Policy Statement:

The United States Department of Health and Human Services (DHHS) and Missouri State University have established standards and guidelines to protect individuals who may be at risk as a consequence of participation in a research activity.  The Institutional Review Board for the Protection of Human Subjects (IRB) is responsible for insuring that adequate safeguards are established to protect any individual who may be at risk as a consequence of participation in research activities. 

Standards for the committee’s reviews are based upon

1. Protection of Human Subjects - Code of Federal Regulations, 45 CFR 46
   
2. Standards for Privacy of Individually Identifiable Health Information – 45 CFR 160 and 164, as described in the Missouri State University Health Insurance Portability and Accountability Act (HIPAA) Policy. *

* Links open in a new window.

Researchers are encouraged to refer to these codes in planning their research.

Policy on the use of Human Subjects in Research

Section 2.8.4 of the Faculty Handbook, "All research involving human subjects in any way, regardless of the source of support funds, must be reviewed by the Protection of Human Subjects Institutional Review Board (IRB) before it is undertaken."

The University policy is in accordance with the federal government regulations 45 CFR 46 - Federal Policy for the Protection of Human Subjects. The regulation defines research as “systematic investigation, including research, development, testing and evaluation, designed to develop or contribute to generalized knowledge.” Projects involving human subjects must receive prior approval from the University’s Institutional Review Board for the Protection of Human Subjects (IRB).  In addition, faculty, staff and students having access to information obtained from human subjects must complete the Collaborative IRB Training Initiative (CITI) training before engaging in such a project.  The University shifted from the NIH to the University of Miami, Collaborative IRB Training Initiative (CITI) training course as of July 1st, 2006. Thereafter, approval of a research project by the IRB requires that all investigators complete the CITI Basic Course and take a refresher course every three years.

Provided are;

1. Procedures for submitting requests for project approval,
2. Instructions for obtaining training, and
3. A member list of the Human Subjects Protection Committee.

The Privacy Rule of the Human Insurance Portability and Accountability Act (HIPAA) took effect on April 14, 2003, and the Security Rule under HIPAA on April 14, 2005. In accordance with HIPAA regulations, projects involving access to individually identifiable health information obtained from within designated covered entities at Missouri State or other organizations e.g. hospitals and clinics, must be conducted in accordance with 45 CFR 160 and 164.

Individually identifiable health information, designated as protected health information (PHI), includes physical or mental health information that can be identified with a specific individual. Individuals involved in the collection, analysis, transportation, storage, retention and destruction of PHI must comply with the HIPAA regulations including the completion of HIPAA training.

The Missouri State University HIPAA policy and designated covered entities (listed under "Privacy Officers"), can be found at http://privacy.missouristate.edu/hipaa/.

Access to this web site is restricted to those with an Missouri State username and password. Individuals who are to be involved in an Missouri State research project that requires compliance with HIPAA regulations, but not having direct access, are to e-mail The Office of Sponsored Research and Programs to obtain a temporary entry. Projects to be conducted in compliance with HIPAA will need to secure additional approvals from the subjects.

Forms to be used for this purpose can be found at http://www.missouristate.edu/eforms/ by using the keyword "HIPAA".

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