Department of Veterans Affairs MEMORANDUM
Date: November 19, 2008
From:
Subj: Research Proposal entitled,”
To: Research and Development Committee
Complete each item
1. Anticipated length of project: From _____ To______
2. Funding source:
3. Please indicate which of the following will be used at the VAMC:
a. Humans: no yes [If yes, please attach copy of IRB approval notification and IRB-approved consent form(s).]
b. Animals: no yes [If yes, please attach copy of approval from appropriate institution (VA or UK, depending on location of housing and use.)]
c. Biohazards (including Human tissue, samples, blood, hazardous chemicals, DNA, gene therapy, etc.): no yes [Please attach copy of VA approval]
d. Radioisotopes: no yes [Please attach copy of VA approval]
4. a. Identify VA space to be used:
b. Identify personnel working at the VA and indicate their status (Staff, Consultant, WOC):
5. a. Will outpatients be included? no yes (If so, Attachment B must be signed by Chief of Ambulatory Care).
b. Will inpatients be included? no yes (If so, Which bed service(s) will be
involved?) NOTE: Service Chief(s) for those services must sign Attachment B.
6. Are there any additional tests, outpatient visits, hospitalization, etc. required for this study (other than those required for routine patient care)? If so, a memorandum must be attached indicating what tests (i.e. specific lab tests, x-rays, etc.), frequency of tests, and how their costs will be covered at the VA. This memorandum must show the concurrence of the appropriate Service Chief(s).
ATTACHMENT A
2. Subj: Research Proposal entitled,”
Response Code: Y = Yes, N = No, N/A = Not applicable
a. Clinical Laboratory: no yes (For information: Phil Flanary, Chief Medical Technologist, Ext 5936. Please flag pages containing clinical laboratory requirements)
b. Dietetics: no yes
c. Infection Control: no yes
d. Pharmacy no yes
(NOTE, attached Investigational Drug Record (amended VA 10-9012) must be completed for each drug used (investigational drugs; combinations of drugs; unapproved use of an approved drug; ancillary “high-cost, commercially-available” drugs) and forwarded to Pharmacy (contact point: Tracy Hart) for their consideration. NOTE: Non-formulary drugs that are furnished on protocol by the sponsor will not be furnished by the VA when the study is closed and/or when the patient goes off study[1].
e. Nuclear Medicine: no yes
f. Nursing (beyond normal patients care): no yes
g. Radiology: no yes
h. SDTU: no yes
i. Operating Room: no yes
j. Procedure Room (e.g. recovery, cath lab, ICU's, etc.): no yes
k. Other: (Please specify)
6. If any additional resources are indicated in 5. above, the appropriate chief of service must indicate his/her concurrence on the attached sheet.
7. Does this study involve a new procedure or device? no yes (If yes, you must provide evidence that the individuals involved (including VA/UK staff and any outside consultants) have the appropriate clinical privileges)
3. Subj: Research Proposal entitled,”
Note: Any practitioner who will be performing or supervising patients care activities at the VA as part of this study must have VAMC-specific clinical privileges. In addition, if this study involves a new procedure or device, VA privileges specific to the device or procedure may be required. Please contact AA/Chief of Staff, or Betsy Budd, Medical Staff Coordinator, Ext 5125, if you have questions or need assistance.
Also, all individuals who will be involved in this study at the VA in other than a patient-care related manner (collecting data, reviewing charts, interviewing, working in a research lab, etc.) must have a VA appointment. Please contact Debie Hayse, Ext 4927, if you have questions or need assistance.
I certify that the information supplied above is correct and that all necessary privileges have been secured for all participants in the study.
______
Principal Investigator Date
ATTACHMENT A
Department of Veterans Affairs Memorandum
Date: November 19, 2008
From:
Subj: Research Proposal entitled,”
To: Research and Development Committee
TO BE SIGNED BY THE CHIEF OF EACH SERVICE INDICATED IN #5. ON COVER MEMORANDUM
I have read the proposal listed above and will provide the assistance/resources required.
______
Dennis D. Doherty, MD Chief, Medical Service Date
Mail code: 111-CDD
Location: A429 Cooper Drive
Ext: 4919 or 4211
ATTACHMENT B
Department of Veterans Affairs Memorandum
Date: November 19, 2008
From:
Subj: Research Proposal entitled,”
To: Research and Development Committee
TO BE SIGNED BY THE CHIEF OF EACH SERVICE INDICATED IN #5. ON COVER MEMORANDUM
I have read the proposal listed above and will provide the assistance/resources required.
______
Randal Schleenbaker, MD Chief, PM&RS Date
Mail code: 117-CDD
Location: A032A Cooper Drive
Ext: 4907
ATTACHMENT B
Department of Veterans Affairs Memorandum
Date: November 19, 2008
From:
Subj: Research Proposal entitled,”
To: Research and Development Committee
TO BE SIGNED BY THE CHIEF OF EACH SERVICE INDICATED IN #5. ON COVER MEMORANDUM
I have read the proposal listed above and will provide the assistance/resources required.
