Frequently Asked Questions
In the Technical Assistance
workshop for potential grantees held June 12, 2003, numerous questions were raised.
The resulting information is distilled here.
Topics
General Application Process
Principal Investigator and Key Personnel
Project Types (Risk Assessment and Implementation
Projects) and Funding Limits
Budget Pages, Indirect Costs, and
Cost Share Requirements
Project Outcome Evaluation Requirements
and Data Issues
Travel Requirements
Required Assurances and Certifications,
IRB Approval
More Information
General Application Process
Question 1: Where can I get the Request for Applications (RFA)?
Answer: RFA HS-03-005
is available in HTML format on the Web site of the Agency for Healthcare Research
and Quality (AHRQ).
Question 2: Where can I get the presentation from the June 12, 2003, Workshop/Conference
Call?
Answer: The presentation
slides used in the June 12, 2003, workshop and conference call are available
in Microsoft® PowerPoint®
or HTML on the AHRQ Web site.
- For the Technical Assistance Workshop Web page, go to: http://www.ahrq.gov/fund/ptsafetyta.htm.
- To navigate from the AHRQ Home Page (www.ahrq.gov), find the heading "Funding Opportunities" and select Grant Announcements. Then select "HS-03-005, Technical Assistance Workshop."
On the Technical Assistance Workshop page, the links
to the PowerPoint®
and text versions are near the
top of the page. The presentation will be available on the Web site at least
through July 15, 2003.
Question 3:
What is AHRQ's new mailing address?
Answer: Because
of AHRQ's recent move to a new building, the address in the RFA is incorrect.
The correct address is:
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Question 4:
Is it necessary to submit a Letter of Intent by June 15, 2003, to
have an application accepted? Can the Letter of Intent be E-mailed to AHRQ?
Answer: You do
not have to submit a Letter of Intent to have your application accepted. However,
AHRQ encourages potential applicants to submit a Letter of Intent, by E-mail
or surface mail, because it helps the Agency plan for the review process.
The surface mail address for Letters of Intent is:
Lisa
Krever
Center
for Quality Improvement and Patient Safety
Agency
for Healthcare Research and Quality
540
Gaither Road
Rockville, MD 20850
The E-mail address for the Letter of Intent is LKrever@AHRQ.gov.
If you E-mail your Letter of Intent, it would be helpful if you send a followup
copy to Lisa Krever by surface mail, at the address above.
Question 5:
If I sent the Letter of Intent to the old AHRQ address on Executive
Boulevard, should I resubmit it?
Answer: The mail should be forwarded from
the old address, but it would help us if you also sent it to the new address
or E-mailed it, using the addresses given above.
Question 6:
What is the due date for grant applications?
Answer: Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040 - MSC 7710
Bethesda, MD 20892-7710
20817 for express/courier service)
Your complete application must be received at the above address by July 15, 2003. This is a fixed deadline. Applications received after July 15, 2003, will not be accepted.
At the time of submission, two additional hard copies and one electronic copy (Word® or WordPerfect® format) of the application, labeled "Advanced Copy(s)" must also be sent to:
Lisa Krever
Center for Quality Improvement and Patient safety
Agency for Healthcare Research and Quality
540 Gaither Road Suite 300
Rockville, MD 20850
Telephone: (301) 427-1306
FAX: (301) 427-1341
E-mail Address: lkrever@AHRQ.gov
Question 7:
When will grant awards be issued?
Answer: Awards will be issued not later than September 30, 2003.
Question 8:
Does the use of U-18 Cooperative Agreements in this solicitation indicate
a trend toward further use by AHRQ of this mechanism on future solicitations?
Answer: This is a one-time RFA. The Cooperative Agreement mechanism has been used
a number of times over the last few years. Its use in the future
will be considered on a case-by-case basis.
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Principal Investigator and Key Personnel
Question 9:
Is it possible for the Principal Investigator to not be located at
the Applicant Organization?
Answer: The Principal Investigator usually
is, but need not be, an employee of the Applicant Organization. If the Principal
Investigator is not an employee, the Applicant Organization must have a contractual
or written arrangement with that person for purposes of programmatic and financial
control and other awardee responsibilities.
