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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

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.

Human Subjects Research Training Policy

On October 1, 2000, the National Institutes of Health (NIH) instituted a policy requiring education and training on the responsible conduct of research involving human subjects for all key personnel on any NIH funded project. The University of Southern Indiana’s Assurance (FWA 00007505) with the Department of Health and Human Services (DHHS) requires that any research involving human subjects be guided by similar principles and regulations.

USI’s Institutional Review Board for the Protection of Human Subjects (IRB) has developed a Blackboard^TM-based tutorial covering the basic principles and procedures related to protecting human subjects and an instrument to test this knowledge. All USI-affiliated personnel (faculty, staff, and students) involved with human subject research projects will be required to complete human subjects research training prior to conducting new research using human subjects and/or prior to renewal of ongoing research using human subjects.

This requirement is in compliance with the Federal mandate, and applies to all academic levels regardless of whether such research receives external funding. USI requires completion of the training before protocol approval or the release of project funds.

All faculty supervising students conducting human subjects research projects in a particular course or by acting as an individual faculty sponsor are responsible for completing the training requirement and for ensuring that students complete the requirement. (Contact SRO to find out how to get your students enrolled in the training module; and/or email a list of students, name of the related-course if applicable, and name of faculty sponsor to usi1sro@usi.edu.)

Training Certification

Option 1: Take the human subjects research training program developed by USI. Contact the Sponsored Research Office to gain access to USI’s Human Subject Research Training Module. Once enrolled, log onto to Blackboard and the link for the Human Subject Research Training Module will be available under My Organizations. Training Module Instructions:

Please read through the twelve outlined content sections.
Then take the Human Subjects Research Certification exam. A score of 70% (14 of 20) is needed to fulfill this requirement. The password is located in the content section.
Researchers should indicate completion of USI's training requirements on each application submitted to the IRB for review.

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 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 Revised 08/07
USI IRB Application Form - Microsoft Word Revised 01/06
USI IRB Renewal Application Form - Microsoft Word Revised 01/06

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 usi1sro@usi.edu. The original with all required signatures and 1 copy should be delivered to the IRB Administrative Office in the Sponsored Research Office, Wright Administration Building, Room 104K.

An application will not 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.

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