Institutional Review Board …for the protection of human participants in research

North Dakota State University

Office of Sponsored Programs Administration Date of Receipt

Rm 130, Research 1, Research & Technology Park

Fargo, ND 58105 231-8908(ph) 231-8098(fax)

Protocol Amendment Request Form

Use this form to request change(s) to a previously approved protocol. Examples may include, but are not limited to: addition of investigators or key personnel, revised recruitment procedures, compensation scheme, a new participant population, research setting, data collection procedures, or additional/changes to the information to be collected. These changes require review and approval by the IRB prior to implementation, except where an immediate change is necessary to eliminate a hazard to the participant. However, very minor changes such as slightly revised wording on a survey or consent form would not require IRB approval, as long as the revised document(s) will not collect identifiable or potentially harmful or sensitive information, or alter participants’ understanding of the study.

Protocol Information:

Protocol #: HS07269 Title: The role of scientists as public advisers

Principal investigator: Dale Sullivan Co-investigator:

Principal or co-investigator Signature, Date: ______

Description of proposed changes:

Provide a complete description of all proposed change(s), including justification for the change(s). Also address whether or not the change(s) will increase any risk of harm (physical, economic, psychological, or sociological) or privacy protections for subjects:

I would like to add two graduate students to the research team as my assistants. I anticipate adding Nurjahan Perveen and Paula Cameau when they have completed IRB training. They will work with the scripts I submitted with the IRB approval form and which were approved. I will supervise their work closely.

Date of proposed implementation of change(s): September 14, 2007 or as soon as possible

Attachments:

Will the change(s) alter information on the previously approved protocol form? No Yes

If Yes, attach a revised protocol form so that IRB files can be updated.

Will the change(s) require a revision to the recruitment materials, informed consent, or other documents? No Yes If Yes, attach revised/new document(s).

------FOR IRB OFFICE USE ONLY ------

Request is: Approved Not Approved
Review: Administrative Expedited method, category # ____ Convened meeting, date: ______
Exemption, category#: No more than minimal risk
IRB Signature: Date:
Comments:

Protocols previously declared exempt: If the proposed change does not alter the exemption status, the change may be administratively reviewed by the IRB Director, chair, or other member. If the change(s) would alter this status, a new protocol must be submitted for Expedited or Full Board review.

Protocols previously reviewed by the expedited method: If the change is limited to addition/change of investigators, key personnel, or research site(s), it may be reviewed administratively. Other changes will be reviewed by the expedited method, unless the change would increase risks to participants, or alter the expedited status of the project.

Protocols previously reviewed by the full board: If the change is limited to addition/change of investigators or key personnel, it may be reviewed administratively. If the IRB had previously categorized the project as no more than minimal risk to participants, and the proposed change(s) would not increase the risk, it may be reviewed by the expedited method. All other changes will be reviewed by the full board.

Protocol Amendment Request Form Page 1 of 2

NDSU Institutional Review Board Last printed 06/09/2006 2:58:00 PM

Form revised May 2006