Possibilities include a consortium or third-party
arrangement with the employer of the proposed Principal Investigator. In this
case, the employing institution is a collaborating institution and would
include a set of three budgets, which will be nested into the Applicant Organization's
budgets via the Consortium/Contractual Costs line item. (Go to section on
Budget Pages, Indirect Costs, and Cost Share Requirements for help
on budget preparation and consortium budgeting.)
Even less common but possible is a contract arrangement
with the Principal Investigator. However, this option is difficult because
it requires an airtight contract that ties the individual to the responsibilities
inherent in the role of Principal Investigator. If you have this type of arrangement
in mind, AHRQ recommends that you call the Grants Management Office (Go to
More Information).
Question 10:
Is it acceptable for the Principal Investigator to have a masters
degree as the senior degree, rather than a Ph.D. or M.D.? How would the peer
review assess that?
Answer: Yes, a masters degree is acceptable.
The choice of Principal Investigator will be judged on that individual's skill
in carrying out the proposed project. These grants are focusing on implementation
of safety practices at the "real world" end. Experience in that environment
is very important for a Principal Investigator. Someone with a masters degree
but highly qualified in terms of relevant experience could very well trump
another individual who has the research skills and a Ph.D. but has never been
"down in the trenches" implementing healthcare practices.
Question 11.
Can we submit an application with two co-Principal Investigators rather
than a single Principal Investigator.
Answer: No. The rule is that one individual
must be the responsible individual for purposes of project management interactions
with the funding agency (AHRQ in this case). For management purposes internal
to the project or the institution(s) involved, you can certainly have co-Principal
Investigators. But one of those individuals must be named as the Principal
Investigator with primary responsibility to the Federal Government.
Question 12:
Is there a limit to the number of Key Personnel that should be listed?
Because these are multidisciplinary projects, is there a reasonable or preferable
number? Will AHRQ consider the number of Key Personnel in the review process?
Answer: For purposes of grant review, the
right number of Key Personnel is the number required to do that particular
project successfully. There is no specific number or range that is right for
every project. You are correct that these projects will be multidisciplinary,
so the strengths represented in the Key Personnel—their individual qualifications
and their contribution to a total team effort—will be considered by the reviewers.
The Key Personnel should be reasonable for the project—a small project that
lists 250 Key Personnel would not be reasonable.
Question 13:
Can the same Principal Investigator submit more than one application
under this RFA? Could one application be for a Risk Assessment Project and
the second for an Implementation Project?
Answer: The answer to the first question is
"no, generally." The answer to the second question is definitely "no." The
RFA states, "It is expected that no organization ready for implementation
will require nor apply for resources for risk assessment projects. Therefore,
an organization may only apply for one type of project, either a risk assessment
or an implementation project, but not both." However, an individual who is
the Principal Investigator for one proposed project could conceivably be among
the Key Personnel for another project—perhaps one proposed by another Applicant
Institution.
Question 14:
Can a Principal Investigator for an application from one institution
also be a subcontractor on an application from another institution?
Answer: Yes, but the subcontract on any other
Federal grant cannot be counted toward the cost share match. (For issues regarding
sources of cost share match, go to FAQs on Budgets, Indirect Costs, and
Cost Share Requirements.)
Question 15:
Can the same institution submit two applications?
Answer: No. See the RFA passage quoted in
the answer to Question 13.
Question 16:
For purposes of the restriction to one application per institution,
how would you define "institution" in the case of a university with different
schools or colleges?
Answer: We generally go by the Entity Identification
Number (Item 11 on the Face Page Form). If two schools have different Entity
Identification Numbers, then each could submit one application under this
RFA. For example, the University of California, Los Angeles, has a different
Entity Identification Number than the University of California, San Francisco.
If two schools or departments within an institution with one Entity Identification
Number both want to submit applications, then the institution's Research Administrator
or analogous officer must adjudicate which application will come from that
institution. If two schools within a large university want to do separate
projects—perhaps one wants to do a Risk Assessment, the other an Implementation
project—you should contact the AHRQ Grants Management office to discuss the
specific situation.
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Project types (Risk Assessment or Implementation) and Funding Limits
Question 17:
Will the 50/50 split between Risk Assessment and Implementation grants
be by funding or by numbers of projects?
Answer: AHRQ intends an approximately equal
number of grants of each type: risk assessment projects and implementation
projects. The dollar distribution will not necessarily be split evenly between
the two project types. This split will ultimately depend upon the number,
quality, and programmatic nature of the applications received.
