Questions from applicants will be posted weekly along with answers from the Autism Council staff.

1. Percent effort of staff

• Are there any guidelines in terms of % effort for the various positions such as PI, statistician, clinician, etc.?  For example, would 50% of a statistician's salary be considered excessive? Are there any differences between the coordinating center and the program sites in expectations/restrictions or % effort for specific positions?
  The Grant Guidelines (Coordinating Center and Program Sites) 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. One could expect that 5% of the PI effort may be considered too little, and 50% of a statistician's effort may be too much for the Coordinating Center. The specifics of the budget can be amended in the out-years based on the evolving needs.
  
  The Grant Guidelines do describe the capabilities necessary for the Coordinating Center and Program Sites on p. 4-6 and p.12-15 of the guidelines.  

2. 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 and Senior Service (DHSS) policies.

• Is there a cap on PI Salary? 
  There is no cap on PI salary. Percent effort must be justified.
  
  
• Is there a cap on Travel each year?
  Travel also must be justified. Travel to training sessions is included in the Coordinating Center budget.
  
  
• Are there restrictions on supplies/equipment such as computers, printers, etc?
  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.
  
  
• Are there restrictions on staff?  i.e., admin staff, students, postdocs?
  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.  

3. Scoring the proposals

• How are the criteria for independent scientific review of the Coordinating Center grants ranked/weighted? The criteria are specified on pages 17-18 of the NJ Governor's Council for Medical Research and Treatment of Autism Clinical Research Program Guidelines, but no weighting is mentioned.
  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 for the Coordinating Center will consider the following core criteria in determining the overall impact score: management capabilities, project support capabilities, project evaluation capabilities, knowledge of clinical research and environment and key personnel. Reviewers will also take into account the budget and the yearly project objectives. 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 impact score.

4. Responsibility for data analysis

• Is the Central Coordinating site going to provide all the statistical and data analysis support? i.e. do program sites need to budget for it?
  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 pages 5-8 in the grant guidelines for the responsibilities of the Coordinating Center and the Program Sites.

5. Co-Principal Investigator

• Can I have a co-Principal Investigator?
  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 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.

6. NJ ACE vs. ATN

• 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?
  We are not seeking to create an ATN model per se, but to spur clinical research in New Jersey. The three Program Sites will be heading three 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.

1. Collaborations

• 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?
  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).

2. IACC Objectives and NDAR

• What does the Council expect? What are their priorities/expectations?
  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 a one of the national priorities described in the Interagency Autism Coordinating Committee (IACC) Strategic Plan (available online at http://iacc.hhs.gov/strategic-plan/2011/index.shtml) and 2) meet the NIH definition for a clinical research project.
  
  
• IACC objectives are so wide open - should we address more than one objective? One objective for all five years?
  The national priorities described in the Interagency Autism Coordinating Committee (IACC) Strategic Plan (available online at http://iacc.hhs.gov/strategic-plan/2011/index.shtml) 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.
  
  
• Haven't these objectives already been done?
  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
  
  
• What are the advantages of using NDAR?
  The new programs 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.

3. Percent effort of staff

• Are there any guidelines in terms of % effort for the various positions such as PI, statistician, clinician, etc.?  For example, would 50% of a statistician's salary be considered excessive? Are there any differences between the coordinating center and the program sites in expectations/restrictions or % effort for specific positions?
  The Grant Guidelines (Coordinating Center and Program Sites) 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. One could expect that 5% of the PI effort may be considered too little, and 50% of a statistician's effort may be too much for the Coordinating Center. The specifics of the budget can be amended in the out-years based on the evolving needs.
  
  The Grant Guidelines do describe the capabilities necessary for the Coordinating Center and Program Sites on p. 4-6 and p.12-15 of the guidelines.  

4. 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 and Senior Service (DHSS) policies.

• Is there a cap on PI Salary? 
  There is no cap on PI salary. Percent effort must be justified.
  
  
• Is there a cap on Travel each year?
  Travel also must be justified. Travel to training sessions is included in the Coordinating  Center budget.
  
  
• Are there restrictions on supplies/equipment such as computers, printers, etc?
  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.
  
  
• Are there restrictions on staff?  i.e., admin staff, students, postdocs?
  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. 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.

5. Acceptable IACC priorities and date of plan

• We have only been able to find a 2011 version of the IACC Strategic Plan. Is there a more updated version?
  The latest version of the IACC Strategic Plan is that from 2011, available at http://iacc.hhs.gov/strategic-plan/2011/index.shtml.
  
  
• In terms of the IACC objectives, should we only focus on the short and long term objectives that are indicated from 2011, or can we address those listed from previous years (i.e. 2009, 2010)?
  Program Site applications can address any of the short- or long-term objectives listed in the 2011 IACC plan, regardless of the year when the objective was added. Since the IACC plan was revised annually, all objectives listed reflect the current needs of the field. The sole additional criterion for relevance is that the proposed project must constitute clinical research according to the NIH definition (see p. 3 of the guidelines for the full NIH definition).

6. Scoring the proposals

• How are the criteria for independent scientific review of the Clinical Autism Research Program Site grants ranked/weighted? The criteria are specified on pages 17-18 of the NJ Governor's Council for Medical Research and Treatment of Autism Clinical Research Program Guidelines, but no weighting is mentioned.
  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 for the Program Sites 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.

7. Sharing staff across Program Sites

• Can one person who is not the PI on any grant applications be included on more than one grant application?
  Yes, staff can be shared across program sites. However, there can be no overlap between a program site and the coordinating center.
  
  
• Can the PI on one grant application be included on other grant applications (not as a PI on the other applications)?
  Yes. However, no person can provide more than 100% effort across his/her projects.

8. Clinical research vs. clinical services

• Is this grant cycle meant for isolated research apart from the clinical work we do?
  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.
  
  
• 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?
  The grant will cover only expenses related to the specific research project including necessary clinical services. 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.

9. Research subjects vs. patients

• 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?
  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.
  
  
• Can we use data collected for routine clinical care for which we are not asking for funding, for example for a control group?
  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.

10. Responsibility for data analysis

• Is the Central Coordinating site going to provide all the statistical and data analysis support? i.e. do program sites need to budget for it?
  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 pages 5-8 in the grant guidelines for the responsibilities of the Coordinating Center and the Program Sites.
  
  

11. Co-Principal Investigator

• Can I have a co-Principal Investigator?
  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 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.
  
  

12. NJ ACE vs. ATN

• 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?
  We are not seeking to create an ATN model per se, but to spur clinical research in New Jersey. The three Program Sites will be heading three 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.
  
  

Questions from applicants will be posted weekly along with answers from the Autism Council staff.

Questions from applicants will be posted weekly along with answers from the Autism Council staff.