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Judicial Watch • 2009 RORA ny conditions of award

2009 RORA ny conditions of award

2009 RORA ny conditions of award

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Number of Pages:10

Date Created:June 20, 2008

Date Uploaded to the Library:July 30, 2013

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Healthcare Systems Bureau 
Clinical Interventions for Increasing Organ Procurement Grant Program (CIOP) 
Application Number 44020 
New York City Health and Hospitals Corporation Conditions Award 	
Please describe more detail the role the transplant surgeon and how conflicts interest, either real perceived will avoided. 	
Please plan and describe what methods will used for achieving buy-in from the public and public officials timely manner that allows for completion the project 	
Address the Object Review Panels' concern that costs associated with public relations expenses and campaign will extensive. Describe what methods you will utilize remain within the proposed budget. 	
Please describe greater detail the community notification process without 

direct informed consent, including how this will implemented and evaluated. 	
The Objective Review Panel felt that the timeline was "markedly" unrealistic meet the objective(s). Please elaborate how you will meet the objectives within the given timeline how you might revise the activities and/or timeline meet the objectives within the timeframe allotted. 	
Address the Object Review Panel's concern that operating the Rapid Organ Response Ambulance one shift per day will decrease already small numbers one-third. 	
Please provide specific metrics regarding the cooling process. 	
Discuss greater detail how the will handle current duties and ensure the success this project. 	
Discuss greater detail how the and co-investigators will work together ensure this projects success. What methods will used remain task, how will the and co-investigators remain action? 

10. 	
Discuss personnel costs related percent effort taking into consideration actual time able spent this project. 

From: Goldfrank, Lewis [mailto:Lewis.Goldfrank@nyumc.org] 
Sent: Friday, August 10, 2007 3:18 
To: Kozlovsky, Bernard (HRSA) 
Cc: Barney, Brad (HRSA) 
Subject: Responses Questions Concerning CIOP Application #44020 was pleasure talking with you this morning. appreciated your assistance hopefully resolving completelyyour queries. Should there any further difficulty following the attached responses, will respond immediately. look forward with great enthusiasm the possibility the funding our proposal. 

Sincerely, 
Lewis Goldf rank 

Question 
Please describe greater detail the community notification process without direct informed consent, including how this will implemented and evaluated. mJYding New Yark State la'riJ irforrml, mnsent ordy n:quirrdfar the donor m::ipient, net: the da:eased. m:ttter cfsensitiU:ty, the Orfpn Donar etuork imdu:s thefaml,y theprrxm d.etermmi,?'f, Wxther the da:eased uauld ha7E wznted donate Dri!fZrlS, ifnet: explicitly statedprior death. cumrdance Wth the !OM report Orfpn Donation Opportunities far a:ion 2006 and nrerrt report issued the Departrrent cfHealth the State New Yark, this pila Wll enable the Rapid OrfpnReaneryA rrbulance team ''-pre;urre mnsent" transport the da:eased and m:tintain the Dri!fZns until sum tim: thefaml,y can mntacted ascertain the uishe; cfthe da:eased arprrxf preexisti?'f, entry the Dri!fZn donation registry deterrrined 1his referred ''-pre;eni?'f, the rigfat donate Dri!fZrlS. 
The wrrmmiry "naifim,tian" JrrrxEs wrrmmiry edua:ttion effort raise awzrme;s alxMt the issues and wzerate suppart far the pila m:maff3 migj.ous, ethiml and pditio:d wncems City Wth 07( 160 distim: atlturr5. 1his Wll cuirJrnplished ronducti?'f,fcx:us groups Wth mricus stakehdders. The data adled from the fcx:us groups Wll help craft the m:trketbrg rrBSaff3 far the projro:. prrfe5sional rmrket rr::searrh firm Wll used cdka and analyze data t:hroog}xut the JrrrxEs inform the teamin the d.erdopm;nt m5Sag:5 and tducational m:tterials that are rm;t aa:eptaUe the mricus stakehdders. key component the strate'i)I deulop ethiml ruhite paper, task /,ed one cfour inu:stigaors Nancy Dubler, LLB wdl-knmm mrli.cal ethicist W?o also participated the rm;t nrerrt!OM Report. 
Question 
Address the concern that operating the Rapid Organ Response Ambulance one shift per day will decrease already small numbers potential UDQ) donors one-third. 