Question 18:
In the requirements for an Implementation project, what counts as
an evidence-based safe practice? How do the ratings used in EPC Report No.
43, Making Health Care Safer: A Critical Analysis of Patient Safety Practices,
relate to how your reviewers will interpret "evidence-based"?
Answer: You need to be able to make a case
for the evidence supporting the safe practice as relevant to reducing the
risk your implementation seeks to address. AHRQ will ask the reviewers to
exercise their judgment from a broad base of evidence. EPC Report No. 43 is
only one of the sources of evidence that could be used to support the relevance
of implementing a particular practice. Evidence could, for example, come from
an AHRQ patient safety research grant, from the peer-reviewed literature generally,
or even from models in other industries. The applicant's
task is to convince the reviewers that the evidence cited is sound, that the
implementation plan is sound, and that the target risk is represented in the
institution(s) where the practice will be implemented.
Question 19:
The RFA states that $3 million is available for award in Fiscal Year
2003. Can we assume there will be additional funding in Fiscal Year 2004 for
the second year of Implementation projects?
Answer: Yes, you can assume that additional
funding will be available for the second year of implementation grants. Of
course, out-year funding by Federal agencies is always subject to availability
of funds.
Question 20:
Is the maximum level of AHRQ support a per year or per project maximum?
Answer: The maximums are per year:
For the Implementation projects, which have a maximum of 24 months of support,
that means $500,000 maximum per year. The Risk Assessment projects have a
maximum level of Federal support of $200,000 within the 12 months of their
duration. The 50/50 cost share requirement in each year means that Risk Assessment
projects must have total costs of at least $400,000 to be eligible for the
maximum Federal match of $200,000. An Implementation project must have at
least $1 million in total costs in a given year to be eligible for the full
$500,000 Federal match for that year.
Question 21.
Can Risk Assessment projects be less than 12 months in duration?
Answer: Yes, 12 months is a maximum, not a
minimum duration.
Question 22:
Is there a penalty for smaller projects (those under the maximum support
levels)?
Answer: No, not at all. We encourage smaller
projects, since they allow AHRQ to fund more projects.
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Budget Pages, Indirect Costs, and Cost Share Requirements
Question 23:
What is meant when the RFA states that "applicants must submit three
separate budgets." Does that mean three separate budgets, each using Form
Pages 4 and 5?
Answer: Yes. The three budgets to be submitted
are (1) a composite budget documenting the total of the Federal and cost sharing
dollars; (2) a budget documenting the cost share from the Applicant Organization
(and other cost share contributors, for example, in a consortium application);
and (3) a budget documenting the Federal share dollars being requested. Each
of these budgets will need a Form Page 4 for the first 12 months of the project
and a Form Page 5 for the entire award period. Both Form Pages 4 and 5 must
be prepared for each budget, regardless of the duration of the award period.
For implementation projects longer than 12 months (i.e., for the second year,
if proposed), Budget Page 5 must show the second year (outyear) costs, as
well as the first year costs. Include appropriate budget justification for
each year and for each of the three budgets.
Note: AHRQ requests
that you order your application with the Page 4, Page 5, and justification
for the combined budget (composite of Federal and cost-sharing dollars) first,
followed by the Form Pages 4 and 5 and justification pages for the cost share
budget. Put the Federal budget Form Pages and justification pages third.
The reviewers will look at the budgets in this order.
Question 24:
In the budget pages (Forms 4 and 5), it appears that the Facilities
and Administrative (F&A) Costs apply only to Consortium/Contractual Costs.
How does the Applicant Organization show its F&A Costs in the budget pages?
Answer: You are correct that the Facilities
and Administrative Costs for the Applicant Organization do not appear on its
budget pages, which only show direct costs. (The F&A Costs of collaborating
institutions are carried forward to the Applicant Organization's budget forms
as direct costs to the Applicant Organization. This is why that item
is included with Consortium/ Contractual Costs.) The Applicant Organization's
F&A Costs appear in the application only as the difference between
the Direct Costs and Total Costs subitems of Items 7 and 8 on the Face Page
(Form Page 1).
