Use of the NCI CIRB Form

Michigan State University’s Institutional Review Boards (IRBs) Biomedical & Health Institutional Review Board (BIRB) Community Research Institutional Review Board (CRIRB) Social Science / Behavioral / Education Institutional Review Board (SIRB)

Instructions: Complete and submit this form to the MSU IRB for projects submitted to the NCI CIRB. See HRPP Manual 1-5, Use of the National Cancer Institute Central Institutional Review Board for more information. Submit completed form and requested documentation to [email protected] 1 MSU PI: 2 Additional Engaged MSU Personnel (Note: “engaged” refers to individuals interacting with subjects or their identifiable data) (continued on page 4) First Name Last Name Title Z-PID / A-PID Role in the project: Co- or sub-investigator Research staff

Clinical research assistant or coordinator Study coordinator Other,

Procedures he/she will be performing (describe): 3 Title of Project: 4 Study Identifier: 5 Cooperative Group: 6 Affiliate institution(s): McLaren Greater Lansing

Sparrow Hospital

ANY sites in addition to those listed above must be submitted by the MSU HRPP to the NCI CIRB and approved by the NCI CIRB before subjects can be enrolled at those sites. 6A Involvement of affiliate institution (check all that apply and explain as appropriate): Lab – Explain:

Pharmacy – Explain:

Nursing staff – Explain:

PHI – Explain:

Other – Explain:

7A Name of Funding Source(s): 7B OSP/CGA eTransmittal Number(s): 8 Does any person responsible for the design, conduct, or reporting of findings of this protocol have a Significant Financial Interest (as defined for the MSU Faculty Conflict of Interest Policy) or other opportunity for tangible personal benefit related to the conduct of the research that might compromise, or reasonably appear to compromise, the independence of judgment with which their responsibilities would be completed under this research protocol? A reportable financial interest includes, but is not limited to, a financial interest in the sponsor, product, or service being tested, or in a competitor of the sponsor or

1V16-03 (10-31-2016) Use of the NCI CIRB Form product or service being tested. Yes | Describe:

9 Has any financial arrangement, including compensation, ownership interest, stock options, or other ownership interest, (e.g., compensation that is: explicitly greater for a favorable result; in the form of an equity interest in the sponsor of a covered study; or in the form of compensation tied to sales of the product, such as a royalty interest) been established whereby the value of compensation or ownership interest to investigators conducting the study could be influenced by the outcome of the study? Yes | Describe:

10 Are you using an FDA approved drug/device/diagnostic test? Yes | Explain (including a description of the product(s)):

11 Is this a clinical study where the results may be used to support marketing applications for new human drugs and biological products and marketing applications and reclassification petitions for medical devices to the FDA, as required by law? Yes | Describe:

12 Have you or the sponsor or will you or the sponsor be registering this project with www.clinicaltrials.gov? Yes

13 Have you or will you be contractually obligated or otherwise obligated to comply with the E6 International Conference on Harmonisation - Good Clinical Practice Guidelines? Yes

14 Does this project involve the use of materials of human origin (e.g. human blood, tissue, or cell lines)? Yes | What are you collecting and why?

15 Will there be any use of radioactive materials and/or use of radiation producing machines? Yes | What will you be using and why?

16 Does this project involve protected health information as defined by HIPAA?

2V16-03 (10-31-2016) Use of the NCI CIRB Form Yes

If you answered yes, submit the Use of Protected Health Information Application. 17 Will some or all of the subjects be prisoners (i.e. involuntarily confined or detained in a penal institution)? Yes

18 Does this project include patient care services or items such as clinic visits, procedures, radiology, labs, etc., that may generate a charge in the billing system? Yes

Documentation 19 Submit the following documents to the MSU IRB:  All funding agreements including notice of award/grant application/subcontract/subaward, work orders (for non-industry and industry funding sources), etc.  NCI CIRB approved consent forms that includes the NCI-approved MSU boilerplate text

As the Principal Investigator, my signature below indicates that :  The provided information is completed and accurate.

 I will report immediately to the MSU HRPP any audit (e.g. NIH or FDA), unanticipated problem involving risks to subjects or others (UPIRSO), subject complaint, serious or continuing noncompliance with the federal regulations or the requirements or determinations of the IRBs, or suspension or termination of IRB approval.

 I will send to the MSU HRPP all reviewing NCI CIRB determination/continuing review letters upon receipt (including renewals, revisions, protocol deviations, closures, etc.).

 I will abide by human research protection training requirements of the NCI CIRB.

 I will be familiar with and review the NCI CIRB’s policies and procedures.

 I will comply with the determinations of the NCI CIRB.

 I will review HRPP Manual 1-5, Use of the National Cancer Institute Central Institutional Review Board.

 Other university review(s) and approval(s) may need to be obtained prior to initiation of research and/or clinical investigations involving human subjects (e.g. conflict of interest, biosafety).

 I agree that I will not begin the research and/or clinical investigation involving human subjects until

3V16-03 (10-31-2016) Use of the NCI CIRB Form I receive an Acknowledgement letter from the MSU HRPP, even if IRB approval has been received by the NCI CIRB IRB.

NAME: DATE: Note: Application can be submitted from the Principal Investigator’s MSU email account.

4V16-03 (10-31-2016) Use of the NCI CIRB Form Engaged MSU Personnel (continued from page 1) 1 First Name Last Name Title Z-PID / A-PID Role in the project: Co- or sub-investigator Research staff

Procedures he/she will be performing (describe): 2 First Name Last Name Title Z-PID / A-PID Role in the project: Co- or sub-investigator Research staff

Procedures he/she will be performing (describe): Copy this page for additional personnel

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