UIC Policy Does Not Provide Investigators with the Authority to Make an Independent s1

Office for the Protection of Research Subjects (OPRS) Institutional Review Board FWA# 00000083

203 AOB (MC 672) 1737 West Polk Street Chicago, IL 60612-7227 Determination of Whether an Activity Represents Phone: 312 996-1711 Fax: 312 413-2929 Human Subjects Research at UIC http://research.uic.edu/compliance/irb Version:2.4; Date: 11/07/2016

UIC policy does not provide investigators with the authority to make an independent determination that an activity does not meet the definition of human subjects research. Investigators who intend to conduct activities that might represent human subjects research must submit this application to the UIC OPRS for a determination of whether an activity represents human subjects research. Guidance on this issue is available in the UIC HSPP policy: Determining Whether Research or Other Activities Represent Human Subject Research at UIC

The completed form must be submitted electronically via OPRS Live (beta): http://research.uic.edu/compliance/human-subjects-irb/investigators-research- staff/submission/oprslive-beta

To be completed by the Investigator: Date Application Completed: Application Document Version #:

I. Title of Activity:

II. Personnel A. Principal Investigator Name (Last, First) Degree(s) Net ID (e.g., [email protected])

Department College University Status/Title

Mailing Address M/C

Phone Number Fax Number UIC E-mail Address

B.Faculty Sponsor – required when PI is a student, fellow or resident Name (Last, First) Degree(s) Net ID (e.g., [email protected])

Department College University Status/Title

Mailing Address M/C

Phone Number Fax Number UIC E-mail Address

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III. Research/Activity Funding A. Is this research/activity funded? No – Skip to Section IV. Yes Pending

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

1. 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 the Protocol Processing Fee for Industry Sponsored and IRB Submissions to the UIC IRB for 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 Appendix Q and submit with this application packet Sub-contract from non-UIC agency or institution: Name: Other - Name:

2. INTRAMURAL: Campus Research Board (CRB) Departmental - Name: Other - Name:

C. Funding Identification: If the research/activity is supported by more than one funding source, complete and submit Appendix Z for each additional source.

1. Institutional Proposal (IP) 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 – Identify the agency or institution with which the above PI is affiliated: Explain the relationship between that agency or institution and UIC: Yes - Copy of Grant is attached as required for review: No – Submission may be rejected due to incompleteness. Yes

3. Is the research federally funded? No Yes - Funding Agency Grant Account Number:

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 – STOP. Complete Development/Center/Training Grant Application and submit in lieu of this application. Submit a copy of the grant, contract, or funding submission if the proposal is federally funded. Please note that the IRB may request the submission of other funding documentation for sponsored research as appropriate.

IV. Proposal Summary

A. Provide a concise (3-5 sentences) summary of the purpose and rationale of the activity, including the endpoints:

B. Describe the proposed methods and study procedures:

C. Describe the role(s) of any UIC faculty, staff or students in the design and/or conduct of the proposed activity:

D. Data collection 1. Describe how data collection will occur and the type of information to be collected about the subjects:

2. Indicate whether data will be: De-Identified (i.e., not linked to individual identifiers) Identifiable Coded – Will the code will be accessible to the investigators? No Yes: How?

V. Activities Determined by OPRS Not to Represent Human Subjects Research

A. Do the following items describe the activities associated with your project?

No Yes Your project is limited to accessing one or more of the following public use datasets: U.S Bureau of the Census, National Center for Health Statistics, National Center for Educational Statistics, U.S. Bureau of Labor Statistics, National Election Studies, National Crime Victimization Survey: School Crime Supplement, 2003, National Epidemiologic Survey on Alcohol and Related Conditions (NESARC), National Survey of America's Families (NSAF), Inter-university Consortium for Political and Social Research [ICPRS- Secure online analysis (publicly available) datasets only], and PRAMS.

No Yes Your project only involves commercially available, de-identified non-embryonic human cell lines.

No Yes Your activity is a case report involving the observation of a single patient whose novel condition or response to treatment was guided by the care provider’s judgment regarding the best interest of the individual.

No Yes Your project involves research that is limited to death records, autopsy materials, or cadaver specimens (provided that the cadaveric tissues/cells are not used for clinical investigations). If you have checked any “Yes” boxes in Item A of this section, STOP and submit the Determination form to OPRS via OPRS Live.

