Amendment Form

Request to Amend A Currently-Approved Project

Institutional Review Board – Human Participants

Part 1 – Administrative Information 

1. Protocol Information
Title:
 

2.

  

Contact Information
Principal Investigator (PI):
Email address:
College:
Department:
Status               Undergraduate Student Graduate Student Post Doctoral Fellow Faculty Staff

Part 2 – Amendment Information

  1. Please select ALL the categories of amendment(s) you are requesting.
    • Change in Study Title
    • Change in Principal Investigator
    • Addition of/change in research personnel Addition of/change in funding source
    • Change to research/study design, methods or procedures (e.g., observations, interventions, collection of biological samples or biometric information, participant tasks, etc.)
    • Addition of/change to study population
    • Addition of/change to recruitment or compensation procedure(s)
    • Addition of/change to survey(s), questionnaire(s), or other research instruments  – please attach the revised instrument/s
    • Addition of/change to the identifiers collected in the study, or any others that would impact the privacy and confidentiality of the study participants
    • Addition of/change to informed consent/assent document(s) and/or procedures  – please attach all related documents
    • Other changes
  2. You selected the following categories of amendments. For each of the following, please describe the change you are proposing.
  3. Please state the reasons you are making amendments to the study.
  4. Are any of these changes the result of something that occurred during human participant interaction or an unexpected event? Yes                No
  5. Will the proposed changes have an impact on the risks or benefits to research participants? Please explain.
  6. Do these changes involve information that might relate to a subject’s willingness to continue to take part in the research?
    Yes                No

Signature
This page is to be signed by the principal investigator. If the principal investigator is an undergraduate or graduate student, the faculty supervisor must also sign in the lower box.

Principal Investigator/ Faculty Advisor

I certify that the information I provide in this application is correct and complete. I also pledge that I will not change any of the procedures, forms, or protocols used in this study without first seeking review and approval from the Institutional Review Board for Human Participants.

Attestation of Principal Investigator                                                 Date


Contact
irb@mountsaintvincent.edu