Rev – 4/17/09Request for Amendments

TulaneUniversity
IRB Secondary Submission Checklist

The IRB will not accept submissions that are handwritten and/or are not complete. This checklist must be submitted with every Ongoing/Secondary submission.

Study #: PI:

Study Title:

Please use this checklist to verify that your submission is complete. The Amendment Form can be found after the checklist.

Required for Continuing Reviews: /  / N/A
  1. A detailed COVER LETTER summarizing the purpose of the submission and listing the enclosed contents.

  1. Continuing Review Application signed by the PI

  1. Updated Consent and Assent if still open to accrual
  2. The appropriate headers and footers/version dates should be current on the Consent Form– use the most current Tulane Consent Form template as a reference.

  1. If participants were enrolled during the last approval period, you MUST include two entire Consent Forms signed by participants with the signatures blocked out.

  1. An updated Conflict of Interest Disclosure Form if there are changes in leadership roles, secondary commitments, or financial interests.

  1. DSMB Reports

  1. Any new or updated materials

  1. Interdepartmental Transfer Form (Industry-Sponsored Studies only)
  2. Continuing Reviews of active studies submitted before 2/1/09 will continue to be charged at a rate of $750. Continuing Reviews of studies initially submitted after 2/1/09 will be charged at a rate of $1000.

Required for Amendments/Revisions: /  / N/A
  1. A detailed COVER LETTER summarizing the purpose of the submission and listing the enclosed contents.

  1. Amendment Form signed by the PI

  1. Amended/Revised Item(s)

  1. Updated Protocol, if affected by the Amendment

  1. Updated Consent and Assent if still open to accrual and affected by Amendment
  2. The appropriate headers and footers/version dates should be current on the Consent Form– use the most current Tulane Consent Form template as a reference.

  1. An updated Conflict of Interest Disclosure Form if there are changes in leadership roles, secondary commitments, or financial interests.

  1. Any new or updated materials

Deferred Major: /  / N/A
  1. A detailed COVER LETTER addressing the IRB letter sent to the PI

  1. Any Additional Materials Requested – 10 copies

  1. Any Materials Needing Revision Requested – 10 copies

Deferred Minor: /  / N/A
  1. A detailed COVER LETTER addressing the IRB letter sent to the PI

  1. Any Additional Materials Requested – 1 copy

  1. Any Materials Needing Revision Requested – 1 copy

Unanticipated Events: /  / N/A
  1. A detailed COVER LETTER summarizing the purpose of the submission and listing the enclosed contents.

  1. Unanticipated Events Form signed by the PI

  1. Any communication regarding the Unanticipated Event

Protocol Violations: /  / N/A
  1. A detailed COVER LETTER summarizing the purpose of the submission and listing the enclosed contents.

  1. Protocol Violation Form signed by the PI

  1. Any communication regarding the Protocol Violation

Closure: /  / N/A
  1. A detailed COVER LETTER summarizing the purpose of the submission and listing the enclosed contents.

  1. Research Closure Form

  1. Any communication regarding the Closure

Other Submissions: /  / N/A
  1. A detailed COVER LETTER summarizing the purpose of the submission and listing the enclosed contents.

  1. Any other documents in relation to the submission.

TulaneUniversity Institutional Review Board
Request for Amendment of IRB Approved Research

Investigators who wish to make any revisions to their originally approved protocols must seek IRB review and obtain approval before initiating changes. Attach any and all research documents or any supportive materials that have been modified due to the proposed Amendment (such as consent forms, protocols, subject recruitment advertising, questionnaires, surveys, results from related studies, etc.) to this form.

The Amendment Request Form may be mailed or hand delivered to the Tulane University Human Research Protection Office. Please note that handwritten and/or incomplete forms will be returned to you. If you have any questions, please contact:

Tulane University Human Research Protection Office
IRB: Biomedical and Social/Behavioral
1440 Canal Street
Suite 1705
TidewaterBuilding TW-36
New Orleans, LA 70112
(504) 988-2665


Protocol Title:

TulaneUniversity IRB #:

Date of Expiration:

NOTE: NO CHANGES IN THE RESEARCH MAY BE IMPLEMENTED WITHOUT PRIOR IRB APPROVAL

Section A: General Information

  1. Principal Investigator:

Last Name: / First Name:
Campus Address: / Mail Code:
City: / State: / Zip Code:
Phone: / Fax: / Email:
  1. Co-Investigator/Study Coordinator:

Last Name: / First Name:
Campus Address: / Mail Code:
City: / State: / Zip Code:
Phone: / Fax: / Email:

Please check here and attach a list of Additional Investigators or Coordinators, if applicable.

Section B: Amendment

  1. Indicate the type of Amendment:

A Minor Amendment is a proposed change in research-related activities that does not significantly affect an assessment of the risks and benefits for the study and does not substantially change the specific aims or design of the study.

Examples of Minor Amendments include:

-Addition or deletion of study team members

-Addition of procedures that do not significantly increase risk to subjects, considering the original purpose and study design of the approved study (i.e. new procedures that fall under any of the expedited categories can usually qualify as minimal risk)

-Removal of research procedures that would thereby reduce the risk to no more than minimal (i.e. procedures now meet expedited research categories)

-Addition of non-sensitive questions to survey or interview procedures

-Revisions of recruitment materials or strategies

-Administrative/Editorial changes to the approved documents

A Major or Substantive Amendment is a proposed change in research-related activities that significantly affects an assessment of the risks and benefits of the study or substantially changes the specific aims or design of the study.

Examples of Major Amendments include:

-Addition of a new and/or separate subject population (e.g. control group, additional cohort, vulnerable population, etc.)

-Addition of research procedures that involve greater than minimal risk to subjects (e.g. addition of a new drug treatment regimen, addition of invasive proceedings, change in route or frequency of drug administration, etc.)

-Addition of surveys/questionnaires/interview procedures that could have adverse psychological consequences for subjects or damage their financial standing, employability, insurability, or reputation

-Removal of follow-up visits that appear necessary for monitoring subject safety and welfare

Type of Amendment:

Minor Amendment
Major Amendment

  1. Describe the Amendment – Describe the proposed change(s) and clearly reference materials attached to this form.
  1. Provide a clear rationale for the proposed change(s).

Section C: The Effects of the Amendment

  1. Will the Amendment affect the risks or benefits to the subjects? If Yes, please provide a justification for the proposed Amendment.
  1. Will the Amendment require a change in the consent process or form? If Yes, please explain the nature of the change.

Section D: Attachments

Revised Protocol, if applicable

Revised Consent Form(s)/Assent Form(s)/any other Informed Consent documents, if applicable

Revised Recruitment Materials, if applicable

Revised Research Materials (survey, questionnaires, instruments), if applicable

Other, Describe:

Section E: Principal Investigator’s Statement of Assurance

I certify that the information provided in this application is complete and correct.

I understand that I cannot initiate any changes in my approved protocol before I have received IRB approval and/or complied with all contingencies/stipulations with regards to that approval. By signing this form, I certify that all relevant information concerning adverse events or other issues that might affect the risk/benefit ratio of this study has been disclosed to the IRB.

Also, I certify that all of the appropriate documents will be submitted to the IRB for review including a study closure form if the research is completed over the course of the approval period.

______
Principal InvestigatorDate

*Forms are subject to change. Check the Tulane IRB web site for the latest forms.1 of 6