Instructions for Pilot Proposal Submission
The Boston Roybal Center for Active Lifestyle Interventions (RALI Boston), funded by the National Institute on Aging, is pleased to issue a call for pilot study proposals focused on behavioral interventions to promote healthy aging, especially those that enable middle-aged and older adults to adopt and/or maintain active and engaged lifestyles.
The Center’s mission is to improve the health and well-being of at-risk, vulnerable populations (e.g., from minority or low income groups; those who are inactive, socially isolated, or have chronic conditions) and to identify the most effective mechanisms for adaptive behavior change. We are interested in multifaceted, holistic interventions engaging multiple systems (e.g., psychological, social, cultural, neural, nutritional, physical, biomedical, spiritual, cognitive, motivational) to promote active, engaged, and healthy lifestyles despite the challenges of aging and disability. All studies should be pilot clinical trials, to be registered on clinicaltrials.gov, that fit within the NIH Stage Model for Behavioral Interventions and the Science of Behavior Change approach. The scope of the project should generally allow for completion within a one-year timeframe, although it may be possible to obtain a no cost extension or permission for two years of funding.
We seek pilot proposals for innovative pilot projects that use behavioral approaches to increase and sustain active engagement. We are also interested in collaborative applications that leverage expertise and resources (e.g., functional assessment core) at the Boston Pepper Older Americans Independence Center. New proposals and ongoing projects that add a behavioral component to the study design will be considered. We encourage the use of measures from the Roybal Center Tool Box and Cores at the Boston Pepper Center. Investigators, including junior faculty and postdoctoral trainees, from the Center’s five collaborating institutions (Brandeis University, Boston College, Northeastern University, Boston University, Hebrew Senior Life/Harvard Medical School) are invited to apply. Those from other Boston-area institutions may apply if they are collaborating with or mentored by a member of the Roybal Center executive committee (see names below).
Applicants should submit an abstract up to 350 words and a 3-page proposal (Arial 11 font, .5" margins, single spaced) that includes specific aims, background and significance, innovation, study design, a description of the intervention, proposed measures, sample and sample size justification, analytic plan, and potential for future publications, products, and independent funding using the application form on our website. Please also submit the following: (1) biosketch on the NIH form for all participating investigators, (2) 1-year budget on Form 4 (maximum of $50,000 to $75,000 direct costs) and total budget with indirect costs and budget justification on form 5, signed by an institutional official, (3) planned enrollment form, (4) plan for the Protection of Human Subjects for Clinical Trials, and (5) Data and Safety Monitoring Plan. More information about the mission of the Center and the instructions and forms for pilot applications can be found on the Roybal Center Website. Selected proposals will require clinical trials paperwork, safety monitoring information, IRB protocol, and a Manual of Procedures for approval by NIH before funding can be released.
Please submit all application materials through the Application link by the deadline of 5pm on January 12, 2023. We expect to select 2-3 of the most meritorious proposals by March 1, and to begin funding on June 1, 2023 after approval by NIA. Funding decisions will be based on the proposal’s significance, innovation, and rigor, relevance to the RALI Boston mission, ability to advance our knowledge of behavioral interventions and associated mechanisms to promote active engagement and healthy aging, and potential for future publications and independent funding. Pilot study investigators will be invited to meet periodically with other Center investigators and develop new collaborative relationships, harmonize their outcome measures (see RALI Toolbox measures on the website), share research findings and data sets, submit progress reports, and attend Roybal Center meetings. For additional information please email us at firstname.lastname@example.org. A letter of intent (LOI) should be submitted by November 15th, 2022 to email@example.com. We encourage you to contact one of us to discuss your ideas before submitting your LOI:
We encourage you to contact one of us to discuss your ideas prior to submitting your LOI.
