Innovation in Regulatory Science Awards

Innovation in Regulatory Science Awards is sponsored by Burroughs Wellcome Fund. This program supports academic investigators developing new methodologies or innovative approaches in regulatory science that will ultimately inform regulatory decisions made by the Food and Drug Administration (FDA) and other agencies.

Innovation in Regulatory Science - Burroughs Wellcome Fund Innovation in Regulatory Science Share this Grant Apply Now BWF’s Innovation in Regulatory Science Awards provides up to $500,000 over five years to academic investigators developing new methodologies or innovative approaches in regulatory science that will ultimately inform the regulatory decisions the Food and Drug Administration (FDA) and others make.

We especially encourage applications from those seeking to advance regulatory science approaches that will expedite the realization of equitable clinical outcomes. The following videos were recorded in 2020 and 2023 and are being shared for informational purposes because they contain a wealth of information about the IRSA program. Note that some deadlines within the videos reference past award cycles.

Progress and financial reports are required of all BWF grants and are due on the date(s) specified in the award letter or agreement. The Advisory Committee and staff depend heavily upon progress and financial reports to evaluate progress. Late reports inconvenience advisory committee reviewers and impede BWF's evaluation of its programs.

Failure to submit progress or financial reports in a timely fashion will result in payments being withheld, and if submissions are missed repeatedly, the award will be terminated. BWF provides the following progress report guidelines to assist in preparing and submitting progress reports in an acceptable manner. The progress report and financial updates are to be submitted through Proposal Central .

You can find the required deliverables listed on the home page after logging in to Proposal Central. Failure to submit any portion of the report by the due date will result in an interruption or cancellation of your funds. If you need help using Proposal Central, please follow the instructions on their Customer Service webpage to contact their tech support team.

Awardees may request a no-cost extension (i.e., no additional grant funds to be provided) at least 30 days before the grant end date. To begin a no-cost extension request, please email our Program Associate, Eliza Gary ( egary@bwfund. org ) with a short description of the purpose for which the extension is requested.

The request for a no-cost extension must be copied to the investigator and the appropriate representative of the investigator’s institution. The BWF team will then add an official no-cost extension request to your award on Proposal Central; there, the awardee should include a detailed explanation of the purposes for which the extension is requested.

Directions are outlined in the award contract/agreement “General Terms and Conditions” and included in Proposal Central. In general, extensions do not exceed 24 months. The Fund reserves the right to deny a request in whole or in part.

If the request is approved, it will be incumbent upon the named investigator and his/her institution to provide annual progress and expenditure reports each year of the no-cost extension period and final progress and financial reports at the end of the no-cost extension period. BWF will request a return of all no-cost extension funds if progress report requirements and deadlines are unmet.

Progress Reporting for Awardees The progress report requires the awardee to submit a written report on the progress of the original or approved update to research project aims, an updated biographical sketch, a summary of research progress, and any recent publications. Details regarding each section are in Proposal Central. The progress report must be submitted annually on November 1st.

Awardees are required to update award spending in the Proposal Central budget summary; awardees should report spending in the “expenses” column. Details regarding financial reporting are in Proposal Central. Financial reports are due annually on November 1st.

All progress and financial reporting materials should be submitted through Proposal Central. If you have questions, please contact our Program Coordinator, Lama Haidar ( lhaidar@bwfund. org ).

Can I submit more than one application? Do I need to be nominated by my institution to submit a proposal? No. You may self-nominate for the proposal.

All applications must be approved by an official responsible for sponsored programs at the institution where the work will be performed (generally from the institution’s grants and contracts office, office of research, or sponsored programs office). Is the BWF application deadline firm? Yes, the application deadline is firm.

Do I need to submit a preproposal prior to submitting a full application? No. We are no longer requesting a preproposal for the Innovation in Regulatory Awards program. Can I submit a paper application?

No. BWF requires that all applications for this program be submitted electronically. Paper applications will not be accepted. The eligibility requirements mention that the primary investigator must be based at a non-profit institution [501(c3) or equivalent] in the U.S. or Canada.

What is a 501(c)(3)? According to the U.S. Internal Revenue Code, a 501(c)(3) organization is an American tax-exempt, nonprofit organization. Almost all degree-granting institutions are classified as such, as are most research institutes and teaching hospitals.

