**Read this form carefully and address all items apply to the
modification(s) or new finding(s). Modifications may not be implemented
until approved by the ORSIRB.** Please call the ORSIRB Administrator at
(865) 576-1725 for assistance. Provide attach a signed copy of this form
to your IRBNet Project ([www.IRBNet.org](http://www.IRBNet.org/)) along
with any supporting documents as noted below.

**Date:       ORSIRB No.:**      

## Project Title:      

**Principal Investigator:**      

Address:       Phone:       Fax:       Email: [     ]{.underline}

Contact person:       Phone:       Fax:       Email:      

**Describe any change or increase in risk to subjects that might result
from the modification or finding and explain how risks will be
minimized. Address all items below that might be affected by this change
(i.e., a change in procedure often requires revisions to the consent and
other information provided to subjects).**

**No change in risk to subjects.**

**Change to consent is not required. Explain below under appropriate
topic.**

**Additional or different risk to subjects. Explain below under
appropriate topic.**

**AMENDMENT TO THE PROTOCOL:** Describe modifications, omissions, or
additions to the current approved protocol. Attach amendment, current
statement of work and supporting documents. ***     ***

**CHANGE IN STUDY PURPOSE AND SCOPE:** Describe the change in study
purpose/scope and explain why the change is necessary. ***     ***

**CHANGE IN RESEARCH PROCEDURES INVOLVING SUBJECTS:** Describe the
change in research procedures involving subjects and provide an
explanation. ***     ***

**CHANGE OR ADDITION TO PROJECT DOCUMENT, such as advertisements,
questionnaires, and data management plans, etc.:** Explain why changes
are required. Highlight the original copy and submit with the new
version. If new, explain the purpose for the document; describe how it
will be used and by whom. ***     ***

**NEW OR SIGNIFICANT FINDING:** Describe the new or significant finding,
how it will increase or change the risk to subjects and possibly impact
their willingness to participate. ***     ***

**CHANGE IN BIOLOGICAL MATERIALS/SAMPLES OR SUPPLIER:** Describe the
change in type, identification, or source of biological materials,
samples, or tissues derived from humans. Explain the reason for the
change and describe additional requirements for subject protections that
may be required. ***     ***

**CHANGE IN SUBJECT POPULATION and/or METHOD OF RECRUITMENT:** Explain
the proposed change in subject population and/or the method of
recruitment. If different from the approved protocol, include inclusion
and exclusion criteria, number and age, gender, vulnerability, approach
and method of recruitment. ***     ***

**REVISION TO CONSENT PROCESS, FORM OR ORAL SCRIPT:** Provide an
explanation for the revision. For revised documents, highlight changes
on one copy and submit with revised copy. If new, please state.
***     ***

**CHANGE IN INVOLVED INSTITUTIONS OR SITES:** Explain the change in
institution or site involvement. Submit a current IRB approval or letter
of cooperation for each institution or site. Provide IRB contact
information as coordination between institutions may be required to
complete this review. ***     ***

**ADVERSE EVENTS:** Use this form to report changes instituted as a
result of "minor" adverse events only (those noted in the consent as
anticipated or no more severe than would normally be expected, such as
minor bruising or fainting from a blood draw). Briefly describe the
event and the changes being implemented in response to the event.
Evaluate the need for revised consent. "Minor" adverse events must be
reported during annual continuing review or upon study completion,
whichever occurs first. ***     ***

**Note:** **Serious events (unexpected or more severe than anticipated)
must be reported [immediately]{.underline} to the ORSIRB using the
ORSIRB "Adverse Event Report Form." Consult with the ORSIRB
Administrator to determine seriousness of the event.**

**CONFLICT OF INTEREST:** Describe any changes in the financial or
professional interest of members of the research team or other
institutions collaborating in this study that might constitute a
conflict of interest. Consult with ORSIRB if in doubt. ***     ***

**CHANGE IN PRINCIPAL INVESTIGATOR:** Provide new PIs current CV/resume
and documentation of Human Subjects training. ***     ***

**CHANGE OF CO-INVESTIGATORS.** Provide list (full name/degree/
affiliation) of new investigators and of investigators no longer
associated with the study/project.. ***     ***

**OTHER CHANGES:** Describe the change, discuss possible impact to
subjects and provide supporting documentation. ***     ***

**Current PI Name:       Phone:       Fax:      **

**Printed Email:      **

**Effective Start Date of Current PI on this Project:      **

I understand that as Principal Investigator, I am responsible for the
conduct and ethical performance of this project, for protecting the
rights and welfare of human subjects, and for strict adherence to any
stipulations imposed by the ORSIRB in accordance with applicable
Federal, State, and Institutional policies and procedures. I will:

-   Conduct this project using only qualified personnel in accordance
    with the approved protocol.

-   Obtain ORSIRB approval before implementing any changes to the
    approved protocol, consent, or supporting documents (except in an
    emergency to safeguard the immediate well being of subjects).

-   Secure legally effective Informed Consent from subjects or their
    responsible representatives, using only the currently approved
    consent form.

-   Immediately report serious or untoward adverse effects to my
    institution's and/or the ORSIRB as applicable.

-   Provide documentation of human subjects training for key project
    staff.

-   Report any potential conflict of interest for my institution's staff
    or collaborating institutions.

**I certify the information provided above is accurate and complete.**

**Current Principal Investigator Signature
:**\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
**Date:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**

**Attachments:      **