______
Walter A. Divers, Jr., MD, MHSA Chief of Staff Date
Mail code: 11A-CDD
Location: A121 Cooper Drive
Ext: 4902
ATTACHMENT B
Department of Veterans Affairs Memorandum
Date: November 19, 2008
From:
Subj: Research Proposal entitled,”
To: Research and Development Committee
TO BE SIGNED BY THE CHIEF OF EACH SERVICE INDICATED IN #5. ON COVER MEMORANDUM
I have read the proposal listed above and will provide the assistance/resources required.
______
Rayudu Polisetty, MD Chief, Radiology Service Date
Mail code: 114-CDD
Location: 110 Cooper Drive
Ext: 4263
ATTACHMENT B
Department of Veterans Affairs Memorandum
Date: November 19, 2008
From:
Subj: Research Proposal entitled,”
To: Research and Development Committee
TO BE SIGNED BY THE CHIEF OF EACH SERVICE INDICATED IN #5. ON COVER MEMORANDUM
I have read the proposal listed above and will provide the assistance/resources required.
______
Wei-Jen Shih, MD Chief, Nuclear Medicine Service Date
Mail code: 115-CDD
Location: A155 Cooper Drive
Ext: 5928
ATTACHMENT B
Department of Veterans Affairs Memorandum
Date: November 19, 2008
From:
Subj: Research Proposal entitled,”
To: Research and Development Committee
TO BE SIGNED BY THE CHIEF OF EACH SERVICE INDICATED IN #5. ON COVER MEMORANDUM
I have read the proposal listed above and will provide the assistance/resources required.
______
Bonnie Mitchell, MD Chief, Pathology and Laboratory Medicine Service Date
Mail code: 113-CDD
Location: B119 Cooper Drive
Ext: 4497 or 4923
ATTACHMENT B
Department of Veterans Affairs Memorandum
Date: November 19, 2008
From:
Subj: Research Proposal entitled,”
To: Research and Development Committee
TO BE SIGNED BY THE CHIEF OF EACH SERVICE INDICATED IN #5. ON COVER MEMORANDUM
I have read the proposal listed above and will provide the assistance/resources required.
______
James A. Flueck, MD ACOS/Ambulatory Care Date
Mail code: 11E-CDD
Location: B129Cooper Drive
Ext: 4905 or 4131
ATTACHMENT B
Department of Veterans Affairs Memorandum
Date: November 19, 2008
From:
Subj: Research Proposal entitled,”
To: Research and Development Committee
TO BE SIGNED BY THE CHIEF OF EACH SERVICE INDICATED IN #5. ON COVER MEMORANDUM
I have read the proposal listed above and will provide the assistance/resources required.
______
Brian Kuehl Chief, Pharmacy Service Date
Mail code: 119-CDD
Location: A164 Cooper Drive
Ext: 5629
ATTACHMENT B
Department of Veterans Affairs Memorandum
Date: November 19, 2008
From:
Subj: Research Proposal entitled,”
To: Research and Development Committee
TO BE SIGNED BY NURSING SERVICE MEMBER OF RESEARCH COMMITTEE IF ASSISTANCE (beyond normal Patients care) IS REQUIRED FROM NURSING PERSONNEL ON UNITS:
I have read and understood the proposal listed above and agree to the involvement of unit nursing personnel in this research.
______
Melinda Washburn Patient Care Services Date
Mail code: 003-CDD
Location: A131 Cooper Drive
Ext: 4922 or 3922
ATTACHMENT B
Department of Veterans Affairs Memorandum
Date: November 19, 2008
From:
Subj: Research Proposal entitled,”
To: Research and Development Committee
TO BE SIGNED BY THE CHIEF OF EACH SERVICE INDICATED IN #5. ON COVER MEMORANDUM
I have read the proposal listed above and will provide the assistance/resources required.
______
Edward J. Kasarskis, MD, Ph.D. Chief, Neurology Service Date
Mail code: 127-CDD
Location: B302 Cooper Drive
Ext: 4219
ATTACHMENT B
Department of Veterans Affairs Memorandum
Date: November 19, 2008
From:
Subj: Research Proposal entitled,”
To: Research and Development Committee
TO BE SIGNED BY THE CHIEF OF EACH SERVICE INDICATED IN #5. ON COVER MEMORANDUM
I have read the proposal listed above and will provide the assistance/resources required.
______
Judy Rittenhouse Chief, Health Administration Date
Mail code: 136B-CDD
Location: (trailer)
Ext: 4877
ATTACHMENT B
Department of Veterans Affairs Memorandum
Date: November 19, 2008
From:
Subj: Research Proposal entitled,”
To: Research and Development Committee
TO BE SIGNED BY THE CHIEF OF EACH SERVICE INDICATED IN #5. ON COVER MEMORANDUM
I have read the proposal listed above and will provide the assistance/resources required.
______
Peter McKeown, MD Chief, Surgical Service Date
Mail code: 112-CDD
Location: B504-01-CDD
Ext: 4967
ATTACHMENT B
Revised: 5/9/07
[1] Any non-formulary drugs involved in patient care must go through the non-formulary approval process.
ATTACHMENT A