Continuing Review of Research, Version 3.6
To Be Completed By the InvestigatorUIC Protocol #: / Date Application Completed:
Institutional Proposal (IP)#: / Application Document Version #:
I. Research Title:
II. Personnel
A. Principal Investigator
Name (Last, First) / Degree(s) / Net IDDepartment / College / University Status
Student/Fellow/Resident
Faculty/Staff
Phone Number / UIC E-mail Address
B. Faculty Sponsor – Complete only when PI is a student, fellow, or resident
Name (Last, First) / Degree(s) / Net IDDepartment / College
Phone Number / UIC E-mail Address
C. Primary Contact Other Than PI – Complete only if the primary contact person is different than the PI
Name (Last, First) / Net ID (e.g., )Phone Number / UIC E-mail Address
Principal Investigator grants this personnel access to OPRS Live for this protocol
D. Include a copy of the current Appendix P as part of the Continuing Review. The names of key research personnel no longer on the study should becrossed out.
III. Conflict of Interest (COI) Disclosure
All investigators must disclose all real, apparent, or potential Significant Financial Interest (SFI) to the IRB.For more information,see theInvestigator Conflict of Interest Disclosure Policy for Human Subjects.
A. Disclosure
1. At present or in the 12 months prior to this disclosure, did or does any investigator or investigator’s family members have a significant financial interest (SFI) with the research sponsor or any subcontract recipient; or have a SFI reasonably related to a product (e.g., drug, device, method, treatment, etc.) that is the subject of the research; or have any other relationships (e.g. fiduciary, even if uncompensated) that may present a potential conflict of interest with this research?
No
Yes – See Section B below
2. Are you aware of an institutional conflict of interest with this study?
No
Yes – See Section B below
B. Management
If YES is checked for any of these questions, complete the disclosure and management plan via START myDisclosures application ( Guidance can be found on the COI website at “Managing Conflicts”. Final IRB approval of the research cannot be provided until a management plan is in place and is approved by the IRB. For additional assistance contact the COI Office at (312) 996-3642 / (312) 996-4070 or email .
If YES to either question in item A, check only one of the following:
The IRB has previously accepted my SFI-DMP stamped “COI-HSR Committee recommended to IRB for approval.” The PI attests that there are no changes to the study that require changes to the SFI-DMP.
The IRB has previously accepted my SFI-DMP stamped “COI-HSR Committee recommended to IRB for approval.” Changes are required for the SFI-DMP. The PI has submitted an amendmentas a separate submissionto the IRB.
IV. Changes to the Research
- Please note that any new changes to the research, or changes not previously approved by the IRB viaan Amendment and/or Protocol Exception, require a separate OPRS Live Amendment submission prior to implementation. The types of changes requiring an Amendment include the following(please refer to the Amendment Application form for specific submission requirements):
1. Addition of Key ResearchPersonnel. (Note: Removal ofpersonnel does not require an amendment;the names of persons no longer on the studycan be crossed out on the current Appendix P and includedas part of the Continuing Review submission).
2.Addition of/changes to the Funding/Sponsorship.
3. Revisions/additions to the Research Protocol and/orInstruments.
4. Revisions to/addition of the type or number of Research Subjects.
5. Addition/removal of Non-UIC Sites.
6. Revisions/additions to the Recruitmentand/orConsent Process/Documents.
7. Revisions/additions to the HIPAA Authorization and/orHIPAA Compliance.
8. Revisions/additions to the Data Security procedures and/or measures.
9. Revisions/additions to the Test Article (including procedures for handling and control of the test article).
10. Other revisions/additions to the research.
V. Purpose and Progress
A.Briefly describe the purpose (scientific aims) of the research:
B.Please provide a summary of the progress of the research including the current status of all enrolled subjects. For multi-site trials (for example: NIH studies) upload any relevant trial reports that would provide summary progress information.
C. If the research was previously approved by the convened IRB, indicate if any of the following apply:
The research is permanently closed to the enrollment of new subjects;ANDall subjects have completed all research-related interventions; AND the research remains active only for long-term follow-up of subjects. (Long-term follow-up refers to collection of data on survival or disease status. It does not include data collection activities such as interviews, clinic visits, lab tests, etc.)
Subjects have never been enrolled on this studyAND no additional risks have been identified since the last approval.
