2019 SPARK Clinical Site Network Request for Applications

Background and Rationale

The overall goal of SPARK (Simons Foundation Powering Autism Research for Knowledge) is to recruit, engage and retain a research community of at least 50,000 individuals in the United States with autism spectrum disorder (ASD), along with their family members. The SPARK research cohort includes children and adults with ASD who span the full spectrum of autism and represent all socio-economic backgrounds. Since its national launch in April 2016, SPARK has recruited over 130,000 participants. This includes over 50,000 individuals with ASD, of whom close to 13,000 have enrolled and provided saliva samples their biological parents and, if applicable, an unaffected sibling.

SPARK participants contribute medical and behavioral information online, collect and mail in saliva samples for DNA analysis, and have the opportunity to participate in additional research studies through the study’s research match program. Individuals who enroll in SPARK will receive up to $50 in gift cards, have access to both aggregate and individual behavioral results from their participation, and can elect to receive genetic results should a genetic cause of their autism be identified. SPARK also publishes timely articles on the latest in autism research and hosts monthly interactive webinars or Facebook live events. Additional information about the program can be found on the SPARK website.

SPARK recruits participants using a range of outreach methods, including clinical sites, digital and traditional media, and partnerships with national advocacy organizations. The primary source of participants is our network of 25 clinical sites throughout the United States (information about the principal investigators at each of these sites is available here). Data from each site’s participants are shared with the site to enrich its local research efforts or research registry. Clinical site investigators are also given expedited access to SPARK participants via the research match program.

SPARK is an initiative of the Simons Foundation Autism Research Initiative (SFARI). SFARI’s goals include supporting research that will lead to better ways to treat and improve the lives of individuals with ASD. Additional SFARI goals include developing more reliable quantitative, objective outcome measures for ASD clinical trials; developing biomarkers to stratify ASD individuals and demonstrate efficacy of treatments; and forming partnerships with individuals with ASD and clinical providers to promote ASD research.

Scope of RFA

SFARI will support additional U.S.-based clinical sites for the purpose of recruiting individuals with ASD and their family members to participate in SPARK. Support to a clinical site will include the following allowable costs:

• Principal investigator (PI) salary — up to 10 percent effort for a PI or PI(s);
• Site coordinator(s) salary — up to two full-time coordinators or the equivalent;
• Funds for conducting community outreach in catchment area (excludes direct payment to participants);
• Funds for recruitment and retention materials and supplies, such as tablets to assist families with online registration.
• If applicable, funds to support return of genetic and behavioral results.

Selected sites will receive funding on an annual basis (see below for renewal details). The maximum amount of funding awarded per year is $200,000 including 20 percent indirect costs (see Simons Foundation policies). Sites will be required to submit biannual progress reports to help determine eligibility for renewal. Annual renewal of funding is based on the site’s performance in meeting recruitment targets. The award start date is March 1, 2019, and sites will be expected to begin enrollment (operating near or at full recruitment capacity) no later than May 1, 2019.

Specific Work to be Accomplished

Selected sites will be responsible for the following:

Recruitment Planning:

• Obtain local IRB approval to cede oversight to a centralized IRB. If your IRB is unable to cede oversight to a central IRB, your site cannot participate in SPARK. SPARK’s central IRB is Western IRB (WIRB). Additionally, local IRBs are expected to accept standard Health Insurance Portability and Accountability Act (HIPAA) language in the centralized consent for bidirectional sharing of participant information.
• Develop a recruitment strategy in alignment with central IRB protocol, which must include identifying existing research cohorts available for recontact, local patient databases with email/phone contacts, and community partners working with individuals with ASD and their family members.

Outreach and Recruitment:

• Conduct in-person recruitment of eligible individuals with ASD and their family members, including completion of online enrollment and submission of saliva samples.
• Facilitate remote enrollment and submission of saliva samples of individuals with ASD and their family members.
• Recruit individuals with ASD and their family members by contacting local research participants and patients who have agreed to be recontacted for future research opportunities.
• Enhance recruitment by presenting at local events, hosting a booth at a walk, etc.
• Follow up with participants to facilitate their completion of new survey modules or participation in research match studies of interest.

Return of Results:

• Follow up with participants to support return of genetic or behavioral results if needed and facilitate participation in research for gene-specific research.

Data Entry:

• Local IRBs are expected to accept standard HIPAA language in the centralized consent for bidirectional sharing of participant information.
• Abstract and enter assessment scores from participant medical records and/or transfer data from a local database into the study portal.
• Upload medical records of enrolled participants into the study portal.
• Assist with data quality inquiries (for example, confirming family information).

