COLLABORATIVE CLINICAL RESEARCH CONSORTIUM TO IMPROVE RESUSCITATION OUTCOMES

Release Date:  September 6, 2001

NOTICE:  NOT-HL-02-002

National Heart, Lung, and Blood Institute
 (http://www.nhlbi.nih.gov)

Response Due Date:  November 30, 2001

PURPOSE

The NHLBI is considering establishment of a research consortium to improve 
clinical resuscitation outcomes from cardiopulmonary and traumatic arrest.  In 
order to determine the most effective and practical program, the NHLBI seeks 
advice from community resuscitation experts, institutions, and organizations 
on the barriers to and the design and implementation of such a consortium.
 
BACKGROUND

Out-of-hospital deaths due to unexpected cardiopulmonary and traumatic arrest 
cause premature death and represent a significant public health problem 
cutting across age, race and gender.   No mechanism presently exists to 
expedite the rapid evaluation and translation of novel promising strategies to 
improve resuscitation outcomes.  A concerted effort is needed to improve 
outcomes and to decrease the associated morbidity, mortality, and public 
health burden of traumatic and cardiopulmonary arrest.  Such an effort will 
likely require intensive clinically-related research, including adequately 
powered randomized trials.   Formation of a resuscitation consortium was a 
major recommendation from the Post-Resuscitation and Initial Utility in Life 
Saving Efforts (PULSE) workshop, organized as a multi-agency initiative 
between NHLBI, NICHD, NIGMS, and NINDS of the NIH and FDA and DOD on June 
29-30, 2000, summarized in the published Workshop Executive Summary Report 
(Circulation 2001,103:1182-1184).

INFORMATION REQUESTED

To aid in the design of possible future research solicitations the NHLBI asks 
for comments and suggestions on each of the six key areas described below on 
or before Friday, November 30, 2001.

The Institute is interested in determining the most effective infrastructure 
and organization to conduct clinically-based resuscitation research and 
trials.  For the purpose of this solicitation, resuscitation research is 
defined as investigations to improve resuscitation outcomes from both trauma 
and cardiopulmonary arrest.  A consortium allows for coordinated efforts and 
opportunities to optimize the research and clinical strategies and 
organizational structure, while reducing redundancies associated with several 
separate research structures.  A consortium could include a network of 
collaborating institutions, such as major medical centers, clinical practice 
centers, professional organizations, paramedic and community organizations, 
spread across different geographic areas (rural, urban, international, etc) 
under a single organizational structure.   It is anticipated that the 
consortium"s scientific activities would be centered around designing and 
conducting phase I-III clinical studies testing resuscitation interventions 
for cardiopulmonary and traumatic arrest.  The NHLBI would like to obtain 
information regarding the critical elements necessary for and barriers to 
establishing the consortium.  The responses should describe:

1)  The organizational structure and overall governance of the Consortium, 
including what type of institutions or organizations and geographic areas 
(rural, urban, etc) should be included in the Consortium,

2)  How the Consortium would develop, prioritize and implement clinical 
protocols, including plans for establishing criteria for review and evaluation 
of potential phase I-III protocols, development and integration of mechanistic 
sub-studies, and how to set  priorities among proposed concepts,

3)  Optimal methods for data management from multiple sites, 

4)  Plans for obtaining consent for conducting clinical resuscitation 
research, including the challenges in achieving community participation and 
consent, and obtaining central IRB consent clearance,

5)  The anticipated personnel, equipment, and supplies needed for research and 
administration of such a consortium and estimated range of related costs, and 

6)  Other critical elements or thoughts not outlined above, including the cost 
of the research.

This Request for Information (RFI) is for information and planning purposes 
only and shall not be construed as a solicitation or as an obligation on the 
part of the NHLBI.  The NHLBI does not intend to award a grant or contract on 
the basis of responses nor otherwise pay for the preparation of any 
information submitted or the Government"s use of such information.  
Acknowledgment of receipt of responses will not be made, nor will respondents 
be notified of the Institute"s evaluation of the information received.  
However, should such a requirement materialize, no basis for claims against 
the Institute shall arise as a result of a response to this request for 
information or the Institute"s use of such information as either part of the 
NHLBI evaluation process or in developing specifications for any subsequent 
requirement.  Responses will be held in a confidential manner.  Any 
proprietary information should be so marked on a page-by-page basis.  All 
respondents are asked to indicate the type and size of your business or 
organization, e.g., Large Business, Small Business, Hubzone Small Business, 
Small Disadvantaged Business, Women-Owned Business, 8(a), Historically Black 
College or University/Minority Institution (HBCU/MI), educational institution, 
profit/non-profit hospital, or other non-profit organization.  Responses 
should be identified with Notice number HL-02-002 and are due by 
November 30, 2001.

Please submit three (3) copies of your response to:

Dr. George Sopko
Division of Heart and Vascular Disease
National Heart Lung and Blood Institute, NIH
6701 Rockledge Drive, Room 9176
Bethesda, MD  20892-7940 (For Fedex or courier, use:  Rockville, MD  20892).
Telefax and email responses will also be accepted at:  
301-480-1336 and [email protected]

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

			Department of Health and Human Services (HHS)
NIH... Turning Discovery Into Health®