Claude D. Pepper Older American Independence Centers (OAICs)
The Claude D. Pepper Older American Independence Centers (OAIC) program was established in honor of the late Representative to establish centers of excellence in geriatrics research and research career development to increase scientific knowledge leading to better ways to maintain or restore independence in older persons. A listing of the currently active OAICs, their achievements, and other pertinent information can be found on the National Pepper Center Website.
OAIC REQUEST FOR APPLICATIONS
RFA-AG-20-019: Claude D. Pepper Older Americans Independence Centers (P30) (Receipt Date: October 2, 2019)
Policies for OAIC-Funded Human Subjects Studies Involving More than Minimal Risk
A study involving more than minimal risk is one in which the probability and magnitude of harm or discomfort anticipated in the research are greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests (see 45 CFR 46). A study need not involve a clinical trial to be considered more than minimal risk. NIA will generally accept an IRB's assessment of a study's level of risk. In unusual cases, NIA may request a DSMP for studies not considered more than minimal risk by an IRB.
OAIC-funded means a study that receives the majority of its funding through the OAIC. Such studies are typically supported by a Pilot/Exploratory Studies Core, Resource Core (RC), or Research Education Component (REC). OAIC-funded studies do not typically include External Projects of a Resource Core, which receive the majority of their funding from other sources and, therefore, are subject to the data and safety monitoring policies of those sources.
Investigators should follow NIA's policies for data and safety monitoring in OAIC-funded studies.
Frequently Asked Questions about the OAIC RFA
New FAQ’s may be added to this site periodically.
The RFA calls for descriptions of pilot projects, developmental projects, and REC projects in the Research Strategy section of each component. If these projects involve human subjects, should we also describe them in the PHS Human Subjects and Clinical Trials Information section? (New)
Yes, human subjects projects proposed for the first year of the award should be described briefly in the Research Strategy section and more thoroughly in the PHS Human Subjects and Clinical Trials Information section according to the SF424 Application Guide instructions.
Can you clarify how many advisory committees are needed? (New)
The RFA calls for an External Advisory Board (EAB) comprised completely of individuals outside the OAIC institution(s) who review and advise on the progress of the OAIC as a whole. The RFA also calls for an advisory body or bodies, of which at least one-third of the members are external to the OAIC institution(s), to select and monitor progress of REC participants, pilot projects, and developmental projects. Applicants can propose a single body that satisfies all these requirements or multiple bodies.
How does RFA-AG-20-019 differ from previous Pepper Center competitions?
RFA-AG-20-019 includes an increase in the number of intended awards to five and an increase in budget limits for the overall center and certain cores. Annual direct cost limits are as follows:
- Overall OAIC: $950,000
- Leadership and Administrative Core (LAC): $150,000
- Research Education Core (REC): $450,000
- Resource Cores (RC): there is no limit for each core per se, but Developmental Projects should range between $35,000 and $70,000
- Pilot/Exploratory Studies Core (PESC): $300,000
- Information Dissemination Core (IDC): $60,000
Other significant changes include an increase in the maximum number of Resource Cores (RCs) to five, elimination of the requirement for a table describing Resource Core Distribution to Research Projects, and discouragement of External Advisory Board membership consisting solely of Directors or Core Leaders from other OAICs.
Note that successful applications requesting maximum direct costs allowed by this RFA may still incur budget reductions at the time of award due to availability of funds and size of carryover balances of renewing awards.
How much science on Alzheimer's Disease and Alzheimer's Disease-related dementias (AD/ADRD) can be supported by an OAIC?
The RFA indicates the following:
Cognitive and Behavioral/Social Research as an Area of Focus. Cognitive or behavioral/social research should not be the major focus of an OAIC, as these areas are more appropriate for other NIA programs that also use the Center mechanism. However, where appropriate, OAICs are encouraged to support a multidisciplinary approach that includes research in these areas as they relate to the theme or focus of the OAIC.
NIA recognizes that integration of multiple disciplines may be needed to achieve the mission of the OAIC program: to increase scientific knowledge leading to better ways to maintain or restore independence in older persons. The following are a few examples of studies involving AD/ADRD that are consistent with the OAIC mission:
- Exploring associations between clinical or neuropathological measures of cognitive impairment/AD/ADRD and mobility or other measures of physical function
- Tailoring an exercise intervention to the particular needs of older adults with cognitive impairment/AD/ADRD
- Identifying patterns of physical functional recovery in older individuals with cognitive impairment/AD/ADRD after a clinical event
Note that the decision to support AD/ADRD science in an OAIC should be based on its expected contribution to the overall focus of the OAIC site and the mission of the OAIC program. Selecting AD/ADRD-related projects for OAIC support should not be based on the expectation of funding advantage, as AD/ADRD funds are generally not available for regular OAIC awards. If you are in doubt about the appropriateness of a proposed study in your OAIC, please contact NIA Program staff.
