Questions and Answers Table of Contents
General Questions
Questions on Applying
Staff Approval and Peer Review Questions
General Questions
What is an R34 planning grant?
An NIAID Clinical Trial Planning Grant (R34) provides PIs with funds to prepare a) materials NIAID needs to determine a project's feasibility and b) documentation required for applying for the second step, an NIAID Clinical Trial Implementation Cooperative Agreement (U01).
When do I need an R34 planning grant?
R34s help PIs plan their research so they can efficiently conduct clinical trials; see the NIH definition of a clinical trial. You must submit an R34 application for the following:
- An international study with an intervention that is not standard of care in the country in which the study is being conducted or does not meet internationally recognized treatment guidelines.
- A domestic study using an unlicensed product.
- Any study comparing two or more interventions.
- Any study that is intended to change public health policy.
- Any study that has a primary safety or efficacy endpoint.
- Any study that is expected to be conducted under IND or equivalent.
Are there other circumstances when an R34 planning grant may be required?
Yes. Here are examples of proposals that must be discussed with an NIAID divisional point of contact:
- Domestic off-label use of a licensed product.
- Combination therapy involving licensed products for approved indication.
- Studies evaluating responses to low-risk procedures or treatments, e.g., immunologic responses to a licensed vaccine.
- Any study meeting the NIH definition of clinical trial that is not in a category listed above.
- Most studies being conducted in vulnerable populations (e.g., children,
pregnant women, prisoners).
Are there circumstances when an R34
planning grant and U01 implementation grant are not required?
Yes, but we encourage you to speak to the NIAID point of contact listed
on the announcement for certainty.
An R34 would probably not be required for clinical
studies that:
- Evaluate a diagnostic test unless the results
of the studies will be used to:
- Evaluate subjects undergoing a procedure or
receiving a vaccine, drug, or biologic as part of clinical care
AND involve collecting additional samples that do not pose more
than minimal additional risk to the subject.
- Evaluate a licensed
vaccine and meet both of the following conditions:
If I
am planning a study that is primarily basic research, and one
of the four aims involves a clinical trial,
can I still submit the study as an R01?
An R01 award
will not support the conduct of a clinical
trial, unless you receive advice from your NIAID
point of contact that an R34 planning
grant will not be required. To learn more,
see Are there circumstances
when an R34 planning grant and U01 implementation grant are not required?
You can submit your basic research
aims as an R01 and include a description of your plans for a subsequent
R34 application to conduct a clinical trial. This will enable reviewers
to understand your current proposal and pave the way for you to gather
preclinical data to support the clinical trial.
We recommend that you call the NIAID point of
contact listed in the announcement for further advice and discussion.
My research
proposal will use samples obtained from subjects receiving
treatments outside the proposed study.
Can I submit my proposal as an R01?
The treatment or prophylaxis is
not a clinical
trial if the subjects are receiving medical treatment or
prophylaxis according to standard care or the best judgment
of their treating physician. If the samples you need can be
obtained from these subjects at minimal risk, then an R01 application
is appropriate.
Make sure your application
clearly states that the treating physician is independent
of the research proposal. For further advice, discuss your project
with the NIAID point of contact listed in the announcement.
If
my research proposal involves studies of samples obtained from
subjects enrolled in a separate clinical
trial, can I submit my proposal as an R01?
Yes you can, as long as providing samples
for your studies represents minimal additional risk to the clinical
trial subjects. You
should explicitly state that you are not requesting support
for the clinical trial. You will need to provide documentation
that the clinical trial sponsor is aware of your proposal
and will provide necessary access to samples.
For additional advice, discuss your project
with the NIAID point of contact listed in the announcement.
If
my research proposal involves human subjects but is not clearly covered
by the examples in this document,
can I submit my proposal as an R01?
For advice, you should discuss your
project with the NIAID point of contact listed in the announcement.
Most proposals for R01s or other funding mechanisms that
include clinical
trials will be administratively withdrawn
before peer
review. Exceptions may apply to some clinical
studies. Read Are there
circumstances when an R34 planning grant and U01 implementation
grant are not
required? How does the R34 process apply to SBIR and STTR applicants?
Small
Business Innovation Research (SBIR) and Small
Business Technology Transfer (STTR) applications for
support of clinical trials must use the Investigator-Initiated
Clinical Trial Planning (R34) and Implementation (U01) SOP. See Requesting
Permission to Submit a Clinical Trial Planning (R34) or Implementation
(U01) Grant Application.
For the nonclinical trial parts of your
research, you can apply for an SBIR or STTR
grant.
To learn more
about small business awards, visit our Small
Business Awards questions and answers.
What if my research does not meet the NIH definition of a clinical trial?
If your study does not meet the NIH definition, it is not a clinical trial. You will have to seek support through other mechanisms, such as R01 or R21 grants.
Why is NIAID adopting this approach?
