NJ Autism Center of Excellence (NJ ACE)
Program Sites Grant Program
Questions
from applicants will be posted weekly along with answers from the Autism
Council Staff.
1. Rolling over applications and addressing critiques
Note: This FAQ refers to those applicants
who applied to the first Notice of Grant Availability (NOGA) announced on July
9, 2012 and were not funded.
Q. I have rolled over my previously submitted
application in SAGE and see that we have to reenter everything. Can we revise
our original submission as we wish, or do we need to re-submit the same
document exactly as before and separately address the critiques?
A. You'll want to revise your
original application as you wish. It is considered a new application. You'll
address the reviewers’ critiques in a new question/box that has been added to
the original SAGE application.
2. Percent effort of staff:
Q: Are there any guidelines in terms of % effort
for the various positions such as PI, research associate, clinician, etc.?
A: The Clinical Research Program Sites
Guidelines (Guidelines) do not include specific guidance regarding the percent
effort of the PI and other staff members to allow flexibility in the organization
of the team. The final proposal will depend on the specific objectives of the program and the capability of the staff members. The
specifics of the budget can be revised during the project period based on the
evolving needs.
3. Collaborations:
Q: Could a clinical site collaborate
with a program site PI, by recruiting patients or by providing specific administrative
expertise, such as entering data in NDAR? Could one clinical site work for two
different program sites?
A: Yes, collaboration among
researchers and clinicians in New Jersey is highly encouraged. It is likely that
program sites will need to work with several clinical sites in order to meet
their recruitment goals. One clinical site could participate in the projects of
two or even three program sites, as a consultant bringing specific knowledge or
expertise, and/or as a clinical site diagnosing and treating ASD patients. If
a clinical site provides letters of assurance and collaboration for two or three
program site applicants, the clinical site must be able to fulfill all of its
commitment if all the applications are funded.
Note regarding recruitment: If a clinical site plans to be involved in recruiting patients to a study, the applicant
should consider the Health and Human Services guidelines on recruiting patients
(see http://www.ninds.nih.gov/research/clinical_research/policies/oig.htm for instance). The guidelines
regarding recruitment incentives, the dual investigator-researcher role and the
confidentiality of medical records are particularly relevant (http://oig.hhs.gov/oei/reports/oei-01-97-00196.pdf).
Q. Can I have a co-Principal Investigator?
A. The Principal Investigator is
responsible for the execution of the project. Furthermore, the application is
not structured to accommodate a co-Principal investigator, but a co-Principal
Investigator (from a NJ research institution) can be listed in the key
personnel and can be a subcontractor. The collaborator can be funded through a
subcontract. Please note that the grant recipient must be a non-profit research
entity in the State of New Jersey.
Q. I see that the new RFA still encourages
collaboration with professionals outside of NJ who have special expertise. Can
someone from outside NJ serve as a "Co-Principal Investigator with
NJ-based PI, or would it be better if "Co-Investigator"?
A. Co-investigator is the correct designation
for the out-of-state professional given that this is a grant funded by the NJ
Department of Health. PIs and co-PIs are researchers with NJ research
institutions.
4. IACC Objectives and NDAR
Q: What does the Council expect? What are their
priorities/expectations?
A: The Council expects to fund strong clinical
research projects that address some of the outstanding questions in the field
of autism and provide data to inform clinical practice. The objective is to
improve the lives of patients with ASD. Meritorious research projects will need
to 1) address one of the subset of IACC objectives listed in the Guidelines
and 2) meet the NIH definition for a clinical research project.
The subset of IACC objectives listed
in the Guidelines were selected from the Interagency Autism Coordinating
Committee (IACC) Strategic Plan (available online at http://iacc.hhs.gov/strategic-plan/2011/index.shtml) and are those objectives with the potential
to improve the physical and/or behavioral health and well-being of individuals
with ASDs. The Council is particularly interested in projects with potential
direct clinical impact.
Q: IACC objectives are so wide open - should we address more than
one objective? One objective for all five years? Is it too narrow to pick just
one objective?
A: The national priorities described in the
Interagency Autism Coordinating Committee (IACC) Strategic Plan, and more
specifically, the subset of IACC objectives applicable to this grant (listed in
the Guidelines), represent the consensus of the experts in the field of ASD.
Very few of these objectives can be met in a year. Successful projects will
need to clearly articulate their research approach, and therefore are unlikely
to be able to address more than one objective. While a research team with
exceptional strengths in many areas and access to large numbers of patients could
possibly propose a couple of small studies related to several objectives, it is
not known whether the Council would ultimately choose to fund such a project
over a focused project that provides strong conclusions related one IACC
objective.
Q: Haven't these objectives already been done?
