Request for Modification to a Protocol Information

REQUEST FOR MODIFICATION TO A PROTOCOL INFORMATION

INSTITUTIONAL REVIEW BOARD

Hello and thank you for accessing this form from the University of Maryland, Baltimore County Institutional Review Board web site.

Prior to submitting, please ensure that spelling and grammar are correct; this will assist in the timely review of this form during the IRB evaluation process.

Enter information by clicking the ☐ box or typing in the Click here to enter text.area.

Please go to UMBC IRB website for all up-to date guidance and information regarding the below questions.

IRB #:Click here to enter text.Investigator(s): Click here to enter text.

Protocol Title: Click here to enter text.

Date modification is submitted: Click here to enter a date.

Original Approval: Expedited ☐ Full Board ☐

Select all appropriate sections that describes the modification.Attach copy of revised protocol application highlighting in yellow and underline)indicating where changes are required.ALL modified documents must be submitted in Microsoft Word format

☐Change in Procedures / ☐ Add / ☐ Delete / ☐ Modify
☐Change in Principal Investigator / ☐ Add / ☐ Delete / ☐ Modify
Indicate CITI training completion dates
☐Change in Study Personnel / ☐ Add / ☐ Delete / ☐ Modify
Indicate CITI training completion dates
Has there any changes to any previous conflict of interest disclosure, as described by UMBC’s Conflict of Interest policies? ☐Yes ☐No ☐ N/A
☐Change in Measures / ☐ Add / ☐ Delete / ☐ Modify
Attach copy of revisions highlighting in yellow and underline.
☐Change in / Add Sponsored Funding / ☐ Add / ☐ Delete / ☐ Modify
Attach copy of the components of grant applications and contract proposals related to human subjects use [e.g. the Human Subjects section]as well as any amendment if it involves changes or additions to sponsored funding (e.g. submission of JIT materials, confirms to an agency that a grant has IRB approval, or adds a new award to an existing protocol).
☐Change in Recruitment/Advertising / ☐ Add / ☐ Delete / ☐ Modify
Attach copy of revisions highlighting in yellow and underline.
☐Change in Number of Participants and/or Participant Selection / ☐ Increase by: Click here to enter text. / ☐ Decrease by: Click here to enter text.
Resulting total to be enrolled: Click here to enter text.
Reason for Change: Click here to enter text.
☐Consent Process Change and/or Change in Consent Documents / ☐ Add / ☐ Delete / ☐ Modify
Attach a copy of the current approved consent document and a copy of the proposed document with changes highlighted in yellow and underlined
☐Change in Data Collection, Storage and Confidentiality / ☐ Add / ☐ Delete / ☐ Modify
☐Change in Location / ☐ Add / ☐ Delete / ☐ Modify
☐Other Change / Specify:Click here to enter text.

Reanalysis of Risk

☐This modification does not increase the risks to participants in the approved protocol

☐This modification does increase the risks to participants in the approved protocol

Provide a narrative summary of all proposed modifications with a description of how the modifications affect research risks and benefits. Also describe any event or new data that precipitated the change.

Click here to enter text.

Electronically submit the protocol and any accompanying documents to .

By typing your name, email address and date, the investigator(s) certify they will abide by all UMBC IRB policies and procedures and understand that no research activities will be conducted with human participants prior to obtaining the required approvals.All changes must be submitted and approved by the IRB prior to their implementation

Investigator’s Signature: Click here to enter text.Email: Click here to enter text. Date: Click here to enter a date.

Faculty Advisor's Signature: Click here to enter text.Email: Click here to enter text. Date: Click here to enter a date.

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IRB Action

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Approval of changes/modifications by the IRB Chair/DateRequires Expedited Review? Yes ☐ No☐

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Approval of administrative changes/modifications, Office for Research Protections and Compliance/Date

(modification request form) –06/06/2016

modificationrequest27 December 2018