Institutional Research Board

Dr. Lanette Poteete-Young

P: 847.628.1097

E: [email protected]

Institutional Review Board

Purpose

Judson University Institutional Review Board policy requires that researchers respect and protect the rights and welfare of human subjects recruited for, or participating in, research sponsored through Judson University.

Therefore, the Judson University Institutional Review Board (IRB) maintains primary responsibility for oversight in the protection of human subjects recruited and/ or participating in research projects.

Judson University IRB is guided by the principles set forth by the Belmont Report in accordance with Title 45 Code of Federal Regulations, Part 46 (45 CFR 46).

Furthermore, the Judson University IRB will conform to all applicable federal, State and local laws and regulations.

The major roles of IRBs in the oversight of research are:

Initial review and approval or disapproval of the proposed research activity
Ensuring that the proposed informed consent process meets all of the requirements of 45 CFR 46.116
- A legally-effective, voluntary agreement that is given by a prospective research participant following comprehension and consideration of all relevant information pertinent to the decision to participate in a study.
Providing continuing oversight for progress reports and protocols for ongoing research studies

Investigator Handbook

The Judson University IRB Handbook gives in-depth information on the history of IRB, the Belmont Report, Protection of Human Subjects, the responsibilities of the University, and details of training and research responsibilities.

Training

Training for IRB Committee Members and Participants

Any investigator and member of the IRB must complete the training for “Protecting Human Research Participants” and have a copy of the certificate on file. Judson faculty and students must self-enroll in eLearn under Human Subjects.

Members of the Judson community can complete this training via eLearn. Instructors of research courses will provide the necessary information to access the tutorial.

Individuals who are not associated with Judson will need to access the training through another source such as Protecting Human Research Participants at https://phrptraining.com/.

Informed Consent

General Requirements for Informed Consent

Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research covered by this policy unless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence.

In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research.

Forms and Instructions

Links to the necessary application documents are below. Instructions for completing, saving, and submitting the documents are included in the forms. If any questions arise, email the Chair of the Institutional Review Board at [email protected].