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Judicial Watch • 2009 RORA obj rev com final-statement

2009 RORA obj rev com final-statement

2009 RORA obj rev com final-statement

Page 1: 2009 RORA obj rev com final-statement

Category:Obtained Document

Number of Pages:3

Date Created:June 20, 2008

Date Uploaded to the Library:July 30, 2013

Tags:investigators, problems, corporation, investigator, patient, proposed, project, process, public, personnel, health, response, program, IRS, CIA

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The applicant understands the problems organ shortage for transplantation and the 
introduction chapter this issue well described and discussed. The application clearly 
describes the methodology and various problems that could have negative effect the 
consent process and organ donation. The application documents the application 
technology and the need for ethical issue evaluation. 
The role the transplant surgeon the project unclear, and may cause potential conflict interest. 

The goals and objectives are well described. The goal tap new donor pool and expand the organ availability. 
The methodology includes the consent process; the follow-up recipients after transplantation, and the collection data for both donor and recipient outcomes. 
The bioethicist, member the research team, will asset this project. Ethical aspects the project will overseen effective manner. 
The applicant proposes the first program implement the Madrid process the 
The consortium well structured involve important stakeholders (e.g., EMS, ED, bioethicist, hospital association, etc.). 
The investigator will using situ cooling technique preserve the organs for transplantation. They also intend utilize EMT and FSC technicians initiate and 

44020 New York City Health Hospitals Corporation

sustain cardiac massage keep the organs perfused after cardiac arrest the field before the patient brought the ED._ These techniques will contribute the success the project. 
The supplies used for rapid cannulation for situ cooling will stored for rapid availability. 
There coordination between the ED, the consent obtaining process, and EMS 

The consent process may difficult conduct within the hour period after cardiac arrest. such cases there alternate plan proposed. 
The anticipated timeline achieve buy-in from the public and public officials seems inadequate meet the objectives. 
The vivo perfusion keep the organs cold and preserve them for transplantation 
depends rapid cannulation femoral vessels, which may difficult cardiac 
arrest patient. 
There lack clarity the community notification process, which allows for 
procedures without direct informed consent (including how this will evaluated and 
approved the IRB and how the process will implemented). 
The timeline markedly unrealistic meet the objectives. 
The proposed methodology (i.e., the Rapid Organ Response Ambulance will operate for one shift per day) may limit potential candidates one-third. 

The proposed evaluations the project are appropriate and include the staff necessary carry out the calculations. 
There lack detail regarding metrics concerning the cooling process. 

The approach proposed innovative for the U.S. 
General protocols and guidelines formulated result this study would beneficial for replicating the approach other locations. 

44020 -New York City Health Hospitals Corporation 
Maintaining the rapid response team proposed may expensive, which may hamper replicability and transferability. 
 unclear how the unique cultural and political aspects New York City will hamper the replicability and transferability the project. 

The project requests appropriate funds for personnel who will call and will available emergency basis. 
Current personnel proposed have demonstrated experience within their given disciplines. 
Training and retaining personnel perform rapid cannulation, obtaining consent, and locating the family may difficult achieve. 
 may difficult and time consuming get buy-in from all the necessary city and civic organizations successfully administer this program. 
The application does not adequately discuss the time and effort necessary achieve community notification. 

None noted. 
The allocation time for the principal investigator (PI) and co-investigators not justified adequate for the success the project. 
There concern about the availability the and co-investigators. The application does not demonstrate that the scope their current duties will allow for the percentage allocation the project. 
There concern that the public relations expense and campaign could substantially more than anticipated.