If you are interested in applying for the NIA-PCORI Fall Injuries Prevention Partnership RFA (RFA-AG-14-009), please read the Questions and Answers below for more information. For further questions, contact: Rosaly Correa-de-Araujo, M.D., M.Sc., Ph.D. (301-496-6762, Rosaly.email@example.com)
Applications are due November 13, 2013.
Applicants should include the study protocol and Manual of Procedures. Appendices should not be used to circumvent the 30-page limit of the Research Strategy section.
A community agency that would screen and enroll the participants is a reasonable venue to consider as part of the consortium. The agency would need to collaborate with a healthcare system for medical evaluation of participants enrolled by the community agency.
Yes, they should be compensated either as the study participants or as the partners.
Yes, they would be eligible if they remain at risk for falling after discharge.
Applicants should propose the definition. Several approaches can be used to develop the definition. For example, a “serious” fall could be one that requires medical attention and generates an insurance claim. Another approach could be to have participants and/or their family members record falls and describe injuries according to a nomenclature developed by the applicant. Other approaches could be used, but all should focus on serious, fall-related injuries that matter to patients.
Before submitting applications for peer review, NIA staff will review them for responsiveness to the criteria listed in the RFA. Those applications that do not meet the criteria will not be submitted for peer review and will be returned to the applicants.
One application with total costs of up to $30 million will be funded.
There is no specific age range for participants selected for this study. Applicants should focus on a high-risk population and propose and justify their selection of the age range. The study should be able to enroll a significant number of participants within a short period of time to meet the RFA’s objectives.
Technically, all reviewers will be NIA reviewers, but a percentage of them will represent patients’ and stakeholders’ perspectives. PCORI will submit to NIA a list of candidate reviewers who have previously reviewed PCORI projects. NIA will select reviewers from this group.
The second level of review involves the Council concurring (or not) with the outcome of the initial review.
The study will be governed by the Steering Committee, whose role and responsibilities are described in the RFA. In accordance with NIH guidelines, NIA will also appoint a Data and Safety Monitoring Board that will oversee participants’ safety, study progress, and data quality. This Board is advisory to NIA Director.
Residents of assisted living facilities are eligible to participate in the study.
Participants should be selected from general population of older people who are at risk for falling. Applications proposing a study in a subset of general elderly population (e.g., patients with stroke or Parkinson’s disease) will not be responsive to RFA and will be returned to the applicants.
Applicants should propose a well-designed clinical trial which is responsive to the RFA. It is recognized that all the study elements may not be well established at the time of submission; the protocol development and refinement phase provides for refinement and/or pilot testing of a number of study elements. Applicants should propose and justify tasks that will be performed during the protocol development and refinement phase, which may include, but are not limited to, secondary analysis of existing data sets, pilot testing of select study elements, or similar activities.
All PHS SF 424 (R&R) Guidelines Part 1, Section 5.5 should be followed, except for the Research Strategy section. As stated in the RFA, the Research Strategy section should contain the following section headings: Significance, Patient Centeredness, Approach, Patient and Stakeholder Engagement, and Innovation.
The page limit for the Research Strategy section is 30 pages.
All types of partnerships ensuring successful completion of the project are encouraged.
It is not known. We will accept, but not necessarily review, all applications submitted.
The guidance is provided in the RFA-AG-14-009.
If your application satisfies all the RFA requirements, it will be accepted for review.
Your institution’s standard NIH indirect costs rate should be used.
Applications should be submitted by consortia which includes a Data Coordinating Center among its components. It is not important whether the entity or study component that serves as the DCC is the primary applicant.
PCORI guidelines on “Patient-Centeredness” and “Patient and Stakeholder Engagement” are available at www.pcori.org/research-we-support/pcori-review-criteria/.
Applications should propose a well-designed and appropriately budgeted study. The budget for Years 2 to 5 should be based on the assumption that Year 1 will be successful, therefore providing continuity to the project. Based on changes made during the protocol development and refinement phase, the grantee will be allowed to appropriately adjust budget for Years 2-5.
Any device that will be used in the study must be approved by FDA when the trial starts, unless it is not FDA-regulated. In addition, such a device must be a part of a multifactorial strategy and must be usable in non-hospitalized populations. It is doubtful that all these conditions could be met, if the development starts during the protocol development and refinement phase. Any device should be validated in diverse populations to be usable in the proposed trial.