Heart, Lung, and Blood Institute
National Institute of Neurological Disorders
Institute of Circulatory and Respiratory Health, Canadian Institutes
of Health Research
CLINICAL RESEARCH CONSORTIUM TO IMPROVE RESUSCITATION OUTCOMES
Frequently Asked Questions
Clinical Research Consortium to Improve Resuscitation Outcomes
Dates: Letter of Intent, October 16, 2003; Application, November 13, 2003
Should protocol proposals be limited to cardiac arrest/resuscitation, or is
there room for work in the pre-arrest period as well?
A: Both responsive
research proposals and estimates of numbers of case contacts could include patients
in the pre-arrest period as well as those who have already experienced cardiac
or traumatic arrest.
Q: Will this RFA support out-of-hospital
research only, or is there room for in-hospital resuscitation research as well?
Although this RFA does specify an emphasis on out-of-hospital resuscitation
research, in-hospital resuscitation research proposals should not be considered
unresponsive to the solicitation.
Q: In providing (at
least) one protocol in the area of trauma and one in cardiac arrest, do these
protocols have to be using the same approach or can they be different?
Proposed protocols in each area can stand independently, addressing specific
needs in a given area.
Q: Should protocols be simple
or can they be more complex?
A: The applicant selects protocols to reflect
what they consider to be important questions to be addressed. Whether the proposed
protocol is complex or simple, it needs to be well outlined and "potentially
ready" for implementation.
Q: Will the consortium
consider pediatric protocols?
A: Yes, although final protocol development
and selection will be the responsibility of the Steering Committee.
Are individual researchers to submit an application for their specific project
or is the institution to submit an application defining its role as an RCC?
The institution should submit an application defining its role as an RCC. Sample
protocol proposals are a required part of that application.
Would the consortium consider protocols that test new devices?
Yes, although final protocol development and selection will be the responsibility
of the Steering Committee.
Q: Are the required 500
case contacts necessary to be at the main institution (of a Regional Clinical
A: No, the 500 case contacts are expected to be from the both
the main institution and any associated facilities.
Q: What is meant by a local consortium/network?
It is anticipated that any given institution will require the coordination
of multiple services to successfully perform out-of-hospital resuscitation research.
This is in addition to the internal interaction required between the departments
of Cardiology and Trauma Surgery. For example, some institutions may require the
participation of multiple clinical centers to gain the required number of potential
participants. Others may need to work specifically with an affiliated pediatric
center to assure the potential participation of children. All institutions will
need to work closely with their regional EMS systems in order to best identify
eligible patients and implement resuscitation protocols. The RFA requires that
a community liaison be identified in order to foster a cooperative relationship
with community leaders and potential participants. The formalization of these
relationships (documented by letter of agreement) is what is required to demonstrate
that a local consortium has been established to support out-of-hospital resuscitation
Q: Should the required two (2) protocol
proposals be submitted as a part of the RCC application in the PHS 398 format,
or should they be submitted separately?
A: Protocol proposals must be
submitted as a part of the single RCC application in the required PHS 398 format.
The bulk of the application should describe the RCC infrastructure. The entire
application may not exceed 25 pages. The budgetary portion of the RCC application
should refer to the yearly cost of the local infrastructure. Each of the two (2)
protocol proposals should be followed by a budgetary proposal that is specific
to the cost of the proposed project, recognizing that actual Consortium protocol
funds will be distributed by the DCC to the participating RCCs on a per-capita
Q: How will a "region" be defined?
Regions will be defined both by geography and by any existing or engineered
relationships that arise out of the development of local "consortia".
Should the two (2) protocol proposals be limited to the resources available
at one RCC, or should they be proposed on a network scale?
A: In order
to eliminate supposition regarding the resources available to other potential
RCCs, the RFA stipulates that the two (2) proposals be written in terms of the
resources available within the local "consortium", however, it is anticipated
that proposals will be broad enough to warrant expansion to a network scale.
Should RCC applicants identify a PI from both cardiology and trauma?
Although the NIH application process requires that one (and only one) PI be
named per application, it is anticipated that RCC applicants will identify Co-PIs
from cardiology, trauma, and any other service that might be expected to have
a significant contribution to the local "consortium" (such as pediatrics
Q: Are RCC applicants required to provide all
proposed services through the primary institution?
A: RCC applicants
are expected to develop a local "consortium" of institutions, hospitals,
EMS operators, and others who together will be able to provide the services required
to perform out of hospital resuscitation research.
Would a solely pediatric center be considered a responsive RCC applicant?
Although any center with the required 500 case contacts would be deemed responsive,
it seems that an even stronger application would bring a combination of pediatric
and adult populations to the Network.
Q: What is required
in a letter of intent?
A: The letter of intent should identify a PI,
the primary institution, and any associated institutions in the local consortium.
The letter should also state whether or not the applicant will apply as an RCC
or DCC. Further inquiries regarding requirements for Canadian centers should be
directed to Ms. Hines-Reimer. (email@example.com)
Is there a requirement for collaboration between Canadian and US centers?
Although collaboration is encouraged by this RFA, there is no absolute requirement.
Can I apply for both RCC and DCC?
A: Yes, the applicant can apply
for both DCC and RCC as separate applications. One of the key issues for DCC will
be applicant's past experience as DCC.
Q: For proposed
protocols should they be designed to be implemented in "just the applicant's
RCC" or can they be designed to be implemented in more than one RCC?
The applicant can propose protocols which can be either conducted in one RCC
or multiple RCCs. In either case, the protocol needs to have adequate information
on required sample size, endpoints and their justification, power calculations
Q: Can there be Co-Principal Investigator
in addition to PI?
A: Yes, one of the approaches would be to have PI
from one discipline (i.e., cardiology or trauma) and Co-PI from the other discipline.
Q: Is there just one PI or can the regional application
include PI and CO-PI?
A: It is anticipated that applications would include
PI and CO-PI (i.e., cardiologist and trauma surgeon or EMS expert), reflecting
the regional leadership and experience.
one institution submit two RCC applications under two different PIs?
Yes, although the requirements of an RCC are so extensive that it is not advised.