NIAID recognizes that the detailed planning, design, and documentation of a clinical trial are time-consuming and expensive. Through the R34, NIAID will provide funding for completing the planning process to investigators whose trial concept is high-priority and meritorious.
The R34 approach ensures that investigators do not spend time and effort preparing applications that NIAID cannot consider for funding.
Are there benefits to PIs other than those listed above?
Yes. PIs will benefit from increased NIAID staff involvement early on and access to NIAID resources. See Can NIAID help me identify Institute-funded resources?
Where can I find more information about clinical trial planning and implementation grants?
Go to our Investigator-Initiated Clinical Trials Resources Web page, and contact the staff members listed in the NIAID Clinical Trial Planning Grants (R34) and NIAID Clinical Trial Implementation Cooperative Agreement (U01) program announcements.
What's the first thing I should do if I plan to submit an application for a clinical trial?
Go to Requesting Permission to Submit a Clinical Trial Planning (R34) or Implementation (U01) Grant, and prepare all the listed information, which you will need for your discussion with an NIAID program officer.
Can I submit an investigator-initiated clinical trial application as an R01 or other mechanism?
No. NIAID will support investigator-initiated clinical trials through the R34/U01 process and will grant exemptions rarely. Please call the NIAID point of contact listed in the announcement to discuss your proposal.
Does the new approach affect requests for applications or requests for proposals?
No. It is only for investigator-initiated applications. Clinical trials supported under a request for applications (RFA) or request for proposals (RFPs) always include requirements equivalent to the planning grant. In fact, our experience with the rigorous trial planning process under RFAs and RFPs was an important factor in deciding to use this concept.
What can the R34 planning grant support?
It supports the development of a research proposal for implementing a clinical trial. Materials for the implementation grant can include the protocol, informed consent documents, investigator's brochure, manual of operations, description of recruitment strategies, necessary agreements and arrangements, and a package for regulatory (e.g., FDA) submission.
Is there anything an R34 planning grant cannot support?
It cannot be used to prospectively gather preliminary data to support or inform a clinical trial.
Can anyone apply for an R34 planning grant?
No. You may only apply after you receive pre-approval from NIAID to submit a planning grant application. NIAID program staff will determine if your application is scientifically important to the Institute. Most organizations are eligible. For a list of eligible institutional types, see the NIAID Clinical Trial Planning Grants (R34) program announcement. For more information on applying, see the question How do I apply for an R34 planning grant?
Can anyone apply for a U01 implementation cooperative agreement?
No. A clinical trial implementation cooperative agreement is open to investigators who have received an R34 planning grant and have received NIAID approval to submit a U01. For more information on applying, see the question How do I apply for a U01 implementation grant?
Do I need separate NIAID approvals to apply for the R34 and the subsequent U01?
Yes.
Is there a limit to the number of R34 planning grant applications I can submit?
Each application should propose development of a single clinical trial. However, with an NIAID division director pre-approval letter, you can send separate applications to request another R34 for the same receipt date.
Can NIAID help me identify Institute-funded resources?
Yes. NIAID program staff may be able to help you identify and access Institute-funded resources, for example, for collaborating with existing networks and laboratories.
Does the clinical trial planning grant process affect career development awards?
Yes. NIAID does not support independent clinical trials under career
development awards. If a clinical trial is proposed under a career
development award, the development and conduct of that trial must
be supported with other resources. Use of career development award
funds is restricted to training and career development.
Does getting an R34 planning grant guarantee I will receive a U01 implementation grant?
No. The R34 provides funding for preparing the U01 application. It is not a guarantee of a U01 award.
Will NIAID's clinical terms of award apply to my U01 implementation grant?
Yes. NIAID Clinical Terms of Award will be part of the terms and conditions of award. Please see the NIAID Clinical Trial Implementation Cooperative Agreement (U01) program announcement for sample terms and conditions of award, which will be modified for each cooperative agreement.
Who will hold the IND for my clinical trial?
NIAID can hold the IND. Other arrangements are possible; please discuss them with the appropriate NIAID program staff.
If I
can't complete a clinical trial within the performance period
of
my current award, can I apply for an extension?
You may be able to apply for an extension. To
learn more, read the NIAID
Policy for Extension of Investigator-Initiated Clinical Trials Guide notice. Also see our Investigator-Initiated Clinical Trial Administrative Extensions SOP and Investigator-Initiated Clinical Trial Administrative Extensions questions and answers.
Questions on Applying
How do I apply for an R34 planning grant?
Follow these steps:
- Review Requesting Permission to Submit a Clinical Trial Planning (R34) or Implementation (U01) Grant for the information you will need to discuss with an NIAID program officer.
- Telephone or email an NIAID point of contact listed in the NIAID Clinical Trial Planning Grants (R34) program announcement to find out how to request approval to submit an R34 planning grant application.
- Follow the instructions in the R34 program announcement, including any additional instructions from the NIAID point of contact, and submit a written request at least 10 weeks before the application receipt date.
See the questions below for details.
