the new IRB electronic submission system, is now live and available for Norman Campus use.
Key dates and deadlines for the iRIS transition:
- 12/5/2011-1/17/2012— iRIS use for new study applications is optional; IRB will continue to accept hardcopy new study applications as well.
- 1/17/2012 –iRIS must be used for all new study submissions.
- 12/5/2012-5/31/2012 – Consider submitting paper-based closure requests if the study will not continue beyond 5/31/2012.
- 5/31/2012 –iRIS must be used for new study applications, on-going Continuing Reviews, Modifications, and other study items.
To facilitate the transition to iRIS, we will be offering several modes of training—traditional classroom, departmental, and online references,
Fridays will be designated for holding departmental training sessions, please contact our office if your department is interested.
Training will be conducted in two part sessions in two-hour increments.
Part 1 will consist of an introduction to iRIS and provide the basics of logging into the system, navigating through the application process,
how to respond to the review stipulations, and submitting a Human Subjects Research Determination or Protocol Development form.
Part 2 will consist of instruction on how to submit a Continuing Review application, Modification requests, Protocol Deviation, and Unanticipated Problem.
The two-hour training sessions, will be held most Tuesdays through Thursdays as listed in the following schedule. Sessions will be held at the OU Norman campus IRB office
(1816 W. Lindsey, Suite 150). Reserve your seat in your preferred session by emailing the date and time to
email@example.com or calling 325-8110. If you wish, you may bring your laptop—iRIS works with PC, Apple/Mac, Linux, etc.—or we will provide
a laptop for you to use during training. Each session will be limited to 8 trainees, so reserve your preferred time and date soon.
The Norman Campus IRB Offices have moved.
The Norman Campus IRB Offices have moved to a new location at One Partners Place, 350 David L. Boren Blvd, Suite 1750 Norman, OK 73019
This location is just east of the National Weather Center.
IRB Graduate Student Training Session
There will be a training session for all Graduate Students who may conduct research that involves human subjects.
This session will be held in 1313 at the National Weather Center Auditorium on Friday, September 28, 2012 at 11 am through 1 pm.
Registration is not required! FREE BOXED LUNCH to the first 100 attendees!
For more information contact: Office of Human Research Participant Protection (HRPP) (405) 325-8110 or by email: firstname.lastname@example.org
Public Health Service (PHS) Financial Conflict of Interest (FCOI):
The new OU FCOI policy has been implemented to correspond with the mandate of the new federal reporting requirement.
These regulations apply to any institution receiving funds from a PHS entity effective August 24, 2012. For all PHS-funded Norman campus investigators,
please refer to the new procedures implemented by the Office of Research Services: http://ors.ou.edu/fcoi/
The following forms have been revised and are available on the "Application Process" section of the IRB website and in iRIS:
- Informed Consent template
- Information Sheet for Consent template
- Protocol Description Form
Please use the most recent forms when submitting your study
New IRB Rosters.:
New Review Board Rosters are available. These are effective 08/28/2012.
New IRB Rosters.:
New Review Board Rosters are available. These are effective 06/25/2012.
How to Start a Study:
This is a new series of documents detailing steps to be taken to Start a Study.
New IRB Rosters.:
New Review Board Rosters are available. These are effective 03/13/2012.
The following forms have been revised and are available on the "Application Forms" link located on the IRB website. Please use the new version when submitting your study:
- Appendix A - Protocol Description.
- Informed Consent template.
New IRB Rosters.:
New Review Board Rosters are available. These are effective 02/13/2012.
The following forms have been revised and are available on the Application Forms page.
The IRB will accept previous versions of these forms through January 17, 2012.
- Informed Consent Template.
- Assent Template.
- Information Sheet for Consent to Participate in a Research Study.
Changes in 2011 Board Meeting Dates:
The Board 2 meeting scheduled on December 13, 2011 has been cancelled.
Meeting dates and deadlines for 2012 are now available in the "Board Meeting Schedules and Deadlines" tab.
New IRB Rosters.:
New Review Board Rosters are available. These are effective 06/29/2011.