On the Checklist Form Page, which should be the last
page of your application, you should enter the latest approved F&A Costs
indirect rate approved by your HHS DCA Regional Office or other cognizant
Federal agency, along with the agreement date. (See Section 10. Checklist,
in the instructions for PHS 398, for further details.) You then apply this
indirect rate to the appropriate direct cost base for Initial Budget Period
from the Applicant Institution's combined budget Form Page 4 to get the first-year
indirect costs (F&A Costs) for the Applicant Organization. Add this indirect
cost to the Total Direct Costs for Initial Budget Period and enter this total
for Item 7B, Total Costs, on the Face Page. Similarly, calculate the F&A
Costs for the entire project period using the appropriate direct cost base
for Entire Proposed Project Period item at the bottom of the Applicant Organization's
combined budget Form Page 5. Add this amount to the Total Direct Costs for
the Entire Proposed Project Period and enter the total for Item 8B, Total
Costs, on the Face Page.
Question 25:
If two institutions are collaborating on one project, should they
each submit a separate application, or can one institution be included as
a collaborator on a single application? If one application can be submitted,
how is the collaborating institution's cost share contribution shown?
Answer: If there is truly one project, a single application is indicated, with
one institution as the Applicant Organization and the other as a collaborating
institution. The collaborating institution must complete a set of three budgets
(Form Pages 4 and 5 plus justification pages for each budget), just as the
Applicant Organization does (see answer to previous question). The totals
from each Form Page of the collaborating institution budgets are carried forward
to the budget pages of the Applicant Organization by including those amounts
in the "Consortium/Contractual Costs" entries of the Applicant Organization's
corresponding budget page. The F&A Costs for collaborating institutions
are calculated by applying each institution's indirect cost rate to the appropriate
direct cost base.
For example, the total for a collaborating institution's
first-year cost share budget on Form Page 4 carries forward to the Consortium/Contractual
Costs-Direct Costs block on Form Page 4 for the Applicant Organization's cost
share budget. Similarly, the collaborating institution's proposed Federal
support for the second year of the project (Form Page 5) will carry forward
to the Consortium/Contractual Costs-Direct Costs block on Form Page 5 of the
Applicant Organization's proposed Federal support budget. The same approach
is used when there are more than two institutions working on the project.
Each institution does a full set of three budgets. The totals from the "collaborating"
institutions are rolled up into the corresponding pages of the Applicant Organization's
budgets, which are sometimes referred to as the "main budgets" for the project.
AHRQ recommends that, in addition to providing these
institutional budgets and the main budget "roll up," each "collaborating"
institution complete and sign a PHS 398 Face Page (Form Page 1) and include
it at the front of its set of budget pages.
Question 26:
For a collaborator or subcontractor, can a Letter of Intent be used
in lieu of including a Face Page for that entity?
Answer: Yes, a Consortium Intent Statement
can be used in lieu of including a Face Page for the collaborator.
Question 27:
What should be included in a Consortium Letter of Intent?
Answer: A Consortium
Letter of Intent should certify that the collaborating institution will enter
into a written contract or agreement that is in compliance with all applicable
Federal statutes, regulations, and policies. Acceptable language would be:
"The
appropriate programmatic and administrative personnel of each institution
involved in this grant application will establish written inter-institutional
agreements that will ensure compliance with all pertinent Federal regulations
and policies."
If the Principal Investigator is an employee of the
collaborating institution, then both the Principal Investigator and the Authorized
Official of the collaborating institution should sign the Letter of Intent.
Question 28:
If a contractor is supplying services to the project, does the contractor
need a separate budget (Form Pages 4 and 5 plus justification), or can the
contractor be listed as a cost item on one of the main budgets?
Answer: You can do it either way, but you
need to provide adequate documentation for however you arrive at the bottom-line
cost for that contractor. If it is an individual, a pro forma invoice indicating
a unit rate and number of units, or other basis, can be included in the budget
justification for the amount listed for Consortium/Contractual Costs on Form
Pages 4 and 5. If an institution is involved, you should have a separate budget
(Form Pages 4 and 5 plus justification pages) for that institution unless
the involvement is strictly fee-for-service. To roll up the total amounts,
include the contractor-institution's bottom line costs under the Consortium/Contractual
Costs on Form Pages 4 and 5 of the main budgets, where appropriate.
Question 29:
Does the AHRQ (Federal) match apply to both direct and indirect costs?
Answer: Yes. For example, if a risk assessment
project had a total (combined Federal and matching) cost of at least $400,000
in direct and indirect costs, up to $200,000 of that could be covered in the
AHRQ grant amount. Be sure, however, that none of your costs are counted both
as direct costs and as part of the indirect cost pool on which your approved
indirect rate is based. (Also go to Question 30.)