1brougfa disa1Ssions Wth wrious City c/ficids, key a:mcem WIS the cat mrrrdng the Rapid RfIDrErJArrbulance day per w:ek. WIS/eh that gi,wi the limimd resouro:5 awilabk this tim;, the rrat ca;t-ejfe:.tiie strategy roould run pilct one shiftperday, da)5 per w:ek for ;et?S. 7his w:uld enabk the study denvnstrate soietd benefit and gUn. support for additim::dfunding/or fall
CityWde effort. W1hik the nwrhers pd:entiaf, donors are m:xkt, they dram1,tia:dly incre:tse the donations that midt fdlooing cardiac death. addition, they are ak]_uate for adJier.e ourprimary analyis and 
three sID17liary analye;. Also, WIS/eh that conduai.ng pilct from midmgfat Barn w:uld perrrit the 
rapid transpart pd:entiaf, donors, gi,ien the significantly rrxluaxi traffic a;ngsstion that tim:. 
Question 
Discuss personnel costs related percent effort taking into consideration actual time spent this project. Please take into consideration the other responsibilities the primaries, the short timeline for completion the project and work flow. 
The pnnci:pal im.estigztor Leu.is Gddfrank, an:l the co-pnnci:pal imestigztor Eric Grassmm, are mmmi.tted this effort. Bethpb;sicians kstn tlxdr interest org;in donation m1,rry )t'a?S ag:;, and both that the future org;in donation depends increasing the pcd awilabk org;ins throorfa donation after cardiac ckath. kaders tlxdr org;inizations, both indi,Uduals haie the ability mblize additional in-kind resoura:s. For ecarrpk, Dr. Gddfrank recently hired Stephen Wall, current AHR mipient 'lfho o:mduaing nktel-mearrh attitudts about org;in donations arrDrf, different ethnicpopulations New Yark City. Dr. Gddfrank Wl1 utilizing the WJrk all nkml-mearrh his departrrmt inspire our lxspital pmonnd and kul the optimization e;sentid moura:s for the HRSA grant should awrded our institutions. d.ditionally, the Departrrmt ErmtP10' Mediane, recently hired its first Via; OJainmn. 7his additWn 
Wl1 pennit Dr. Gddfrank rdieud m1,rry adninistratiie tasks permitting him fcx:us this 
researrh and a:herpuhHc health and em:rwicy healthcare issues. 

Lewis Goldfrank, 1v1D Professor and Chair, Emergency Medicine 

New York University School Medicine Director, Emergency Medicine Bellevue HospitaVNYU Hospitals/ Medical Center Medical, New York Gty Poison Center 
Telephone: 212.562.3346 

Healthcare Systems Bureau 
gJ11I 

TO:  Associate Administrator  
FROM:  Director, Division Transplantation  
SUBJECT: 2007 Extramural Grant Program: Increase Organ and Tissue Donatio Social and Behavioral Interventions n-ACTION  
ISSUE  

Fourteen applications were submitted for the 2007 Extramural Grant Program: Social and Behavioral Interventions Increase Organ and Tissue Donation. One application was deemed ineligible. objective review committee (ORC) reviewed the remaining thirteen applications May 15-17, 2007. All applications reviewed were scored for merit using scale 10-100. 
DISCUSSION 
Based upon the recommendations the ORC and the availability funds, the Division Transplantation recommends funding five (5) applications from this grant cycle. Attached chart the recommended grants for funding. Any organization that has not submitted 100 percent the data required the policies the Organ Procurement and Transplantation Network (OPTN) will not receive grant funding. 
The CAN number 7-3880701 and Allowance number 7-97003 will used for this grant cycle. 
RECOMMENDATION recommend that you approve the attached grant list. 
DECISION 

James Burdick, M.D. 
Attachment 
Prep by:HRSA/HSB/DoTNW ALKER:H:/Shared/DT/General/Controlled/Funding Memo/Social 

Healthcare Systems Bureau 

Clinical Interventions for Increasing Organ Procurement Grant Program (CIOP) 

