Questions and Answers
The following questions and answers feature responses from the Agency for
Healthcare Research and Quality (AHRQ) to questions submitted on
or before October 23, 2009, to
iADAPTgrants@ahrq.hhs.gov regarding
the Agency's funding opportunity announcement (FOA) RFA-HS-10-004:
Recovery Act 2009 Limited Competition: Innovative Adaptation and Dissemination
of AHRQ Comparative Effectiveness Research Products (iADAPT) (R18).
Select to access the
FOA.
How To Get Answers to Questions on the FOA
Question 1: Can we discuss our proposal in a phone conversation
with AHRQ?
Answer 1: Due to AHRQ resource constraints and fairness
and consistency considerations for all applicants, all questions should
be addressed to AHRQ in writing using the iADAPT E-mail box. If you
have a concept on which you would like specific feedback, please share a
brief (one- or two-page) synopsis by E-mail and AHRQ will reply in writing.
How To Determine Which Topic Areas Are Candidates for Adaptation
and Dissemination
Question 2: How can I determine whether my specific interest
area, research, or intervention fits within the scope of products that can
be adapted and disseminated under the FOA?
Answer 2: To be responsive to the FOA, applicants must
base their proposed work upon at least one Comparative Effectiveness Research
(CER) Review, Executive Summary, or Summary Guide that will be completed
by the anticipated time of award and project startup, which is approximately
June 2010. CERs and associated products that are completed, nearly
complete, or anticipated to become available before the anticipated June
2010 awards under this RFA are available through the links published in
the RFA: http://effectivehealthcare.ahrq.gov/healthInfo.cfm?infotype=sg and http://effectivehealthcare.ahrq.gov/healthInfo.cfm?infotype=rr.
As
of October 27, 2009, both hyperlinks now direct the viewer to a search page
on the updated Effective Health Care Web site, where a boxed "Notice:
AHRQ RFA-HS-10-004, iADAPT (R18)" on the right-hand top of the page
further directs and links potential applicants to a table of candidate CER
products with embedded hyperlinks. The table captures the same content
as was available at the RFA links before October 27 and also now explicitly
identifies seven CERs that are in progress and expected to be available
in at least draft form by June 2010. Please study the table closely
for topics that may be relevant to your proposed development, implementation,
and evaluation of customizations to target your proposed audience(s), stakeholder(s),
system(s), or setting(s).
The seven applicable in-progress CER Reviews are listed below for convenience:
Cancer (N=3)
Functional Limitations and Disability (N=1)
Pulmonary Disease/Asthma (N=1)
Depression and Other Mental Health Disorders (N=2)
If, after reviewing the links and table information, you remain
uncertain as to whether a current or forthcoming CER Review, Executive
Summary, or Summary Guide is an acceptable candidate for adaptation,
please contact the iADAPT mailbox.
Question 3: Does AHRQ anticipate additional
CER products and their content being released during the life of
the grant? If so, please provide guidance on the timeline
and topics of pending releases.
Answer 3: As described in the answer to the previous
question (#2), applicants can propose to adapt one or more of seven
CER Reviews that are currently under development and anticipated
to be available in at least draft form by June 2010. Applicants
who believe they can adequately address all aspects and requirements
of the FOA for multiple and future CER products should provide
appropriate and acceptable justification and support for the feasibility,
timeliness, quality, and evaluation of their planned approach.
Question 4: Are the topics from the Original
Research (DEcIDE projects and CERTs projects) page (http://effectivehealthcare.ahrq.gov/ehc/index.cfm/search-for-guides-reviews-and-reports/?category=&search=&trackID=2&methodCategory=&agencyType=3&agencyType=4&language=1)
in scope for adaptation, customization, and dissemination?
Answer 4: New research topics are not in
scope for this FOA.
Question 5: Should products for dissemination
be limited exclusively to "Final Report" products? Or
can you propose to disseminate "Research in Progress" products?
Answer 5: As described under the response to
question 2, above, applicants can adapt/disseminate CER Reviews,
Executive Summaries, or Summary Guides that are complete or from
the list of topic areas that are expected to be available in at
least draft form prior to the time of award.
Question 6: Should you only propose to distribute products
for which a Clinician, Consumer, or Policymaker Summary Guide is available?
Answer 6: You may distribute or adapt CER products
without a Summary Guide, using either the CER Review or its Executive
Summary. The FOA suggests that applicants consider such customizations
via the adaptation of the original CER Review or Executive Summary
contents to a specialized clinical audience of potential users
(such as formulary or pharmaceutical and therapeutics committees
and health care systems with electronic platforms such as electronic
medical records that could support clinical decision support). However,
it does not constrain applicants to do so.
