Use to request a modification to previously approved activity




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FORM: Modification
NUMBER

DATE


PAGE
HRP-213

03/10/2016



of


Use to request a modification to previously approved activity

IRB Number:

     

Protocol Name:

     

Principal Investigator Name, Email, Phone:

     

Primary Contact Name, Email, and Phone:

     

Funding Source:

     

Current Protocol Status1

Check all that are true If any part of the statement is not true, do not check the box.



The protocol is permanently closed to enrollment at this institution.



All subjects enrolled at this institution have completed all protocol-related interventions and interactions, including interventions and interactions related to collection of long-term follow-up data.



No additional identifiable private information about the subjects is being obtained by this institution’s investigator.



Analysis of private identifiable information at this institution is completed. (This can be checked even if a statistical center at another institution will analyze private identifiable information from subjects enrolled at this institution.)

If all above are checked, submit a continuing review to close this protocol.



Subjects are currently enrolled (currently enrolled is defined as subjects that have been consented, met formal inclusion and exclusion criteria, and are actively participating in the research in accordance with the protocol)

Describe Modification

If modifying/amending the IRBNet Initial Review Application include the following:

Section title where changes are being made, information being removed, and information being added

     


Provide A Rationale For The Requested Revision

     

Does this change involve foreseeable risks to subjects?

 Yes  No

If this change involves new foreseeable risks, please enter the date you became aware of this information:

       NA

Please enter the total number of subjects currently enrolled at this institution.

     

Current subjects will be notified of these changes by:

Former subjects will be notified of these changes by:

 Signing the revised consent form

 IRB-approved Letter

 Current subjects will not be notified of the changes

 Other      



 Signing the revised consent form

 IRB-approved Letter

 Former subjects will not be notified of the changes

 Other      



If notifying current subjects, explain when you think you will complete this process:      

If notifying former subjects, explain when you think you will complete this process:     

Provide the following documents when they have changed:

  • Investigator Protocol (See TEMPLATE PROTOCOL (HRP-503) for instructions)

  • Evaluation of any Related Financial Interest.

  • Written materials meant to be seen or heard by subjects

    • Evaluation instruments and surveys

    • Advertisements (printed, audio, and video)

    • Recruitment materials and scripts

    • Consent documents (The IRB does not require an informed consent document for HUD use.)

    • If consent will not be documented in writing, a script of information to be provided orally to subjects

    • Foreign language versions of the above

  • Complete sponsor protocol

  • DHHS Grant application, DHHS protocol, and DHHS-approved sample consent document

  • For Department of Energy (DOE) research, a completed “Checklist for IRBs to Use in Verifying that HS Research Protocols are In Compliance with Department of Energy (DOE) Requirements”

  • A copy of all revised documents in “Tracked Changes” format or similarly notated to indicate what changes were made, with "clean" copies of all revised documents.

  • FORM: Administrative Approval (HRP-226) - when there is a change in study Principal Investigator (PI).

 Yes  No

Does your modification include changes to patient care services?

If yes, please complete the Qualifying Clinical Trials form (QCT) and attach with the submission.

Principal Investigator Acknowledgement

I will conduct this protocol in accordance with requirements in the INVESTIGATOR MANUAL (HRP-103) listed in the section “What are my obligations after IRB approval?”

Principal Investigator Signature

*If signing in IRBNet write “Electronic Signature” below

Date




     




1 This refers to the status of the protocol under the supervision of the investigator, not the status of the protocol at all centers.



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