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OU
Health Sciences Center HRPP
Frequently
Asked Questions (FAQ)
Application
Submission
Q What is the OUHSC Federal Wide Assurance (FWA) number?
A FWA 00007961
Q How many copies must I submit for new protocol
submissions?
A
Full Board - submit the
original and 10 copies
Exempt
and Expedited - submit the original only
Q
How many investigator brochures should
I include with the submission of my protocol?
A
Two
Q
What is a protocol number?
A
A Protocol number is a number assigned
to your protocol by the industry sponsor, sponsoring pharmaceutical
company or by a cooperative group such as Gynecologic Oncology Group
(GOG).
Q
Why does the application for Continuing
Review require that I submit a copy of the protocol? Doesn't the
IRB office already have a copy of my protocol on file?
A
Based on guidance from the Office of Human
Research Protection (July 11, 2003), IRB policy states that during
the continuing review process, IRB members must receive and review
a copy of the complete, most current version of the protocol, including
any modifications previously approved by the IRB. In order to ensure
that Investigators have submitted all protocol modifications to
the IRB and are conducting their research with the most recently
reviewed and approved IRB version, Investigators must submit a copy
of the version they are currently using.
Q
For Non-English
consent forms, are we required to use a certified translator for
the translation of the consent form, or, can we use a translator
that submits an attestation that the documents are the
same?
A
According to our revised IRB policies, the translated
informed consent must be accompanied by a certified attestation
from the translator. The translator is thus certifying by the attestation
that the translated informed consent accurately reflects the IRB
approved English informed consent. Our policy doesn't state that
the translator must be certified. We also encourage that if you
don't have a translator available that you refer to the following
website: www.globallanguages.com
Approval
Process
Q
What is the status of my submission, (New
Study, Continuing Review, Protocol Modification, or Board Requested
Revisions)?
A
You can check the status of your submission
by calling the IRB office with your IRB number in-hand. If you have
yet to receive an IRB number, have the name of the Investigator
and the study title in-hand.
Q
Can I be granted an extension to the deadline
due date for my Continuing Review (CR)?
A
Since federal regulations do not
allow for a grace period or extension of an
approval period, the IRB sends reminder notices to Investigators
in advance of the approval period expiration. The reminder
notices require the Continuing Review (CR) to be submitted by the
deadline due date in order for the CR to be reviewed
and approved by the IRB prior to the approval period expiration.
For inquiries regarding an extension for submitting
your CR after the deadline due date , contact Donna Hogan by e-mail donna-hogan@oushc.edu
or by calling 271-2045.
Education
Requirements
Q
What are the education requirements for
IRB?
A
•
Human Research Participant Protection in-house training
•
Completion of the CITI (Collaboarative IRB Training Initiative)
•
Faculty only are required to sign and date the Written Attestation
form.
For more information
visit Education in Human
Research.
Q
Where can I locate the Written Attestation?
A
The Written Attestation can be found
at the Education
in Human Research link. Click Written
Attestation .
Q
How do I enroll for the Human Research
Participant Protection in-house training course?
A
You can enroll for the HRPP course by
emailing pamela-cedeno@ouhsc.edu
You will need the following information at the time of enrollment.
- First
and last name
- Credential
(MD, PhD, RN, BA)
- Title
(Professor, Research Coordinator, Fellow)
- Department
- Campus
Address
- Phone
Number
Forms
Q
Where do I find IRB forms?
A
IRB forms are located on the IRB website
at IRB Forms.
Informed Consent
Q Is a faxed copy of the signed consent form acceptable to document informed consent?
A Yes, if it is more convenient for the subjects to fax a signed copy of the consent form to the investigator, the
research participants may fax the signed form.
IRB
Membership Rosters
Q
Where can I locate Board Member Rosters?
A
These are located on the IRB web
site at Meeting Informantion, then click Boards.
Mailing
Address
Q
What is the mailing address of the IRB
office?
A
For regular mail the IRB office
address is:
University
of Oklahoma Health Sciences Center
Institutional
Review Board
1000
Stanton L. Young Blvd., Room 176
Oklahoma
City, Oklahoma 73117
For
campus mail the IRB office address is: LIB 176
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