FORM – External IRB Continuing Review of Research Version 3.0
To Be Completed By the Investigator / UIC Protocol #:Date Application Completed: / For OPRS Use Only
Application Document Version #: / Assigned IRB:
PAF #:
I. Name of Research Network:
II. Name of External IRB:
III. Protocol Title:
IV. Personnel
A. Principal Investigator
Name (Last, First) / Degree(s)/ University Status/Title
Department / College
Mailing Address / UIC E-mail Address
Phone Number / Fax Number / M/C
V. Conflict of Interest (COI)
All investigators must disclose all real, apparent, or potential Significant Financial Interest (SFI) to the IRB. For more information, see the Investigator 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 (https://myresearch.uillinois.edu/myDisclosures/). Guidance can be found on the COI website at http://research.uic.edu/compliance/coi under “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 .
VI. Documents Required for Review:
Provide a copy of the Continuing Review submission provided to the external IRB and the approval notice. The following documents should be submitted if revised since the initial registration or last continuing review: research protocol, consent document(s), HIPAA Authorization(s), recruitment material(s).
IX. Subject Enrollment and Demographics
A. By age range, indicate the number of subjects enrolled (include all subjects who signed a consent document, for whom documentation or written consent was waived, or the number of cases entered).
AGE RANGE
/Total number of subjects at sites under UIC IRB oversight enrolled since the last IRB approval (initial or continuing review)
/Total number of subjects at sites under UIC IRB oversight enrolled to date (since initial IRB approval- over all years)
/Total number from non-UIC Sites
(if UIC is the grant holder or lead institution)
Age: Newborn to 6 Years
Age: 7 to 11 Years
Age: 12 to 15 Years
Age: 16 to 17 Years
Age: 18 to 64 Years
Age: 65+ Years
TOTAL
B. By population description, indicate the number of subjects enrolled.
POPULATION DESCRIPTION
/Number enrolled at
at sites under UIC IRB oversight since the last IRB approval (initial or continuing review)
/Total number (by category) of subjects at sites under UIC IRB oversight enrolled since initial IRB approval (over all years)
Adults: Healthy Subjects or Controls
/ /Adults: Patients
/ /Minors (less than 18 years of age)
/ /Total
/ /Special populations
/ /Pregnant Women, Neonates, Fetuses/Fetal Tissue: Primary focus of research
/ /Prisoners: Primary focus of research
/ /Prisoners: when prisoners are not approved for inclusion
/ /UIC Employees
/ /UIC Students
/ /Students in a Classroom Setting
/ /UIC Psychology Student Subject Pool
/ /Decisionally Impaired Individuals
/ /Economically or Educationally Disadvantaged Individuals
/ /Jesse Brown VAMC Veterans
/ /Other: Specify:
/ /C. By designated demographics, indicate the number of subjects enrolled at sites under UIC IRB oversight since inception of study.
Demographic
/American Indian or Alaskan Native
/Asian or Pacific Islander
/Black, not of Hispanic origin
/Hispanic
/White, not of Hispanic origin
/Other or unknown
/Total
Females
/ / / / / / /Males
/ / / / / / /Unknown
/ / / / / / /Total
/ / / / / / /D. If subjects enrolled are different by type (age, gender, race/ethnicity, special populations) and/or proportion (for example: 50% White/50% Hispanic) from the IRB-approved subject population for this research, please provide detail below:
INVESTIGATOR ASSURANCE
I certify that the information provided in this application is complete and correct. I understand that as Principal Investigator, I am ultimately responsible for the protection of the rights and welfare of human subjects and the ethical performance of the research. I agree to comply with all applicable UIC policies and procedures of the IRB of record and the UIC OPRS, and applicable federal, state and local laws. I also agree to the following:
· The research will only be performed by qualified personnel as specified in the approved research application and/or protocol,
· No changes will be made to the research protocol (except when necessary to eliminate apparent immediate hazards to the subject), or the consent process (if one is required) without prior approval by the UIC IRB of record,
· Legally effective informed consent/assent will be obtained from all human subjects, unless this requirement is waived by the IRB of record, using only the recruitment materials and informed consent/assent documents that have been approved by the IRB of record. The potential benefits of participation will not be overstated and reasonably anticipated risks will not be minimized. Subjects will be asked open-ended questions to try and ensure adequate comprehension of the information so as to allow for truly informed consent to participate.
· All problems that require prompt reporting to the IRB have been reported according to policies and procedures of the external IRB and the UIC OPRS.
I certify that I have completed the required educational program on ethical principles and regulatory requirements in Human Subject Protections. I further certify that the proposed research is not currently underway and will not begin until IRB approval has been obtained.
Principal Investigator Signature ______DATE______
Name printed: ______
DEPARTMENT HEAD* SIGNATURE
*If the Department Head is the Principal Investigator or any of the Co-Investigators, the Department Head’s superior (for example: Dean), must sign in place of the Department Head.
As department head (or signatory official), I acknowledge that this research is in keeping with the standards set by our department and I insure that the Principal Investigator has met all departmental requirements for review and approval of this research.
By my signature as department head (or signatory official) on this research application, I certify that the Principal Investigator has the training and expertise to conduct research at UIC and that the research meets the standards of the specific discipline, as well as the standards and guidelines of any relevant professional organizations, societies, or licensing bodies.
Department Head Signature______Date______
Name printed:______
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