SPARK Clinical Site Network Request for Applications

Grants awarded through this request are intended to support a network of U.S.-based clinical sites to recruit individuals and families affected by autism spectrum disorders (ASD) to participate in SPARK. The overall goals of SPARK are to recruit, engage and retain a community of 50,000 individuals with ASD, along with their family members in the United States. This research cohort will include children and adults with ASD, who span the full spectrum of autism and include individuals of all socio-demographic backgrounds. Selected clinical sites will receive funding of up to $150,000/year for a maximum of three years.

Maximum Budget

$150,000 per year

Important Dates
  • Application deadline
  • Notification date
  • Start date
Contact Info

Background & Rationale

The overall goal of SPARK is to recruit, engage and retain a research community of 50,000 individuals with autism spectrum disorders (ASD), along with their family members in the United States. This research cohort includes children and adults with ASD, who span the full spectrum of autism and includes individuals of all socio-demographic backgrounds. In the months since the initiative launched in April of 2016, SPARK has recruited over 30,000 participants, including 5,000 “trios,” which are families comprised of a child with ASD and both of his/her biological parents.

SPARK participants contribute medical and behavioral information online, collect and mail in saliva samples for DNA analysis, and are invited to participate in future research studies. In addition, the SPARK community will provide researchers with an efficient way to identify eligible participants for their research studies. Individuals who enroll in SPARK will receive up to $50 in gift cards as well as access to the following: 1) an opportunity to receive aggregate and individual behavioral results from their participation, 2) an opportunity to receive individual genetic results that are pertinent to their autism diagnosis, and 3) interactive webinars and recent articles regarding autism research. Visit www.SPARKforAutism.org for additional information about the study as well as the clinical sites that are currently supported.

In order to effectively build the SPARK community, we will recruit participants through clinical sites, including past and current research registries, and through partnerships with advocacy organizations and service providers. Participant data will be shared back to the clinical site or registry that referred them to enrich the local research efforts of the clinical site or research registry.

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 to improve the lives of individuals with ASD. Some of SFARI’s major goals are: to develop more reliable quantitative, objective outcome measures for ASD clinical trials; to develop biomarkers to stratify ASD patients and demonstrate efficacy of treatments; to develop partnerships with individuals with ASD and clinical providers to promote ASD research; and to enable and evaluate new, potential therapies and supports for individuals with ASD.

Scope of RFA

SFARI will support a network of U.S.-based clinical sites for the purposes of recruiting individuals and families affected by ASD to participate in SPARK. Annual support to each clinical site will include the following allowable costs:

  • Site director(s) salary — we will allow up to 10 percent effort for a PI or PI(s), but the total amount of funding requested, including indirect costs, must not exceed $150,000 per year;
  • Site coordinator(s) salary — a site can have more than two coordinators, but we strongly encourage the arrangement of one full-time site coordinator or two part-time site coordinators at 50 percent effort each;
  • Funds for conducting community outreach to catchment area (excludes direct payment to participants);
  • Funds for recruitment and retention materials and supplies, such as tablets to assist families with online registration; and
  • If applicable, funds to support return of genetic and behavioral results

Sites will be required to submit quarterly progress reports to help determine eligibility for renewal. Annual renewal of funding is based on the site’s performance in meeting recruitment targets of individuals and families who qualify for the study, entering relevant clinical data and promoting retention of the cohort.

The award start date is April 1, 2017, and sites will be expected to begin enrollment no later than June 1, 2017.

Specific work to be accomplished

Selected sites will be responsible for the following:

Recruitment planning

  • Obtain local IRB approval to waive 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.
  • Develop a recruitment strategy in alignment with central IRB protocol, inclusive of identifying existing research cohorts available for re-contact; local patient databases with email/phone contacts; and community partners working with individuals with ASD and their family members.

Outreach & Recruitment

  • Conduct remote and in-person recruitment (defined as enrolling eligible participants through the submission of saliva samples) of individuals with ASD and their family members who visit the clinical site
  • Recruit individuals with ASD and their family members via re-contact of local research participants and patients who have agreed to be re-contacted for future research opportunities
  • Reach out to community groups and organizations that serve individuals with autism and their family members to enhance recruitment by speaking at local events, hosting a booth at a walk, contacting local advocacy groups, etc.
  • Following up with participants with regards to return of genetic results and completion of new survey modules

Data entry

  • Abstract and enter assessment scores from participant medical records or transferring data from a local database into the study portal. We expect IRBs to accept the standard HIPAA language in the centralized consent.
  • Upload medical records of enrolled participants into the study portal

Tracking progress over time

  • Track the number of individuals with ASD and their 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, units of state and local government; and eligible agencies of the federal government. Applications may also be submitted by for-profit companies, in which case the funds provided for the grant are to be used only for charitable purposes toward research related to autism spectrum disorders. 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.

SPARK will hold an informational conference call on Thursday, December 15, 2016. Please email Alex Stephens at astephens@simonsfoundation.org if you are interested in participating.

