Please use this form only when:
IRB Project # STU0000__________
 You are submitting a continuing review for research form in eIRB
 The VA is a study site
Please complete this document when submitting your continuing review application in eIRB. Then upload it as a
supporting document into the system.
12.
Section 12.1 must be completed for studies that are clinical trials*, or include the JBVAMC as a study
site, or are funded by grants which require subject breakdown by ethnic origin and gender. For all
other studies, complete this section or provide justification for not doing so:
12.1 Indicate the total number of subjects consented, specimens obtained or charts reviewed of the following
members of minority groups and their subpopulations during the past year and to date
TOTAL NUMBER OF SUBJECTS ENROLLED SINCE LAST
TOTAL NUMBER OF SUBJECTS
YEAR
ENROLLED TO DATE
Total Number of
Total Number of
Ethnic Origin
# Male
# Female
Males and
# Male
# Female
Males and
Females
Females
American Indian/
Alaskan Native
Asian
Black/African American
Hispanic/Latino
Native Hawaiian/Pacific
Islander
White/Caucasian
Other or unknown
TOTAL
*For the definition of clinical trial, please see the overview, guidance and instruction column on our Forms
Page.
12.2 VULNERABLE POPULATIONS: To be completed for VA Studies only. If your study includes the special
populations listed below, please complete the chart.
There are no vulnerable populations enrolled in this study
Study Population
Total # Enrolled
To date
# of enrolled within
the past 12 months
Children
Pregnant Women and Fetuses:
Mentally disabled and those with impaired decision-making capacity
Prisoners
Economically/Educationally Disadvantaged:
16.5 Have there been any complaints about the research in the past 12 months?
No
Yes If yes, please describe
the substance of the complaint, the complainant’s relationship to the study, and how the situation was resolved.