___________________________________________________________________________________________________
NEBRASKA’S HEALTH SCIENCE CENTER
OFFICE OF REGULATORY AFFAIRS (ORA)
Institutional Review Board (IRB)
CONTINUING REVIEW OF MEDICAL RECORDS RESEARCH
SECTION I
1. IRB #:
2. TITLE OF PROTOCOL:
3. PRINCIPAL INVESTIGATOR (PI)
A. Department:
B. Phone:
C. Email:
D. Address/campus ZIP:
4. LEAD COORDINATOR:
A. Phone:
B. E-mail:
5. STUDY STATUS: Mark the status of the study and complete sections as indicated:
Category
Complete Sections
A.
Closure requested. No protected health information (PHI)
collected.
B.
No protected health information (PHI) collected. Re-approval
requested.
C.
Protected health information (PHI) collected. Re-approval
requested.
D.
No further protected health information (PHI) will be collected.
Research-related analysis ongoing. Re-approval requested.
1-5, 7, 10
E.
Protected health information (PHI) collection and research
analysis have been completed. Request IRB classification of the
study as completed.
1-3, 5, 7
None
1, 4, 6, 8-10, 12
All
6. CERTIFICATION OF PRINCIPAL INVESTIGATOR
This application contains complete and accurate information.
_________________________________
Signature of Principal Investigator
Continuing Review Medical Records (11-08-10)
______________
Date
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7. PRINCIPAL INVESTIGATOR'S ASSURANCE
Note: Signature is required only for on-going research in categories B, C, and D
The Principal Investigator understands and accepts the following obligations to protect the
rights and welfare of research subjects in this study:
I certify that I, and all listed research personnel, have the necessary qualifications, expertise, and
hospital credentials to conduct this study in a manner which fully protects the rights and welfare of
research subjects.
I recognize that as the Principal Investigator it is my responsibility to ensure that this research and the
actions of all research personnel involved in conducting the study will conform to the 1) IRB approved
application, 2) detailed protocol, 3) HRPP policies, and 4) HHS regulations for the protection of human
subject protections (45 CFR 46).
I recognize that it is my responsibility to ensure that valid informed consent/assent (if required) has
been obtained from all research subjects or their legally authorized representatives. I will ensure that
all research personnel involved in the process of consent/assent are trained properly and are fully
aware of their responsibilities relative to the obtainment of informed consent/assent according to
HRPP policy, HHS regulations at 45 CFR 46, and state law.
I certify that the minimum amount of protected health information (PHI) necessary will be used and
disclosed to conduct this research study. I will implement reasonable safeguards to protect the PHI.
I will promptly inform the IRB of any unanticipated problems involving risk to the subjects (e.g., breach
of confidentiality) or to others in the time frame defined by HRPP policies.
I will promptly inform the IRB if I become aware of 1) any complaints from research subjects (or their LARs) about research participation, 2) violations of HHS regulations at 45 CFR 46, 3) violations of the
HIPAA Rule, or 4) violations of HRPP policies.
I will not initiate any change in protocol without IRB approval except when it is necessary to reduce or
eliminate a risk to the subject, in which case the IRB will be notified as soon as possible.
I will maintain all required research records on file and I recognize that representatives from the IRB,
OHRP and HHS are authorized to inspect these records.
I certify that there are adequate resources and facilities to safely carry out and complete this research.
This includes sufficient staff, funding, space, record keeping capability, and resources. If the
necessary resources become unavailable, I will notify the IRB.
I understand that approval of non-exempt research requires continuing review by the IRB at least
annually in order to maintain approval status. I will maintain IRB approval as long as this study is
active. Exempt research is approved for five years and continuing review is not required.
I understand that if there are any changes in the financial interests of key personnel during the course
of the research, the IRB will be notified as soon as possible.
I certify that I and all other personnel listed in Section I of the IRB Application have disclosed all
potential financial conflicts of interest as required and are in full compliance with the UNMC Conflict of
Interest Policy. I further certify that all potential financial conflicts of interest are appropriately managed
in order to ensure protection of the rights and welfare of patients.
I understand that failure to comply with HHS regulations, HRPP policies and the provisions of the IRB
Continuing Review Medical Records (11-08-10)
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approved protocol may result in suspension or termination of my research project, and/or other
administrative or legal actions.
____________________________________________________________________________________________________________________________________________
Printed Name of Principal Investigator
___________________________
__________
Signature of Principal Investigator
Date
Continuing Review Medical Records (11-08-10)
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SECTION II
Instructions: Non-exempt research must be re-reviewed and approved by the IRB no less often than
annually. In order to review your Application for Continuing Review, the IRB must have the following
information pursuant to its charge by HHS Regulations at 45 CFR 46.109(e) and FDA Regulations at
21 CFR 56.109(e).
The Study Status category (see section I) determines which subparts must be completed. Each
subpart must be titled using boldface subheadings as described below and addressed
independently. Please include sufficient information to facilitate an effective review by all members of
the IRB including non-specialists. All abbreviations and terms not part of common usage should be
defined and simplified language should be used as much as possible. Pages should be numbered.
