Institutional Review Board

• Submission Deadlines
• Initial Full Board Review
• Expedited Review
• Exempt Review
• Rapid Response IRB Review
• Single Subject Protocol Deviation
• Emergency Treatment using FDA Unapproved Drug, Device or Biologic
• Continuing Review
• Adverse Event Reporting

Submission Deadlines

The IRB meets twice monthly on the first and third Thursdays of the month. The IRB will continue to meet once a month in January and July.

Protocols and other items for consideration of the board must be submitted in the proper format to the IRB office two weeks prior to the meeting. A calendar with deadline dates and IRB Meetings is available under the "schedule" tab.

The IRB will review no more than 15 protocols (ie., new submissions and previously tabled protocols) at each meeting. Reviews will be assigned on a first-come first-served basis. Protocols in excess of 15 will be assigned to the following meeting.

Note: There may be other applicable deadlines:

Proposals that qualify for expedited review (see below) or exempt status (see below) may be submitted to the IRB at any time.

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Initial Full Board Review

Applications for 1) Biomedical Research and 2) Social science and Behavioral Research will be reviewed at the next possible IRB meeting, as detailed above. Investigators will be required to supply all necessary copies to the IRB office upon submission.

Thirty (30) packets must be assembled in the exact order specified below. The original packet must be printed single-sided and clipped (not stapled). The remaining 29 packets should be copied front to back and stapled.  In addition to the packet, if applicable you must submit 3 copies of the detailed protocol, Investigator's Brochure and Federal grant.

   New Submissions (Initial)

1. IRB Application
2. Consent/Assent Forms: 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/Assent Forms: Adult, Parental, Proxy, Youth, Child, or Addenda

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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. A list of procedures which may qualify for expedited review is given here: http://www.hhs.gov/ohrp/humansubjects/guidance/expedited98.htm

If you feel your new submission is eligible for Expedited review, please contact the IRB Administrative office (402-559-6463) prior to submission to obtain verification of this type of review and the number of copies needed by the IRB office.

Qualifying protocols will be reviewed and the investigator will be informed of the IRB's decision within 10 business days.

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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. Only an Exemption Application must be submitted and approved by the IRB. 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.

If a submitted proposal/Exemption Form is determined by the IRB to qualify for exempt status, the investigator will be notified within approximately five - seven business days following receipt of the proposal/Exemption Form.

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Rapid Response IRB Review

The UNMC/The Nebraska Medical Center IRB has procedures for rapid review of industry-sponsored protocols. To be eligible for this review, the sponsor deadline for IRB Approval must be such that consideration at a scheduled IRB meeting would not be acceptable. Further, the protocol must have been provided by the sponsor to the PI too late for submission to the previous scheduled IRB meeting. Suitable protocols must also represent an important research venture for the PI and the University of Nebraska/The Nebraska Medical Center.

Eligibility for Rapid Response IRB Review will be determined by the Chairs of the IRB on a case by case basis. For futher information please contact:

• Bruce Gordon
  phone: 559-7257
  pager: 888-1125
  e-mail: bgordon@unmc.edu or
  
• Ernest Prentice
  phone: 559-6463
  e-mail: edprenti@unmc.edu

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Single Subject Protocol Deviation

The UNMC/The Nebraska Medical Center IRB has a mechanism whereby a physician can be granted approval to enroll a single ineligible patient on an approved research protocol, or to make a patient specific deviation from an IRB approved protocol (e.g., adding or deleting a drug).

To obtain Single Subject Protocol Deviation approval, a Single Subject Protocol Deviation Request must be submitted PRIOR to the implementation of the deviation.  This form can be found under the "Miscellaneous" heading on the FORMS page.  Once signed by the PI, the form can be submitted by email as a PDF file to irbora@unmc.edu.    Once the form is received, the deviation will be reviewed and processed for further review if necessary by Sue Logsdon, the IRB Compliance Coordinator.  Deviations may be approved in one of two ways:

1. Deviations that are minor are eligible for expedited review under the provisions of HHS regulations at 45 CFR 46.110(b)(2) and FDA regulations at 21 CFR 56.110(b)(2), as applicable.  
2.  Deviations that are more than minor do not qualify for expedited review and therefore must be reviewed by the full IRB.

Once the deviation is approved, an approval letter for the Single Subject Protocol Deviation will be sent to the PI and lead coordinator via email.

NOTE: A patient enrolled in a study thru the approval of a deviation is a research subject, and the investigator is still required to obtain informed consent of the subject or the subject's legally authorized representative.

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Emergency Treatment using FDA Unapproved Drug, Device or Biologic

Under certain circumstances a physician may treat a patient with an investigational (non-FDA approved) drug, biologic or device, or treat a patient utilizing a non-IRB approved protocol; Pursuant to FDA regulations, the patient must be suffering from a serious, life-threatening or debilitating illness for which there is no satisfactory treatment alternative(s) and there must not be sufficient time to obtain full IRB review and approval. Emergency treatment as defined here is not research. The FDA regulations do not provide for expedited IRB approval in emergency situations.

UNMC/The Nebraska Medical Center policy requires that the IRB be notified prior to such use, by contacting the IRB office. This notification is not IRB approval. The IRB will only state that it is aware of the proposed use and considers the use to meet the requirements or 21 CFR 56.104(c).

The investigator is still required to obtain informed consent of the subject or the subject's legally authorized representative. The consent form must contain appropriate elements structured to reflect that consent is for treatment purposes as opposed to research. A sample Consent Form for Emergency Treatment (Word and PDF) has been provided.

The UNMC IRB Emergency Treatment Report (Word and PDF) and a signed copy of the consent form must be submitted to the IRB within five business days following the treatment.

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Continuing Review

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 protocols only during the 3rd Thursday IRB meeting.

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. Last consented subject consent/assent document
4. Section I and II of the IRB Application
5. Request for Change Form (if applicable)
6. All consent/assent documents currently valid for the study.

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.

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Adverse Event Reporting

External Adverse Events (AEs)

Please be advised that the RSS system will no longer accept External AE reports.  As a result of FDA Guidance, the IRB no longer requires submission of External AE reports for drug studies unless the PI and/or the sponsor determines that a change in protocol or a revision of the consent document is necessary upon analysis of the External AE report.   For those External AEs that require a change in protocol or revision of the consent document, the External AE report (ie., IND Safety Report) received by the PI from the sponsor, should be submitted to the IRB with a Request for Change form along with the revised IRB Application and consent form(s). 

For device studies, the External AE report for any serious and unexpected Adverse Device Effect (ADE) which occurs must be submitted to the IRB within five (5) business days following receipt of the report from the sponsor.  All External AE reports for device studies that are submitted to the IRB will be reviewed by the full Board.

For questions regarding the submission of External AE reports, please do not hesitate to contact the Office of Regulatory Affairs at 559-6463. 

Internal Adverse Events

The IRB only requires submission of internal AE reports when the event is unexpected and related/possibly related. Internal adverse events occurring on a study which satisfy this criteria must be submitted to the IRB within two business days following the time it becomes known. Any death, which occurs while the subject is being treated on protocol or occurs within 30 days of completing research related interventions, must be reported immediately.

One original of the Internal AE Report form (or Internal Fatal Event form), and one copy of the current IRB approved consent form must be submitted, along with any other relevant information, to the IRB.