Application Number 44020 

New York City Health and Hospitals Corporation Conditions Award 	
Please describe more detail the role the transplant surgeon and how conflicts interest, either real perceived will avoided. 	
Please plan and describe what methods will used for achieving buy-in from the public and public officials timely manner that allows for completion the project 	
Address the Object Review Panels' concern that costs associated with public relations expenses and campaign will extensive. Describe what methods you will utilize remain within the proposed budget. 
Please describe greater detail the community notification process without direct informed consent, including how this will implemented and evaluated. 	
The Objective Review Panel felt that the timeline was "markedly" unrealistic meet the objective(s). Please elaborate how you will meet the objectives within the given timeline how you might revise the activities and/or timeline meet the objectives within the timeframe allotted. 	
Address the Object Review Panel's concern that operating the Rapid Organ Response Ambulance one shift per day will decrease already small numbers one-third. 	
Please provide specific metrics regarding the cooling process. 	
Discuss greater detail how the will handle current duties and ensure the success this project. 	Discuss greater detail how the and co-investigators will work together 
ensure this projects success. What methods will used remain task, how will the and co-investigators remain action? 

10. 	
Discuss personnel costs related percent effort taking into consideration actual time able spent this project. 

Clinical Interventions Increase Application Grant# 
44020 

Total 

t'1/ 
__, 

Kozlovsky, Bernard (HRSA) 
From:  Goldfrank, Lewis [Lewis.Goldfrank@nyumc.org]  
Sent:  Thursday, August 09, 2007 5:51  
To:  Kozlovsky, Bernard (HRSA)  
Cc:  Barney, Brad (HRSA)  

Subject: Responses Questions Concerning CIOP Application #44020 was pleasure talking with you this morning. appreciated your assistance hopefully resolving completely your queries. Should there any further difficulty following the attached responses, will respond immediately. look forward with great enthusiasm the possibility the funding our proposal. 
Sincerely, 
Lewis Goldfrank 

Question 
Please. describe greater detail the community notification process without direct informed consent, including how this will implemented and evaluated. 

According New York State law, informed consent onfy required for the donor recipient, not the deceased matter sensitivity, the Organ Donor Network involves the famify the process determining whether the deceased would have wanted donate organs, not explicitfy stated prior death. accordance with the IOM report Organ Donation: Opportunities for Action 2006 and recent report issued lry the Department Health the State New York, this pilot will enable the Rapid Organ Recovery Ambulance team 
"presume consent" transport the deceased and maintain the organs until such time the famify can contacted ascertain the wishes the deceased proof preexisting entry the organ donation registry can determined This referred ''preseroing the right donate organs." 
The community "notification"process community education effort raise awareness about the issues and generate support for the pilot manage religious, ethical and political concerns City with over 160 distinct cultures. This will accomplished conducting focus groups with vanous stakeholders. The data culled from the focus groups wzll help creft the marketing message for the prqject. professional market research firm will used collect and anafyze data throughout the process i!ifbnn the team the development messages and educational maten.als that are most acceptable the various stakeholders. kry component the strategy develop ethical white paper, task led lry one ofour investigators Nanry Dubler, LLB well-known medical ethicist who also participated the most recent IOM Report. 
Question 
Address the concern that operating the Rapid Organ Response Ambulance one shift per day will decrease already small numbers potential UDCD donors one-third. 
Through discussions 1JJith various City officials, kry concern was the cost running the Rapid Organ Recovery 

8/14/2007 

Ambulance dqys per week. was felt that given the limited resources available this time, the most cost-effective 
strategy would run pilot one shift per dqy, dqys per week for 2years. This would enable the stuqy 
demonstrate sodetal benefit and gain support for additional Jundingfor Jull-Cirywide effort. While the numbers 
potential donors are modest, they dramaticalfy increase the donations that result following cardiac death. addition, they 
are adequate for achieve our primary ana!Jsis and three secondary anafyses. Also, was felt that conducting pilot 
from midnight 8am would permit the rapid transport potential donors, given the significantfy reduced trqffic congestion that time. 
Discuss personnel costs related percent effort taking into consideration actual time spent this project. Please take into consideration the other responsibilities the primaries, the short timeline for completion the project and work flow. 

