HRPP Policy and Procedures

Human Research Protection Program

Introduction

The University of Illinois at Springfield Institutional Review Board (IRB) operates under policies and procedures mandated by the U.S. Department of Health and Human Services and the Office for Human Research Protections. These policies are available for review at www.hhs.gov/ohrp/. (Update: The federal “Common Rule” was revised on 19 January 2017, to go into effect 21 January 2019).  UIS has therefore updated it’s policies.

The HHS document serves as a guideline for the development of the UIS policy statement, and as a handbook for investigators involving human subjects in their research.

Questions regarding this document or submission of materials should be directed to the UIS Human Subjects Review Officer.

HRPP Policy

The current UIS HRPP policy is posted on the UIS Academic Handbook webpage:

HRP Policy

IRB Policies

IRB Policy Glossary (PDF)

Payment to Human Subjects Policy (11/15/2017)

IRB procedures (Box folder for UIS personnel)

Campus-Wide Survey Policy

Any survey conducted on campus or with alumni must be approved by the Institutional Data Steering Committee. See the campus policy for further details: https://www.uis.edu/academicstaffhandbook/university-policies/campus-wide-survey-policy/

External Researchers and Organizations Seeking IRB Approval

Thank you for your interest in including UIS students and employees in your research. We value human subjects research on this campus and encourage collaboration with our academic professionals and staff members. Please send us a copy of the IRB approval letter from your institution along with all the other necessary documents you submitted to your IRB (this should include your proposal, consent documents, applications, material, interview questions, surveys etc.) This information will be used as part of our internal review by our IRB. You may submit your information electronically to ora@uis.edu.

Conflict of Interest – Investigators

All Investigators and key research personnel must follow the U of I Conflict of Commitment and Interest Policy. Key research personnel are those individuals who (a) recruit human subjects; (b) obtain consent from human subjects; (c) collect data from human subjects; or (d) evaluate the response of human subjects. Where a conflict of interest exists, with a protocol involving human subjects, the RPI must develop and submit a conflict management plan, for the IRB to consider along with the proposed protocol. The HSRO/IRB Chair (or designee) will review the conflict management plan to determine if the conflict will adversely affect the protection of human subjects and if the management plan is adequate.

A copy of the final, approved conflict management plan will be filed in the Office of the VCAA.

The IRB application asks protocol-specific questions regarding conflict of interest for the investigators and key personnel. As part of its review process, the IRB will make a determination as to whether the conflict adversely affects the protection of human subjects.

If a conflict of interest exists, final IRB approval cannot be given until an approved conflict management plan that adequately protects the human subjects in the protocol is in place. If the conflict of interest status of an investigator changes during the course of a study, the individual is required to notify the IRB Office within ten working days of the change. The IRB will review the change as a modification to the protocol.

At the time of continuing review, the investigator will be asked whether there has been any change in the conflict of interest status relating to the research. The IRB will review conflict of interest as part of its continuing review.

References

Food and Drug Administration regulations related to Human Subjects

NIH guidelines for Human Subjects Research.