Policy and Procedure
RESEARCH POLICY SERIES
POLICY AND PROCEDURE STATEMENT ON
HUMAN SUBJECTS AT MISSISSIPPI STATE UNIVERSITY
PURPOSE
The purpose of this policy and procedure is to provide for appropriate use of human subjects in research performed under the auspices of Mississippi State University.
This policy and procedure will be reviewed as needed by the IRB Officer and IRB with recommendations for revision presented to the Regulatory Compliance Officer for review and transmission to the Vice President for Research.
University policy and federal regulation require that all research involving human subjects be reviewed and approved by the University's Institutional Review Board for the Protection of Human Subjects in Research (IRB) prior to initiation of the research. This requirement applies to all human subject research conducted by faculty, staff, and students, on- and off-campus, regardless of the funding support, if any, for the project. Projects conducted by non-MSU affiliated persons at MSU facilities also fall under the auspices of this policy.
In this context, research is defined broadly as a formal investigation designed to develop or contribute to knowledge that might be generalized; some "demonstration" and "service" projects may include research activities.
The IRB consists of at least five (5) individuals of diverse backgrounds (including cultural and racial) and having sufficient maturity, experience, and competency to ensure that the IRB will be able to discharge its responsibilities and that its determinations will be accorded respect by University investigators and by the community served by the University. The IRB is comprised of members of various areas of expertise, including at least one scientist, non-scientist, and at least one person not otherwise affiliated with the university. Standing members are the Director of the Student Health Center and the Human Subjects (IRB) Officer.
The IRB reviews all proposed research involving human subjects for the protection of the rights, welfare, and well-being of the subjects, and the rights of the researcher and of the university. The IRB shall make periodic reports to the Vice President for Research. Decisions of the IRB are in accord with Federal Policy for the Protection of Human Subjects (the Common Rule), published in the Federal Register on June 18, 1991, and by Federal Regulation 45 CFR 46, "Code for the Protection of Human Subjects in Research," published in the Federal Register in March 1983, and applicable ethical standards as published by professional groups and societies.
Procedure
The University Human Subjects (IRB) Officer manages all administrative details for the IRB, including developing educational programs, conducting training sessions, receiving applications, reviewing for completeness, logging, and reviewing them to determine the appropriate level of approval for each. There are highly specific areas of behavioral, education, and social research wherein possible risks to subjects would stem primarily from breach of confidentiality; these are exempt from mandatory Full Board review. The IRB has authorized the IRB Chair or Human Subjects (IRB) Officer to issue administrative approval to those projects after determining that safeguards for confidentiality and the methodology of obtaining informed consent are adequate. For certain other highly specific areas of research wherein risk to subject well being is minimal, an expedited review process may be used. In this case, the IRB Chair or Human Subjects (IRB) Officer and often, one other Board member reviews the application. If it meets all criteria, they issue an approval. In the case of both administrative and expedited procedures, all Board members are notified in a timely manner of the actions taken by the IRB Chair or Human Subjects (IRB) Officer. Should any member disagree with an action, a full IRB review is required.
All applications that do not qualify for either administrative or expedited review receive full IRB review. The protocols for all applications to be considered at a review meeting are forwarded to IRB members before the date of the meeting. To hold a review, it is necessary that a quorum (a majority) of members be present. The IRB may call consultants to advise on a complex protocol and/or request that the researcher present the application. The IRB may approve, approve contingent upon modification of elements of the protocol, or disapprove an application. In the latter case, the application is returned to the researcher with a statement of why it was deemed unacceptable, and recommendations for modifications.
The Human Subjects (IRB) Officer, together with the researcher, prepares the human subject research protocol documentation required in proposals submitted for funding support to federal agencies and other sponsors.
The IRB has the authority to conduct for cause and not-for-cause audits to assure compliance and monitor on-going studies.
All researchers who plan to use human subjects in research must complete a University approved training course on human subject protections. A detailed course is taught each semester covering the basic areas of human subject regulation and compliance. After completion of a course, the researcher will receive a certification effective for three years. If a researcher presents an IRB application and has not completed a training session, he/she will be notified that they cannot receive review and approval until they have completed the course. Researchers must complete a course every three years to remain eligible to conduct research using human subjects.
Failure of the researcher to comply with IRB policies and procedures may endanger human subjects and jeopardize University federal funding; therefore, it is not permissible for the researcher to initiate research involving human subjects prior to IRB approval. Failure to comply with IRB policies and procedures will result in the initiation of an investigation, issuance of a finding and recommendation regarding appropriate remedial action, including possible termination of the research.
OP 79.3
08/16/04
For information about this policy, contact the
reviewing department.