Information should be provided by site for all studies involving more than one site for which the UNMC
IRB or PedsIRB is the only IRB of record.
The Continuing Review Application must provide sufficient information to facilitate an effective review
by all members of the IRB including non-specialists. There is an educational guide to this application
available on the IRB website titled “Educational Guide – Continuing Review Medical Records”.
Questions that have an educational note that explain the information requirements will be referred to
the Guide with the statement “See Educational Guide – Continuing Review Medical Records”.
Applications that do not allow for an effective review may be returned to the investigator, without IRB
review, for revision and resubmission.
CATEGORY OF RESEARCH AND SUBJECT ACCRUAL (1-2)
1. CATEGORY OF RESEARCH
Which of the following categories does this research fall under? Check all that apply.
A. Use of existent information with subject identifiers that are maintained.
2.
B.
Use of prospectively collected information without subject identifiers being
recorded.
C.
Use of prospectively collected information with subject identifiers that are
maintained.
NUMBER OF SUBJECTS
A. How many medical records did the IRB approve to be accessed during this research?
B. What is the total number of medical records from which information was collected:
1. Since activation of the study?
2. Since last IRB review?
C. If no information from records has been collected since activation or since the last IRB
review, or if the number of records reviewed is significantly lower than anticipated, please
explain and describe measures to improve collection rates. See Educational Guide –
Continuing Review Medical Records
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STUDY RESULTS & LITERATURE REVIEW (3-4)
3. STUDY RESULTS
Describe the current status of the research and provide information regarding the
progress of data collection and analysis to date.
4.
CURRENT LITERATURE See Educational Guide – Continuing Review Medical Records
A. Has any data been published or presented by anyone since the last IRB review that
makes the aims of this research more or less important?
No
Yes. Describe the data that has been published or presented and explain why it has
affected the aims of this study.
B. Can the aims of the research still be accomplished by using the source(s) of protected
health information (PHI) and other resources available to the investigators?
Yes
No
UNANTICIPATED PROBLEMS (5)
5. UNANTICIPATED PROBLEMS INVOLVING SUBJECTS OR OTHERS
Since initial IRB approval of the research have there been any unanticipated problems
involving subjects or others reported to the IRB? See Educational Guide – Continuing Review
Medical Records
No
Yes. Describe each problem. Mark problems occurring since the last IRB review with
an asterisk (*).
INFORMED CONSENT EVALUATION (6-9)
6. WAIVER OR ALTERATION OF INFORMED CONSENT
A. Was a waiver or alteration of informed consent initially approved by the IRB?
No
Yes
B. If yes, has anything occurred since the last IRB review that alters the original IRB
approved waiver or alteration of informed consent? See Educational Guide – Continuing
Review Medical Records
No
Yes. Describe what has happened to alter the waiver or alteration of informed
consent.
7.
OBTAINMENT AND DOCUMENTATION OF INFORMED CONSENT
Since initial IRB approval of the research have there been any problems in the obtainment
and documentation of informed consent?
No
Yes. Provide a brief summary of the problems. Mark problems occurring since last
IRB continuing review with an asterisk (*).
Not applicable. A waiver of consent was approved by the IRB.
8.
CURRENT INFORMATION ACCURACY ASSESSMENT
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Are the consent and/or assent forms still acceptable? See Educational Guide – Continuing
Review Medical Records
Yes
No. Attach a Request for Change Form describing the required modifications in the
consent and/or assent forms.
Not applicable. A waiver of consent was approved by the IRB.
9.
TYPES OF CONSENT AND ASSENT FORMS
Check all types of consent and assent forms/information sheets which are being used in
the protocol.
Adult consent form
Authorized representative consent form
Adult assent form
Youth assent form/information sheet
Parental consent form
Child assent form/information sheet
Not applicable. A waiver of consent was approved by the IRB.
Other:
ADDITIONAL INFORMATION (10-12)
10. PROJECT PERSONNEL
A. List all personnel to be involved in the study according to the classifications below.
1. Principal Investigator:
2. Secondary Investigator(s):
3. Participating Personnel:
4. Lead Coordinator:
5. Coordinator(s):
6. Administrative/data management:
B. List personnel added or deleted to the study at this time. Include the classification for
each person (i.e., Secondary Investigator, Participating Personnel, Lead Coordinator,
Coordinator, Administrative/data management). DO NOT list individuals who have been
previously added or deleted. See Educational Guide – Continuing Review Medical Records
Typed Full Name
PLEASE DO NOT USE
NICKNAMES.
