Agreements with the Harrington Discovery Institute.

Non-public applicant information is always kept confidential (and limited in distribution to the reviewers and Harrington Discovery Institute administrative team). The abstract summary, including the applicant’s name and institutional affiliation, for those selected as Scholar-Innovators, may be used by Harrington Discovery Institute for publicity and marketing purposes (on the Harrington Discovery Institute website, news releases, etc.) at Harrington Discovery Institute's sole discretion.

Applicants acknowledge that University Hospitals Health System may conduct research that is related to or competitive with proposals submitted by applicants, but University Hospitals Health System commits not to use information submitted by applications in connection with such research.

The Harrington Scholar-Innovator Review Panel

The review panel will consist of subject matter experts with specialized scientific expertise in the area(s) designated in the application, as well as seasoned professionals with expertise in drug development and commercialization.

Projects will be assessed based on:

  • Quality of the science and the scientist
  • Novelty and innovative quality of the work
  • Potential for impact on human health

The Scientific Advisory Board at Harrington Discovery Institute will make the final selections of winners. Applicants who fail to fill out their applications by the deadline and/or in accordance with the detailed instructions are subject to disqualification at the outset of the review period or any time during the review period.

Letters of Intent will be reviewed and the Harrington Discovery Institute will select those projects which have the greatest clinical potential, as well as demonstrate a highly innovative approach to significant clinical problems.

The Harrington Discovery Institute will subsequently invite selected PIs to submit a full proposal. Notices will be emailed by the end of June and full proposals will be due on August 3, 2015. Barring any unforeseen delays, final selection of winners will be in November and the effective date of this grant will be January 1.

Comments from Review Committee

Harrington Discovery Institute is unable to provide reviewers’ comments or feedback.

Award Start Date

Selection committee results, including winners and those rejected, are released in November. Winners of the grant must be prepared to sign the grant agreement in December.

The award start date is January 1 and runs on a calendar year basis.

Annual Scientific Symposium Builds a National Network of Physician-Scientists

Part of Harrington Discovery Institute’s mission is to build a broad connected community of physician-scientist-innovators. Harrington Discovery Institute will hold an annual symposium that awardees are required to attend.

The Symposium, held in late spring in Cleveland, Ohio, will bring together drug development experts, national disease foundation leadership, international leaders in medicine and Harrington Scholars. Awardees are expected to present their project and findings-to-date. A stipend for travel and lodging will be provided by Harrington Discovery Institute, subject to the terms of the Grant Agreement.

Program Description

Harrington Discovery Institute will provide up to 12 new Harrington Scholar-Innovator Awards each year. The award includes:

  1. Up to $700,000 over two years ($100,000 guaranteed)
  2. Additional funding according to the needs of specific projects
  3. Project management support through our Innovation Support Center.
  4. Investigators will also receive drug development support and related resources through the Harrington Discovery Institute’s Innovation Support Center including:
    • Consulting services from highly experienced drug development personnel
    • Business and commercialization advice
    • Clinical development advice
    • Regulatory assistance
    • IP review and advice
    • Assistance identifying and securing additional financial support based on project needs

The Harrington Discovery Institute and its Innovation Support Center team will work closely with the awardee and their affiliated institution to maximize the clinical and commercial potential of selected projects.

Use of Grant Funds

General: No more than $10,000 of the total grant can be used for capital expenditures or equipment. The award may only be used for direct project expenses, not for institutional overhead.

Salary: The award may be used to cover salaries for post-docs equivalent to the % effort devoted to the project. Please note that PI’s salary is limited to 10% of the total award amount.

Travel: The award may not be used for travel, meetings, professional fees, publication fees, etc.

Intellectual Property Guidelines

Harrington Discovery Institute does not claim any rights whatsoever to patents, copyrights or trademarks to intellectual property (“IP”) created as a result of work sponsored by Scholar-Innovator Grants.

On all aspects of Intellectual Property, Principal Investigators are encouraged to confer with their technology transfer office and/or office of sponsored programs for guidance. Harrington Scholar-Innovators may seek input and advice on patent protection, including ways to strengthen intellectual property, from the Innovation Support Center, which also claims no rights whatsoever to IP.

Awardees should take measures to ensure protection of any Intellectual Property in accord with Federal and institutional requirements.

NIH Data Sharing Policy

Scientific research depends on the free flow of information and ideas. A data-sharing plan is not requested or required. However, in its annual evaluation of progress as outlined in the Scientific Reporting & Review of Progress section below, Harrington Discovery Institute will consider, as part of the criteria for continued funding, adequate progress in sharing unique research resources developed with funds from the award, as well as a demonstrated willingness to make research resources developed during the project widely available to the research community.

In accordance with a mission to advance research and accelerate the development of new therapeutics, the HDI encourages compliance with the National Institutes of Health (NIH) data sharing policy. Unique research resources (developed with funds from the Grant should be made available to the research community according to NIH guidelines. Grantees may distribute reagents and data without HDI approval in compliance with the norms and rules of their institution.

Scientific Reporting & Review of Progress

Yearly renewal of the award is dependent on timely submission of a written progress report, as well as attendance at the Harrington Discovery Institute’s Annual Scientific Symposium.

The progress report should be approximately one (not exceeding two) pages and should cover findings to-date, status, and future direction. It should also include a one page financial report accounting for expenditures during the prior period and an updated budget (if applicable).

The report is due on November 15th each year.

Changes to Project Scope

A significant change in the project scope or work should be discussed with Harrington Discovery Institute’s Director and approved in writing or by email by the Director.

Grants may be transferred to another institution that agrees to assume the Policies, Terms & Conditions of the grant agreement. Permission to transfer a grant to another institution must be obtained from Harrington Discovery Institute’s Director.

Compliance and Administrative Matters

Awards are funded by Harrington Discovery Institute, after the recommendations of the Scientific Advisory Board. Harrington Discovery Institute Staff will assure compliance with grant policies and will be responsible for all administrative matters.

The Principal Investigator and his or her institution are solely responsible for execution of the project, including compliance with all relevant Federal and State laws and guidelines.

Harrington Discovery Institute reserves the right to refine and amend policies as required.

Questions

For all questions, please contact us via email at .

Grant Policies

Download the PDF version of Grant Policies.

Dates to Know

May 1, 2015
Deadline for Letter of Intent

End of June 2015
RFP to selected applicants

August 3, 2015
Deadline for complete proposals

End of November 2015
Harrington Scholar-Innovator winners notified

For Questions

For questions about the Scholar-Innovator grants or the application process, please email hdiquestions@HarringtonDiscovery.org.