Request for Modification of IRB Approved Research

LSCDVAMCModifications

April 2014Page 1 of 3

IRB #:
Required
CPA #: ______
(Assigned by IRB Office) / IRB Use Only
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Louis Stokes Cleveland Department of VeteransAffairsMedicalCenter

Request for Modification of IRB Approved Research

All modifications require Prospective IRB Approval

Request expedited review as minor changes in previously approved research 45 CFR 46.110(b)(2)

Section 1 – General Information

1. Date:

2. Title of Project:

IRB #:

3. Principal Investigator (name):

E-mail:

Pager Number/Cell Phone Number:

Signature: Date:

4. Research Contact/Research Coordinator (name):
E-mail:

Pager Number/Cell Phone Number:

Section 2 –Submission Type

5. Please check all applicable boxes and complete corresponding section:

Revised Study Protocol/Research Plan(Section 3)

Revised or additional Informed Consent (Section 3)

Revised Investigator Brochure (section 3)

Data Safety Monitoring Reports (Section 5)

Routine Monitoring Visit Report (Section 5)

New or Revised Recruitment Materials (Section 4)

Revisions to Inclusion/Exclusion (Section 3)

All Other Changes (Section 6)

Section 3 – Protocol Changes

7. Please check all that apply:

Sponsor requested change in Consent Formand/or Research Plan–provide amendment number and/or protocol revision date

Sponsor Amendment or Revised Investigator Brochure Not Requiring Change in Consent Formand/or Research Plan-provide amendment number and/or revision date

Investigator requested Change in Consent Form and/or Research Plan

8. Please summarize the Amendment and/or Investigator requested modification and list the changes to the consent formand/or Research Plan.Submit relevant documentation:

9. If the protocol change/modificationaddresses an issue related to biosafety or radiation safetythe Subcommittee on Research Safety and/or the Radiation Safety Committee must first approve the amendment/modification request.

N/A Approval issubmitted

Section 4 – Change in Recruitment Practices

10. Please check all that apply and respond accordingly. Submit relevant materials:

Recruiting other Subjects -describe:

Request to recruit Non-veterans-provide justification;

Bulletin Boards, brochures, fliers,newsletters, etcdescribe:

Letters to Physicians

Media such as Internet Ads, Press Releases, radio etc.describe:

Other describe:

Section 5 – Data Safety Monitoring Reports or Routine Monitor Visit

11.Please summarize the findings of the Data Safety Monitoring Committee / Boardand/or Monitor Visit and submit the Report:

12. As the LSCDVAMC investigator describe the changes you think are necessitated by the findings of the data monitoring or site visit report:

No changes needed.

Change in Research Plan -describe:

Changes in consent document- describe:

Change in study approval period -describe:

Section 6 – All Other Changes and Requests

15. Please summarize and list any other changes and submit related documentation:

**When modifying a previously approved Research Plan or Informed Consent, work from the most recent approved copy. Submit a “bolded” copy with additions identified as bolded text and deletions identified as strikethrough text. A clean copy that incorporates your revisions must also be submitted.