You must check with your institutional officials, usually called the grants and contracts office or the sponsored programs office, etc., to confirm your institution’s classification. BWF cannot make this determination for you. I am a permanent resident.

What documentation is required to verify my residency status? BWF does not require documentation of your permanent residency for the proposal. Your institution must verify your permanent residency status by certifying the eligibility of your application upon signing the proposal.

Can I include cover letters or supplemental materials with my proposal? Do not include a cover letter or supplemental materials. If extra materials are included, your proposal will be rejected out of fairness to all applicants.

Can co-investigators be located at different institutions? Yes. However, the primary investigator must be based at a non-profit institution [501(c3)] in the U.S. or Canada, which will be the administering institution for the award.

The primary investigator must meet all eligibility requirements for the program. Can I change my application once it is submitted? After a proposal has been submitted, applicants have the option to unsubmit it to make changes, if necessary, only if: 1.

The application deadline hasn’t passed; 2. BWF has not already routed the application to a committee for review. If an applicant needs to edit an application, please review the instructions on page 27 for “Unsubmitting An Application” in the “How to Create an Application Using Proposal Central” guide accessible at this link https://docs.

proposalcentral. com/CreateApp. pdf .

Can I contact BWF to determine my eligibility? Applicants are responsible for reading the published guidelines and FAQs to determine eligibility. The FAQs are updated regularly in response to questions received.

BWF staff will do their best to respond to every inquiry but will prioritize questions not already clearly addressed in the published guidelines. Please do not contact BWF to ask if we can make an exception to clearly stated guidelines. To ensure a timely response, please email your questions to the program contacts provided.

I do not have a tenure-track position. Am I eligible for this award? Possibly, as long as you hold a faculty appointment or adjunct faculty appointment at a non-profit institution in the U.S. or Canada, which may include degree-granting institutions, research institutes, and teaching hospitals affiliated with academic degree-granting institutions.

You do not need to hold a tenure-track position. I’m currently a postdoc. Am I eligible for this award?

I am a temporary resident of the United States. Am I eligible for this award? Possibly.

Temporary residents of the U.S. who are legally qualified to work in the U.S. are eligible. Candidates who are temporary U.S. residents must hold a valid U.S. visa (J-1, H1B, F-1 or O-1 visas). If a grant is awarded and your visa does not allow for such a stay, BWF may terminate the grant.

BWF will not intercede on behalf of non-citizens whose stay in the U.S. may be limited by their visa status. I am a temporary resident of Canada. Am I eligible for this award?

Possibly. Temporary residents of Canada who are legally qualified to work in Canada are eligible. Temporary Canadian residents must hold a valid Canadian visa (Study Permit, C-43, C44, C-10, or C-20 work permits/visas).

If a grant is awarded and your visa does not allow for such a stay, BWF may terminate the grant. BWF will not intercede on behalf of non-citizens whose stay in the U.S. may be limited by their visa status. I’m at an independent research institute.

Am I eligible for this award? Possibly. You must be based at a non-profit institution [501(c)(3) or equivalent] in the U.S. or Canada, and hold a faculty appointment, or adjunct faculty appointment, at the institution.

If you have such an appointment and your research institute is a non-profit institution [501(c)(3) or equivalent] in the U.S. or Canada, you are eligible. Examples of such institutions may include but are not limited to degree-granting institutions, research institutes, and teaching hospitals affiliated with academic degree-granting institutions. I’m a past BWF grantee.

Am I eligible for this award? Yes, as long as you meet all the eligibility requirements for the program. What internet browsers are compatible with the BWF Grant Submission System?

Most internet browsers are compatible with the Grant Submission System including, Internet Explorer, Mozilla Firefox, Safari (for Mac), and Google Chrome. I forgot my user ID/password. What should I do?

For a forgotten password or user ID, access the grant submission system log-in screen and click the forgotten password link. Do I need to complete an application in one session? No, you can start an application and return later to complete it.

When beginning a new application, you are required to establish a login and password. At any time during the application process, you may click the "save and close" button, exit the application, and return later.

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B. , Ch. B, FRCP, FACP (Chair) Professor of Medicine, Emeritus Professor of Pharmacology, Emeritus Director, Stanford Cardiovascular Institute Simon Stertzer Professor of Medicine Additional members may be added to the committee.