History of the IRB
IRB’s were formed as a result of an unfortunate history of crimes against humanity in the name of science and research.
News of the Public Health Service’s Tuskegee Syphilis Study
led to the National Research Act of 1974. This act led to the National Commission for the Protection of Human Subjects.
In 1981, the Department of Health and Human Services (DHHS) & FDA published regulations based on the Belmont Report.
In 1991 (after 10 years of negotiation), 16 federal departments and agencies agreed to adopt the basic human subjects protections, referred to as the “Common Rule”.
Role of the IRB
- The mission of the OU Office of Human Research Participant Protection (HRPP) and Institutional Review Board (IRB) is to protect the rights, privacy, and welfare of all human participants in research projects conducted by OU faculty, staff, and students, or otherwise conducted under its oversight. We operate as an accredited institution under the Association for Accreditation of Human Research Protection Programs, Inc. (AAHRPP).
- IRB Chairs & Vice Chairs review the materials presented to assess whether it meets the IRB’s criteria for approval and determines the level of risk.Studies are pre-reviewed to determine if the risk is significant to be reviewed by a board or by an individual Chair/Vice Chair.
Human Subjects Research
What qualifies as Human Subjects Research?
- A systematic investigation (research development, testing, and evaluation) designed to develop or contribute to generalizable knowledge.
- Data collected by means of a systematic investigation of participants
- Generalized conclusions drawn from the analysis of aggregate data
- Information from the investigation is to be disseminated publicly
Does my study qualify as human subjects’ research?
- Classroom-based research projects – This includes research activities that are considered a course requirement and are being conducted for the purpose of learning research skills as a course assignment, are not required to be submitted for IRB review.
- Determination of Human Research Application – This form is designed to use when you are not sure if your specific study requires IRB approval.It consists of a mini-application with four general questions.It is important to provide as much detail and information when addressing each question.Submit the form and we will email you the official determination made by the IRB Chair or Vice Chair.
Principal Investigator Requirements
Completion of online education course on human subjects’ protections – Collaborative Institutional Training Initiative (CITI). This course is valid for 2 years.The first time you will complete the Basic Course module, and then there are 2 refresher courses in the series.
Undergraduate students must designate a faculty member to serve as Principal Investigator. This individual must also complete the CITI training.
You must use the electronic submission system called iRIS.
- IRB Application Form – provides information required by regulations.
- Protocol Description Form – provides more detailed information and summarizes how the project will be completed.
- Informed Consent – explains the important aspects of the study to potential participants in lay language.The templates provided on the website contain the essential elements required by regulations.
- Supporting documents – provide copies of any instruments, funding information, letters of support, interview questions, surveys/questionnaires, and advertisements/recruitment materials for the IRB to review.
- Templates for the Protocol Form and Informed Consent documents are found on the Application Forms page.
IRB Review Process
- The OU HRPP receives your electronic submission and checks your CITI status and if your submission materials are included.
- Studies are pre-reviewed by an administrator to confirm if they can be sent on to the Chair/Vice Chair for further review.
- You will receive an email that explains your status and will instruct you how to proceed.
- Studies are reviewed by a Chair/Vice Chair and a notification of stipulations is sent to the study contacts via email through iRIS. You must log into iRIS to view and respond to these stipulations.
- Address all stipulations and contact the HRPP office if you require any additional assistance by phone or email.
- NOTE: You may sign-off on stipulation responses yourself; however, you should still consult with your faculty Principal Investigator as well.
Once all stipulations have been satisfied, you will receive notification via email that your study has been approved.A formal approval letter and the stamped consent form (if applicable) will be available in iRIS. You are required to make copies of the stamped version of the consent form for use when consenting participants.
Post Approval Modifications
- You may modify your study at any time after your study has been approved.
- Submit the Modification form located in iRIS and explain what you are specifically changing.
- If the revision requires changes to other forms or documents, include a copy of the revised form.
- YOU MUST HAVE YOUR MODIFICATION APPROVED PRIOR TO IMPLEMENTING THE NEW CHANGE.
Continuing Review Application
- If your study is approved as Expedited or Full Board, the study is approved for one year.You must submit a Continuing Review/Final Report Form to renew for an additional year.
- You will receive a notification 60 days in advance to your expiration date to remind you that your study is due to expire.
- If your study is approved as Exempt, your study remains active and does not require follow up unless you modify.
- Check your CITI to see if this is current; if not, you must complete the Refresher Course on the CITI system. This also applies to any Key Study Personnel and your faculty Principal Investigator.
- The Continuing Review Application will ask the status of your study.You must address all questions in order to renew.
Closing Your Study
The inactivation process is as follows:
- Expedited & Full Board studies – complete the Continuing Review/Final Report form
- Exempt studies – complete the Exempt Study Progress/Closure Report form
Guidance & Resources
- Determine when to begin and how much time you will need to complete the entire process (submission; conduct research study; analyze data; close study).
- See the “How To” Instructional Guide for guidance on submitting forms through the iRIS system.
- How long does the IRB approval process take?
- Exempt/Expedited studies can take up to two weeks for review
- Full Board studies can be longer because the board meets once a month
- These estimates assume approval without significant problems or stipulation
Office of Human Research Participant Protection (HRPP) - Administration
Sierra Smith, Director
Karen Braswell, Quality Improvement/Education & Training Coordinator
Nicole Cunningham, IRB Administrator
Teresa (Shelly) Smith, Administrative Assistant
Location: Five Partners Place
201 Stephenson Pkwy, Suite 4300A
Norman, OK 73019
**Call to schedule an appointment
The following TIPS will provide you with additional guidance:
Check all documents for consistency before submitting.
Review all documents with your Faculty Sponsor prior to submission.
Answer all the questions, even if N/A. Be consistent in your response with all documentation.
Add yourself as a study contact in the application.
Write a clear summary of your research design.The more specific and detailed, the better.
Complete all documents and have them ready to upload prior to completing the application.
Include all documents – refer to the checklist at the end of the application.
Write the protocol for understanding (avoid technical language) and review the information/examples provided.
Write the consent form using lay language.
Don’t assume you can use information from students, employees, etc., for research purposes just because you have access to that information as a function of your job or position. Consent is required for use of non-research materials for research purposes.
All stipulations must be addressed before you resubmit. If you are not able, please note and explain the reason why.
If you disagree with stipulations, provide a response or justification why you disagree.
Make an appointment or call the IRB office for assistance if you need clarification regarding the stipulations.
Respond promptly to IRB requests (missing documents, revisions, etc.).
iRIS will keep a copy of all submitted documents.
Retain all research records as noted in the IRB application.
Do not wait until the last minute to submit.
Do not change any research activity without prior approval from the IRB.
- Maintain good record keeping. You may have an evaluation of your study.
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