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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

 

 

 

 

Institutional Review Board (IRB) - OU Health Sciences Center
Library Building, Room 176
Phone: 405/271-2045 - Fax: 405/271-1677
IRB@ouhsc.edu

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