A: The IACC objectives are
revised yearly, to reflect the evolving state of the science and public health
needs. Most if not all of the IACC short- and long-term objectives will
require data from more than one research project.
The yearly evaluation of the IACC
strategic plan is based on an analysis of the existing grants portfolios.
Detailed lists of funded projects and relevant programs are available at http://iacc.hhs.gov/portfolio-analysis/2009/index.shtml and http://www.aucd.org/docs/policy/autism/2011
Q: What are the advantages of using NDAR?
A: The program sites will use the National
Database for Autism Research (NDAR). The New Jersey data will therefore be
made available to autism researchers from around the United States,
highlighting the New Jersey effort. Furthermore, participation in NDAR
demonstrates that the funded sites are capable of meeting the National
Institutes of Health (NIH) requirements and will help them develop stronger
proposals for submission to the NIH and biomedical research foundations.
5. Staff included on more than one grant application
Q. Can one person
who is not the PI on any grant applications be included on more than one
grant application?
A. Yes, staff can be shared across
program sites. However, there can be no overlap between a program site and
the Coordinating Center. Montclair State University is the NJ ACE
Coordinating Center.
Q. Can the PI on one
grant application be included on other grant applications (not as a PI on the
other applications)?
A. Yes. However, no person can
provide more than 100% effort across his/her projects.
6. Clinical research vs. clinical services
Q. Is this grant cycle meant for isolated
research apart from the clinical work we do?
A. Yes, the grant program does not
fund services for patients per se. The subjects involved in the research
project will receive clinical care within the parameters set by the study. The
Council expects to fund strong clinical research projects that address some of
the outstanding questions in the field of autism and provide data to inform
clinical practice. The objective is to improve the lives of patients with ASD.
Q. Our assumption is that the RFA is not
looking for a service program, but clinical research. Our clinical research
project will involve diagnostic testing and treatment interventions, but not
necessarily asking for funding for all of these. What can we utilize grant
funds for?
A. The grant will only cover clinical research expenses related to the
specific research protocol. The use of funds from
other sources is allowed and should be detailed in the application. The other
sources of funds must be within the parameters set by the funding source, be
fully disclosed and not duplicative.
7. Research subjects vs. patients
Q. When research subjects are recruited from a clinical
center, do the clinical patients diagnosed with autism all need to be enrolled
in the NDAR protocol with the minimal data requirements described in the grant?
A. Information
about subjects involved in the research project will be shared via NDAR. Information
about patients, who do not participate in the research project, should not be
shared, even if they are treated at the same clinic.
Q. Can we use data collected for routine clinical care for
which we are not asking for funding, for example for a control group?
A. Yes, it is acceptable to pay for part of the research
project via other funds. A Principal Investigator can use data collected
through routine medical care IF the patients have consented and the medical
care is part of the established protocol. This should be made clear in the
application.
8. Responsibility for data analysis
Q. Is the Coordinating Center going to
provide all the statistical and data analysis support? i.e. do program sites
need to budget for it?
A. Program sites should expect to do
their own data analysis. The Coordinating Center may help with sharing
expertise across program sites. The Coordinating Center can provide
statistical consulting. See the grant guidelines for the responsibilities of
the Coordinating Center and the Program Sites.
9. NJ ACE vs. ATN
Q. Is the intent to create an "ATN"
like model whereby there will be a central coordinating site, and three sites
that each have a certain expertise to contribute to an "ATN"-like
network?
A. We are not seeking to create an
ATN model per se, but to spur clinical research in New Jersey. The Program
Sites will be heading separate research projects. The Coordinating Center will
provide assistance and support with common functions to reduce redundancy and
increase efficiency. Each program will be judged on its individual merit.
10. Budget
In general, there are no specific
budgetary caps or restrictions, except that all requests must be necessary and
justified for the grant. The SAGE application contains links to relevant Department of Health (DOH) policies.
Q. Is there a cap on Principal Investigator’s (PI) Salary?
A. There is no cap on PI salary. Percent effort must be justified.
Q. Is there a cap on Travel each year?
A. Travel also must be justified. Travel to training sessions is the
responsibility of the Coordinating Center.
Q. Are there restrictions on supplies/equipment such as computers, printers, etc.?
A. Supplies and equipment can be included only if they
are necessary for the project. Applicants proposing
to purchase equipment which will be used across multiple grants/programs should
pro-rate the costs of the equipment across programs and show the calculation of
this pro-ration in their justification. If an irregularity is found where equipment
is being used by other programs without reimbursement, funding will be reduced
accordingly.
Q. Are there restrictions on
staff (i.e., admin staff, students, and postdocs)?
