ADDENDUM APPLICATION FORM
Submitting an Addendum Request
The UMCP IRB will no longer accept an email request
for an Addendum Application without an Addendum
Application Form
attached. Addendum Applications Forms may be
submitted via email, campus mail or in person.
Important Points Regarding Addendums:
-
Federal Regulations
require that all revisions be approved by the
IRB prior to their implementation.
-
Addendums that
increase the risk of research participation must
be approved by the fully convened IRB
committee.
-
If the proposed
revisions heavily modify the protocol, the IRB
may request that a New protocol application be
submitted. Contact the IRB
Office if you have questions.
Definitions
Addendum:
This is a modification to a currently IRB Approved
protocol. Also known as an amendment. Any
changes to an IRB Approved protocol
(Exempt/Expedited/Full Board) must be submitted to
and approved by the IRB prior to implementation.
Addendum during Continuing Review: The IRB does not recommend submitting
addendum requests during the Continuing Review
process as this will increase the turnaround time
for these applications. However, if the
requested modifications are minor (for example:
editorial or research staff changes) please make the
changes to the appropriate section of the protocol
and clearly identify the changes in the Continuing
Review application. In certain cases the IRB
will make an exception to this policy, please
contact the IRB with questions.
Risk Classification:
The protocol application presents minimal risk
or greater than minimal risk.
Submission Process
Requests to modify an active protocol may be
submitted by completing the
Addendum Application Form
and submitting the completed form to the IRB Office.
This can be accomplished by emailing the form to
irb@umd.edu.
Please Note: The email must be sent from the
Principal Investigator. The subject line of
the email must be addressed as follows:
Addendum Request for Protocol XX-XXXX
Approval Dates
The approval of an Addendum Request will not change
the expiration date of the protocol. The
expiration of IRB Approval will remain the same as
determined at the previous Initial IRB Approval or
Continuing Review. For example if the protocol
expires 6/14/09 and the Addendum Request is approved
on 2/10/09, the Addendum Approval Letter will
reflect the following approval period: 2/10/09 –
6/14/09.
Please Note:
Addendum Requests do not change the duration of IRB
Approval.
Revised Documents
If revised versions of documents (consent documents,
flyers, etc) previously approved by the IRB are
submitted with changes, please note this in the
footer of the document. For example:
Revised-3/10/09. This helps maintain a
proper protocol review history.
Adding Investigators to the Research Team
If additional members will be added to the research
team, IRB Approval is required prior to these
members engaging in any research activities.
All research team members must complete appropriate
human subjects research training. We currently
require all Principal Investigators and research
team members to complete the NIH Human Subjects
Training.
https://phrp.nihtraining.com/users/login/php.
We will be offering additional human subjects
training in the near future.
If there will be a change to the Principal
Investigator, a signed letter from both the current
PI and new PI must be submitted with the Addendum
Request. The letter should clearly state that
both PIs agree to the change. A signed letter
from each PI may be submitted with the Addendum
request if signatures cannot be obtained on a single
letter.
Download
Addendum Application
Form
Download Consent Form
|
