Addendum Request Form

Addendum Request Form The Institutional Review Board (IRB) on the Use of Human Subjects in Research James Madison University

In accordance with federal regulations, the IRB must review and approve all changes to previously approved research prior to implementation. Please complete this form to describe the proposed changes to your study.

IRB Protocol #:

Project Title:

Name of Researcher(s):

Faculty Advisor (if applicable):

1. Provide an abstract of findings or summary of progress to date:

2. Type of addendum request:

Changes in personnel Funding source

Data collection tools/procedures Subject recruitment methods/selection criteria

Project goals Other (please specify):

Informed consent process/forms

3. Provide a brief description of changes and rationale:

4. Attach amended material, as applicable (highlight all changes):

Certification: I certify that the information supplied on this form and in accompanying attachments is complete and accurate and that no procedures other than those disclosed on this form will be used in this protocol. I will promptly report to the IRB all research-related accidents, injuries, complaints, problems, or breeches of

Submit electronic copy to [email protected] and a “signed” hard copy to the Office of Research Integrity, MSC 5738 | Burruss Hall, First Floor, Room # 109 (Electronic signatures are accepted. If including electronic signature(s), a hard copy is not needed.) confidentiality. I will report any significant new findings that may affect the risks and benefits to the subjects and other participants in writing to the research participants and to the IRB.

Signature: Date:

Faculty Advisor Signature: Date: