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regulations

Human Subjects Research

Institutional Review Board for the Protection of Human Subjects of Research (IRB)
Human Subjects Research Training Policy
Training Certification
IRB Application Forms & Instructional Materials
IRB Meeting Schedule
IRB Adobe Application (coming soon)

Institutional Review Board for the Protection of Human Subjects of Research (IRB)

Persons conducting research involving human subjects have an ethical as well as professional obligation to ensure the safety, protection, and rights of participants. It is the intent of the University through the Institutional Review Board for the Protection of Human Subjects of Research (IRB) to assist those engaged in human subject research to conduct their research according to ethical guidelines reflecting professional as well as community standards. This institution recognizes its duty and obligation to protect the rights and welfare of research participants regardless of the source of funding.

The University has an obligation to ensure that all research involving human subjects meets regulations established by the United States Code of Federal Regulations. It is not the intent of the University or the IRB to interfere in any way with the competent, ethical, and sound research involving human subjects. However, the University must ensure that its personnel comply with the regulations governing human subject research. It is important for us to observe the “spirit” as well as the “letter” of these regulations, because the manner in which we conduct research involving human subjects reflects on our professional, personal and community commitments to rigorous ethical and scientific standards of conduct.

The University’s IRB is responsible for reviewing all research or related activities which involve humans as subjects by any member of the USI faculty, staff, or student body (whether full or part-time). The principal investigator of the project should file a request for review with the IRB before initiating any such research. In addition, all personnel (faculty, staff, and students) involved with human subject research projects are required to complete human subjects research training.

To determine if a project qualifies for IRB review, consider these two questions:

Is it research?

DHHS defines research as "a systematic investigation, including development, testing, and evaluation, designed to develop or contribute to generalizable knowledge."

Does it involve human subjects?

According to U.S. Department of Health & Human Services (DHHS), a human subject is "a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, (2) identifiable private information."

Human Subjects Research Training Policy - CITI

As of October 4, 2010 the USI IRB has implemented the Collaborative Institutional Training Initiative (CITI) web-based model administered by the University of Miami. All USI-affiliated personnel (faculty, staff, and students) conducting human subject research projects are required to complete the necessary education and training regarding the ethical research with human subjects. Faculty who supervise students conducting human subject research projects in a particular course or by acting as an individual faculty sponsor should complete the training and ensure that students complete the requirement.

The CITI training model provides the basic principles and procedures related to protecting human subjects. CITI is divided into multiple modules. The number of modules each researcher must complete is based on the review category (exempt, expedited, or convened) your research falls under. Each module corresponds to a web-based exam that researchers must pass with a score of 70% or higher in order to fulfill the certification requirement.

The CITI training must be completed for any new or ongoing human subject research applications unless the USI Blackboard^TM-based tutorial has been completed within the last year. The USI Blackboard^TM-based human subject research training is valid for one year only. After one year, researchers wishing to conduct human subject research projects will be required to complete the CITI training course.

To register and begin using CITI please review the CITI Instructions PowerPoint.

To visit the CITI website go to citiprogram.org.

If you have any questions, first review the CITI FAQ’s. If your questions are not answered in the FAQ’s contact the IRB coordinator at rcr@usi.edu.

Training Certification

Option 1: Take the CITI human subjects research training program. Refer to the CITI instructions PowerPoint for enrollment information. A score of 70% is needed to fulfill the requirement.

Option 2: Certification from an applicable course on research involving human subjects.

USI-affiliated personnel may select their own educational program to meet the requirement. However, researchers must submit documentation of training certification from external sources with applications submitted to the IRB for review. If documentation is unavailable, they can request access to USI’s training module. Documentation or completion of training is required prior to protocol approval.
Unaffiliated (external) researchers named as principal investigators or co-investigators on applications to the USI IRB must provide documentation of human subjects research training with the protocol. If documentation is unavailable, they can request access to USI’s training module. Documentation or completion of training is required prior to protocol approval.

IRB Application Forms & Materials

Information Packet contains instructions on filing a request for review, selecting the appropriate review application form, determining whether your project is eligible for exempt or expedited review or will require full board review, obtaining and documenting informed consent. To download the IRB Information Packet, IRB Application Form, or IRB Renewal Application Form click below.

USI IRB Information Packet - Microsoft Word
USI IRB Application Form - Microsoft Word
USI IRB Renewal Application Form - Microsoft Word

USI IRB Amendment Application Form - Microsoft Word

Informed Consent Template - Microsoft Word

Informed Consent Template for Online or Web Based Surveys - Microsoft Word

Informed Consent Template for Audio, Video, or Photographs - Microsoft Word

Informed Consent Template - Verbal Script - Microsoft Word

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Minor Assent Template - Microsoft Word 
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How to Get my IRB Application Approved as Fast as Possible - Microsoft Word

IRB Meeting Schedule

Convened meetings are not scheduled in advance. Please submit any research project involving human subjects that are NOT eligible for exempt or expedited review at least 4 weeks prior to your proposed start date (to ensure adequate time for review). Projects qualifying under any exempt or expedited category can be submitted at any time and will be reviewed regularly.

The IRB application and all required attachments should be submitted electronically to the Sponsored Projects Office. The original with all required signatures and 1 copy should be delivered to the IRB Administrative Office in the Sponsored Projects Office, Wright Administration Building, Room 104K.

An application will not be forwarded for review until all required electronic elements are received. An application will not be approved until the signed original is received.

In the event an application requires review by a convened board, applicants and/or faculty sponsors (if applicable) will be invited to attend and notified of the results within one week of the meeting date.

Spring 2012 IRB Meeting Schedule

Orr Center Room 3076 at 3:00pm

January 18, 2012
February 15, 2012
March 14, 2012
April 11, 2012
The last day for IRB protocol review will be May 2, 2012

8600 University Boulevard - Evansville, IN 47712-3596 - 812/464-8600