The prindpal investigator Lewis Goldjrank, and the co-prindpal investigator Eric Grossman, are committed this effort. Both p1'!Jsidans began their interest organ donation ma'!Y years ago, and both recognize that the future organ donation depends increasing the pool available organs through donation after cardiac death. leaders their organizations, both individuals have the abiliry mobilize additional in-kind resources. For example, Dr. Golr!frank recentfy hired Stephen Wall, current AHRQ redpient who conducting related-research attitudes about organ donations among dijferent ethnic populations Neu; York Ciry. Dr. Golr!frank will utilizj,ng the work all relatedresearch his department inspire our hospital personnel and lead the optimization essential resources for the HRSA grant should awarded our institutions. 
Additionalfy, the Department Emergenry Medidne, recentfy hired its first Vice Chairman. This addition will pmnit Dr. Goldfrank relieved ma'!Y administrative tasks permitting him focus this research and other public health and emergenry healthcare issues. 
Lewis Goldfrank, 
Professor and Chair, Emergency Medicine 
New York University School Medicine 
Director, Emergency Medicine 
Bellevue Hospital/NYU Hospitals/ Medical Center 
Medical, New York City Poison Center 
Telephone: 212.562.3346 
Fax: 212.562.3001 

8/14/2007 

From: Goldfrank, Lewis [mailto:Lewis.Goldfrank@nyumc.org] 
Sent: Friday, August 10, 2007 3:18 
To: Kozlovsky, Bernard (HRSA) 
Cc: Barney, Brad (HRSA) 
Subject: Responses Questions Concerning CIOP Application #44020 was pleasure talking with you this morning. appreciated your assistance hopefully resolving completely your queries. Should there any further difficulty following the attached responses, will respond immediately. look forward with great enthusiasm the possibility the funding our proposal. 
Sincerely, 
Lewis Goldfrank 
Question 
Please describe greater detail the community notification process without direct informed consent, including how this will implemented and evaluated. 
According New York State law, infirmed consent on!J required for the donor recipient, not the deceased. matter sensitiviry, the Organ Donor Network involves the fami!J the process determining whether the deceased would have wanted donate organs, not explicit!J stated prior death. accordance with the IOM report Organ Donation: Opportunities for Action 2006 and recent report issued the Department Health the State New York, this pilot will enable the Rapid Organ Recovery Ambulance team ''presume consent" transport the deceased and maintain the organs until such time the fami!J can contacted ascertain the wishes the deceased proof preexisting entry the organ donation registry can determined. This referred "preserving the right donate organs." 
The communiry "notijication" process communiry education effort raise awareness about the issues and generate support for the pilot manage religious, ethical and political concerns Ciry with over 160 distinct cultures. This will accomplished conductingfocus groups with various stakeholders. The data culled from the focus groups will help craft the marketing message for the project. professional market research firm will used collect and ana!Jze data throughout the process inform the team the development messages and educational materials that are most acceptable the various stakeholders. key component the strateJ!)l develop ethical white paper, task led one our investigators Nanry Dubler, LLB well-known medical ethicist who also participated the most recent IOM Report. 
Question 
Address the concern that operating the Rapid Organ Response Ambulance one shift per day will decrease already small numbers potential UDCD donors one-third. 

Through discussions with various City officials, key concern was the cost running the Rapid Organ Recovery Amblance dqys per week. was
most cost-effective strategy would run pilot one shift per dqy, dqys per week for would enable the stuqy demonstrate societal benefit and gain support for additional funding for Citywide effort. that result following cardiac death. addition, they are adequate for achieve our primary ana!Jsis and three secondary ana!Jses. Also, was felt that conducting pilot from midnight 8am would permit the rapid transport potential donors, given the signi.ficant!J reduced traffic congestion that time. 
Question 
Discuss personnel costs related percent effort taking into consideration actual time spent this project. Please take into consideration the other responsibilities the primaries, the short timeline for completion the project and work flow. 
The principal investigator Lewis Golc!frank, and the co-principal investigator Eric Grossman, are committed this effort. Both pl?Jsicians began their interest organ donation ma!!J years ago, and both recognize that the future organ donation depends increasing the pool available organs through donation after cardiac death. leaders their organizations, both individuals have the ability mobilize additional in-kind resources. For example, Dr. Golc!frank recent!J hired Stephen Wall, current AHRQ recipient who conducting related-research attitudes about organ donations among different ethnicpopulations New York City. Dr. Golc!frank will utilizing the work ofall related-research his department inspire our hospital personnel and lead the optimization essential resources for the HRSA grant should awarded our institutions. 
Additional!J, the Department ofEmergenry Medicine, recent!J hired its first Vice Chairman. This addition will permit Dr. Golc!frank relieved ofma'!Y administrative tasks permitting him focus this research and other public health and emergenry healthcare issues. 

Lewis Goldfrank, Professor and Chair, Emergency Medicine New York University School Medicine Director, Emergency Medicine Bellevue Hospital/NYU Hospitals/ Medical Center Medical, New York City Poison Center



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