Checklist: Initial Review Application Social and Behavioral Sciences

Development/Center/Training Grant Application, Version 2.0

I. Research Title:

II. Personnel

A. Principal Investigator

B. Faculty Sponsor – required when PI is a student, fellow or resident

C. LIST ALL ADDITIONAL CO-INVESTIGATORS/KEY RESEARCH PERSONNEL (INCLUDING THOSE FROM OTHER INSTITUTIONS) ON APPENDIX P and SUBMIT WITH THIS APPLICATION PACKET.

III. Performance Sites

Definition of a Performance Site: A performance site is a location at which the research is conducted, data is gathered from subjects and/or records, and/or subjects are consented into the research. Sites are performance sites whether the research activities there are funded or not funded.

Non-UIC Performance Site: A non-UIC performance site is a non-UIC location at which a UIC investigator conducts research under research protocols which are not funded (for example, most thesis and dissertation research is not funded) and/or funded research protocols. Support for funded research protocols may include, but not be limited to, grants, cooperative or collaborative agreements, contracts, sub-contracts, clinical trial agreements, industry sponsors, fellowships, and scholarships.

Lead Performance Site: The performance site at which the research is initiated and, for funded research, the site designated as the lead by the research sponsor [the entity paying for the research] and/or the site that receives funding directly from the research sponsor. For example, if a UIC investigator receives a contract or grant to conduct research, and then sub-contracts with other non-UIC investigators to do part of the research, UIC is the lead performance site. If, on the other hand, a UIC investigator receives a sub-contract from a non-UIC investigator, UIC is not the lead performance site. In some cases, such as research sponsored by the pharmaceutical industry, there will be no lead performance site and each site will act as an independent performance site, even though the research may take place at many performance sites at once and is supported by the same research sponsor.

A. Performance Site Identification:

1. Will UIC be a performance site?Must be YES unless the research is conducted only at the Jesse Brown Veterans Administration Medical Center [JBVAMC]

No Yes

2. Will JBVAMC be a performance site? Please note that the JBVAMC has special status as a performance site and that alternative documentation will be required in lieu of Appendix K for research activities conducted at the JBVAMC.

No Yes

B. Non-UIC Performance Sites:

1. Are there non-UIC performance sites?

No Yes (After completing this application, complete Appendix K and submit with this application packet)

2. Are there international performance sites?

No Yes (After completing this application, complete Appendix I and submit with this application packet)

C. Lead Performance Site?

1. Is UIC the Lead Performance Site?

N/A – Research is industry sponsored and the sponsor is the Lead Performance Site, OR the study does not have a Lead Performance Site

Yes (Skip to section IV)

No (Complete the questions below)

Name of Non-UIC Lead Performance Site:

City: State:

IRB Approval Date/Exemption from non-UIC Lead Performance Site:

IRB Approval from non-UIC Lead Performance Site is pending

The IRB will request documentation of IRB approval(s), IRB Authorization Agreement(s), letter(s) of support, and/or other documents as needed.

IV. Research Funding

1. Is this research funded?

No. Go to Section V.

Yes or pending. Complete the rest of this Section (below).

1. Check all of the appropriate boxes for funding sources (including pending sources) for this research.

EXTRAMURAL:

Federal Agency Name:

Foundation Name:

State Agency Name:

Industry Sponsor Name:

The UIC OVCR assesses an administrative fee for the IRB review of all pharmaceutical 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:

Department of Defense – Complete and submit Appendix Q

Sub-contract from non-UIC agency or institution: Name:

Other - Name:

INTRAMURAL:

Campus Research Board (CRB) Departmental Other - Name:

1. Funding Identification: For each funding source, provide the following information. Use Appendix Zif this study is supported by more than one funding source. Note: Any subsequent change in funder or funding status requires the submission of Appendix Z via an IRB amendment.

PLEASE ATTACH A COPY OF THE GRANT or CONTRACT TO THIS APPLICATION FOR FEDERALLY FUNDED RESEARCH WHERE UIC IS THE AWARDEE INSTITUTION OR LEAD SITE.

1. Proposal Approval Form (PAF) Number:

2. a. Name of the PI on the grant or contract received directly from the sponsor:

b. Is the PI of this grant or contract affiliated with UIC? No Yes

If NO,

Identify the agency or institution with which the above PI is affiliated:

Explain the relationship between that agency or institution and UIC:

3. Funding Agency Grant Account Number:

Grant, contract or sub-contract pending.

Not Applicable, Non-federally funded research

4. Grant, contract or sub-contract title:

5. Is this grant a Master, Training, or Development grant (grants used to train fellows or support the development of other research protocols)? No Yes

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 theInvestigator Conflict of Interest Disclosure Policy for Human Subjects.

Investigator is defined as any person responsible for the design, conduct, or reporting of the research. This includes, but is not limited to, the principal investigator, faculty sponsor, co-investigators, collaborators, consultants, and key research personnel.

Family members include spouse or domestic partner, parents, siblings, and children.

Significant financial interest (SFI) (42 CFR 50.603) is identified when:

1. The value of any remuneration received from an external entity at present or in the 12 months preceding the disclosure that when aggregated for the investigator and family members totals or exceeds $5,000. The $5,000 threshold also applies to salary, royalties, and other payments aggregated for the investigator and family members.
2. The value of a publicly-traded equity (plus any remuneration) meets or exceeds $5,000.
3. Any level of ownership of privately-held equity regardless of the dollar value.
4. Intellectual property rights (e.g., patents, trademarks, copyrights, licensing agreements, and royalties from such rights) excluding intellectual property rights assigned to the University of Illinois and agreements with the University of Illinois to share royalties related to such rights.
5. Any other relationships that might present a financial conflict of interest, such as fiduciary interests (paid or unpaid positions as director, officer, or other management role in a for-profit or not-for-profit entity sponsoring or related to the research) or interests in which compensation or the value of equity or property rights or the combination of interests might affect the outcome of the research.

