Jump to FAQ's about: Data Sharing, Full-Proposal Application Stage; Mentorship & Institutional Support; Budget and Allowable Costs; Other Funding, and Miscellaneous Issues (including DDF's definition of clinical research, IRB requirements, public access policy, preliminary animal research and success rates).
If your question is not answered after reviewing the FAQs, email email@example.com with “2023 CSDA-[applicant last name]” as the subject line. The foundation is committed to making the application process accessible to all. If an alternative communication format would better assist you in having your questions answered, please email firstname.lastname@example.org, and staff will work with you to provide reasonable accommodation.
Full-Proposal Application Stage
How do I return to my proposal once I have started it?
You may use this link to access a proposal that is in progress. Bookmark this page to facilitate future access. Log in with the username and password that was created to submit a pre-proposal application in the first stage of the competition. A link to the Stage 2 form will be found under Active Applications.
If you do not remember your login information, use the “Forget Password” feature on the login page.
Mentorship and Institutional Support
Is there a template for letters of support?
No, for the second stage of the competition, the department chair must provide a signed letter on institutional letterhead. Guidelines for the content of this letter are specified in Attachment 3 of the “Stage 2 Application Instructions” document sent to applicants in their full proposal invitation email. Please provide those guidelines to the recommender and append the letter to the proposal as indicated in the instructions. The mentorship letter was already evaluated at the pre-proposal stage of the competition and should not be included as a part of the full proposal.
May I include mentor letter(s) of support in the full application?
No, the mentorship letter was already evaluated at the pre-proposal stage of the competition and should not be included as a part of the full proposal.
My mentor is the chair of my department and already wrote a letter of support as my mentor. Do they need to write another letter?
Yes, your chair should provide a letter that addresses their role as chair confirming institutional support. Guidelines for information requested from the chair may be found in Attachment 3 of the “Stage 2 Application Instructions” document sent to invited applicants. Please make sure to review this document to ensure that all the requested information is addressed. The institutional commitment letter must be signed, be on institutional letterhead and not exceed two pages.
I would like to replace my mentor or mentorship team. Is that allowed?
No, mentor or mentorship team replacements are not possible at this stage of the competition. The peer review of pre-proposals during the first stage of the application process evaluates the ability of the designated mentor and mentorship team to support career development of the applicant. Additions to the original team are allowed and can be indicated in the online application form. Biographical sketches of all mentors should be included in the full proposal.
The Doris Duke Foundation (DDF) will evaluate a request if there is a compelling reason for a change. Please get in touch by email (email@example.com).
I have a mentorship team; can each person provide a letter of support?
No, the mentorship letter was already evaluated as part of the pre-proposal stage of the competition. Therefore, mentorship letters of support should not be included as a part of the full proposal.
Do I need to provide my mentor(s) "Other Support" document?
No, mentor(s)' NIH-format "Other Support" document was already requested and evaluated in the first stage of the application process and should not be included in the full proposal.
Mentor(s)' NIH-format non-fellowship biographical sketches are required as part of the full proposal atachment.
Budget and Allowable Costs
Is there a budget guideline reference document available to prepare the budget?
Guidelines for preparing a budget, as well as a budget template, are part of the “Stage 2 Application Instructions” emailed to applicants on January 17, 2023. If you are preparing a budget on behalf of an applicant and do not have access to the instructions, please email firstname.lastname@example.org and include the name of the applicant for whom the budget is being prepared.
Does the award provide coverage of indirect costs?
Indirect costs for the duration of the award can be up to $15,000 (10% of direct costs) per year for three years for a total of $45,000.
Is there a salary cap for this award?
No, the foundation does not have a salary cap for what can be charged against this award. However, if the Clinical Scientist Development Awards (CSDA) proposal requests salary support for the CSDA grantee, the percent effort committed to the CSDA project must be equal to or greater than the percent of salary charged.
Can I request salary support for my mentor in my budget?
Yes, up to 5% of the mentor's effort can be included in the budget for applicants with a single mentor.
I have a mentorship team; can I request up to 5% salary support for each of them?
No, salary support for up to 5% of each mentor’s salary is not allowed for applicants with mentorship teams. Please see the following question about requesting salary support for mentorship teams.
I have a mentorship team; can I request any salary support for them?
Yes, you may request salary support for the mentorship team. However, the amount equivalent to 5% of a single mentor’s salary must be split between the mentorship team members for which salary support is being sought.
Can I request salary support for a graduate student or mentee in my budget?
Yes, graduate students or trainees, nurses and research coordinator efforts are allowable costs as long as these positions directly support the proposed research plan. Please include these individual(s) and descriptions of their role(s) on the project in the budget justification, as detailed in the “Stage 2 Application Instructions” document. If trainees are post-doctoral fellows, salary must be greater than or equal to the NIH National Research Service Award (NRSA) Fellowship stipend, determined by the number of full years of relevant postdoctoral experience when the award is issued. Relevant experience may include research experience (including industrial), teaching assistantship, internship, residency, clinical duties, or other time spent in a health-related field beyond that of the qualifying doctoral degree.