Question 30:
How should indirect costs be shown, to avoid counting them twice toward
the institution's cost share?
Answer: Most institutions that receive grants
from Federal agencies already have established an approved indirect cost rate,
which they use in Federal grant applications. Any cost items that have been
included in the basis for an approved indirect cost rate cannot be included
in the direct costs shown in the budget forms of your application.
Question 31:
Does AHRQ have a specific indirect cost rate that it allows on applications?
Answer: No. An
Applicant Institution should use the indirect cost rate approved for it by
a cognizant Federal agency. If it does not yet have an approved indirect rate,
see the next question.
Question 32:
If my institution does not have an indirect cost rate approved for
Federal funding applications, how does it get one?
Answer: If an Applicant Institution is seeking
a Federal grant and does not yet have an approved indirect cost rate, the
following procedure can be used. Using the guidelines contained in the applicable
cost principles on what should be included in the indirect cost pool, the
institution should calculate a proposed indirect rate. Use this rate to calculate
the Total Costs for the grant application Face Page, as explained above. Enter
the rate used on the Checklist Form Page and indicate that it is a provisional
rate. If the application is successful and an award is made, the Applicant
Organization is required to submit an indirect cost proposal to the appropriate
Federal oversight entity within 90 days of grant award, and will be informed
at that time of the specific procedures to be followed. Failure to submit
the indirect cost proposal within the 90-day period may result in loss of
recovery of those indirect costs from the Federal agency funding the project.
This could also impact the value of the cost share match, if indirect costs
were included in the budgets.
For awardees that do not yet have their indirect cost
proposal approved, the maximum that AHRQ can reimburse, as a provisional F&A
rate prior to the approved rate, is 10 percent of salaries and wages. After
an indirect rate is approved, adjustments can be made to account for the difference
between this provisional rate and the approved rate.
Question 33:
Must an organization have a Federally approved indirect cost rate
to include indirect costs (F&A Costs) in the Total Costs requested in
the application?
Answer: This is a difficult question. An Applicant
Organization is not required to have an indirect rate agreement to receive
an award. But it is very difficult to allocate indirect costs to these projects
except through an indirect cost pool approved by a Federal cost accounting
entity. Any allocation of indirect costs must be done consistently across
the entire institution, for all projects. Once an institution takes the route
of allocating what would be indirect costs as direct project costs, any future
negotiation of an approved indirect cost rate becomes extremely complicated.
We would encourage an institution new to the Federal funding environment to
develop a provisional indirect rate and prepare to submit this as the proposed
rate for Federal approval when it receives its first grant award. (Go to Question
and Answer 32.)
Question 34:
Can an indirect cost rate be specific to the proposed project?
Answer: No, with very rare exceptions.
Federal agencies are required to negotiate an indirect cost rate at the institution
level. That rate will apply to the entire institution for purposes of seeking
funding from any Federal agency.
Question 35:
We're a new organizational entity that does not yet have the cost
experience on which we can base a reasonable indirect cost pool and proposed
indirect rate. What should we do to be able to count some of the indirect
costs toward the cost share match?
Answer: The difficulty is that the Federal
government will not negotiate an indirect rate until the organization has
been awarded its first grant. Once you have the award, you have to submit
the indirect cost proposal within 90 days of the award date, to be eligible
to recover F&A costs. For the grant application, you still need to develop
a reasonable indirect cost pool analysis to arrive at an indirect rate for
your F&A costs, as explained above. We suggest that you call the AHRQ
Grants Management Office (select for More Information), to see what
we can work out for your particular situation.
Question 36:
Can investigator time be counted toward the cost sharing match?
Answer: Yes, but an investigator's time counted
toward the match has to be time compensated by the institution (or another
nonFederal source of support). It cannot be time compensated under other Federally
funded research grants, for example. Both direct and indirect cost for investigator
time can be used toward the match. An authoritative statement on the nature
of costs eligible to be applied to the cost sharing requirement can be found
in 45 CFR 74.23 at http://www.access.gpo.gov/nara/cfr/waisidx_99/45cfr74_99.html.
Question 37:
Does in-kind support from a Federal hospital, such as a Veterans Affairs
(VA) hospital, count toward the institution's cost share?
