The IRB requires that all student research involving human subjects be sponsored by a WLU faculty member, both Undergraduate and Graduate students.
Additional responsibilities not listed may be required per federal regulation or local policies or procedures.
A. All WLU human subject researcher responsibilities: This includes faculty sponsors and student researchers.
- Protect the rights and welfare of human subjects that participate in research
- Understand the ethical standards and regulatory requirements governing research activities with human subjects
- Complete any required human subjects research training before submitting an IRB application
- Follow WLU policies and procedures associated with human subject research
- Ensure all research activities have IRB approval and are implemented as approved
- Comply with IRB requirements for timely reporting of unanticipated problems involving risks to subjects or others including adverse effect, safety reports, or data safety and monitoring summary reports
B. Principal Investigator (P.I.) responsibilities:
- The P.I. personally conducts or supervises the research
- Communicates appropriately with the IRB in a timely manner
- Communicates relevant information, such as IRB decisions, to any others listed on the IRB application
- Obtains IRB approval for any proposed changes to the research plan, including but not limited to, methodology or personnel changes, prior to its implementation
- Make provisions for secured retention of complete research records and research materials as required
- Ensure the confidentiality and security of all information obtained from and about human subjects
- Ensure reporting compliance with IRB and, if applicable, federal and funding sponsor requirements.
C. Faculty-student research sponsor responsibilities:
- Completion of the appropriate ethics training before sponsoring student research
- Reviewing student project proposals before they are submitted for IRB review
- Overseeing the conduct of the projects
- Ensuring that students comply with appropriate ethical principles for the treatment of human subjects
- Ensuring that students comply with WLU policies and procedures associated with human subjects research
- Communicate appropriately, and in a timely manner, with student researchers and IRB
Prior to IRB submission, faculty sponsors should discuss with their student researchers who is the primary investigator for each project proposal (the faculty member, or the student, and any co PI’s or co investigators). It is also suggested, but not required, that prior to IRB application submission, faculty members discuss and clearly indicate individual researcher responsibilities regarding the project. Additionally, faculty research sponsors should also consider discussing anything related to research dissemination, such as authorship order, with their research students.
D. Student Human Subjects Researcher responsibilities:
- Obtain a faculty research sponsor
- Communicate appropriately, and in a timely manner, with the faculty sponsor and IRB as needed
E. Cooperative research: For projects that involve more than one institution, each institution is responsible for protecting the rights and welfare of human subjects and for complying with any federal regulations or local laws.