Classification
Principal Investigator
Secondary Investigator
Participating Personnel
Lead Coordinator
Other Coordinator
Data/Administrative
Secondary Investigator
Participating Personnel
Lead Coordinator
Other Coordinator
Data/Administrative
Continuing Review Medical Records (11-08-10)
Document
informed
consent?
No
Yes
Financial
Interest in
the
research?
No
Yes
*See
Added or
Deleted?
Added
Deleted
Educational
Guide
No
Yes
No
Yes
Added
Deleted
*See
Educational
Guide
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Secondary Investigator
Participating Personnel
Lead Coordinator
Other Coordinator
Data/Administrative
Secondary Investigator
Participating Personnel
Lead Coordinator
Other Coordinator
Data/Administrative
No
Yes
No
Yes
Added
Deleted
*See
Educational
Guide
No
Yes
No
Yes
Added
Deleted
*See
Educational
Guide
1) Is an Appendix - Personnel Change Form** attached?
No
Yes. Please specify # of forms attached
** If additional space is needed for personnel changes, fill out the “Appendix - Personnel Change
Form” located in the Miscellaneous section of the Forms sections on the IRB website and answer
questions above.
C. List all personnel who are authorized to document the obtainment of consent (that is,
sign the consent form). See Educational Guide – Continuing Review Medical Records
11. FINANCIAL DISCLOSURE UPDATE
Are there any changes in the financial interests of investigators or other responsible
personnel?
N/A. This study is not funded by a commercial sponsor.
No
Yes. Submit an updated UNMC Disclosure of Potential Conflict of Interest form to the
ORA.
12. PERFORMANCE SITES
A. List all UNMC IRB-approved performance sites at which this research is conducted.
See Educational Guide – Continuing Review Medical Record
B. If University of Nebraska Medical Center/The Nebraska Medical Center, University of
Nebraska – Omaha or Children’s Hospital and Medical Center (UNMC, TNMC, UNO or
CHMC) is the lead site for a multi-institutional protocol, and data is collected and analyzed
at UNMC, or adverse events tracked at UNMC, list all sites.
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SECTION III
GENERAL INFORMATION

In order to facilitate IRB re-review of your project and to avoid unnecessary delays, please ensure that
each applicable section of the Application for Continuing Review of Medical or Clinical Records Research
is completed according to the instructions. Information must be provided in sufficient detail to allow the IRB
to perform the required review. Failure to provide all necessary information may delay IRB re-approval of
your protocol and could result in an expiration of IRB approval if there is not sufficient time for the IRB to
complete its review prior to the expiration of approval.

Per institutional policy, ALL investigators and participating personnel being added to the project must have
successfully completed the CITI Training before IRB approval for continuation of the study can be granted.

HHS and FDA Regulations prohibit the IRB from granting extensions or temporary approval. Should
expiration of IRB approval occur, all data acquisition must cease as of the date of expiration, and research
using any acquired data must be halted.

Upon IRB re-approval of your research project, you will be given an approval letter to continue the project
and, if applicable, a stamped/dated original of all approved consent forms, assent forms and/or information
sheets. The originals should be kept on file as masters and all outdated copies of consent/assent forms
must be destroyed as they are no longer valid for use.
SUBMISSION DEADLINE
The IRB strongly recommends your application be submitted at least 60 days prior to the date of expiration of
IRB approval. Unless your project is re-reviewed and re-approved by the IRB within twelve (12) months from
the date the protocol was last reviewed by the IRB (or within any shorter approval period specified by the IRB),
Federal regulations require immediate expiration of IRB approval.
SUBMISSION CHECKLIST
A. Submit the one (1) original (printed singled-sided) and one (1) copy (printed double-sided) of
following items to the Office of Regulatory Affairs (UNMC – 7830):
This Continuing Review form
The consent form used to enroll the last subject in this study, if applicable. The subject’s name and
signature must be obliterated to protect confidentiality.
The current IRB-approved Medical Records Research Application (Section I and Section II).
B.
Include one (1) original (printed singled-sided) and one (1) copy (printed double-sided) of the
following as applicable :
The IRB-approved Waiver Addendum.
If subject accrual remains open, email the Word file of each consent form, assent form and/or
youth/child information sheet (saved on departmental letterhead) intended for use during the next IRB
approval period. Documents should indicate the IRB# and be emailed to irbora@unmc.edu and Gail
Kotulak at gkotulak@unmc.edu.
All publications derived from this study since last IRB review.
The Request for Change form and all supporting documents relating to all modifications to the protocol
and/or consent/assent forms. Note: A Request for Change is not required for adding or deleting
personnel.
ADDITIONAL REVIEW REQUIREMENTS
UNMC Eppley Cancer Center Scientific Review Committee (SRC): Continuing review by the
SRC is required for all protocols involving cancer patients.
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