Data collection is complete. The study remains open for data analysis only.
Not Applicable
D. Updated Research Information
Indicate whether any of the reports/documents listed below have been received since the last approval, indicate the date of the report/document, and indicate the date the report/document wassubmitted to the IRB. (If any of the items listed have not been submitted to the IRB for review, submit a separate submission with the item and an Amendment form at this time.)
Not Applicable –The research does not involve any of the reports/documents listed below or there have not been any changes to the documents since the last approval. Skip to Section VI.
Type of Report/Document / Date of Report/Document / Date Submitted to IRBDSMB/DMC/ Safety Monitoring report
Multi-Center Trial report
Interim Analysis by Sponsor or Investigator
Investigator’s Brochure
Change in FDA status (i.e, labeling change or withdrawal from marketing of test article used in study)
Annual report to FDA
Other. Describe
E. Findings from this Research
1.Do the findings or interim results from any of the above sources indicate a change in any of the following?
The current risk/benefit assessment based on study results: No Yes
Potential for benefit to be gained from the research: No Yes
Alternatives to subject participation in the research: No Yes
Subject willingness to continue participating in the research: No Yes
If NO to all of the above, skip tosection VI.
If YES to any of the above, complete the remainder of this section.
2.Describe how the findings or interim results impact the risks, benefits, alternatives or subject willingness to continue participation.
3. Provide the status of the amendment that describes the changes in the research as a result of the findings.
Pending submission to the IRB.
Submitted to the IRB, but not approved yet. Submission Date:
Approved by the IRB.
Submission Date: ApprovalDate: UICAmendment #
Not Required – Explain:
VI.Summary of Recent Literature
A. Has any literature published or presented since the last IRB approval demonstrated an impact on the risk, potential benefits, alternatives and willingness to continued participation?
N/A. There has not been any recent literature published or presented since the last IRB review.
No.
Yes. If YES, an amendment is:
Pending submission to the IRB.
Submitted to the IRB, but not approved yet. Submission Date:
Approved by the IRB.
Submission Date: ApprovalDate: UIC Amendment #
Not Required – Explain:
VII. Subject EnrollmentandDemographics
A.Indicate the number of subjects enrolled. Include all subjects who signed a consent document, subjects enrolled under a waiver of documentation of consent, or the number of cases/charts reviewed under a waiver of consent.
Population Description
/A.1.Total number of subjects at sites under UIC IRB oversight enrolled since the last IRB approval
/A.2. Total number of subjects at sites under UIC IRB oversight enrolled to date
/A.3. Total number from non-UIC Sites
(Complete Only if UIC is the grant holder or lead institution)
Minors (less than 18 years of age)
Adults: Healthy Subjects or Controls
Adults: Patients
TOTAL
B. If subjects enrolled are different by type (age, gender, special populations) and/or proportion from the IRB-approved subject population for this research, please provide detail below:
C. If this research involves a retrospective review, are you planning to review additional charts/records?
No
Yes
N/A – This research involves prospective subject enrollment only.
D. If no subjects have been enrolled since the last review, indicate why the research should remain open:
N/A – Subjects have been enrolled since the last review.
Research is closed to enrollment but data collection and/or analysis are ongoing
Study is in long-term follow-up
Other – Explain:
VIII.Informed Consent Process
A.Are you planning to enroll additional subjects? (Note: If research involves a retrospective review only, skip to section IX.)
No - Are you requesting that the consent materials continue to be used for currently enrolled subjects only?
No
Yes - Upload clean copies of IRB approved consent materials that you will continue to use and justify the request to continue to use these documents:
Yes - Uploadclean copies of IRB approved recruitment and consent materials that you will continue to use and require a new approval stamp. Previously approved materials with an expiration date that are not provided for review will be considered inactive.
B. Informed Consent in Other Languages
1. Have any subjects whose primary language is not English been consented to participate and enrolled in the research since the last IRB approval (initial or continuing)?
No
Yes – Indicate the process(es) used:
IRB approved short-form consent for non-English speaking subjects
Number of subjects:
Language(s):
IRB approved translation of full (i.e., long-form) consent document
Number of subjects:
Language(s):
Other. Explain process used:
2. Have subjects been excluded because English is not their primary language since the last IRB approval (initial or continuing)?
