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Human Subjects Division (HSD)

Documents

Document Details

Last Updated 04/15/2014
Version 6.30
Filesize 2.76 MB
Audiences Researcher
Doc Type Form
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APPLICATION: Modification, Approved Project

Purpose

Use this form to request modifications to an already approved IRB application, add or remove research team members, and submit offsite adverse event reports. See the APPLICATION: Modification, Approved Project (No Hidden Branching) linked below to see the form in its entirety, without interactive features.

HSD NO LONGER ACCEPTS THE OLD MODIFICATION FORM

Change Notes

  • Related to Ver. 6.30, noted 04/15/2014 @ 11:19am
    Updated text on landing page. Form not changed.
    - sherrye
  • Related to Ver. 6.30, noted 03/03/2014 @ 12:25pm
    Fixed issue with breaking text boxes.
    - sherrye
  • Related to Ver. 6.20, noted 02/28/2014 @ 10:49am
    Added reference to new Genetic Supplement.
    - sherrye
  • Related to Ver. 6.10, noted 02/06/2014 @ 11:17am
    Fixed bug in funding table. Made hidden headers visible in print. Future versions will work to have them not print or take up space on the page.
    - sherrye
  • Related to Ver. 6.00, noted 01/31/2014 @ 10:25am
    New PDF version. Please use this version going forward.
    - sherrye
  • Related to Ver. 6.00, noted 11/22/2013 @ 10:52am
    Added references to FDA, DOJ, FERPA, and PPRA. Please use this version going forward.
    - sherrye
  • Related to Ver. 5.90, noted 11/01/2013 @ 01:26pm
    Added reference to GWAS dbGap suppelement under procedure changes. Okay to use previous version.
    - sherrye
  • Related to Ver. 5.80, noted 10/19/2013 @ 04:41pm
    Updated name to new naming convention on website.
    - sherrye
  • Related to Ver. 5.80, noted 05/31/2013 @ 09:55am
    Updated mailing address information. Okay to use previous version.
    - sherrye
  • Related to Ver. 5.70, noted 01/25/2013 @ 09:29am
    Updated FCOI language. Okay to use previous version.
    - sherrye
  • Related to Ver. 5.60, noted 12/28/2012 @ 09:37am
    Updated to reflect change that we require only a notation of how frequently a sponsor may require training refreshers, rather than full documentation. Question added to section E. Okay to use previous version.
    - sherrye
  • Related to Ver. 5.50, noted 09/28/2012 @ 09:22am
    Clarified signatures in changing lead researcher-current lead researchers signature is always preferred unless truly unattainable. Clarified that new DoD supplement is not required when adding new staff, just the assurance that they will comply with DoD training requirements. Okay to use previous form version 5.4 until 11/30/12.
    - sherrye
  • Related to Ver. 5.40, noted 05/25/2012 @ 09:04am
    New questions added for anesthesiology. New questions added for changing Lead Researcher. Do not use older versions of this form. HSD will not accept older versions after July 1, 2012.
    - sherrye
  • Related to Ver. 5.10, noted 03/30/2012 @ 08:49am
    Questions in Section I, Table C 1.d and 1.e and Section J, Table A 5.d and 5.e were combined and changed to more accurately discover if the researcher or site are engaged in the research. Okay to use previous versions.
    - sherrye
  • Related to Ver. 5.00, noted 03/16/2012 @ 08:55am
    Fixed typo.
    - sherrye
  • Related to Ver. 5.00, noted 02/24/2012 @ 08:38am
    Update to signature policy when changing PI. Okay to use previous version.
    - sherrye
  • Related to Ver. 4.90, noted 11/30/2011 @ 02:48pm
    Removal of NW Hospital from Section J: Sites and Locations, Table A: Adding Research Sites. Use latest version.
    - sherrye
  • Related to Ver. 4.80, noted 10/28/2011 @ 09:05am
    Fixed typos. Okay to use earlier version date.
    - sherrye
  • Related to Ver. 4.70, noted 10/07/2011 @ 09:59am
    Fixed internal document link - okay to use forms with earlier date.
    - sherrye
  • Related to Ver. 4.60, noted 08/12/2011 @ 01:43pm
    Minor adjustments to instructions to make more clear.
    - sherrye
  • Related to Ver. 4.50, noted 07/29/2011 @ 11:10am
    Reformatting of training section from flat text to question and answer. Addition of links to training policy.
    - sherrye
  • Related to Ver. 4.00, noted 05/27/2011 @ 09:14am
    Addition of double-sided instructions, updated training requirements, remove mention of ARRA funding, updated Confidentiality Agreement instructions.
    - sherrye
  • Related to Ver. 3.97, noted 04/11/2011 @ 10:36am
    Added clarifying note to section I, table C, question 1a.
    - sherrye
  • Related to Ver. 3.97, noted 03/09/2011 @ 04:25pm
    Added text to instructions regarding signature submission in section I, table A.
    - sherrye
  • Related to Ver. 3.96, noted 02/25/2011 @ 09:27am
    Updated copy # instructions on first page for clarity.
    - sherrye
  • Related to Ver. 3.94, noted 10/01/2010 @ 08:54am
    Very minor update to front page checklist - addition of two examples for section N.
    - sherrye
  • Related to Ver. 3.93, noted 09/20/2010 @ 05:24pm
    Updated document authors.
    - sherrye
  • Related to Ver. 3.93, noted 09/16/2010 @ 11:03am
    Updated document links.
    - sherrye
  • Related to Ver. 3.92, noted 08/17/2010 @ 02:55pm
    Report of Other Problems is now a stand-alone form. Modification form has been altered to reflect that.
    - sherrye