Instructions for submission

The deadline for receipt of applications is January 13, 2017. Applications must be completed electronically and submitted using forms provided at http://proposalcentral.altum.com/. Please log in as an applicant, go to the grant opportunities tab, scroll to clinical research associates and click apply now for the SPARK Clinical Site Network Request for Applications program.

Full applications require the following components to be included (for more details, see the “Instructions” document, available for download in the download templates and instructions section of proposalCENTRAL):

  1. Completed Application Form:
    • Patient population and enrollment estimates across catchment area
    • Waiver of oversight to central IRB
    • Recruitment objectives
    • Site experience
    • Other site capabilities
  2. Recruitment plan: Description of how site plans to recruit participants and partner with local organizations for outreach/recruitment (1 page)
  3. Activity timeline: Month-to-month description of activities with clear start and end dates (1 page)
  4. Budget: Should include cost estimates for components listed above; budgets are limited to up to $150,000 per year for up to three years, inclusive of 20% indirect costs.
  5. Budget justification (one page)
  6. Biographical sketch of PI, site coordinator and all clinical staff who evaluate children/assign diagnosis
  7. Research environment and resources: Investigators should demonstrate access to appropriate resources for high-capacity data collection and analysis, although we will work with awarded investigators to provide additional informatics support as needed.
  8. Optional: Letters of support from community organizations (up to three)

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 February 1, 2017. 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

The aforementioned criteria are by no means exhaustive.

Contact information

Scientific inquiries:
adaniels@simonsfoundation.org
646-362-0062

Administrative inquiries:
grants@simonsfoundation.org
646-654-0066

proposalCENTRAL (technical support):
pcsupport@altum.com
800-875-2562

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The Simons Foundation uses an electronic grants submission process. All interested grant applicants must submit their applications online through proposalCENTRAL

Maximum Budget

$150,000 per year

Important Dates
  • Application deadline
  • Notification date
  • Start date
Contact Info
Read More
  • Frequently Asked Questionsplus--large
    1. Where do I submit my application proposal?plus--large

      All applications must be submitted through proposalCENTRAL. New users first need to create a user account on proposalCENTRAL (https://proposalcentral.altum.com/). For all users, log in and select CREATE NEW PROPOSAL or click on the GRANT OPPORTUNITIES tab. Filter the grant maker by selecting CLINICAL RESEARCH ASSOCIATES from the drop down and then select FILTER LIST BY GRANT MAKER. Then click on APPLY NOW next to the Clinical Site Network for the National Autism Cohort Request for Applications program. Once all sections are complete and the attachments are uploaded, the SUBMIT button will be activated.

    2. How do I create a proposalCENTRAL user account?plus--large

      Go to https://proposalcentral.altum.com/ and click CREATE ONE NOW under NEED AN ACCOUNT? Fill in the required fields, check the boxes to agree to proposalCENTRAL’s Terms of Service and Acceptable Use Policy and then click SAVE.

    3. Can I email or mail my application?plus--large

      No, all applications to the SPARK Clinical Site Network must be submitted online through https://proposalcentral.altum.com/, which will be open for applications beginning December 5, 2016.

    4. Can someone else (assistant, staff member, etc.) submit my application for me?plus--large

      Yes, you can add users with administrator access to the proposalCENTRAL application so that someone other than the principal investigator (PI) can edit and submit the application. To add another user, go to Section 3, Enable Other Users to Access this Proposal, and complete the required fields.

    5. Can I change the named PI?plus--large

      Yes, linked instructions for how to change the named PI can be found in the application. The person who starts an application will be named as the PI on the Applicant/PI page. If the Applicant/PI section does not show the correct person (e.g., someone else started the online application and you are the PI, or you started the application and someone else is the PI), you must update this section before submitting. PI details carry over to the full proposal.

    6. As the applicant PI, should I be listed under Key Personnel in the application on proposalCENTRAL?plus--large

      No. Please list only additional key personnel on the application (i.e., site coordinators, non- applicant PI(s)).

    7. Where do I enter additional key personnel and non-applicant PI(s)?plus--large

      You can save personnel details in the Key Personnel section.

    8. Can foreign institutions apply for a grant?plus--large

      No, only domestic clinical sites may apply.

    9. Can postdoctoral associates apply as principal investigators?plus--large

      No, postdoctoral associates may not apply as PIs. 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 facility.

    10. Can multiple PIs apply for a grant?plus--large

      SFARI strongly discourages applications with multiple sites and/or multiple PIs for the purpose of this RFA. Applications from multiple sites and multiple PIs will be considered under rare circumstances.

      If the proposal includes multiple PIs at more than one site, all investigators should have demonstrated prior success in similar collaborations. For projects that have multiple PIs at different institutions, applications must be submitted by the PI designated as the contact PI and his/her institution. 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 facility, and must submit a biographical sketch.

      Applications with multiple PIs from different institutions who would like to be paid separately must upload the following items in the Proposal Attachments section:

      • Signed signature page for each PI (available for download in the Proposal Attachments and Download Templates and Instructions sections).
      • Budget template for each non-applicant PI (available for download in the Proposal Attachments and Download Templates and Instructions sections).
      • The direct costs for all non-applicant PIs must be included in Section 8 (Budget Period Detail) in the Consortium & Contractual Direct section, and indirect costs for all non-applicant PIs should be included in the Indirect Costs section. Please add a separate line for both direct costs and indirect costs for each non-applicant PI.

