All changes are effective as of Revision Date. Applications submitted before Revision Date are not affected.
Users of the on-line version of the IRB Manual are hereby advised that changes have been made to the Manual as indicated below.
Holders of paper versions of the Manual are asked to keep a copy of the most recent Change Page with their Manual, indicating with their initials that the changes have been made (typically by downloading the revised docments or pages and replacing the obsolete documents or pages with the new pages).
The IRB Manual was issued effective 7/1/00.
|Chg #||Pages changed||Revision Date||Entered by:|
|1||Title Page (non-substantive chg.)||8/31/00||JRB|
|2||Protocol Renewal Form: New Question #7 (and renumbering ff.)||10/12/00||JRB|
|3||Standard/Expedited Application Form: Revised Question #5||10/12/00||JRB|
|4||Standard/Expedited Application Instructions: Number of copies for Standard Applications changed to 16||10/12/00||JRB|
|5||Standard/Expedited Application Form: Revised Question #6||10/27/00||JRB|
|7||Interactive Review for Exemption Status Program revised; Exempt Review Application Form deletion of reference to Standard Review in question 6.A.||12/15/00||JRB|
|8||IRB Procedures established (New Section L.)||12/15/00||JRB|
|9||Standard/Expedited Application:Question #15 rephrased||12/19/00||JRB|
|10||Code of Federal Regulations Documents. All CFR documents on Human Subjects now listed. 45 CFR 46 linked to two formats.||12/21/00||JRB|
|11||Dear Colleague Letter of 1/22/01 and change to Faculty Sponsor' Statement form||1-22-01||JRB|
|12||Change to Question #12 of the Standard/Expedited Application Form and Instructions
Please note that the IRB has authorized the inclusion of the Responsible Conduct in Research Website as a resource within the IRB Manual. See Section M.
These changes include changing the name of the "Exempt (from IRB Review) Application" to the "Administrative Review Application."
Changes to the Administrative Review Application, parallel change to the Administrative Review Application Instructions, and changes to the Administrative Review Decision Program. These changes are effective immediately for persons who have not aleady begun an application using the old form and in any case for all applications received June 1, 2001 or later.
Three Application form questions have been completely changed and the remainder restated for clarity. The Administrative Review Decision Program has been simplified in the area of Risk Analysis. Also one category of research (on instructional strategies and pedagogy in regular and special education settings) has been more made more readily eligible for Administrative Review.
|14||The CSULB Policy on the Use of Existing Data has been modified to permit researchers to NOT APPLY for IRB or Administrative under certain circumstances. Please see new section N. of this IRB Manual, "Research Use of Existing Data Involving Human Beings".||11/01/01||JRB|
|15||A link to the NIH Certificate of Responsibility website has been added to the Manual at Appendix W. See: http://grants.nih.gov/grants/policy/coc/index.htm.||4/2/02||JRB|
|16||New IRB Procedures (replacing the existing IRB Procedures, Appendix L.) of the IRB were approved in the May meeting of the Board. They are posted in the IRB Manual as Appendix L.||5/24/02||JRB|
|17||Added new Application Form for Standard, Expedited, or Administrative Review, and new Application Form for Use of Existing Human Data, and new Instructions for Completing the IRB Application Forms.||1/31/06||JAT|
|18||Replaced IRB combined appliction with new version dated 3/10/06||3/13/06||JAT/jh|
|19||Replaced Application for Use of Existing Human Subject Data with new version dated 4/10/06||4/10/06||JAT/jh|