Theresa Ellis (firstname.lastname@example.org) Boston University
Arthur Kramer (email@example.com) Northeastern University
Margie Lachman (firstname.lastname@example.org), Brandeis University
Lewis Lipsitz (email@example.com), Harvard Medical School and Hebrew SeniorLife
Monty Montano (firstname.lastname@example.org), Boston Pepper Center and Harvard Medical School
Carmen Sceppa (email@example.com), Northeastern University
Instructions for submisson:
- Project Proposal
- Cover page with project title, investigators' names and affiliations, and an abstract up to 350 words
- A 3 to 4-page proposal: The 3 to 4-page body of the proposal should include specific aims, background and significance, innovation, study design, a description of the intervention, proposed measures, sample and sample size justification, analytic plan, and potential for future publications, products and independent funding. Please use Arial size 11 font and 1/2 inch (.5) margins all around with single spacing.
- Protection of Human Subjects Plan (Guidelines for the Protection of Human Subjects Plan)
- Data and Safety Monitoring Plan (NIA/BSR DSMP Template (docx) and DSMP Requirements Checklist (docx))
- Some clinical trials may require a Data and Safety Monitoring Board (DSMB), if so please refer to the Sample DSMB Charter (docx) . To determine if your proposed study requires a DSMB, please consult the DSMP Decision Tree (docx).
- The project proposal should also acknowledge and fit within the NIA Stage Model.
- A biosketch on the newest NIH form(.docx) [Download a sample of the biosketch (.docx)]. Include biosketches for all investigators as well as the name, highest degree, institution, address, phone number, and email address of each co-investigator in one pdf file for submission.
- A 1-year detailed budget on Form 4(pdf) (maximum of $50,000 - $75,000 direct costs).
- Total 1-year budget and budget justification on Form 5(pdf) signed by an institutional official. In total costs include the overhead for your institution. List all investigators and their specific roles on the budget justification form, even if not drawing salary.
- A Planned Enrollment Form(PDF) detailing the planned enrollment counts for the proposed study.
- Overview of NIA Roybal Centers
- Roybal Coordinating Center
- All pilot projects must address their plans to address the Stage Model for Behavioral Intervention Development (PDF)
- Pilots should follow the Science of Behavior Change Model
- The NIH Science of Behavior Change Program: Transforming the science through a focus on mechanisms of change – Nielson and colleagues, 2018
- If your proposal is selected, all investigators will be required to complete the CITI Human Subjects Training and the Good Clinical Practice Training Course.
- Pilot data will be made available for resource sharing. For more details, see the NIA's resource sharing policies. De-identified data must be submitted to the Roybal Center for data sharing.
- Selected pilot projects must be registered on clinicaltrials.gov
- Those who are funded will have to complete the PHS Human Subject and Clinical Trials Information form.
- NIA Guidance on Clinical Trials
- Adverse Event and Serious Adverse Event Collection and Reporting
- NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information
- Data Safety Monitoring Plan (.docx download)
We expect to select 2-3 of the most meritorious proposals by March 1, and to begin funding on June 1. Funding decisions will be based on the proposal’s relevance to the RALI Boston mission, ability to advance our knowledge of behavioral interventions and associated mechanisms to promote active engagement and healthy aging, and potential for future publications and independent funding. Pilot study investigators will be invited to meet periodically with other Center investigators and develop new collaborative relationships, harmonize their outcome measures (see RALI Toolbox measures on the website), share research findings and data sets, submit progress reports, and attend Roybal Center meetings.
- If your proposal is selected for possible funding you may be asked to make revisions by March 1.
- NIA will make the final funding decisions. In order to receive funding you will be asked to provide the following information listed below for approval by NIA by June 1.
- You will be asked to submit a: Manual of Procedures (MOP Checklist), an approved IRB protocol, the Informed Consent document (see Informed Consent Template; Informed Consent Checklist), and justification for proposed level of safety monitoring (e.g., Safety Officer- SO to be approved by NIA). The SO must inform NIA if they approve of the protocol before recruitment can begin.