The University of Kansas IRB (HSCL) maintains a database in order to keep track of the 500 or so additional applications HSCL receives each year. >At any one time, there are more than 1000 human subjects research projects going on all over the world. Completed projects or those designated Inactive due to termination by the investigator or by HSCL through failure to provide annual status reports are transferred to an archive database and the hard copy folders are sent to university archives.
Structure for database table: Number of data records: 1000+ Date of last update: 8/01/2003
| Field | Field Name | Type | Width | Purpose |
|---|---|---|---|---|
| 1 |
HSC NUM |
Numeric |
10 |
Internal Control Number |
| 2 |
CODE |
Character |
1 |
A (active/approved) C (contingent) I (inactive) N (not approved) D (disapproved) |
| 3 |
APPL DATE |
Date |
8 |
Date application was received in HSCL office |
| 4 |
CONTINGENT |
Date |
8 |
Date Contingency letter was sent to applicant |
| 5 |
APPROV DATE |
Date |
8 |
Date project was approved |
| 6 |
MONTH APPR |
Numeric |
2 |
Month project was approved. Used to generate monthly requests for report updates |
| 7 |
UPDATE |
Date |
8 |
Date of approval for a change in protocol of previously approved project |
| 8 |
STATUS |
Date |
8 |
Date status report from investigator received in HSCL office |
| 9 |
COMPLT DATE |
Date |
8 |
Date project was completed or terminated |
| 10 |
APPRV TYPE |
Character |
8 |
Exempt, Expedite, or Review |
| 11 |
RISK |
Character |
1 |
Y for Yes, greater than minimal risk, or N for No |
| 12 |
EXEMPTION |
Numeric |
1 |
Exemption category based on 45 CFR 46 46.101 (b) (n) |
| 13 |
EXPEDITED |
Character |
1 |
Category based on 45 CFR 46 46.110 (b) (n) |
| 14 |
FIRST NAME |
Character |
20 |
First name of primary investigator or director |
| 15 |
DIRECTOR |
Character |
20 |
Last name of primary investigator or director |
| 16 |
ASSOCIATES |
Character |
140 |
Researchers other than supervisor conducting research in this project |
| 17 |
SUPERVISOR |
Character |
40 |
Faculty supervisor for projects with student as primary investigator |
| 18 |
DEPARTMENT |
Character |
25 |
University department of primary investigator |
| 19 |
DEPT BLDG |
Character |
20 |
Main university building of department |
| 20 |
ADDRESS 1 |
Character |
35 |
Street address of primary investigator |
| 21 |
ADDRESS 2 |
Character |
35 |
City, State address of primary investigator |
| 22 |
PHONE |
Character |
20 |
Phone number of primary investigator |
| 23 |
TITLE |
Character |
240 |
Title of project |
| 24 |
SUBJECTS |
Numeric |
5 |
Number of subjects or participants in project |
| 25 |
UMBRELLA |
Numeric |
6 |
Internal control number to designate main project that has subprojects |
| 26 |
FED FUND |
Character |
1 |
Y or N are federal funds involved in this project |
| 27 |
GRANTOR |
Character |
20 |
Source of funding, if any, may be federal, state, etc. or private |
| 28 |
EXPIRATION DATE |
Date |
8 |
Date when HSCL approval expires |
| 29 |
INACTIVE TYPE |
Character |
2 |
Choose from drop-down menu |
| 30 |
EXPEDITED |
Character |
2 |
Choose from drop-down menu |
| 31 |
CLINICAL |
Character |
2 |
Choose from drop-down menu |
| 32 |
HIPAA |
Character |
1 |
Y or N does the project come under HIPAA regulations |
| 33 |
KUMC |
Character |
1 |
Y or N is the project to be conducted at KUMC |
| 34 |
SUBJECT TYPE |
Character |
1 |
Choose from 5 items on menu |
| **Total** |
717 |
Questions? Please contact:
Mary Denning
785-864-7429 | mdenning@ku.edu
Coordinator |Human Subjects Committee of
Lawrence (HSCL)