Question 7: What if I want to innovate, adapt,
and disseminate in a comparative effectiveness priority area where
there is no Comparative Effectiveness Research Review, Executive
Summary, or Summary Guide available?
Answer 7: The FOA seeks adaptations and novel
dissemination mechanisms of a finite group of comparative effectiveness
products that are described and referenced at length in question
2. Due to changes in the EHC Web site that occurred on October 27,
2009, the two hyperlinks listed in the request for applications
(RFA) now reference a new Web page with a boxed "Notice:
AHRQ RFA-HS-10-004, iADAPT (R18)" that directs applicants
to a table with all relevant information. The content available
for adaptation remains the same; only the appearance has changed. Adaptations
and innovations should be based on the referenced CER products
and not on unlisted priority or topic areas; the latter
will not be considered responsive to the RFA.
Question 8: Can I combine two or more CER products?
Answer 8: The FOA allows applicants to propose
combining two or more CER Reviews, Executive Summaries, or Summary
Guides.
Question 9: Can you propose to disseminate "Final
Report" products in year 1 and "Research in Progress" and "Draft
Complete" documents in years 2 and 3 to allow time for these
documents to become Final Reports?
Answer 9: Applicants who believe they can adequately
address all aspects and requirements of the FOA for multiple and
future CER products should provide appropriate and acceptable justification
and support for the feasibility, timeliness, quality, and evaluation
of their planned approach.
Question 10: Can we propose
to adapt all available CER products?
Answer 10: Applicants can propose to adapt many
or all of the available CER Reviews, Executive Summaries, and Summary
Guides; we note and repeat the answer to question 4 above: the
new research projects are not candidates
for adaptation. Whatever applicants propose, they are reminded
to consider, address, and support their planned activities, including
their feasibility.
Questions Regarding Potential Modifications to Comparative
Effectiveness Research Reviews, Executive Summaries, and Summary
Guides
Question 11: Can innovations and adaptations
be based on evidence that was not produced by the Effective Health
Care Program? Specifically, can we use evidence produced
by society guidelines that is not derived from Comparative Effectiveness
Research Reviews or Executive Summaries (produced by the Evidence-based
Practice Centers ) or Comparative Effectiveness Summary Guides
(produced by the John M. Eisenberg Center for Clinical Decisions
and Communications Science)?
Answer 11: As per the FOA, applicants are to
propose innovative customizations or adaptations to the content,
presentation, and/or delivery mechanism(s) of one or more Comparative
Effectiveness Research Review products, such as Comparative Effectiveness
Research Reviews, Comparative Effectiveness Research Review Executive
Summaries, or Comparative Effectiveness Research Summary Guides. We
note that the FOA does not require the basis to be a Comparative
Effectiveness Research Review Summary Guide, which is only one
of three categories of materials developed through the Effective
Health Care Program that may be adapted.
Any applicant proposing to incorporate additional or complementary
evidence in the contents of a CER Review, Executive Summary, or
Summary Guide that has been completed or is expected to be available
by June 2010 (see question 2) will need to provide strong scientific
justification for including that evidence and indicate how this
additional evidence will further the use of the CER product upon
which customizations and adaptations are based.
Question 12: Can an applicant propose to address only a portion
of a CER Review, Executive Summary, or Summary Guide?
Answer 12: As long as fidelity to the original
content is preserved and an appropriate and defensible justification
is supplied, applicants may limit their customizations or adaptations
to a portion of a CER Review, Executive Summary, or Summary Guide
that is deemed self-contained and valid from the standpoint of
evidence presentation and translation.
Question 13: Can an applicant propose to address
only a portion of a priority area?
Answer 13: Applicants should be careful not to
confuse the 14 priority conditions (described in the FOA under
the "Background on Comparative Effectiveness" subsection
under Section I.1 Research Objectives) with the specific
CER products that are candidates for adaptation and dissemination
under this FOA. CER products are based upon defined topics
that fall within the 14 priority conditions. Adaptations
and customizations are not applicable to the broad categories of
priority conditions themselves.
Question 14: Does this FOA apply to new research
findings of comparative effectiveness, say from the DEcIDE or CERTs
programs, or is it restricted to Comparative Effectiveness Research
Reviews?
Answer 14: The FOA is restricted to CER Reviews,
Executive Summaries, and Summary Guides and does NOT pertain to
new research done by the DEcIDE or CERTs programs.
