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.

The HSIRB is appointed by the provost and consists of:

• The chairperson;
• A faculty member from each of the following areas: agriculture, biology, business, education, graduate studies, liberal arts, nursing, and psychology; and
• One member not affiliated with McNeese State University and not an immediate family member of a person affiliated with the University.

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 looks at four principal issues when reviewing a proposal:

1. Are the rights of human subjects safeguarded?
2. Does the proposal ensure that the University meets relevant federal guidelines?
3. Do the procedures cause the least amount of risk necessary?
4. Are the procedures and design sufficiently effective to justify involving human subjects?

Each proposal must detail the measures taken to protect the confidentiality and privacy of the subjects. The depth to which the HSIRB examines proposals depends on the research question, subjects, and/or methods. Working with individuals at special risk or using unusually invasive procedures requires more extensive justification.

The federal government recognizes three categories of research proposal review: full reviews, expedited reviews, and exempt reviews (in this case, exempt means “exempt from full review”). Exempt reviews are conducted by the HSIRB chair or an appointed HSIRB member rather than by the full board. Expedited reviews are conducted by a two-person subcommittee instead of the entire HSIRB.

HSIRB approval is for one year only, unless the risk level, subject population, or research protocol has changed. Any change in the risk level, subject population, or research protocol requires immediate HSIRB review. For any project in which the use of human subjects extends beyond one year, the investigator must apply for renewal one month before the expiration date. Applications for renewal must include the last two signed consent forms from subjects and stipulate the following:

1. The human subject protocol is the same as in previous studies.
2. There have been no ill effects suffered by the subjects due to their participation in the study.
3. There have been no complaints by the subjects or their representatives related to their participation in the study.
4. There has been neither a change in the research environment nor new information that would indicate greater risk to human subjects than that assumed when the protocol was initially reviewed and approved.

Complaints or ill effects that result from the research must be reported and sufficiently described for HSIRB review as soon as possible after occurring.

Outside Requests for Research

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.