No
Yes-Please explain.
IX. SubjectParticipation
A. Complaints
Have any complaints been received about the research since the last IRB approval (initial or continuing)?
No
Yes– For each complaint, describe the substance of the complaint, when it occurred, the complainant’s relationship to the study, and how the situation was resolved.
B. Participation Declined
Have any recruited persons (and/or parents, guardians, or legally authorized representatives for the subject) declined to participate in the research after being approached since the last IRB approval (initial or continuing)?
No
Yes– Please provide:
1. Total number of persons recruited who were not enrolled:
2. Summarize your understanding of the reasons participation in the study was declined:
C. Withdrawal
1. Have any subjects dropped out of the research after providing consent?
No
Yes – Please provide:
a. Total number of subjects who have dropped out since the last IRB approval (initial or continuing):
b. Total number of subjects who have dropped out to date:
c. Summarize reasons subjects have dropped out:
2. Have any subjects been lost to follow up (for example: not attended follow-up appointments or responded to phone call reminders) after initial enrollment (after being consented) since the last IRB approval (initial or continuing)?
No
Yes – Please provide:
a.Total number of subjects who have been lost to follow up since the last IRB approval (initial or continuing):
b.Total number of subjects who have been lost to follow up to date:
c.Summarize the steps taken to locate lost subjects:
3. Have any subjects been withdrawn from the research by the investigator or sponsor since the last IRB approval (initial or continuing)?
No
Yes – Please provide:
a.Total number of subjects who have been withdrawn by the investigator or sponsorssince the last IRB approval (initial or continuing):
b.Total number of subjects who have been withdrawn by the investigator or sponsorto date:
c.The phase of the study in which the withdrawals have occurred (for example: during screening, intervention, or data collection) and the reason(s) for the withdrawals:
X. Changes to the Research
A. Have any amendments been submitted for review since the last IRB approval (initial or continuing)?
No - Skip to section XI.
Yes
B. List all of the amendments that have been submitted to the IRB for review since the last IRB approval (initial or continuing).
Amendment # / Date of IRB Approval / Description of AmendmentXI. Research Compliance
A. Have any unanticipated problems involving risks to subjects or others (i.e., unanticipated problems) occurred since the last IRB approval?
No
Yes
B.Have any adverse events occurred at a higher frequency or level or severity than documented in the research protocol, informed consent document, or investigator brochure?
No
Yes
If the answers to both questions are NO, skip to question D.
If the answer to at least one question is YES, proceed with question C.
C. List all reportable (i.e, only those that met UIC reporting criteria) unanticipated problems and events associated with this protocol since the last IRB approval (initial or continuing). These events should have already been reported through the prompt reporting form. If not, please explain below why they were not submitted and submit a prompt reporting form for each event at this time (requires a separate OPRS Live submission).
Date of Event / Date of IRB Notification / Description of EventD. List any serious adverse events that occurred locally (i.e. internal) since the last IRB approval (initial or continuing), but did not meet the criteria for required reporting as a result of being expected or not related to the research.
Date of Event / Description of Event / Expected / Related to researchYes No / Yes No
Yes No / Yes No
Yes No / Yes No
Yes No / Yes No
E. Has an audit of the research been conducted by a federal agency or sponsor since the last IRB approval (initial or continuing)?
No
Yes- Please upload a copy of the audit report with this form.
XII.Multi-Center Research
N/A – UIC is only site
UIC is lead site or coordinating center –upload copies of the most recent IRB Approval for each participating site with this application packet.
UIC is not the lead site – upload a copy of the Lead Site’s most recent IRB Approval
XIII. Suspension (Stopping) of Research Activity
A.Has any non-UIC ethical review board or IRB disapproved, suspended or terminated this research?
No
Yes – Provide additional information (who, when, why, etc.):
B. Since the last approval, has there been an administrative hold by the investigator or sponsor, or suspension of any research activity (for any reason), that has not already been reported to the IRB?
No
Yes - Complete the table:
Description of the suspended activities
/Period of time the activities were suspended
/Reason the activities were suspended
XIV. Presentations and/or Publications
Have there been any presentations or publications (including abstracts) from this research since the last review? No
Yes – Complete the table and upload copies of each item listed below:
Copy Uploaded
/Citation/Description of Publication/Presentation
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