Revised SOP 602-G:
Revised SOP 602-G effective 02/15/11 is available from the Policies & Procedures page. Definitions were added for Medical, Clinical, and FDA regulated research for clarification in Sec. 1.1.1. Paragraphs 5 and 6 were added to Sec. 1.1.2. Section 1.1.3 was added.
New CITI Education Requirements:
CITI Education Course has changed from renewing annually to every two years effective 10/01/2010.
Anyone who has completed the course as of this date forward will expire in two years.
New Office Location:
We have recently moved our offices to 1816 Lindsey Street, Suite 150 in Norman, OK.
The location is on the south side of Lindsey St. and has plenty of free parking.
Call (405)325-8110 if you need directions.
Revised Policy/Procedures, SOP 104B - "Conflict of Interest - IRB Members":
Policy revised to define "non-financial" conflict of interest for IRB members or consultants
and note that they must disclose any financial or non-financial interest.
Also, policy revised to include procedures to incorporate this process.
IRB Forms Help Sessions:
Graduate Students/Faculty are encouraged to attend
this help session from 3pm to 4pm, every Friday, beginning September 3, 2010.
The HRPP staff will provide an overview of the IRB application form or other IRB forms
(Continuing Review form, Request for Modification form) and answer any questions.
Help with IRB Submissions:
The HRPP staff can help researchers prepare an IRB submission and navigate
through policies and procedures. Please call our office to schedule an appointment.
Due to the length of time for this process, these are available by appointment only.
The office number is (405) 325-8110.
OU Norman-Tulsa researchers:
The HRPP staff is available to provide help sessions by appointment only.
We have business hours available once a month and can schedule a session with you.
Please call our office for further information, (405) 325-8110.
Revised Policies and Procedures effective 01/15/10 are available on the OU-NC Policies page.
Summary of major revisions.
The following new form is available on the Applcation Forms page.
New Research Project Application Supplement for DoD (Version date 01/15/10)
This form includes specific questions concerning Human Participant Research Involving Department of Defense (DoD).
The following forms have been revised and are available on the Application Forms page. The IRB will accept previous versions of these forms through March 5, 2010.
Determination of Human Research Worksheet (Version date 01/15/10)
Added definition of experimental subject in Part 2, Determination of Human Research.
Unanticipated Problem Report Form (Version date 01/15/10)
Added two bullets to clarify Section III, Determination of Unanticipated Problem.
- Revised rosters for Boards 1 and 2 available from Rosters page.
The following forms have been revised and are available on the Application Forms page. The IRB will accept previous versions of these forms through October 14, 2009.
- IRB Application (version date 09/01/09)
- Part I-Investigator and Key Research Personnel, revised question regarding investigator's time allocation to read: "Does this individual have sufficient time to conduct and complete the research?"
- Part I-Additional question: "Are all investigators and research staff qualified by training and experience for their roles and responsibilities in conducting the research?"
- Part V-Additional question, page 4, Question 4, Recruitment and Enrollment Procedures: "Classroom Recruitment from the researchers class-describe measures of recruitment and consenting to minimize undue influence and/or coercion? and "# of participants expected from this method".
- Part IV, Additional question, page 6, Question 9, "Include a description of additional safeguards included in the protocol to protect the rights and welfare of vulnerable populations you listed in question 8 above".
- Part IV, page 7, Question 13, Non-OU sites: Revised to explain the process required for approval of Non-OU Sites. Directs the Principal Investigator to contact the IRB office if they are requesting OU IRB to be the IRB of record for the research
- Information Sheet for Consent to Participate in a Research Study (version date 09/01/09).
- Added phrase to Section "Contacts and Questions" - "or about your rights"
- Determination of Human Research Worksheet (version 09/01/09).
- Instructions: revised to state that completed worksheets should be submitted to the IRB office for an official determination by an IRB Chair or Vice Chair.
- Removed "Yes" or " No" comments indicating if the activity was human subjects research.
- Authorization to Use or Disclose Protected Health Information For Research (version 09/01/09):
- Change to the Privacy Official phone number
- Revised Standard Operating Procedures and Revised Forms.
- Consent Form now available on Application Forms page.
- Revised risk section to remove deception language.
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