Following are some of the questions we have received regarding the application form and the application process, and the answers to them. If you do not find the answer to your question here, please contact Sarah Meyer Hughes at firstname.lastname@example.org.
1. Here is an explanation of fields 3f and 3h, and sections 4 and 5 on the application form:
3f- If the applicant is in the Department of General Surgery, then the Major Subdivision might be Plastic Surgery or Orthopaedic Surgery (if it is not a department). Alternatively if the PI is a rheumatologist, then the department is internal medicine.
3h. If the PI has ever submitted an NIH proposal or has been a Co-Investigator on any NIH proposal, then they must have this name. If they have not, they should leave it blank.
4. If the research proposal involves human beings, then check yes and continue with 4. If it involves animals, then check no and move onto 5.
4a. There are rare situations where the studies are exempt and still involve humans. Most often, this box should be checked no.
4b. All universities have this number assigned to them. The PI should be able to obtain this from the university administration.
4c. Does this involve a clinical trial? If so, then check yes.
4d. This defines if it is a Phase III study- meaning that the animal studies have already been done (phase I) and the human safety studies (phase II) have also been done. For phase III clinical trial, the PI is determining efficacy of the intervention.
5. If the research plan involves animals, then check yes
5a. If animals are being used, then the PI must submit an IACUC protocol and this is the date that the study was approved.
5b. All universities have this number assigned to them. The PI should be able to obtain this from the university administration.
2. For the 4a field (Research Exempt) we are doing a human study. Does this apply?
Number 4 applies if the research involves human beings/subjects. If so, they need to have an IRB approval and the necessary other info.
3. In the #7 field, (Costs for initial budget period) can you tell me what this is? Is it the period to complete the application?
#7a should be for the initial year of the application. The total amount of the award is for $20K. In some research proposals, the PI may want it all in one year or would rather have it split into two years. This provides that option.
4. In the table of contents section, it states that the research plan is not to exceed 10 pages... in the instructions it says not to exceed the space provided (a box less than one page). I’m assuming 10 pages is the correct limit, right?
Yes, 10 page limit. It should be either: Helvetica, Times Roman, or Geneva at 11 point font with at least ½’ margins.
5. I wanted to confirm that we are not able to request salary support for a PI on the grant application. Is that correct?
Grant funds cannot be used to pay for PI salaries. Funds can be used to support salaries for research assistants.
6. We understand the grant does not support PI salaries; can we put in staff time for data collection and secretary support? The question is: does the grant support only direct cost? Any fringe benefits allowed? If indirect is allowed, what is the rate for indirect?
Some funds may be used for lab personnel or research coordinator if explained appropriately in the proposal. The AFSH does not allow for any Indirect Costs for this proposal. By having the university officials sign off on the proposal, they are acknowledging and accepting the condition of the grant submission.
7. For the IACUC paperwork, my doctor is listed as a Sub-I, but will be applying for the grant as PI, because he is the one who has ASSH membership. Is this acceptable?
The ASSH member does not have to be the PI -- just simply one of the investigators on the ASSH grant. The person doing the lion’s share of the work and is ultimately responsible for the project completion should be the PI.
8. The equipment allowance is for minor pieces of equipment. What is the cut-off for minor vs. major, is there a dollar amount?
This limit is placed so that the funds are not used by a large lab to purchase another piece of equipment for work that was already to be performed. Roughly, $5,000 is the cut-off for significant purchases requiring approval as capital expenditures.
9. Can we use the grant money to reimburse patients for a study visit that is not a standard of care visit (research related visit only), reimbursement would be in the form of a gas card.
As far as patient reimbursement, it would be better if they were referred to as "subjects" - it's less confusing. As long as this is clearly not covering clinical costs for treatment, it is appropriate.
10. Do we have to provide the ethics application if the Research Ethics Board at our institution is in the process of reviewing the study?
Applicants need to provide proof that the ethics application has been submitted and is being reviewed. Applicants are not required to have approval at the time of the grant submission.
11. Is it possible to apply for the ASSH Clinical Research Grants from non-USA institutes?
Yes, as long as an ASSH member is listed on the grant.
12. For the ‘Official Signing for Applicant Organization,’ who is this supposed to be? Can it be the PI?
No, the PI is not the ‘Official Signing for Applicant Organization’. This is the individual in the PI’s university who has signing authority for the university. Whenever funds are awarded, they are never given directly to the PI. Rather, they are given to an institution. With this signature, the sponsoring institution acknowledges that there will not be any indirect costs provided and that they are also responsible for monitoring the research conduct of the PI.
13. About the budget and budget narrative: Are you looking for the actual costs of the project, or are you looking for the portion we are requesting from ASSH? I ask because the limit for the research grant is $20,000, which would cover only a portion of our costs, which we are securing from other sources.
This should only include the costs that the PI is requesting from the ASSH. Most often, the research will often cover more than this amount. That is part of the PI’s environment for research.
14. Can you please clarify an item from the budget section – what is the “initial period” referring to…is that Year One only… or is the total grant period (2 years)…if it is referring to only Year 1, where would you like me to put the requests for year 2?
The total amount of the award is for $20K. In some research proposals, the PI may want it all in one year or would rather have it split into two years. This provides that option. Generally, we distribute funds for Basic Science grants for one year. Funds for Clinical grants are divided into 2 years.
15. Can a hospital be the applicant for this grant submitted by a doctor?
It can be anybody that has an Institute Research Board or Institute Animal Welfare Committee.
16. What needs to be included in the letter of support, and who should it come from?
The letter of support is intended to verify that the researcher will have time (as in time away from clinical practice) and enough resources in addition to the grant to complete the project in a timely fashion. The letter should come from a Department or Division head or equivalent.
17. What happens once my application is submitted, and when will I find out whether my application has been chosen for funding?
Applications are due April 1st. In June, the Research Management Committee reviews all the applications and then their recommendations are sent to the ASSH Council and the AFSH Board of Trustees for approval. Grant letters are then mailed out the beginning of August.
18. What should I put as the start date for my study?
A start date of October 1st or November 1st would be appropriate. Since grant letters are mailed out in August, and there is some paperwork that needs to be done prior to the check being sent, give yourself 2-3 months from when you receive the letter to start your study.