B. Does the following item describe the activities associated with your project?

No Yes Your project is limited to course-related activities designed specifically for educational or teaching purposes; where data is collected from and about human subjects as part of a class exercise or assignment and is not intended for use outside of the classroom.

If you checked the “Yes” box in Item B, STOP. OPRS has determined this event does not represent human subject research and waived the requirement for submission to OPRS of an application for a human subjects research determination. If an application is submitted, it will be returned to your attention without review.

If all of the boxes in Section V were checked “No”, continue to complete the application.

VI. DHHS Criteria for Research Involving Human Subjects

A. Does the activity meet the DHHS definition of research? Select the appropriate response in regards to your project.

No Yes The activity employs a systematic approach involving predetermined methods for studying a specific topic, answering a specific question, testing a specific hypothesis, or developing a theory.

No Yes The activity is intended to contribute to generalized knowledge by extending the results beyond a single individual or an internal unit (e.g., publications or presentations).

B. Does the activity involve human subjects according to the DHHS definition? Select the appropriate response in regards to your project.

No Yes The investigator will obtain data about an individual through intervention or interaction with that individual (e.g., interviews, surveys, physical procedures, manipulations of the subject’s environment, private or limited access internet sites, or any other direct contact or communication with a subject).

No Yes The investigator is obtaining identifiable private information about living individuals (e.g. chart reviews, lab studies on tissues or specimens, information from data or tissue repository).

No Yes The data or specimens are received by or provided to the investigator with identifiable private information.

No Yes The data or specimens are coded and the investigator has access to a link that would allow the data or samples to be identified.

Note: If both boxes were checked “Yes” in Item A AND at least one box was checked “Yes” in Item B, STOP. Your activity meets the DHHS definition of human subjects research, and either exempt, expedited, or convened review is required. For additional information regarding the review of human subjects research, please refer to OPRS website. Otherwise, please continue to complete the application.

VII. FDA Criteria for Research Involving Human Subjects (Clinical Investigations)

A. Is the activity subject to FDA human subject research regulations? Select the appropriate response in regards to your project.

No Yes The activity involves one or more human subjects and any use of a drug other than the use of a marketed drug in the course of medical practice.

No Yes The activity involves one or more human subjects and determining the safety and efficacy of a medical device.

No Yes The results of the activity are required to be later submitted to or held for inspection by the FDA as part of an application for a research or marketing permit.

B. Does the activity involve human subjects according to FDA regulations? Select the appropriate response in regards to your project.

No Yes The activity involves one or more individuals who are or become participants in research, either as a recipient of the test article (i.e., drug, biological product, medical device, food additive, color additive, electronic product, or any other article subject to regulation under the Food, Drug & Cosmetic Act) or as a control.

No Yes The activity involves one or more individuals who participate in an investigation, either as an individual on whom or on whose specimen an investigational device is used or as a control.

Note: If at least one box was checked “Yes” in Item A AND at least one box was checked “Yes” in Item B, STOP. Your activity meets the FDA definition of human subjects research (clinical investigation), and either exempt (only category 6 is eligible for research under FDA purview), expedited or convened review is required. For additional information regarding the review of human subjects research, please refer to the OPRS website. Otherwise, please continue to complete the application.

VIII. Federal Bureau of Prisons

A. Will the Federal Bureau of Prisons be involved in the research? No – Skip to Section IX Yes

B. If Yes, will the research involve the implementation of Bureau programmatic or operational initiatives made through pilot projects? No Yes – This is not considered to be research

IX. UIC Engagement Note: If UIC is not engaged as part of research, UIC IRB approval is not required. Adjunct faculty may still refer to their UIC credentials in publications resulting from this research. Please refer to the UIC HSPP policy Engagement of UIC in Human Subjects Research for additional information.

A. Will UIC receive direct federal funding through a grant, contract, or cooperative agreement for the research? Page 5 of 6 OVCR Document #0255 FORM - Determination of Whether an Activity Represents Human Subjects Research at UIC, Version 2.4

No Yes

B. Will UIC faculty, staff, or students interact or intervene with subjects or identifiable data or specimens for research purposes by performing invasive or noninvasive procedures, including analysis, or manipulating the environment? No Yes

C. Will UIC faculty, staff, or students obtain the informed consent of subjects for the research? No Yes

D. Will UIC faculty, staff, or students obtain for research purposes identifiable private information or identifiable biological specimens from any source for the research, even if not directly interacting or intervening with subjects? No Yes

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