Question 15: What if my dissemination and translation
interest area or audience does not have a CER Review, Executive
Summary, or Summary Guide?
Answer 15: Applicants whose audiences, stakeholders,
systems, or settings cannot be addressed within the available CER
products (see question 2) may consider applications to AHRQ's Health
Services Research Demonstration and Dissemination Grants (R18)
opportunity, described at http://grants.nih.gov/grants/guide/pa-files/PA-09-071.html.
Question 16: Does this FOA include applications
to develop new comparative effectiveness research or information
in a topic area without a CER Review, Executive Summary, or Summary
Guide?
Answer 16: No. The primary purpose of this
FOA is to adapt, customize, and disseminate existing information
as described in the FOA. Applicants wishing to develop new
information by conducting empirical (primary or secondary) research
of alternative treatments should consider applying to the CHOICE
FOA at http://grants.nih.gov/grants/guide/rfa-files/RFA-HS-10-003.html.
Question 17: To what extent can a Comparative
Effectiveness Research Review product (CERRP) be surrounded by
or integrated into related but different (not contradictory) health
information about a condition or a treatment? If it is possible
to surround or integrate CERRP content into related health information,
how should it be sourced, cited, or linked back to AHRQ information?
Answer 17: An adapted CERRP may be surrounded
by or integrated into related but different (not contradictory)
health information about a condition or a treatment if the applicant
provides strong justification about its scientific validity and
the need for including that evidence to further the use of the
CERRP that is being adapted or customized. Justification
for the additional information may include assessment of the evidentiary
strength of the information and/or provision of the source, citation,
or link for the additional information in the application. In
the adapted product(s), the nature of the information and its source
should determine the manner in which its source is referenced,
cited, or linked.
Nature of Allowable Collaborations
Question 18: Can we include disease/condition/other
experts in our application? Is it acceptable to have a consultant
or consultants whose expertise is complementary to that of the
principal investigator (PI)--for instance, a disease/treatment
expert for a PI with expertise in dissemination, or in dissemination
for a PI who is an expert in the disease/treatment? Are
there any requirements for how such experts' roles are defined
or reimbursed? Should they be engaged as consultants or
collaborators with a percentage effort?
Answer 18: There are no restrictions on the use
or roles of experts beyond what is stated in the FOA under Eligibility
Information. The nature and extent of their planned involvement,
as well as advice from your institution's sponsored programs
office, are the best determinants of how you choose to engage them.
Question 19: Can AHRQ share the names of applicants
who have expressed an interest in this FOA so that contacts and
potential collaborations be explored?
Answer 19: AHRQ cannot share information about
the parties who have expressed an interest in this FOA or who have
stated an intent to apply for it.
Target(s) for Adaptation and Dissemination Efforts
Question 20: Are there any limits on the geographic
scope of the planned activities under this FOA?
Answer 20: No, the geographic scope can be narrow
or broad as long as it is defended and justified appropriately
within the overall application.
Question 21: Are the priority populations of
interest limited in any way?
Answer 21: Within the requirements of the FOA,
applicants have wide latitude in defining their targeted audience(s),
whether they be patients, clinicians, or policymakers.
Question 22: Is adaptation of CER products to
Native American populations of interest?
Answer 22: Adaptation for Native American populations
is of potential interest.
Eligibility Questions
Question 23: Is my organization able to apply?
Answer 23: The FOA states that the following
organizations/institutions are eligible to apply. Consistent with
the purposes of the American Recovery and Reinvestment Act (ARRA)
(in particular, to preserve and create jobs and promote economic recovery
in the United States and to provide investments needed to increase
economic efficiency by spurring technological advances in science
and health), applicants must be a domestic (U.S.) institution/organization
of one of the types listed below. The U.S. institution/organization
must be located in the 50 States, or in the territories and possessions
of the United States, Commonwealth of Puerto Rico, Trust Territory
of the Pacific Islands, or District of Columbia. Foreign
organizations/institutions are not permitted as the applicant organization.
You may submit an application(s) if your institution/organization
has any of the following characteristics:
- Public or nonprofit private institution, such as a university,
college, or a faith-based or community-based organization.
- Units of local or State government.
- Eligible agencies of the Federal Government.
- Indian/Native American Tribal Government (federally recognized).
- Indian/Native American Tribal Government (other than federally
recognized).
- Indian/Native American Tribally Designated Organizations.
Current AHRQ contractors or grantees are eligible to apply.
