Indiana University East

Protection of Human Research Subjects

Pursuant to federal law and University policy, all research involving human subjects conducted by IU East investigators must be reviewed and approved by the Indiana University East Institutional Review Board (IRB). These policies and procedures are designed to provide an efficient avenue for the processing of applications. The smooth flow of applications is the only way to ensure that each research protocol is provided the level of review it deserves. Cooperation by faculty, students, and staff with the Board is essential if we are to comply with federal and University regulations. The Board recognizes that the federal regulations and our interpretations of the regulations can be daunting to an investigator on first encounter. The Board will provide whatever assistance it can to investigators or departments to explain our procedures and to secure compliance with a minimum of delay or disruption of research. We welcome suggestions for improvement of the information that is provided here on the Web. Feel free to contact us through the Office of Academic Affairs.

• Guidelines and Policies for Investigators. This document provides general guidelines and procedures pertaining to IRB review of all research involving human subjects conducted by investigators of Indiana University East.
• Instructions and Forms for applying for IRB approval. This packet contains instructions and the needed forms to seek IRB approval for all research projects involving human subjects, including research that falls under exempt, expedited, and full review guidelines. In all circumstances, researchers must obtain prior approval from the IRB before initiating any research project involving human subjects.
• Study Amendment Form. This form should be used when an approved project needs to be amended. Under such circumstances, the researchers must obtain prior approval for the proposed changes before making any alterations to the on-going project.
• Continuing Review Form. This form should be used when an approved project will continue beyond the originally approved conclusion date. Under such circumstances, the researchers must obtain prior approval from the IRB to continue the research beyond that date.
• Indiana University Assurance of Compliance. This document is the agreement that Indiana University has signed with DHHS that describes the responsibilities that we accept when doing research involving human subjects.
• Federal Code 45 CFR 46. This document is the section of the federal code that pertains to the protection of human subjects and the creation of IRBs and their duties.
• The Belmont Report. This document outlines the philosophical thinking behind the work of the IRB and provides the principles that all researchers using human subjects must uphold.