Nci Central Irb

Registration for Protocol Review by Western IRB, Version 1.10

To Be Completed By the Investigator / For OPRS Use Only
Date Application Completed: / UIC Protocol #:
Application Document Version #: / Assigned IRB:

I. Research Title:

II. Personnel

A. Principal Investigator (PI)

Name (Last, First) / Degree(s) / University Status/Title
Department / College
Mailing Address / M/C
Phone Number / Fax Number / E-mail Address

B. LIST ALL ADDITIONAL KEY RESEARCH PERSONNEL ON APPENDIX P and SUBMIT WITH THIS APPLICATION PACKET.

III. Research Funding

1. Industry Sponsor Name:

The UIC OVCR assesses an administrative fee for the IRB review of all industry sponsored human subjects research. Please refer to theProtocol Processing Fee for Industry Sponsored and IRB Submissions to the UIC IRBfor an explanation of this policy and fee schedule. The account number to be charged must be provided below before IRB review commences.

Account Number to be charged:

Please note that the fees may change based on business decisions by WIRB. While OPRS will try to provide advance notice of any increases, this should be accounted for in budget planning

IV. Conflict of Interest (COI)

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.

Note: If a Financial Interest has been declared that exceeds $5000, you must complete a a Significant Financial Interest – Disclosure and Management Plan (SFI-DMP). The SFI-DMP form and guidance on how to write the SFI-DMP are available on the COI website at IRB approval of the research cannot be provided until a management plan is in place. For additional assistance contact the COI Office at (312) 996-3642/ (312) 996-4070 or email .

V. Institutional Reviews Required

Reviews may be required for this study. Please indicate which of the reviews below apply to this study. If you have already received review approval documents, please attach.

Review / Review Required? / If YES, check that necessary documents are attached
UIC Clinical Trials Office Review is required prior to submission to the WIRB for Industry Sponsored Research / Yes
No / CTO Coverage Analysis is attached
Approval date:
UIC Cancer Center Review is required prior to submission to the WIRB for Cancer-Related Protocols. / Yes
No / Cancer Center approval is attached
Approval date:
Clinical Interface Core (CIC) The application (CIC IRB Application Appendix G) must first be submitted to the CIC for Approval. Only submit for WIRB review after all issues have been addressed and final CIC Approval has been obtained / Yes
No / CICapprovaldate:
Investigational Drug Service (IDS) provides registration and clearance of any drug involved in the research, including investigational and FDA approved drugs.
To secure IDS registration and clearance, Appendix E must be faxed to IDS for review and signature. / Yes
No / Appendix E is signed and attached
IDS registration date:

VI. WIRB Review Checklist

Please check your response to the following questions:

1. Does the study meet the NIH definition of a Clinical Trial? “A prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices)”

No Yes (If No, submit to OPRS for UIC IRB Review)

1. Does the study involve human subjects designated to prospectively evaluate the safety and/or effectiveness of new drugs or devices or of behavioral interventions?

No Yes (If No, submit to OPRS for UIC IRB Review)

1. Is the study a Phase II, III,or IV Multi-Center Clinical Trial?

No Yes (If No, submit to OPRS for UIC IRB Review)

1. Is the protocol designed and written by the sponsor?

No Yes (If No, submit to OPRS for UIC IRB Review)

1. Is the sponsor of the research a for-profit entity or company?

No Yes (If No, submit to OPRS for UIC IRB Review)

1. Does the sponsor hold ALL IND’s/IDE’s for this project?

No Yes (If No, submit to OPRS for UIC IRB Review)

If Yes, Appendix A1 or A2 is attached

1. Does the proposed research involve funds from a federal agency or other not-for-profit funding source?

No Yes (If Yes, submit to OPRS for UIC IRB Review)

1. Is the research Greater than Minimal Risk?

No Yes (If No, submit to OPRS for UIC IRB Review)

1. Has the research been previously submitted to the UIC IRB for review?

No Yes (If Yes, submit to OPRS for UIC IRB Review)

1. Regarding Recombinant DNA and its derivatives. Does the research involve any of the following: (If the answer is Yes to any of the questions below, obtain UIC IBC Approval (contact and submit to OPRS for UIC IRB Review)

No Yes Deliberate transfer of recombinant DNA, or DNA or RNA derived from recombinant DNA into one or more human subjects

No Yes Deliberate transfer of recombinant DNA, or DNA or RNA derived from recombinant DNA into cells that will be transferred into one or more human subjects

No Yes Deliberate transfer of synthetic nucleic acid molecules, or DNA or RNA derived from synthetic nucleic acid molecules, that meet any one of the following criteria:

a) Contain more than 100 nucleotides; or

b) Possess biological properties that enable integration into the genome (e.g., cis elements involved in integration); or

c) Have the potential to replicate in a cell; or

d) Can be translated or transcribed.