AHRQ's authorizing legislation does not allow for-profit
organizations to be eligible to lead applications under this research
mechanism; thus for the purpose of this FOA, AHRQ will make grants
only to nonprofit organizations. For-profit organizations
may participate in projects as members of consortia or as subcontractors
only. Because the purpose of this program is to improve health
care in the United States, foreign institutions may participate
in projects as members of consortia or as subcontractors only. Applications
submitted by for-profit organizations or foreign institutions will
not be reviewed. Organizations described in section 501(c)
4 of the Internal Revenue Code that engage in lobbying are not
eligible.
Question 24: Is a nonprofit 501c 6 professional
association eligible to apply if it has a government affairs department
that engages in lobbying on behalf of the association, but which
does so as a separate cost center that does not use Federal funds
for any lobbying activities? Can ARRA funds be used for projects
by the portion of the organization that does not engage in lobbying
in any way?
Answer 24: What you describe is allowable. Relative
to lobbying, applicants for HHS grants with total costs expected
to exceed $100,000 are required to certify that they have not made,
and will not make, such a prohibited payment; will be responsible
for reporting the use of nonappropriated funds for such purposes;
and will include these requirements in consortium agreements, other
subawards, and contracts under grants that will exceed $100,000
and will obtain necessary certifications from those consortium
participants and contractors. Disclosure reporting is required
after award as indicated in Part II of the Grants Policy Statement
(http://www.hhs.gov/grantsnet/docs/HHSGPS_107.doc#_Toc155580124; Word® file, 1.8 MB).
Also, there are new provisions related to communications regarding
ARRA applications:
Applications submitted under ARRA are subject to restrictions
on oral conversations during the period of time commencing with
the submission of a formal application by an individual or entity
and ending with the award of the competitive funds. Federal officials
may not participate in oral communications initiated by any person
or entity concerning a pending application for a Recovery Act competitive
grant or other competitive form of Federal financial assistance,
whether or not the initiating party is a Federally registered lobbyist.
This restriction applies unless:
(i) the communication is purely logistical.
(ii) the communication is made at a widely attended gathering.
(iii) the communication is to or from a Federal agency official
and another Federal Government employee.
(iv) the communication is to or from a Federal agency official
and an elected chief executive of a state, local, or tribal government,
or to or from a Federal agency official and the Presiding Officer
or Majority Leader in each chamber of a state legislature.
(v) the communication is initiated by the Federal agency official.
Question 25: Can we propose collaborations or
consortia arrangements with components of the current Effective
Health Care Program--Evidence-based Practice Centers (EPCs), Developing
Evidence to Inform Decisions about Effectiveness (DEcIDE), the
John M. Eisenberg Center for Clinical Decisions and Communications
Science (Eisenberg Center), or the Centers for Education and Research
on Therapeutics (CERTs)?
Answer 25: Please refer to the list of eligible
institutions in Section III.1.A of the FOA. As long as these
conditions are met, there are no prohibitions against applications
from any AHRQ grantees or contractors.
Question 26: Can I apply for this FOA if I have
a K award from a Federal agency?
Answer 26: You should review the funding opportunity
announcement under which your K award was issued and, if necessary,
consult with your sponsored projects office and the agency that
funded the K award to see if there are any prohibitions about applying
for other sources of support. The iADAPT FOA does not prohibit
an application from someone with a K award; however, the more critical
factor is whether your K award places any limits on this. For
example, the K awarding agency may bar your receiving salary support
from an AHRQ grant if your application is selected for funding.
Question 27: Was RFA-HS-10-004 modified since
publication--in particular, in its description of eligible applicants?
Answer 27: The RFA published in the NIH Guide
on September 25, 2009, was complete and final and has not been
modified. It can be accessed at http://grants.nih.gov/grants/guide/rfa-files/RFA-HS-10-004.html. Notices
of modification 1 and modification 2 sent out by the Grants.gov
on September 25, 2009, and October 7, 2009, reflected only revisions
to the descriptive synopsis of the full announcement itself. There
has been no change to the FOA.
Questions Regarding Potential Approaches to the FOA
Question 28: Does AHRQ expect a fidelity to the
actual language or format or is changing both of those okay and
part of the funded translation process?
Answer 28: The FOA lists examples of adaptation
and dissemination that may be considered but does not limit applicants
to the listed options. Adapted contents should preserve
the fidelity of the original's technical contents and evidentiary
criteria and assessments, so as to avoid distortions or misrepresentations
of the technical subject matter.
Question 29: In allocating resources, there is
a tension between disseminating less to more individuals vs. disseminating
more intensively to fewer individuals. Is there a preference for
achieving maximum impact with fewer individuals (so it is clear
just how much impact is possible) or toward achieving a more minimal
impact with greater numbers?
