Human Subjects Institutional Review Board (HSIRB) Policy

Purpose

McNeese State University established a Human Subjects Institutional Review Board (HSIRB) in compliance with the Protection of Human Subjects Code of Federal Regulations (45 CFR 46). The HSIRB ensures that all human subjects used in research, training, experimentation, or instruction at McNeese State University are afforded the rights and protection from risk guaranteed by 45 CFR 46.

Human Subjects Institutional Review Board

McNeese State University’s HSIRB assures that research involving human subjects is done ethically. To this end, the principles and applications discussed in The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, April 18, 1979) are applied to guide researchers in formulating informed consent, assessing risks and benefits, and selecting subjects. The principles of respect for persons, beneficence, and justice will prevail in HSIRB reviews of research involving human subjects.

All individuals conducting research involving human subjects must have their proposed research studies reviewed. Any McNeese State University faculty member, unclassified staff person, or other personnel performing, advising, or supervising research involving human subjects must comply with all McNeese State University HSIRB requirements and ensure that the students involved comply with the same requirements.

Authority

The responsibilities of the HSIRB are:

• To advise the University administration on all matters regarding human subjects’ rights and welfare during research; and
• To ensure University compliance with all applicable federal, state, and University policies and regulations regarding the use of human subjects.

The functions of the HSIRB are:

• To authorize the use of human subjects for research, teaching, training, and experimentation when required after reviewing the human subjects use protocol application;
• To prepare and submit all appropriate evaluation forms to the Doré School of Graduate Studies;
• To make recommendations to the administration regarding any aspect of the University’s human subjects use program; and
• To review any concerns involving the use of human subjects at the University.

Required Training for Researchers

All researchers involved in research with human subjects must complete a CITI Program training module about human subjects protection, either “Biomedical Comprehensive” or “Social/Behavior/Educational Comprehensive” depending on the discipline of the research. After completing the module, researchers can download a certificate of completion to submit with an HSIRB application. This certificate constitutes adequate documentation of training in the protection of human research.

Review Procedures

The HSIRB has a procedural manual that lists in detail the various review processes. The manual can be found in the Graduate School SharePoint. Any revisions made to the procedural manual are approved by the HSIRB members.

If an individual or group from another institution requests to conduct research on McNeese State University faculty, staff, and/or students, they must submit their request and the institutional research board approval documentation from their institution to the executive director of the Doré School of Graduate Studies at irbchair@mcneese.edu.

Communication

This policy is distributed via the University Policies webpage.