No Yes Deliberate transfer of an infectious agent (ie. bacteria, virus) including attenuated infectious agents into human subject(s).

11. Is this Industry Sponsored study Investigator Initiated?

No Yes (If Yes, submit to OPRS for UIC IRB Review)

12. Does the research involve the use of Radioactive Drugs or Biologics?

No Yes (If Yes, obtain RDRC Approval and submit to OPRS for UIC IRB Review)

13. Does the research involve the use of radioactive materials?

No Yes (If Yes, obtain Radiation Safety Approval and submit to OPRS for UIC IRB Review)

*Research that includes the following criteria may qualify for submission to WIRB depending upon the design of the study. It is requested that the Protocol Synopsis be provided to the OPRS WIRB Administrator for review.

• Research that involves subjects under the age of 18 (i.e., Children, Minors)

NOTE: The UIC IRB reserves the right to withhold any new research protocol, regardless of industry sponsorship, from being sent to WIRB for review.

VII. Subject Population and Recruitment

A. Subject Population

Requested number of subjects: Total UIC:

B. Vulnerable Populations (check all that apply):

Pregnant Women, Neonates, Fetuses/Fetal Tissue –

Prisoners –(Not eligible for review by WIRB) Decisionally Impaired*

Economically and/or Educationally Disadvantaged*

Vulnerable to Coercion or Undue Influence*

Children (< 18 years of age)

Other, specify:

C.Recruitment Materials

Please note that WIRB does not stamp recruitment materials. Final WIRB Approved recruitment materials to be posted within the UIC Campus must be stamped by OPRS. Please bring to OPRS the materials that require stamping for posting. Please note that OPRS will stamp a maximum of 1 of the same type of recruitment materials.

VIII. CONTACT INFORMATION

Who should be the primary person contacted (for example, Research Coordinator) by OPRS if further information about this protocol is needed? This person may be someone other than the PI or other individuals listed as key research personnel (i.e., Administrative Coordinator).

Do you wish to grant this individual OPRSLiveaccess to this research protocol?

Yes No

Name (Last, First) / Title
E-mail Address / Date
Phone Number / Fax Number

• Have you used any services provided by the UIC Center for Clinical and Translational Science (CCTS) on this protocol?

No Yes

• Would you like to give the CCTS coordinators access to this protocol in OPRSLivefor tracking and facilitation purposes?

No Yes

• Do you agree to have this research listed on the UIC research directory (web page)?

No Yes

If YES, please submit the following:

Title:

Investigator Name:

Three (3) Keywords describing the research:

Contact Information for further information (if different from contact information given immediately above):

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 WIRB policies and procedures, 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 WIRB IRB,
• Legally effective informed consent/assent will be obtained from all human subjects, unless this requirement is waived by the WIRB IRB, using only the recruitment materials and informed consent/assent documents that have been approved by the WIRB IRB. 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.
• Unanticipated problems involving risks to subjects or others (including adverse events), other reportable events, and subject complaints will be reported to the WIRB IRB in a timely manner.
• If applicable, all research staff that are involved in the research will comply with the HIPAA regulations. Further, I assure that all research staff will have completed the HIPAA research training requirement prior to research participation. I agree that any breach or suspected breach of confidentiality (data security) meeting the definition of an unanticipated problem will be promptly reported to the WIRB IRB. I also agree that any breach or suspected breach involving UIC PHI in the custody of the principal investigator, co-investigator(s), research staff, students, or business associate will be immediately reported to the HIPAA Privacy Officer: (312) 355-5650 . I assure that the information obtained as part of this research (including protected health information) will not be reused or disclosed to any other person or entity other than those identified on this form, except as required by law. If at any time I want to reuse this information for other purposes or disclose the information to other individuals or entities I will seek approval by the IRB.
• The investigator is responsible for all fees incurred as a result of submission to WIRB.

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, I insure that the Principal Investigator has met all departmental requirements for review and approval of this research, and I acknowledge that WIRB is responsible for the disclosure and management of any conflict of interests related to the 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,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, and sufficient resources available to carry out the research.

Department Head Signature______Date______

Name printed:______

Checklist: Material to Submit with Application for Protocol Review by Western IRB

Registration for Protocol Review by Western IRB

Account Number to be Charged

Appendix P

Appendix E

Any other committee review and approval that was required prior to submission to OPRS (e.g., Investigative Drug Service (IDS), Cancer Center (CC PRC), Radiation Safety Committee (RSC), Clinical Interface Core (CIC)).

Sponsor Informed Consent Template

Sponsor Research Protocol

CTO Coverage Analysis

Copy of Western IRB Application and Financial Disclosure (if a Conflict of Interest has been identified)

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