Policy and Procedure
RESEARCH POLICY SERIES
POLICY AND PROCEDURE STATEMENT ON
HUMAN SUBJECTS AT MISSISSIPPI STATE UNIVERSITY
PURPOSE
The purpose of this policy is to provide for appropriate use of human subjects in research performed under the auspices of Mississippi State University.
DEFINITIONS
1. Human subject – a living individual about whom an investigator (whether professional or student) conducting research obtains
1) Data through intervention or interaction with the individual, or
2) Identifiable private information.
2. Research – a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.
3. IRB – MSU’s Institutional Review Board for the Protection of Human Subjects in Research
4. Institutional Official – the key University leader authorized by the President to act on the University’s behalf, specifically committing the University to compliance with all requirements of the Code of Federal Regulations, 45 CFR 46, and other applicable federal regulations (e.g., FDA 21 CFR 50 and 56).
POLICY
Mississippi State University holds a federal-wide assurance (FWA 00000203, IRB 00000709) from the Office of Human Research Protection. Under this assurance, MSU must comply with 45 CFR 46. MSU chooses to limit this assurance to federally funded research; however, the regulations under 45 CFR 46, including all of Subparts B, C, and D, provide the practical basis for the review and approval of all research at MSU regardless of funding.
The IRB is the only entity with the authority to review all proposed research involving human subjects performed under the auspices of Mississippi State University. The IRB is authorized to create specific procedures that relate to the operation of the program of human subjects protections. All research involving human subjects must be reviewed and approved by the IRB prior to initiation of the research. The IRB’s authority is granted by the Vice President for Research and Economic Development who is the Institutional Official. The IRB has the authority to act independently to bind all activities falling under their purview.
No other University official or committee may approve human subjects research that has not been approved by the IRB. Any attempt to inappropriately influence the IRB will not be tolerated.
All researchers who plan to use human subjects in research must complete a training course on human subjects protections endorsed or sponsored by the Office of Regulatory Compliance. Alternate courses may be accepted but only at the discretion of the IRB Officer. Approval of an IRB application will be withheld until all project personnel have completed the course. A refresher course is required every three years to remain eligible to conduct research using human subjects.
The IRB may conduct for cause and not-for-cause audits to assure compliance. Failure to comply with federal regulations or IRB policies and procedures will result in the initiation of an investigation. Findings and recommendations will be made by the IRB and may include remedial action including the termination of the project and/or disqualification of the researcher from conducting any further human subjects research. The researcher should communicate directly with the IRB to resolve any concerns that may arise regarding a specific IRB decision.
Any individual may file suggestions or concerns regarding MSU’s human research protection program, the Office of Regulatory Compliance and/or IRB administrative procedures with the IRB Chair, IRB Officer, Director of Regulatory Compliance, Vice President of Research and Economic Development, or other University official as appropriate.
REVIEW
This policy will be reviewed every four years, or as needed, by the IRB Officer and the IRB with recommendations to the Director of Regulatory Compliance for transmission to the VP for Research and Economic Development.
OP 79.03
11/25/09
For information about this policy, contact the
reviewing department.
