_____________________________________________________________________________
NEBRASKA’S HEALTH SCIENCE CENTER
OFFICE OF REGULATORY AFFAIRS (ORA)
Institutional Review Board (IRB)
EDUCATIONAL GUIDE
CONTINUING REVIEW OF BIOMEDICAL RESEARCH
NOT ALL QUESTIONS WITHIN THE APPLICATION CONTAIN AN EDUCATIONAL NOTE.
THE NUMBERS AND LETTERS CORRESPOND WITH THE QUESTIONS ON THE APPLICATION.
SECTION II
ACCRUAL & DEMOGRAPHIC INFORMATION (1-4)
1. NUMBER OF SUBJECTS APPROVED BY UNMC IRB/PEDSIRB
This number must be the same as the number in Section II.3c of the most recently approved
Biomedical Research application. The IRB approves a maximum number of subjects to be
consented, NOT the number of subjects who are eligible after screening, or who are actually
evaluable for the aims of the research. The number of consented subjects may not exceed the
maximum accrual approved by the IRB without a change in protocol. This section refers only to
sites approved by the IRB, for which the IRB has oversight responsibility. This does not include
other sites participating in a multicenter study that have their own IRB.
2.
ACTUAL ACCRUAL
A. 3) The IRB is responsible for assuring that the risk-benefit relationship of the research is
favorable. If the study cannot satisfy the aims as described in Section II.1 of the application
(that is, no scientific benefit will result), then the risk-benefit relationship of the research is
necessarily unfavorable. A study that has accrued significantly fewer subjects than expected
may be closed by the IRB.
3.
DISTRIBUTION OF SUBJECTS BY DEMOGRAPHIC CHARACTERISTICS
B. For example, this data may not be available for survey studies which do not collect this
information.
STUDY RESULTS & LITERATURE REVIEW (5-6)
6. CURRENT LITERATURE
B. No. This information will aid the IRB in determining if the research is still practical and
relevant.
ADVERSE EVENTS (7-8)
7. INTERNAL ADVERSE EVENTS
B. Yes. It is the responsibility of the PI to determine if the frequency of these events is greater
than predicted. This information aids the IRB in determining if the risk-benefit relationship of
this study remains acceptable.
PROTOCOL DEVIATIONS AND PROTOCOL VIOLATIONS (9-10)
9. SINGLE SUBJECT PROTOCOL DEVIATIONS
A single subject protocol deviation is: 1) a treatment of an ineligible subject using an IRB
approved protocol where the change in eligibility criteria is a minor change; or 2) a minor subject
specific deviation from the research plan of an IRB approved protocol.
10. PROTOCOL VIOLATIONS
A protocol violation is a deviation from protocol procedures which has not been prospectively
reviewed and approved by the IRB.
Continuing Review – Biomedical (07-27-10)
Page 1 of 2
PROBLEMS AND COMPLAINTS (11-12)
12. COMPLAINTS
Complaints which should be described are generally expressions of dissatisfaction or a grievance
related to research participation. If the complaint relates strictly to a non-research treatment part
of the protocol, it is usually not a reportable complaint.
CURRENT RISK/BENEFIT ASSESSMENT (13)
13. MINIMIZATION OF RISK
Investigators have an obligation to minimize risk to the greatest extent possible during on-going
research by substituting less risky procedures (e.g., MRI vs. CT scan) or reducing the number of
invasive procedures (e.g., blood draws, biopsies) when this will not compromise the scientific
validity of the research.
INFORMED CONSENT EVALUATION (14-17)
15. CURRENT INFORMATION ACCURACY ASSESSMENT
The investigator should consider whether the information contained in the document is accurate
and complete and whether there is any information that may have been obtained since the last
IRB review which should be provided to the subject.
ADDITIONAL INFORMATION (18-20)
18. PROJECT PERSONNEL
B. 1) Personnel may be added or deleted at this time without submitting a Request for
Change Form. Do not indicate personnel that have been added or deleted at other times
throughout the past year. Submit a revised Biomedical Application (i.e., Section I and
Section II if they are documenting informed consent.)
All personnel must be CITI trained prior to approval of the change. In order to verify CITI
training, please provide each new individual’s full name (i.e., first, middle and last). For
UNMC/UNO personnel, the name should match the legal name utilized by the University of
Nebraska. Please do not use nicknames.
A new Principal Investigator must sign the Assurance Statements found in Section I of the
IRB research application.
* Per University of Nebraska Board of Regents policy, all Principal Investigators must
complete a UNMC Disclosure of Potential Conflict of Interest Form. All other responsible
personnel (i.e., Secondary Investigator, Participating Personnel, Lead Coordinator,
Coordinator) declaring a financial interest must also complete this form. The original
disclosure form must be sent to the UNMC Compliance Office (Campus Zip 7810) and a
copy attached to this application.
C. Any individual who is authorized by the PI and the IRB to document the obtainment of
informed consent from the subject or the subject's legally authorized representative must
have the necessary clinical expertise as well as sufficient knowledge about the protocol and
IRB consent requirements. The PI is ultimately responsible for ensuring the obtainment of
valid consent and assent from all subjects. Revise the IRB application accordingly.
20. PERFORMANCE SITES
A. A performance site is defined as a site whose staff, facilities or private records of identifiable
individuals are utilized in the conduct of research, or at which consent is solicited. The sites
listed here and in Section I of the Application are sites over which the UNMC IRB/PedsIRB
has responsibility.
Continuing Review – Biomedical (07-27-10)
Page 2 of 2