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Student Research Requiring IRB Approval

Federal regulations and university policies require IRB approval for research with human subjects. This applies whether faculty or students conduct research. Research projects conducted by students, such as theses, dissertations, honors projects, capstone projects, and independent study projects, that collect data through interactions with living people or access to private information fall under the jurisdiction of the IRB.

All student-led protocols must be reviewed and submitted to the IRB by the faculty advisor. In addition, all IRB applicants are required to complete CITI IRB training prior to submitting their applications. Research applications will not be approved until all training requirements are fulfilled.

Research Integrity and Compliance (RIC) understands that student projects are usually very time sensitive. Therefore, students are encouraged to begin their discussions with their Faculty Advisor about the nature of their intended research and its potential IRB review as soon as possible.

IRB review times vary and are affected by the following factors:

• Level of review and risks to research participants: One or two reviewers can read low risk studies, while higher risk studies may require Full Board Review.

• Complete information: Follow the information on the RIC webpage and closely review your application to ensure that it is complete. All applications should be submitted in Kuali Protocols. Incomplete protocols and missing documentation will delay the review process.

• Attention to detail: Creating a clear and detailed application will greatly affect the reviewer's ability to make a determination in a timely manner. Information presented in more than one location should be consistent. Inconsistent information will result in additional information requests to ensure that regulatory requirements are met. Reviewers cannot make determinations based on assumptions, so clearly and consistently state your research plan throughout all your submission materials.

• Faculty advisor review: Faculty advisors play a vital role in student-led protocols. They serve as active mentors for student researchers and share responsibility for the ethical conduct of research conducted by students. All research proposals from undergraduates, graduate students, and postdoctoral fellows must include a faculty advisor as members of the research team.

   

  Prior to submission, it is strongly encouraged that students and faculty advisors meet to discuss and review the research protocol. Faculty advisors are expected to:

   

  • Discuss general principles of research ethics with students prior to the initiation of any project involving human subjects
  • Help students determine whether their project requires IRB review
  • Guide students through the IRB application process
  • Support students in the conduct of research after a project has attained IRB approval.

• Time of Year: The volume of student IRB submissions peak in the middle of the fall and spring semesters. Consequently, due to the high volume, applications submitted in the second half of the semester tend to take longer to review. The chart below details a month-by-month account on the number of student IRB submissions. Additionally, RIC suspends operation during the Holiday Break. Applications submitted immediately prior to the break will take longer to process and approve.

Classroom Research Projects

Research conducted as part of an in-class or course assignment generally does not require IRB review. These projects typically fulfill course requirements, are often completed in one semester, and are designed to teach research methods. Course instructors design these assignments to engage students in interaction with individuals, gather data about individuals, and/or illustrate concepts covered in the course. Therefore, they do not require IRB oversight.

The purpose of an IRB is to provide oversight of all research activities involving human subjects on campus, ensuring that all research participants are treated ethically and in compliance with all federal and state regulations.

For the purposes of SHSU鈥檚 IRB, research is defined as:

• A Systematic investigation, including research development, testing, and evaluation, designed to create generalizable knowledge.

• Generalizable knowledge means new information intended to be shared, published, presented, and is intended to have an impact (theoretical or practical) on others within one鈥檚 discipline. Activities that are disseminated with the intent to influence behavior, practice, theory, or future research designs are contributing to generalizable knowledge.

Knowledge that can be generalized is collected under systematic procedures that reduce bias, allowing the knowledge to be applied to populations and settings different from the ones from which it was collected. Most in-class projects where research is conducted using human subjects is not systematic or generalizable. In general, if the project is meant to complete an assignment for a class and has no relevance beyond the class, it does not require IRB review.

If students or instructors are uncertain if a research activity or classroom project requires IRB, they should contact RIC or submit an IRB Determination Request Form .