Answer 29: The FOA states no preference for the
size or intensity of the target(s) or adaptations. Applicants
should propose and justify whatever approach(es) they choose in
light of the content and target(s) they have chosen.
Question 30: How important is the evaluation
component relative to the implementation? Does AHRQ recommend
any rough proportion or ceiling of funding that should be allocated
to evaluation?
Answer 30: There is no recommended proportion
of effort or funding for evaluation. Because the nature
of the proposed adaptation(s) will influence the nature of the
proposed evaluation(s), individual applicants should use their
best judgment as to the level of effort and funding to allocate
to this activity. Pertinent sections of the FOA are Evaluation
Plan Requirements in Section I and Evaluation, Assessment, and
Reporting the Intervention's Translatability in Section IV.6.IV.
Question 31: Would a randomized trial of
an educational effort employing one or more adapted
CER products meet the intent of the RFA?
Answer 31: The FOA permits the use of a broad
range of methodological designs, including randomized trials,
to assess the effectiveness and impacts of dissemination and/or
education efforts as proposed by the investigators. It is advisable
that the application justify the specific methodological approaches
employed in the evaluation component of the proposed project,
as well as the appropriate design and, if applicable, statistical
considerations.
Question 32: Should the PI have expertise
in a specific disease/condition area, in communication/dissemination,
or both?
Answer 32: The FOA invites PIs with the skills,
knowledge, and resources necessary to carry out the proposed research. As
stated in the FOA, the PI and investigators in the application
will be reviewed and evaluated with the following questions: Are
the PD(project director)/PI and other key personnel appropriately
trained and well suited to carry out this work? Is the work proposed
appropriate to the experience level(s) of the PI(s) and other researchers?
Do the PD/PI and investigative team bring complementary and integrated
expertise to the project (if applicable)?
To paraphrase, the FOA provides broad latitude in the PI's specific
areas of expertise, which will be evaluated independently as well
as in the context of the overall expertise of the assembled project
team.
Question 33: Is it AHRQ's intention that Clinician,
Consumer, and Policymaker Summary Guides be disseminated exclusively
to these respective stakeholders?
Answer 33: No such intent is stated in the FOA.
Question 34: If mass media interventions are
developed (e.g., public service announcements), do we also need
to implement them in the project? In other words, would we include
the cost of airing them? Or is it sufficient to produce such interventions
and then provide them to AHRQ?
Answer 34: We invite you to consider how an unaired
media intervention could satisfactorily address the evaluation
requirements of the FOA.
Question 35: Can we propose an overall strategy
that uses AHRQ input to choose among competing options at different
phases of the project?
Answer 35: The grant mechanism does not allow
the Federal Government to give directions on the work to be done. You
should propose what you think is/are the likely best option(s),
and if necessary, build in an external advisory function that excludes
AHRQ and Federal Government employees.
Question 36: How can we build in contingencies
for different funding amounts that we might need based upon preliminary
research findings, such as needs assessment? We anticipate
different cost scenarios for adaptation based upon the needs and
preferences we elucidate in a particular target.
Answer 36: If the scope of a later phase of your
planned activities is contingent upon as-yet-unknown findings from
an earlier phase of your project, you should propose an amount
of funding that would cover the most likely option or options that
you can reasonably project. Peer review and AHRQ will need
to review and ultimately determine a single funded amount if your
application is funded and awarded.
We can imagine several options and invite you to consider others
along the same lines. One alternative you might consider
is to submit multiple applications for each of the potential design
and implementation approaches that are possible, using the first
phase of research to screen your target(s) to see which fit the
mechanism you have proposed. Another option would be to do
your market research in several audiences and then budget an appropriate
amount of funds for design, implementation, and evaluation that
could be applied to one or more alternative approaches that can
reasonably and defensibly be accomplished within those funds. For
example, you could state that based on early-phase needs assessment
findings, you would be able to do X number(s) of community-based
interventions, Y number(s) of thought-leader interventions, and/or
Z number(s) of yet another intervention. Different permutations
of options could also be proposed.
Current as of November 2009
Internet Citation:
Questions and Answers on Innovative Adaptation and Dissemination of
AHRQ Comparative Effectiveness Research Products (iADAPT) (RFA) HS-10-004.
November 2009. Agency for Healthcare Research and Quality, Rockville, MD.
http://www.ahrq.gov/fund/HS-10-004QandA.htm
540 Gaither Road Rockville, MD 20850