Institutional COI includes financial interests of the university or a university official acting within his or her authority on behalf of the institution might affect or reasonably appear to affect institutional processes for the design, conduct, reporting, review, or oversight of human subjects research. Examples of institutional conflict of interest include but are not limited to:

1. The university has an equity interest in a company or the university holds a patent, license, or some type of intellectual property interest related to the product that is the subject of the research.
2. A university official acting within his or her authority on behalf of the institution has equity interest, serves on an advisory or other Board, or serves in a fiduciary role in an entity that has an interest in the outcome of human subjects research.
3. Gifts to the university or university official from a company or other entity that has an interest in the outcome of human subjects research.

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 (If yes, see Section B below.)

2. Does an institutional conflict of interest exist with this study?

No Yes (If yes, see Section B below.)

B. Management

If YES is checked for any of these questions, attach 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.

UIC and JBVAMC personnel: For additional assistance contact the COI Office at (312) 996-3642/ (312) 996-4070 or email .

VI. Lay Summary

Please provide ONLY a general overview of the proposed research using non-technical language that can be understood by members whose primary concern are non-scientific. The summary should not exceed a total of 200 words. Use complete sentences. NOTE: This application should only be used for the developmental activities or for the training and center grants listed in Section VII below and NOT to obtain approval for pilot studies or any research activities that involve human subjects.

VII. Affirmation of Grant Status Request

In accordance with 45CFR46.118, there are some applications for grants, cooperative agreements, or contracts that are submitted to federal departments or agencies with the knowledge that subjects may be involved within the period of support, but these applications do not include specific plans for human subjects research in order to accomplish the aims of the proposal. These applications generally fall into one or more of the following categories:

1. “Core” or “Center” grants—these are institutional grants that will support individual research projects that are “yet to be determined” at the time of the Core or Center grant application.
2. Training grants—these applications request funding for research fellows or others who will be supported for the purpose of implementing human subject research, but the specific studies on which they participate are not part of the training grant application.
3. Development only applications—these applications include plans for the development of specific human subjects research studies, but those studies will only be initiated after some preliminary projects are completed (e.g., development of instruments or compounds, or prior animal studies).

At UIC, IRB approval is required for Core, Center and Training grants using this application form.

Regardless of the category above, under NO circumstances may an investigator initiate human subjects research funded by the grant/contract, including pilot studies, prior to the review and approval of a separate IRB application or a Claim of Exemption (through OPRS).

Please clarify the type of developmental status you are seeking (check one or more from the following options)?

This application is for an institutional “Core” or “Center” grant/contract/agreement in which the specific activities involving subjects remain to be determined or selected.

Each research project involving human subjects that is funded from this center or core grant/contract/agreement will be separately submitted, and no research activity will begin until each individual project is approved. Those individual applications will cross-reference this protocol as a source of financial support.

This application is for an institutional “Training” grant/contract/agreement which will provide support for research personnel who will be involved in human subject research, but the specific studies on which they participate are not included within this grant/contract/agreement.

Each research project involving human subjects and utilizing research personnel who are funded through this training grant/contract/agreement will be separately submitted, and no research activity will begin until each individual project is approved. Those individual applications will cross-reference this protocol as a source of financial support.

This application is for a grant/contract in which the human subject involvement will depend on the development or completion of instruments, recruitment/consent procedures, prior animal studies or purification of compounds.

• After completion of the preliminary activities, a complete research protocol and application must be submitted for review, and the project must be approved prior to the initiation of any component of the research involving human subjects. Those individual applications should be submitted as an amendment to this protocol using the appropriate initial review application (either IRB review or Claim of Exemption application).

VIII. Contact Information

Who should be the primary person contacted by OPRS if further information about this protocol is needed?

Name (Last, First): Title:

Email Address:

Phone Number: Fax Number:

Do you wish to grant this individual RiSCWeb access to this research protocol?

Yes No

IX. Assurances

INVESTIGATOR ASSURANCE

I certify that the information provided in this Development/Center/Training Grant 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, and applicable federal, state and local laws. I also agree to the following:

• No research activities involving human subjects will be initiated under this approval status until after the review and approval of a separate IRB application or Claim of Exemption (through OPRS),
• Any research funded by this grant/contract will be performed by qualified personnel according to the approved research protocol.

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: ______

FACULTY SPONSOR* ASSURANCE

*The faculty sponsor must be a member of the UIC faculty. The faculty member is considered the responsible party for legal and ethical performance of the project.

By my signature as sponsor on this Development/Center/Training Grant application, I certify that the student, fellow, resident, or guest investigator is knowledgeable about the regulations and policies governing research with human subjects and has sufficient training and experience to conduct this particular study in accord with the approved protocol.

In addition,

• I agree to meet with the investigator on a regular basis to monitor study progress,
• Should problems arise during the course of the study, I agree to be available, personally, to supervise the investigator in solving them,
• If I will be unavailable, as when on sabbatical leave or vacation, I will arrange for an alternate faculty sponsor to assume responsibility during my absence and I will advise the UIC IRB via an amendment of such arrangements, and
• I insure that the investigator has completed the required educational program on ethical principles and regulatory requirements and will complete all required continuing education.

Faculty Sponsor 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, 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: ______

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