Investigator Responsibilities
Investigator Responsibilities Heading link
YOU, as a UIC investigator, are responsible for conducting research in an ethical and professional manner. This responsibility entails a positive obligation to know and act in accordance with federal regulations (both the general regulations pertaining to human subjects protection in 45 CFR 46 and 21 CFR 50 & 56, and any specific regulations that may be imposed by the federal agency funding the research), state and federal laws (HIPAA, the Health Insurance Portability and Accountability Act is a federal law relevant to all research involving medical records), and UIC policies and procedures.
Checklist: Investigator Responsibilities
This checklist has been designed to serve only as an aide to investigators and should not be considered comprehensive. You are strongly encouraged to regularly consult the UIC OPRS website, federal OHRP and FDA websites, and the websites of your specific federal, state, foundation, and other agency funders for updated guidance regarding ethical research practices and the protection of human research subjects.
Section 1: Ready to go Heading link
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Section 1: Ready to go
Research Application and/or Protocol
- There is a finalized research application and/or protocol in place that has been approved by the IRB and, if applicable, the funders/sponsors.
- There is a finalized clinical trial agreement, where appropriate, approved by UIC and the funders/sponsors.
- There are adequate procedures in place for the control of the drugs, biological products, and/or devices under investigation, when applicable.
- You are knowledgeable of the investigator’s responsibilities, UIC policies and procedures, state laws, federal regulations, and Good Clinical Practice regulations.
Research Recruitment and Consent Processes and Documents
- All recruitment materials (posters, flyers, brochures, information letters, introduction and recruitment scripts, web ads, emails and listserv notices, newspaper/tv/radio ads, etc.) have been approved and stamped by the UIC IRB.
- All consent documents have been approved and stamped by the UIC IRB.
- All HIPAA authorization documents, where appropriate, been approved and stamped by the UIC IRB.
- Waivers of consent, waivers of HIPAA authorization, and/or waivers of documentation (signed consent documents), where appropriate, have been approved by the UIC IRB.
- There is an adequate plan in place to maintain secured files of signed consent and authorization documents for the required amount of time. Refer to the UIC HSPP policy Investigator Essential Documents for additional information.
Research Personnel
- All research personnel have sufficient professional training and experience, including professional licensure where appropriate, to perform their roles.
- All research personnel understand the research and their role(s) in it.
- All research personnel have completed appropriate human subjects training. Refer to the OPRS Investigator Training website for more information.
- Research personnel who have a financial or institutional conflict of interest have an OVCR-approved conflict management plan in place.
Non-UIC Research Sites
- Collaborative agreements or sub-contracts with non-UIC sites, where appropriate, have been approved by UIC and the non-UIC sites.
- Appropriate human subjects protection documentation from all non-UIC site(s) have been submitted to, and approved by, the UIC IRB.
Note: Appropriate human subjects protection documentation may include an IRB approval from the non-UIC site IRB, a finalized IRB Authorization Agreement between UIC and the non-UIC site, and/or a letter of support from an authorized executive at the non-UIC site. Please consult UIC OPRS regarding the documentation necessary for your research. - A local sponsor, host, or supervisor at all international sites have been secured and, where appropriate, approved by the UIC IRB.
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Section 2: Staying on Course
Continuing Review
- Your research may or may not require a Continuing Review. Refer to the Initial Review Approval Notice and stamped consent document. If the research has an expiration date, then a Continuing Review is required.
- If your research expires all research activities – including subject recruitment, subject enrollment, data collection, and data analysis – must stop. Refer to the UIC HSPP policy Lapse in IRB Approval.
Making Changes
- All proposed changes to the research must be submitted via an Amendment.
Changes include, but are not limited to:
- Research design, methodologies, and instruments
- Research funding, sponsors, contracts, sub-contracts, collaborative agreements, and clinical trial agreements
- Recruitment and consent processes and documents
- Research personnel
- Number or type of research subjects, particularly when vulnerable populations may be involved (for example, minors, prisoners, and/or the developmentally/decisionally impaired)
- Research sites
- Handling and control of drugs, biological products, and devices
- Data and research document security and storage
- You may not initiate any amendments or changes to the research without first obtaining written IRB review and approval.
- The only exception is when it is necessary to avoid direct risks to subjects and the IRB should be immediately informed of this emergency change via a Prompt Report.
Adverse Events and Unanticipated Problems
- You have reviewed with your staff the types of events that require prompt reporting to the IRB, and the specific timelines for reporting the events, as described in the UIC HSPP policy Unanticipated Problems and Other Events Requiring Prompt Reporting.
Reporting and Record Keeping Requirements
- A signed consent/assent document/parental permission, unless a waiver of consent or a waiver of signed consent has been granted by the IRB, has been obtained for each subject enrolled in the research.
- Only the approved number of subjects (or less) have been enrolled.
- You have submitted a copy of research reports to and/or from the FDA or other funder/sponsor to the UIC IRB (usually in the annual continuing review packet submitted to the IRB).
- You will immediately notify the IRB if the FDA or other funder/sponsor have initiated a review, inspection, or audit of your research.
- You will maintain receipts and records of the use and disposition of all drugs, biological products, and/or devices if not managed by the Investigational Drug Service (IDS).
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Section 3: Crossing the Finish Line
Completing Your Research
- All data has been stripped of both direct and indirect identifiers or destroyed.
- Note: Fully de-identified data may be maintained after the closure or completion of the research. However, the data cannot be used for additional research beyond the original intent.
- Data should be de-identified or destroyed in strict accordance with the terms agreed to by subjects in the informed consent documents and approved application and/or protocol.
- You have permanently closed or completed work on your research and submitted a final report to the UIC IRB.
- Note: Research remains open until all analysis of directly or indirectly identifiable data are completed.
- All drugs, biological products, and/or devices have been returned or destroyed in accordance with FDA standards and/or funder/sponsor agreements.
- Adequate and appropriate provisions have been made for the secure storage of all data and identifiable research-related documentation (such as consent documents).
- All data has been stripped of both direct and indirect identifiers or destroyed.
Questions? Heading link
Call OPRS at 312-996-1711 or email uicirb@uic.edu.