      Applications with multiple PIs from different institutions who will be paid directly by the contact PI’s institution are considered subcontracts. Subcontracts must submit:

      • Subcontract Detailed Budget (available for download in the Proposal Attachments and Download Templates and Instructions sections) for each subcontract.
      • Subcontract direct costs must be included in the Consortium & Contractual Direct section, and subcontract indirect costs should be included in the Indirect Cost section. Please add a separate line for both direct costs and indirect costs for each subcontract.
      • Only one signature page from the institution of the applicant PI submitting the application is required.

      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 in Section 8 (Budget Period Detail), and only one signature page is needed. 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 act as the main point of contact for the foundation by coordinating all administrative deliverables.

    11. What is required for a subcontract? Where do I access the subcontract budget and upload the subcontract budget?plus--large

      SFARI strongly discourages applications with multiple sites and/or subcontracts for the purpose of this RFA. Applications from multiple sites and subcontracts will be considered under rare circumstances.

      Applications with a subcontract (including PIs who will be paid directly by the contact PI’s institution) must submit:

      • Subcontract Detailed Budget & Justification (available for download in the Proposal Subcontract Detailed Budget and Download Templates and Instructions sections) for each subcontract.
      • Subcontract direct costs must be included in the Consortium & Contractual Direct section, and subcontract indirect costs should be included in the Indirect Cost section. Please add a separate line for both direct costs and indirect costs for each subcontract.
    12. Does SFARI require letters of support or collaboration?plus--large

      We do not require letters of support or letters of collaboration from community organizations. If a letter is prepared, it can be uploaded as “Appendix: In-press papers on related topics.”

    13. Is there a minimum percent effort required for the principal investigators/site directors or co- investigators?plus--large

      There is no minimum percent effort required for the principal investigator, but there is a 10 percent paid effort cap.

    14. What can funds be used for? Are there any restrictions?plus--large

      Funds can be used to support the following:

      • Site director(s) salary — we will allow up to 10 percent effort for a PI or PI(s), but the total amount of funding requested, including indirect costs, must not exceed $150,000 per year.
      • Site coordinator(s) salary — a site can have more than two coordinators, but we strongly encourage the arrangement of one full-time site coordinator or two part-time site coordinators at 50 percent effort each.
      • Outreach and recruitment activities (including, but not limited to, recruitment and retention materials and supplies, such as tablets to assist families with online registration, reimbursement for travel and food expenses at network events, and registration fees for information/recruitment booths at community walks and fairs).

      Note: Funds cannot be used for direct incentive payments to participants.

    15. How are applicants selected?plus--large

      Applicants will be selected based on the entirety of the application submitted and criteria described in the RFA. Notification of application status is expected by February 1, 2016.

    16. What are the file format, font style and size requirements of the application?plus--large

      Please submit a PDF of all documents. Type should be set in 11-point, legible font. All margins should be set at 0.5 inches.

    17. Are references, figures and figure legends included in the application form limit? How should they be included?plus--large

      References are not included in the page limit for the application form. Please attach them at the end of the application form in the same PDF file.

    18. What can I include as an appendix?plus--large

      “In-press” papers can be included as appendices, as well as any papers that you consider essential for the work of the review committee (not more than three). Any other material should be included in the application form if possible. If you have video attachments for your proposal, please upload as an appendix (all file types are accepted). All appendices should be uploaded in the Proposal Attachments section of the application.

    19. Does the PI need to sign the signature page?plus--large

      No, only the signing official is required to sign the signature page.

    20. Is validating my proposal the same as submitting it?plus--large

      No. Validating the proposal checks for errors and omissions and will alert you to missing requirements of your letter of intent or application. If the application is complete, you must then click SUBMIT. You will receive an email within 10 minutes, and should contact pcsupport@altum.com if you do not receive confirmation and do not see your application in the SUBMITTED tab or with the status changed to “Submitted.”

    21. I get an error message citing a missing section when I try to submit?plus--large

      The VALIDATE button reviews your application for missing sections. The submission instructions list the required sections and attachments. You must complete the missing sections listed. If you are still receiving error messages after completing and saving the indicated sections, please contact pcsupport@altum.com.

    22. Where is the SUBMIT button?plus--large

      The SUBMIT button is located in the last section of the application. You will be unable to submit if you have not provided all the required information. If the problem persists, please contact pcsupport@altum.com.

    23. Can I make changes to the application once it has been submitted?plus--large

      You must contact SFARI to un-submit your full application before you can edit attachments or HTML sections. Please email grants@simonsfoundation.org or call 646-654-0066 if you would like to un-submit your application prior to the January 13, 2017, deadline.

    24. Is there a confirmation email when I submit?plus--large

      A confirmation email is sent upon submission of the application. Please contact pcsupport@altum.com if you submitted your application and have not received a confirmation email within 10 minutes. Make sure that spam filters allow emails from pcsupport@altum.com.

SPARK

  • Awarded: 2016
  • Award Type: SPARK

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