Frequently Asked Questions for the RFA-HL-10-003: Phase II Clinical Trials of Novel Therapies for Lung Diseases (U01)

IMPORTANT: NEW FAQS have been added on January 8, 2009 to update this FAQ site and CORRECT page limit requirements to conform with published RFA

Q: Will the page limitations for this FOA changed in response to the new NIH page limitation policy (
A: Yes. For receipt dates January 29, 2010 and September 15, 2010 the page limitations will conform to new NIH rules:

  • One page permitted for Specific Aims should be used to provide an Overview.
  • The research plan for the clinical trial is now limited to 12 pages.
  • Each ancillary study is limited to 6 pages.

Human subjects and budget pages do not count against these limits. The full protocol and consent must be included in the appendix.

Please consult the RFA for details.

(A previous FAQ INCORECTLY stated that the page limits were 10 for the clinical trial and 2 for any and all ancillary studies.)

Q: The RFA asks for information about previous participation in clinical trials to (Section IV, part 6) support the feasibility of patient recruitment plans. Where should this information be included and does this count against the 12 page limit for the research plan?
A: Information about previous participation in clinical trials for each of the recruitment sites should be included in the Human Subjects Section, after the Target Enrollment Plan. This information does NOT count against the 12 pages permitted for the research plan of the clinical trial.

Q: Must my application include a proposal for an ancillary study or can the application include a clinical trial only?
A: No. Each application must include at least one ancillary study proposal along with the clinical trial.

Q:  Do I need a separate budget for the ancillary study(s)?
A:  Yes. Each ancillary study must have a separate budget. If one ancillary study is proposed, it cannot exceed $150,000 in direct costs. If multiple ancillary studies are proposed the budget for all of them together may not exceed $250,000 in direct costs.

Q: Would a high score on my ancillary study interfere with my chances for funding?
A: No. The clinical study and the ancillary study(s) will receive separate scores. A highly meritorious clinical study might be funded on its own. Conversely, an ancillary study will NOT be funded by itself with out a clinical study.

Q: Ability to recruit is usually a challenge in clinical trials and an important review criterion. How will this be evaluated?
A: The RFA recommends inclusion of at least one subcontract to assure adequate recruitment. Recruitment in previous trials involving a similar patient population should be documented and a statement about the willingness and ability to recruit should be provided from each site. If the applicant or subcontractor is from an institution that is participating in a Network or other major trial, details should be provided as to how the patient population in the proposal is different or how sufficient patients will be obtained. The peer reviewers will evaluate these details and there will be an administrative review by NHLBI staff.

Project Officer:

Andrea Harabin , Ph.D.
Division of Lung Diseases
National Heart, Lung, and Blood Institute
6701 Rockledge Drive
Bethesda, MD 20892-7952
Telephone: (301) 435-0222

Last updated: January 8, 2010

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