HPRB Form: Request for Renewal/Amendment of Approved Proposal
HPRB Identification (Project Reference) Number:
Principal Investigator(s):
Title of Project:
Most Recent Date of Approval:
Note: It is highly recommended that you have theHPRB Instructions to Request Renewal-Amendmentopen as you fill out this form.
PART I: This request is primarily for: Renewal Modification/Revision
I am requesting renewal and I certify that I have made no major modifications in the protocol or consent form(s) since the approval date cited above.
I am requesting approval of the modifications in the protocol and/or consent form(s) as identified in Part II below. I amincluding brief statements describing/justifying any deletions/changes made.
I am requesting both renewal and approval of the following modifications in the protocol and/or consent form(s) asidentified below in Part II. I have indicated the HPRB proposal section item(s) where modifications are proposed and amincluding brief statements describing/justifying any deletions/changes within the appropriate sections. I have incorporated all proposed changes into the attached research materals, protocol, and consent form(s), as applicable.
Before proceeding with your request for modification or amendment, please answer the following:
a) Have any participants experienced adverse reactions or harm from the research procedures?
Yes No
b) Did any of the participants withdraw from the study due to experiencing adverse reactions or harm from the research procedures?
Yes No
c) Have there been any major unanticipated problems? Yes No
If you answered “Yes” to any of the above questions, please identify the question and explain:
PART II: Please check the categories, if any, in whichyou are proposing modifications at this time. If possible, describe the changes you are proposing in 1-2 sentencesin the space provided with each item below, using the format provided in the instructions. If a significant number of changes are required, please also attach the revised documents and list them in Item #12 Research Materials.
Research Team Principal Investigator(s) (Remember to make changes in contact information on the Consent Form):
Item #1 Type of Risk:
Item #2 Deception:
Item #3 Vulnerable Participants:
Item #4 Research Timeline for Data Collection/Analysis (If requesting Renewal rather than just Amendment, fill in new anticipated timeline.):
Item #5 Research Participants/Exclusionary Criteria/Recruitment:
Item #6 Anticipated Use of Data:
Item #7Risks and/or Benefits:
Item #8 Anonymity/Confidentiality:
Item #9Informed & Voluntary Consent (NOTE: All requests for renewal and amendment MUST include the Cover Letter/Consent Form that will be used upon approval of request for renewal/amendment): Identify attachment here: “” (Use consistent labeling conventions.)
Item #10 Debriefing:
Item #11 Research Procedures (e.g., data collection, design and/or method):
Item #12 Research Materials (i.e., list and attach all new and/or amended materials; you mustinclude the Consent Form you plan to use upon approval of this request):
Item #13 Other Approvals (identify documents here):
Any Other Revisions?
PART III: To finalize and submit your application for renewal/modification, please verify that you have completed this form fully and completely. Then, please read the following statement carefully:
I have read PLU HPRB’s policy on the treatment of human research participants. I will comply with the informed consent requirement, and I will inform the HPRB if significant changes are made in the proposed study.
Submitting this form means that you affirm the statement above and will comply with the content. This counts as your legally binding signature. (Note to Student Researchers: Submitting this form also indicates that your faculty supervisor has approved submission of the proposed changes/modifications/renewal you are requesting at this time.)
Researcher’s NameDate of SignatureDate Last CITI Certification Completed
Email this document as a [last name(s)] request-renewor request-amend Word or .pdf document along with all necessary attachments (using conventions for labeling within instructions) to . Include your original HPRB Project Number and “Request Amendment” or “Request Renewal” in the subject heading of your email.
Pacific Lutheran University: HPRB Form Request Renew/Amend (9/1/2017)1