Answer: No. In-kind support from any Federally
funded source cannot be counted toward the 50 percent cost share. In general,
you cannot leverage Federal funding from any source as a basis for receiving
additional funds under a Federal cost sharing mechanism.
Question 38:
Can rent be included in the cost share match, if it is not included
in the indirect cost pool?
Answer: Yes, as long as it is accounted for
consistently. If rent is included in the indirect rate computation, then it
cannot be counted as a direct cost for matching purposes.
Question 39:
Can support from foundations (non-Federal sources) be included in
the value of the cost share match? Can that foundation's indirect costs be
included in the cost share match?
Answer: The answer to both questions is "yes."
The constraints on sources that can be counted toward the match apply only
to Federal sources of support. If you have a Federally negotiated indirect
rate, you can include all or part of the indirect costs (F&A costs) calculated
using that rate as part of your cost share match.
Question 40:
To count equipment purchased for use in the project toward the institution's
cost share, can the equipment be purchased prior to the grant start date?
If so, what time period for purchase or receipt of the equipment determines
eligibility?
Answer: If equipment is acquired prior to
the grant start date, the problem is how to value it, for purposes of cost
share matching, under applicable depreciation and amortization guidelines.
Therefore, AHRQ urges applicants to minimize the amount of matching from pre-award
acquisitions. Any cost included in the total cost budget must be allocable
to the project. Only that percent of the use of a piece of equipment or resource
necessary for and devoted to the project may be included in the application.
It doesn't matter if the resource is funded by the institution or the Federal
government.
Question 41:
If equipment has been purchased, but has not been used (or has not
been received) prior to the grant period start date, does that resolve the
valuation problem for purposes of counting it toward the cost share?
Answer: It is difficult to give a single,
definite answer, since details of the acquisition and the role of the equipment
in the project may make a difference. If the equipment is literally "still
in the box" and is truly essential for the project, the full cost is probably
attributable toward the cost share match. But you should check with your institution's
accountants on how they would handle that equipment for purposes of amortization.
The question the accountant needs to answer is, "what is the current value
of this particular equipment at the grant start date?" In any case, if the
purchase was initiated prior to the grant start date, you should have documentation
that the cost attributed to the project is a credible valuation of a pre-existing
resource.
Question 42:
Is there a cap on institutional salaries for purposes of cost share
matching?
Answer: AHRQ is limited by statute to a salary
cap of $171,900 on an annualized basis. You cannot count anything over that
amount toward the cost share match.
Question 43:
What documentation does AHRQ require for the in-kind support shown
in the budgets as an institutional cost share contribution?
Answer: By signing the Face Page (see Item
13 and the signature block in the bottom right corner), the official of the
Applicant Institution commits the institution to what has been stated in the
application concerning in-kind resources shown in the budgets. That signature
suffices to bind the institution legally to what is stated in the application.
If the signing official wants more detail about what she/he is committing
the institution for, that detail should be explicit in the budget pages (Form
Pages 4 and 5 and the supporting budget justification pages). It often helps
in the review process to include a letter signed by appropriate senior officials
of the institution stating their strong support for the project. Such a letter
helps to communicate to the review panel the commitment of the institution
to the project.
Question 44:
If the actual cost of items included in the Federal share budget for
a given year turns out to be less than the cost estimated when the application
was prepared, can the excess Federal share be used for other allowable costs
(providing that the amount of institutional match does not change)?
Answer: Yes. In general, U.S. Public Health
Service (PHS) sources of funds are rebudgetable to other allocable and allowable
costs, as long as you continue to meet the equal match requirement on the
institutional contribution. If the cost savings also reduces the institution's
total cost contribution, then the eligible Federal match is reduced by the
same amount.
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Outcome Evaluation and Data Issues
Question 45:
My institution is concerned about liability resulting from Freedom
of Information Act (FOIA) requests. Is there an expectation that a public-use
dataset will be created from the work done under one of these grants?
Answer: Not necessarily. It depends on the
nature of the project. For an Implementation project, AHRQ primarily wants
documentation of the intervention that was implemented and the evidence for
how it worked. If there are data that describe the degree of success of the
implementation, AHRQ would want that information to be available, but not
as data with individuals identifiable. For a Risk Assessment project, AHRQ
would like to have the data on the results of the risk assessment sharable
with others. In all cases, any data delivered to AHRQ are subject to the confidentiality
provisions of the Health Insurance Portability and Accountability Act of 1996
(HIPAA), which requires that identifiers of individuals receiving care be
removed before the data come to AHRQ.
