Date:
From: Name of Investigator>, VA Investigator (554/151)
Subj: Recruitment of Non-Veteran Research Subjects
To: Director, Eastern Colorado Health Care System (554/00)
Thru: ACOS/R&D (554/151)
Chair, R&D Committee (554/151)
Chief, HAS (554/136)
Chief of Staff (554/11)
1. I am requesting permission to recruit non-veteran research subjects for the study, . This study is being submitted for funding from the (Identify source of funding). (Insert a brief description of the study and justification why you need to recruit non-vet population.) The approximate number of non-veterans to be enrolled is and this represents % of our total enrollment. (NOTE: If project has VA funding, permission may be necessary from ORD.)
2. In order to meet the goals of this important research project, we are asking your permission to recruit non-veterans. The enrollment of non-veterans is necessary as there are insufficient veterans available to complete this study. Although non-veteran subjects will be utilized, we believe the results will be generalizable to the veteran population.
3. The enrollment of non-veterans was approved by the IRB on (insert date or is pending).
4. The study budget has been reviewed and additional funding (identify: has been allocated / is not required) to accommodate the enrollment of non-veterans.
5. All regulations pertaining to the participation of veterans as research subjects including requirements for indemnification in case of research related injury pertain to non-veteran subjects enrolled in VA-approved research.
6. If I have failed to provide all the information you require, please feel free to contact me at . Your consideration of this request for permission to recruit non-veterans as research subjects is greatly appreciated. I look forward to hearing from you.
Requester Name> (sign above name, no title is needed since it is used above on the “From” line UNLESS it varies from the listed title)
Page 2
Recruitment of Non-Veteran Research Subjects
Concur/Non-Concur
Robert Keith, MD
ACOS R&D
Concur/Non-Concur
Edward N. Janoff, MD
Chair, R&D Committee
Concur/Non-Concur
Joshua Pridgen
Chief, Health AS
Approve/Disapprove
Ellen Mangione, MD
Chief of Staff
Approve/Disapprove
Carolyn L. Adams
Interim Director