A. Administrative staff that will support the project can be included in
the application. Students or postdocs would similarly need to be specifically
working on the project. Applicants proposing to
utilize the same principal investigator or contractual staff across multiple
grants/programs should assure that the combined funding for each position does
not exceed 100% FTE. If such an irregularity is found, funding will be reduced
accordingly.
Note: Upon acceptance of a grant award, the applicant's organization assumes legal and financial
responsibility for awarded funds and the conduct of supported activities. It
is the responsibility of the applicant's institution and principal investigator
to assure the accuracy and validity of all fiscal, scientific, and
administrative information pertaining to the awarded grant. Failure to comply with these terms may
result in grant termination.
11. Scoring the Program Site proposals:
Q. How are the criteria for independent
scientific review of the Clinical Autism Research Program Site grants
ranked/weighted? The criteria are specified in the Guidelines, but no
weighting is mentioned.
A. The reviewers will assign to each application
an overall impact score reflecting the potential impact on the field of autism
and ultimately on New Jersey ASD patients and their families. The impact score
will be based on NIH criteria. Scores range from 1 to 9 with 1 being the
highest impact score.
The reviewers will consider the
following core criteria in determining the overall impact score: significance,
innovation, experimental design and capability, environment and key personnel.
The overall potential impact of a Program Site depends on both the importance
and the feasibility of the proposed research project. The significance and
innovation core criteria will inform the importance of the project, whereas the
other core criteria inform its feasibility.
Reviewers will also take into account
the budget, yearly project objectives, the protection of human subjects,
inclusion of women, children and minorities, the recruitment plan and the
resource sharing plan.
Each of the core criteria is scored
and used to help the reviewers determine the overall impact score, but the
criterion scores are not to be weighted explicitly. It is up to each reviewer
to determine an overall score that best describes the likely overall impact
that each application will have on the field of autism and ultimately on New
Jersey ASD patients and their families.
The application does not need to be
strong in all categories to be judged likely to have a major scientific impact
and thus deserve a high impact score. For example, an investigator may propose
to carry out important work that by its nature is not innovative but is
essential to move the field forward.
Q. It looks as though the biosketches in the Pilot Project application in SAGE have been condensed to one page only (no detail page). Is this correct?
A. Yes, that is correct. The additional support page includes questions that were previously included in the detail page.
Q. In the Pilot Project biosketch section in SAGE I see that there is a page for additional support. I am assuming I am inserting additional support for all of the key professional staff here. Am I reading this correctly?
A. You are correct - Individual one page biosketches and a single page with everyone’s additional support information.
Q. Under ‘Other Support’, my data is exceeding the approved length allotted and I am only up to my 4th person! Can the character length be increased?
A. The character limit cannot be increased for these applications. You can note at the end of the page that the remaining information is included as a miscellaneous attachment (include the name of the attachment).
Q. We plan for a two year pilot study. Can we divide the $400,000 unevenly between the two years with justification?
A. The budget can be no more than $200,00/year so you would have to budget evenly. If you don't use the $200,000 the first year it will roll over to the second year assuming Council approves continuation funding based on your progress report for the first year. If the $400,000 is not spent after year 2 you can request a no cost extension.
Q. For a Pilot Project for two years, it is up to $200K per year?
A. Yes, the Pilot Project grants are up to $200,000/yr., total of up to $400,000 for two year grants.
Q. Is there a limitation for budgeting purchase of a device for the project?
A. Supplies and equipment can be included only if they are necessary for the project. Applicants proposing to purchase equipment which will be used across multiple grants/programs should pro-rate the costs of the equipment across programs and show the calculation of this pro-ration in their justification. If an irregularity is found where equipment is being used by other programs without reimbursement, funding will be reduced accordingly.
Q. What are the budget period and project period for the Program Site RFA in SAGE?
A. Both dates are June 28, 2013 to June 30, 2018.
Q. What are the budget period and project period for the Pilot Project RFA in SAGE?
A. Both are June 28, 2013 to June 30, 2015.
Q. When I open the SAGE program Autism Pilot Project 2013 I see a combination of letters and numbers that I’m not familiar with, as the Account reference.
A. This is a SAGE generated number. You are in the correct program for the Autism Pilot Project application.
Q. Can we add the CV's as an attachment vs. filling in the CV grid page on SAGE?
A. The CV grid page on SAGE needs to be filled in. If you need additional space you can attach as a miscellaneous.
Q. Will reviewers access the grant electronically or printed copy (we have graphics which show up differently electronically vs. print).
A. Reviewers will have access electronically. In addition to completing the narrative questions on SAGE we recommend attaching a complete narrative with graphics, charts etc. as a miscellaneous attachment.