Does the CSDA allow budgeting for equipment?
Yes, allocations for equipment—defined as non-expendable, tangible property that has a useful life of more than one year and is needed to perform the proposed research—are allowed. However, equipment allocations are only allowed in the first year of the grant and must not exceed $50,000.
I have a National Institutes of Health K series award, which requires 75% research effort. Can I still apply for the CSDA?
An awardee must devote 75% of their professional time to research, but there is no minimum effort requirement for the CSDA project itself. Holding a K award or other career development awards does not preclude the applicant from receiving a CSDA grant.
I have been successful in obtaining other research funding. Will this hurt my chances of getting an award?
Reviewers are instructed not to penalize applicants for having other sources of funding. If concurrent sources of funding exist, there must be no budgetary overlap between the proposed aims of the CSDA research and those of other awards. Applicants cannot be a principal investigator or co-principal investigator on a National Institutes of Health R01 research grant (or equivalent) or a multi-year grant with annual direct costs of $225,000 or higher on or before the CSDA start date of July 1, 2023.
I have a National Institutes of Health K series award or other research support. Can I propose the same scientific aims?
No, the aims proposed on your CSDA application must be distinct from those of other awards, with no budgetary overlap. In the event that your proposal receives a funding recommendation, we strongly suggest that you do not propose the same aims and budget in different grant applications.
What is the foundation’s definition of clinical research?
Clinical research involves the scientific investigation of the etiology, prevention, diagnosis or treatment of human disease using human subjects, human populations (including health outcomes, health services and epidemiology) or materials of human origin. Included in the definition are studies that utilize tissues or pathogens only if they can be linked to a patient.
It is expected that the research protocols of grant applicants will require Institutional Review Board (IRB) approval. Occasionally, the foundation has funded research that does not require IRB approval, such as research using de-identified patient populations. If the research project proposed does not require IRB approval, applicants are strongly encouraged to contact program staff to discuss whether the proposed research falls within the foundation's definition of clinical research.
In keeping with the wishes expressed in Doris Duke’s will, experiments that use animals or any tissues derived from animals, including established cell lines, cannot be supported by this program.
Would the public access policy adopted by DDF limit the journals to which I can submit my DDF-funded work?
No, the policy only requires that you submit an electronic copy of your final peer‐reviewed manuscripts in the PubMed Central online archive immediately upon acceptance for journal publication. The manuscript will have to be made publicly available in PubMed Central no later than 12 months after the official date of journal publication.
When is Institutional Review Board (IRB) approval or submission required to be in effect—at the time of the full proposal submission or before an award is forthcoming?
IRB approval can be pending at the time of full proposal submissions; however, if you receive a grant, we expect that you will have approval by the start date of July 1, 2023, or no later than October 1, 2023.
When is Investigational New Drug (IND) approval required to be in effect—at the time of the full proposal submission or before an award is made?
IND approval must be in place by the deadline for the full proposal, March 14, 2023 by 3 p.m. ET. Full proposals for projects with IND requirements that do not have approval at the time of submission will be disqualified.
My preliminary research has included research in non-human animal models. Can I include this in my proposal?
Yes, preliminary research in non-human animal models may be included in your application. However, no CSDA funds may be used for experiments that utilize non-human animals or tissues derived from them. If you are planning non-human animal studies concurrent to your proposed CSDA research and mention these in your proposal, you must clearly state that these will be supported by other funds and include the source of these funds.
What is the success rate for CSDA applicants?
Based on previous competitions, we estimate that the success rate for 2023 will be approximately 10%.
How many awards will be made?
The foundation plans to award approximately 16 grants in 2023.
Will I have to share my data if I am awarded a CSDA grant?
No, the Doris Duke Foundation Medical Research Program does not mandate data sharing at this time. Indicating a data sharing plan does not oblige applicants to share their data should an award be made.
My plan is not to share data that would be generated from the CSDA proposed project. Do I have to include a Data Sharing section in my research plan?
Yes, a Data Sharing section must be included in the research plan as instructed, even if the data will not be shared. The Data Sharing section in the proposal will be considered in the evaluation of the project’s significance.
Why is a Data Sharing section required in the application?
The Doris Duke Foundation Medical Research Program believes that sharing clinical research data has great potential to unlock and accelerate new discoveries for the advancement of human health.
Should the Data Sharing plan section include my plans to share resources expected to be derived from the project?
No, the Data Sharing plan must address the specific information outlined in the “Stage 2 Application Instructions” document. Do not include information about how you plan to share other resources such as methods, tools or reagents.
Is compliance with NIH data sharing policies an acceptable response to the Data Sharing plan section?
No, indicating that data sharing will be done as required by the NIH is not an acceptable response for the Data Sharing plan section. Please address the specific information outlined in the Stage 2 Application Instructions.
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