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Indiana University Northwest

Human Subjects Committee

Background

Recognizing the need to safeguard the rights and welfare of human subjects who participate in social and behavioral science research, The National Research Act of 1974 requires institutional review for research involving human beings. The Federal Policy for the Protection of Human Subjects, known as the Common Rule and published in the Federal Register, Vol. 56, No. 117, June 18, 1991, represents the latest Federal regulations for protection of human subjects.

This Policy went into effect August 19, 1991. The 16 federal departments and agencies that have adopted these regulations are: Office of Science and Technology Policy, Dept. of Agriculture, Dept. of Energy, NASA, Dept. of Commerce, Consumer Product Safety Commission, International Development Cooperation Agency (AID), Dept. of Housing and Urban Development, Dept. of Justice, Dept. of Defense, Dept. of Education, Dept. of Veterans Affairs, EPA, Dept. of HHS (Office of the Secretary & FDA), NSF, and Dept. of Transportation. The Office for Human Research Protections (OHRP) within the Department of Health and Human Services (HHS) retains general jurisdiction over these matters.

Under the regulations, all institutions receiving funds from any of these departments/agencies are required to establish institutional review boards to review and monitor all funded research involving humans. Institutions are further required to submit periodic letters of assurance to the Federal government that they are complying with the regulations. Indiana University has such a letter on file with HHS, which letter commits the University to abide by the provisions of title 45 CFR, part 46, subparts A-D of the HHS regulations concerning protection of human subjects. The IU assurance of compliance number is FWA00003544. Moreover, Indiana University, like most institutions, has assured the federal government that it will review all research proposals involving human subjects regardless of whether or not they are funded. It is the policy of this University to apply the federal regulations to all research and research related activities which involve humans. The regulations require that all projects involving human subjects be approved by the HSC prior to the commencement of any data collection.

As of October 1, 2000, the National Institutes of Health (NIH) requires researchers with NIH funding to have institutional certification of educational training with respect to the use of human subjects in research. Indiana University has developed a web based educational module on the basic principles and procedures of human subjects research, available at :

In order to be certified by Indiana University, researchers must successfully take a multiple choice, web based test covering these basic principles and provide evidence of participation in an education program on the use of human subjects in research. Completion of the module or participation in a workshop will satisfy this requirement. Renewal of the certification will be required every three years. This is now a campus requirement, regardless of funding. See Education Requirement for more details.

Infractions of the regulations could have very serious consequences: not only could grant or contract support be withdrawn from a single offending project, but the host institution could lose all federal funding. Consequently, the University takes the protection of human subjects very seriously, not only for ethical reasons, but for fiscal reasons as well.

The IU Northwest Campus Committee for the Protection of Human Subjects, known as the Human Subjects Committee (HSC) is the institutional review board for the IU Northwest campus. It is charged with safeguarding the rights and welfare of human subjects, and no research or related activity involving humans can be undertaken without HSC approval. Every research project involving human beings in any way must be reviewed by the HSC, including, but not limited to, projects dealing with data already collected by someone else, and pilot studies. Even projects which qualify as exempt from the federal regulations must be submitted for review to the HSC prior to commencement. Consequently, every investigator should consider all ramifications of his/her research before determining that human subjects are not involved and that HSC approvals therefore are not required.