What information may NIAID request for the internal pre-approval?
If you are considering a request for permission to submit an R34 planning grant, please think through the items listed on Requesting Permission to Submit a Clinical Trial Planning (R34) or Implementation (U01) Grant before you call or write us, so we can discuss them with you in detail.
Do I need to prepare a letter of intent?
No. You do not need a letter of intent.
How do I know if NIAID approved my request to apply for an R34 planning grant?
An NIAID division director will send you an approval letter to submit an R34 application.
How do I include the division director approval letter in my R34 planning grant application?
Attach a copy in the PHS 398 Cover Letter File of the R34 application package.
What is the timeframe for a response from NIAID regarding approval to submit my application?
NIAID's goal is to respond to you within six weeks of receiving your request for permission to submit an application.
How much time can I request for an R34 planning grant?
You can receive up to one year of support.
How much money can I request for an R34 planning grant?
You may request up to $75,000 in direct costs for planning and design of a phase I trial and up to $150,000 in direct costs for planning and design of a phase II, III, or IV trial.
When can I submit my R34 planning grant or U01 implementation grant application?
R34s and U01s use standard receipt dates for research grants -- go to NIH's Standard Due Dates for Competing Applications.
Should I check the box in my R34 planning grant application that human subjects are involved?
No. Click the "No" button in field 2, Human subjects, clinical trial? in the PHS 398 Cover Page Supplement.
How do I prepare and submit my R34 planning Grant Application Package?
Apply electronically using Grants.gov PAR-06-384, NIAID Clinical Trial Planning (R34) Grants. Find more information about electronic application in our Applying for a Grant questions and answers.
When is the due date for my electronic application?
Submit your electronic application by 5:00 p.m. your institution's local time on the receipt date stated in the program announcement.
Can I submit a revised R34 planning grant application?
Yes. Before resubmitting a revised application, you must repeat the pre-approval process and
get a new approval from the appropriate NIAID division director.
Use the results from the previous review to strengthen your project.
Submit your application using Standard Due Dates for Competing Applications. To resubmit,
follow the suggested format in the electronic Grant
Application Package.
How do I apply for a U01 implementation grant?
Follow these steps:
- Call or write your NIAID point of contact for guidance.
- Follow the instructions in the U01 program announcement, including any additional instructions from the NIAID point of contact, and submit a written request for approval for the U01 implementation grant application.
- For further details, go to:
How do I prepare and submit my U01 implementation grant application?
Prepare the U01 application using the PHS 398, and include a copy of the pre-approval letter from the appropriate NIAID division director.
Submit a typewritten original, including the checklist, and three copies in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (Use this ZIP code for the U.S. Postal Service, including express mail.)
Bethesda, MD 20817 (Use this ZIP code for commercial carriers such as FedEx and UPS.)
AND
Send two copies of the application and a CD with appendix materials in PDF format (or five paper copies of the appendix) to:
Priti Mehrotra, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3138, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616 (Use this ZIP code for the U.S. Postal Service, including express mail.)
Bethesda, MD 20817 (Use this ZIP code for commercial carriers such as FedEx and UPS.)
Telephone: 301/435-9369
Fax: 301/480-2408
Email: pmehrotra@niaid.nih.gov
By what date must my U01 application arrive at NIH?
CSR must receive the U01 by the receipt date stated in the NIAID Clinical Trial Implementation Cooperative Agreement (U01) program announcement.
Must I have permission to submit a U01 implementation grant application?
Yes. Even though you had permission to submit an R34 planning grant application, you must have a separate permission to submit a U01 application.
How much time and money can I request for a U01 implementation grant?
Request resources and time appropriate to conduct and complete the proposed clinical trial. You may request up to five years of support.
NIAID Approval and Peer Review Questions
How does the NIAID pre-approval process differ from peer review?
NIAID will determine whether your proposed research meets NIAID's scientific priorities and can be supported with available resources. In contrast, external peer reviewers assess a proposed project using the initial peer review criteria stated in the program announcement: significance, approach, innovation, investigators, and environment. For more information, see How NIH Review Criteria Affect Your Score.
Who will peer review the R34 planning grant and U01 implementation grant applications?
NIAID's special emphasis panels will peer review both award types.
If NIAID rejects my application, can I send it to NIH as an investigator-initiated application?
NIAID will not accept any investigator-initiated clinical trials that did not go through the R34 planning grant and U01 implementation grant pre-approval processes. We encourage you to contact other institutes to see if they might accept your application.
If my U01 implementation grant is rejected, do I have other options for NIH funding?
Possibly. Contact an NIAID program officer to determine whether you can receive permission to submit a revised application. You can always submit a new R34 planning grant application for a different clinical trial.
What if my question wasn't answered here, or I'd like to suggest a question?
Email deaweb@niaid.nih.gov with the title of this page or its URL and your question or comment. We answer questions by email and post them here. Thanks for helping us clarify and expand our knowledge base. |