How should human subject enrollment be reported in competing renewal applications?
Cumulative enrollment during the previous award period should be described in narrative form as part of the progress report in the Research Strategy. New enrollment expected in the renewal award period should be reported in Inclusion Enrollment Reports.
The tab for Inclusion Enrollment Report does not appear for the component I am working on. How do I add this section?
ASSIST may not display this tab automatically, but you can add it as an optional form. Go to the Application Information page and expand the appropriate component from the Component Type section. Then click on Add Optional Form and choose the desired form from the drop-down list.
Should biosketches be included for Program Faculty in the Research Education Component (REC)?
The RFA indicates that biosketches should be included for each senior/key person of a Core or component including the co-Leader(s) and other Core staff. REC program faculty are not considered senior/key persons, so their biosketches should not be included. Instead, their qualifications should be described in the Program Faculty part of the Research Strategy section.
What are the salary and professional effort guidelines for REC participants?
There is no minimum salary or professional effort requirement for REC participants. In addition, REC participants may receive salary support from other federal sources consistent with the institution's salary scale as long as those sources do not specifically prohibit such salary supplementation. Individuals supported by NIH training and career development mechanisms (K, T, or F awards) may receive, and indeed are encouraged to receive, educational experiences supported by the REC as participants, but may not receive salary or stipend supplementation from the REC.
What are the page limits for the REC Research Strategy?
The REC Research Strategy includes a Program Plan that is limited to 12 pages. Subsections within the Program Plan are
- Proposed Research Education Program
- Core Leader(s)
- Program Faculty
- Program Participants
- Recruitment Plan to Enhance Diversity
- Plan for Instruction in the Responsible Conduct of Research
- Evaluation Plan
Other sections outside the Program Plan include Other Attachments (described below), Protection of Human Subjects, Letters of Support, Resource Sharing Plans, and Appendix (if necessary). These sections may not contain information that should be included in the Program Plan.
Are REC participants considered senior/key personnel? How should specific REC participants be described in the application?
Participants in REC are not considered senior/key personnel. Up to five REC participants proposed for support during the first year of the award may be described as indicated in the RFA. Biosketches for REC participants should not be included; rather, all information pertaining to REC participants should be contained within the Program Plan of the REC section.
How should the composition and functioning of the REC advisory committee be described?
As noted in the RFA, this should be provided as an Other Attachment to this component. This attachment should be no longer than one page.
If I am submitting a competing renewal application, how should I handle the progress report for the REC component in ASSIST?
As noted in the RFA, progress report information should be included in the “Proposed Research Education Program” subsection. New applicants may use this section to describe current research education opportunities or other preparatory activities for an REC. Do not upload a separate progress report.
How should the different components be ordered in ASSIST?
Allow ASSIST to order the application components itself.
Should biographical sketches be provided for pilot/exploratory study awardees?
Yes, biographical sketches may be provided for pilot/exploratory study awardees identified in the application. These individuals should be considered as senior/key personnel.
There are some sections of the application that do not have page limits. Can I include information that does not fit elsewhere in these sections?
No. According to NOT-OD-17-098 and its related Notices, information should not be included in appendices or sections lacking page limits as a way of circumventing page limits of other sections of the application. NIH may withdraw applications in egregious cases.
Can I include internet addresses in my application?
As indicated in NOT-OD-00-004, internet addresses or URLs should not be included in the application to convey information necessary for review.
How should Pilot/Exploratory Studies (PESs) be presented within the page limits of the PESC section?
Descriptions of Pilot/Exploratory Studies are intended to serve as examples of the kind of science that the Pilot/Exploratory Studies Core will support. Applicants are encouraged to keep descriptions of first-year proposed PESs brief and limited to only the most consequential information. Applicants are encouraged to make maximum use of space within the PESC section, as well as other areas of the application, to convey relevant information about proposed PESs, provided that the information is appropriate for inclusion in such areas. Applications that do not adhere to the page and content limits of individual sections may be returned.
What is the budget limit for Resource Cores?
There is no budget limit for Resource Cores themselves. Applicants may request as much as is available for Resource Cores after budgeting for all other OAIC components. However, there are budget limits on Developmental Projects, which must range between $35,000 and $70,000 in first-year direct costs.
Should Inclusion Enrollment Reports be provided for RC-associated External Projects?
No. Only human subjects enrolled as part of an OAIC-supported project should be reported.
Can renewing OAICs use extra pages for their progress reports?
No. Competitive renewal applications must fit their progress reports within the Research Strategy page limits for each component. Applications that include progress report information in other sections may be sent back.
Can an institution submit more than one OAIC application?
No. An applicant institution may submit only one OAIC application.