Question 46:
We would prefer to use data that are not institution-specific, because
that would be beyond the requirements for [medical error] reporting? Is that
acceptable?
Answer: Yes.
Question 47:
For an Implementation project, does the requirement for evaluation
and assessment of impact require an evaluation of patient outcomes, or are
changes in compliance with a safety practice adequate as the assessed outcome?
Answer: It will depend on the specific safety
practice you are implementing. In some cases, you may not be able to get adequate
information on patient outcomes, so compliance with the safety practice may
be the major portion of the evaluation of outcome.
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Travel Requirements
Question 48:
How many people can be proposed for travel to the annual patient safety
meeting in Washington, DC? How long is the meeting?
Answer: The Principal Investigator and at least
one program staff member from the project are required to attend the annual
meeting. You may propose that more than two persons from the grant project
attend, but the number of slots for attendees may be limited by space and
resource constraints. Therefore, in preparing your budget, include travel
funding for this meeting for the number of persons you anticipate bringing,
if slots are available. The annual meeting runs for 2½ days.
Question 49:
Should the budget include travel for the Principal Investigator to
attend Steering Committee meetings in Washington, DC?
Answer: No. AHRQ will select one Principal
Investigator from the group of awardees under this RFA to sit on the AHRQ
Patient Safety Coordinating Center Steering Committee. Reimbursement for travel
to Steering Committee meetings comes from the Coordinating Center's funds,
not from your grants. After the grants are awarded, there will be a process
by which awardees can nominate their representative to the Steering Committee.
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Required Assurances and Certifications, IRB Approval
Question 50:
Can HHS Form 690 be submitted in lieu of filling out all the assurances
and certifications required under Section G of Form PHS 398?
Answer: If your institution has completed
a Form 690 and filed it with the Office of Civil Rights, HHS, then the signature
of the official identified in Block 13 of the Face page signifies that the
institution has already complied. However, the portions of the Research Plan
that deals with Human Subjects Research and Vertebrate Animals address project-specific
requirements. These sections must be completed, as appropriate for your
project.
Question 51:
Is a letter from the Institutional Review Board (IRB) required with
the grant application.
Answer: No, IRB approval is not required at
the time the application is submitted. Ideally, you should have the IRB approval
letter in hand by the time of award. AHRQ understands that the time between
notification of award and the award date will be short, so we would appreciate
it if you could have the IRB approval prior to September 30, 2003.
Question 52:
If the Applicant Organization is a non-profit that does not have an
in-house IRB, and the proposed project involves intervention at the hospital
level rather than with individual patients, is IRB approval required?
Answer: If the project involves human subjects
as defined by HHS regulations, you will need an IRB approval, as well as institutional
assurance of intent to comply with all applicable regulations, before an award
can be made. You do not need an in-house IRB. There are for-profit companies
with whom the Applicant Organization can contract, or you may be able to negotiate
with another institution to use its IRB. You can either discuss the situation
with the HHS Office for Human Research Protections or consult its Web
site at http://www.hhs.gov/ohrp/.
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Question 53:
If I have questions about this RFA or the application process, whom
should I contact?
Answer: Contact:
James B. Battles, Ph.D.
Senior Service Fellow for Patient Safety
Center for Quality Improvement (CQuIPS)
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Phone: (301) 427-1332
E-mail: JBattles@ahrq.gov.
Question 54:
If I have financial or grant management questions, whom should
I contact?
Answer: Contact:
Joan Metcalfe
Grants Management Specialist
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Phone: (301) 427-1450
E-mail: JMetcalf@ahrq.gov.
Question 55:
If I have questions about the peer review process, whom should
I contact?
Answer: Contact:
Michele Hindi-Alexander
Health Scientist Administrator
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Phone: (301) 427-1547
E-mail: MHindi@ahrq.gov.
Return to Technical Assistance Workshop
Current as of June 2003
Internet Citation:
Frequently Asked Questions: Safe Practices Implementation
Challenge Grants. June 2003. Agency for Healthcare Research and Quality,
Rockville, MD. http://www.ahrq.gov/fund/ptsaffaq.htm
540 Gaither Road Rockville, MD 20850