Tracking Progress Over Time:

• Track the number of individuals with ASD and family members recruited per month.
• Participate in monthly site coordinator conference calls to share information about recruitment efforts and receive updates on overall project status

Eligibility and Collaboration

All applicants and key collaborators must hold a Ph.D., M.D. or equivalent degree and have a faculty position or the equivalent at a college, university, medical school or other research institute. Applications may be submitted by domestic nonprofit organizations; public and private institutions, such as colleges, universities, hospitals, laboratories, and units of state and local government; and eligible agencies of the federal government. There are no citizenship or national residence requirements for applicants. If the proposal includes investigators at more than one site, all investigators should have demonstrated prior success in similar collaborations. 

Important Deadlines

Application deadline                                     November 30, 2018

Notification date                                           January 11, 2019

Start date                                                      March 1, 2019

SPARK will hold an informational conference call on Friday, November 2, 2018. Please email Alex Stephens at astephens@simonsfoundation.org if you are interested in participating.

Instructions for Submission

The deadline for receipt of applications is November 30, 2018. Applications must be completed electronically and submitted using forms provided at proposalCENTRAL. Please log in as an applicant, go to the “Grant Opportunities” tab, scroll to “Simons Foundation” and click “Apply Now” for the “SPARK Clinical Site Network Request for Applications.”

The following components must be included in the application (for more details, see the Instructions document, available for download in the Download Templates and Instructions section of proposalCENTRAL):

1. Completed Application form:
   1. Patient population and enrollment estimates across catchment area
   2. Waiver ceding IRB oversight to central IRB.
   3. Recruitment objectives
   4. Site experience
   5. Other site capabilities
2. Recruitment plan: Description of how site plans to recruit participants and partner with local organizations for outreach/recruitment (one page).
3. Activity timeline: Month-to-month description of activities with clear start and end dates (one page).
4. Budget: Should include cost estimates for components listed above; budgets are limited to up to $200,000 per year for up to three years, inclusive of 20 percent indirect costs.
5. Budget justification (one page).
6. Biographical sketch of PI, site coordinator(s) and all clinical staff who will be supported by the award.
7. Research environment and resources: Investigators should demonstrate access to appropriate resources for accessing clinical data.
8. Signed signature page.
9. Optional: Letters of support from community organizations (up to three).
10. Optional: Additional documents for multiple PIs and/or subcontracts:
    1. Budget for additional PI (only if additional PI will be paid separately).
    2. Signed signature page from additional PI’s institution (only if additional PI will be paid separately).
    3. Subcontract budget template.
    4. Subcontract budget justification.

Evaluation Process

SFARI will evaluate proposals based on information provided in the application and associated documents. External reviewers will most likely not be used. SFARI scientific staff will make final funding decisions, and notification of award is expected by January 11, 2019. Preferred applicant sites will be able to demonstrate the following:

• Extensive history of participating in/leading research studies of individuals with ASD.
• Proven track record of successful recruitment for large-scale research projects.
• Extensive history of providing clinical care to individuals with ASD.
• Large number of individuals with ASD seen per year.
• Large number of individuals with ASD available for re-contact.
• Large catchment population.
• Diverse catchment population.

Funded clinical sites will be expected to recruit at least 200 complete families (defined as an individual with ASD and his/her biological parents who have completed online enrollment and submitted saliva samples) per year. Additionally, preference will be given to applicant sites from cities or regions that do not already have a SPARK clinical site.

The aforementioned criteria are by no means exhaustive.

The deadline for application submission is Friday, November 30, 2018, at 5:00 p.m. EDT.

proposalCENTRAL Login Information
Applications must be submitted via proposalCENTRAL (pC). To start an application in pC, users must first login to their pC account.

To submit a full application, you must complete the following proposalCENTRAL sections:

1. Title Page: Enter the proposal title in this section. 
2. Download Templates and Instructions: Templates can be found under Templates and Instructions or Proposal Attachments.
3. Enable Other Users to Access This Proposal: This module allows you to give other users access to your grant application. You can give them one of three levels of permission: view, edit or administrator.
4. Applicant/PI: The principal investigator (PI) should be listed here. While someone other than the PI can submit the application, this section must be filled in for the intended PI on the project. For grants with multiple PIs, the contact PI should be listed here.
5. Organization/Institution: Enter the contact information for the signing official and the financial/fiscal officer from your institution. Select from the menu or enter new names.
6. Key Personnel: Indicate key personnel, including but not limited to: PIs, co-investigators, consultants and postdoctoral research associates. In rare circumstances, the applicant organization may designate multiple PIs who share the authority and responsibility for leading and directing the project, intellectually and logistically. For more information on the responsibilities of PIs or co-investigators, please refer to the personnel definitions in the Clinical Site Network RFA FAQ.
7. Budget Period Detail: Enter your budget period detail in this section.
   1. Award start date: Proposals selected for funding will be announced by January 11, 2019, and funding will begin on March 1, 2019.
   2. Indirect costs (IDCs): IDCs are limited to 20 percent of direct costs. The following items may not be claimed as indirect costs: equipment, tuition, and any subcontracts with budgets including IDCs. IDCs paid to a subcontractor may not exceed 20 percent of the direct costs paid to the subcontractor. While IDCs on most equipment are not allowable, IDCs on small equipment (costing up to $10,000) are permissible.
   3. Equipment: The Simons Foundation (SF) will own equipment purchased with SF grant funds with a unit cost of $50,000 or more. At the end of the grant funding period or in the case of grant termination for any reason, SF reserves the right to retain ownership or cede ownership to the PI’s institution. Equipment with a unit cost of less than $50,000 shall be the property of the institution.
   4. Budget: Please complete a budget for years 1–3 on the individual budget tabs provided in the online application. Budgets should not exceed $200,000 per year, which includes 20 percent indirect costs.
   5. Multiple PIs:
      1. SFARI discourages applications with multiple sites, multiple PIs and/or subcontracts for this RFA. Applications from multiple sites, multiple PIs and/or subcontracts will be considered under rare circumstances.
      2. Please note that the applicant PI will be the designated contact PI for the project. The contact PI will be responsible for directing the project and will coordinate all administrative deliverables.
         1. Applications with multiple PIs from different institutions who would like to be paid separately must upload in the Proposal Attachments section:
         2. Signed signature page for each PI (available for download in the Proposal Attachments and Download Templates and Instructions sections).
         3. Budget Template & justification for each non-applicant PI (available for download in the Proposal Attachments and Download Templates and Instructions sections).
         4. The direct costs for all non-applicant PIs, which must be included in section 7 (Budget Period Detail) in the Consortium & Contractual Direct section, and indirect costs for all non-applicant PIs, which should be included in the Indirect Costs section. Please add a separate line for direct costs and one for indirect costs for each non-applicant PI.
      3. Applications with multiple PIs from different institutions who will be paid directly by the contact PI’s institution are considered subcontracts. Please refer to the subcontract instructions in section 7f below.
      4. Applications with multiple PIs from the same institution do not need to submit additional materials. Additional non-applicant PIs should be listed as key personnel in section 6 (Key Personnel) and section 7 (Budget Period Detail), and only one signature page is needed.
   6. Subcontracts:
      Applications with subcontracts (including PIs who will be paid directly by the contact PI’s institution) must submit:
      1. Subcontract detailed budget & justification(available for download in the Proposal Attachments and Download Templates and Instructions sections) for each subcontract.
      2. Subcontract direct costs, which must be included in the Consortium & Contractual Direct section, and subcontract indirect costs, which should be included in the Indirect Costs section. Please add a separate line for direct costs and one for indirect costs for each subcontract.
8. Budget Summary: The Budget Summary will populate from the saved detailed budget. 
9. Proposal Attachments: The following documents are to be uploaded in this section, where they are also available for download:
   1. Completed application form, including:
      1. Patient population and enrollment estimates across catchment area.
      2. Waiver ceding IRB oversight to central IRB.
      3. Recruitment objectives.
      4. Site experience.
      5. Other site capabilities.
   2. Recruitment plan: Description of how site plans to recruit participants and partner with local organizations for outreach/recruitment (one page).
   3. Activity timeline: Month-to-month description of activities with clear start and end dates (one page).
   4. Budget: Should include cost estimates for components listed above; budgets are limited to up to $200,000 per year for up to three years, inclusive of 20 percent indirect costs.
   5. Budget justification (one page).
   6. Biographical sketch of key personnel (PI, site coordinator and all clinical or research staff who will be supported by the award).
   7. Research environment and resources: Investigators should demonstrate access to appropriate resources for accessing clinical data.
   8. Signed signature page.
   9. Optional: Letters of support from community organizations (up to three).
   10. Optional: Additional documents for multiple PIs and/or subcontracts:
       1. Budget & justification for additional PI (only if additional PI will be paid separately).
       2. Signed signature page from additional PI’s institution (only if additional PI will be paid separately).
       3. Subcontract budget template.
       4. Subcontract budget justification.
10. PI data sheet: Your professional profile will populate this section of the application. If revisions are required, please select “Edit Professional Profile” and go to section 4 (Personal Data for Applications).
11. Validate: You must click the “Validate” button to check for any missing required information or files. All missing required information will be listed on the screen. Please correct any missing information before proceeding to the next step.
12. Signature page(s): The signed signature page is available for download in the Signature Page section and must be signed by the applicant and signing official, then re-uploaded in the Proposal Attachments section. Applications with multiple PIs from different institutions who would like to be paid separately must submit a signed signature page for each PI institution.
13. Submit: You will be unable to submit if you have not provided all the required information. Any missing information will be listed on the screen. If your submission is successful, you will receive a confirmation message on the screen and a confirmation email.