Submission Process

Initial Full Board Review

Investigators will be required to supply all necessary copies to the IRB office after the electronic submission has been given an IRB#.  Investigators will be notified of the assigned IRB# by email.  DO NOT submit the paper copies until the IRB# has been assigned. Paper copies submitted without the IRB# will not be accepted.

NOTE: Full Board studies existing prior to January 16, 2012 will continue in paper format and will not be entered into the online system.

Applications for Full Board Review will be reviewed at the next possible IRB meeting.  Investigators will be required to supply all necessary copies to the IRB office.

Thirty (30) packets must be assembled in the exact order specified below  and should be copied front to back and stapled. In addition to the packet, if applicable you must submit 2 copies of the detailed protocol, Investigator's Brochure and /or Federal grant (these documents must also be attached to the online application).  DO NOT submit the paper copies until the IRB# has been assigned. Paper copies submitted without the IRB# will not be accepted.

New Submissions (Initial)

  1. IRB Application
  2. Consent Forms/information sheets: Adult, Parental, Proxy, Youth, Child, or Addenda
  3. Subject Recruitment Material (as applicable)
  4. External study site approval letters (as applicable)
  5. Other relevant material (eg. surveys) (as applicable)

Tabled - Re-Submissions

  1. Copy of the IRB's tabled letter
  2. Investigator's response letter
  3. Revised IRB Application
  4. Revised Consent Forms/information sheets: Adult, Parental, Proxy, Youth, Child, or Addenda

Expedited Review

Certain studies involving no more than minimal risk may qualify for expedited review status under 45 CFR 46:110 or 21 CFR 56:110. View a list of procedures which may qualify for expedited review. 

Expedited reviews of new protocols are now handled through the electronic submission only.  Paper copies of applications are no longer required.  NOTE: Expedited studies existing prior to January 16, 2012 may have to be transferred to the online application system at the time of continuing review.  Please contact the IRB office for this determination. 

 New submissions eligible for expedited review will be reviewed by the IRB Executive Chair/designee and the investigator will be informed of the IRB’s decision by email.

Exempt Protocols

Research activities in which the only involvement of human subjects will be in one or more of the categories specified by 45 CFR 46:101(b) are exempt from the requirements of 45 CFR 46. The exempt categories do not, however, apply to research involving deception of subjects, sensitive behavioral research, or to research involving pregnant women, prisoners, individuals who are decisionally impaired and other subject populations determined to be vulnerable.

Reviews of new Exempt protocols are now handled through the electronic submission only.  Paper copies of applications are no longer required.  NOTE: Exempt studies existing prior to January 16, 2012 will have to be entered into the electronic system at the end of the 5 year approval period if the study is to continue.

 New submissions eligible for exempt review will be reviewed by a member of the IRB staff and the investigator will be informed of the IRB’s decision by email.

Continuing Reviews

Federal Regulations prohibit the IRB from granting extensions or temporary approval. Should expiration of IRB approval occur, all subject accrual must cease as of the date of expiration. In addition, research related procedures can no longer be performed on human subjects who are currently enrolled in the study for follow-up or other reasons unless this restriction represents a health hazard to the subjects. In this case, the IRB will grant an exception upon receipt of written justification.

The IRB Application for Continuing Review must be submitted no later than the last business day of the month prior to the expiration date (which is 12 months from the date of the last IRB review). The IRB re-reviews continuing reviews for full board protocols only during the 3rd Thursday IRB meeting.

Full Board studies existing prior to January 16, 2012:

One original and one copy of the Application for Continuing Review including all material must be submitted single-sided. The materials that should be included are as follows:

  1. Any study results submitted
  2. Publications
  3. A copy of the signed consent form of the last subject enrolled.  NOTE:  ONLY the subject’s name should be redacted.
  4. Section I and II of the most current IRB Application
  5. Request for Change Form (if applicable)
  6. All consent forms/information sheets currently valid for the study.

Expedited studies existing prior to January 16, 2012 that are no longer enrolling subjects:

One original of the Application for Continuing Review including all material must be submitted single-sided. The materials that should be included are as follows:

  1. Any study results submitted
  2. Publications
  3. A copy of the signed consent form of the last subject enrolled.  NOTE:  ONLY the subject’s name should be redacted.
  4. Section I and II of the most current IRB Application
  5. Request for Change Form (if applicable)
  6. All consent forms/information sheets currently valid for the study.

Studies submitted through the electronic system:

Please follow the instructions found in the online submission system instruction manual. 

NOTE:  Expedited studies that existed prior to January 16, 2012 that are either still enrolling subjects or have a waiver of informed consent, must be put through the online system at the time of Continuing Review.

Request for Change

Any proposed major or minor change in a research activity must be reviewed and approved by the IRB prior to implementation in accordance with the requirements of 45 CFR 46.103(b)(4); 21 CFR 56.108(a)(4) except when: 1) a change is necessary to eliminate an apparent immediate hazard to the subject(s), or 2) a subject needs to be advised immediately of significant new information.  Administrative changes do not require IRB review and can, accordingly, be approved by ORA

Studies which are not in the electronic submission system:

  1. Complete the Request for Change Form (RFC) found in the “forms” section of the website under “Applications”.
  2. Submit the revised IRB Application and/or consent form(s)/information sheet(s), advertisements etc...  All information added to the application should be underlined and deletions should be crossed out.

Studies submitted through the electronic system:

Please follow the instructions found in the online submission system instruction manual. 

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