Any student serving as the principal investigator for a study involving human subjects must have a faculty or staff Research Advisor actively engaged in the research project.
The IRB holds the Research Advisor responsible for the overall management of an approved research protocol in conjunction with the student investigator.
As a Research Advisor, faculty and staff members have a variety of responsibilities to the student investigator and Macalester College in the process.
Before application submission
Research Advisors are expected to work with the student investigator on the following matters before an application is submitted to the IRB.
- Ensure that the student investigator fully understands the importance of the informed consent process and discuss any additional protections and best practices that may be necessary, depending on the intended population and proposed interventions.
- Develop with the student investigator a plan for secure data storage as well as plans to transfer any identifiable data to the advisor prior to the student’s graduation.
- Make sure that the student investigator has secured appropriate permissions from organizations, schools, community leaders, oversight committees, and/or other sites where research activities make take place.
- Review all parts of the research application to check for its completeness, accuracy, and best practices in human subjects research protections. Research proposals should comply with the ethical principles outlined in the Belmont Report, human subject research regulations including 45 CFR 46, College policies, and other applicable federal or state laws.
Once the application is prepared, the Research Advisor must sign a Research Advisor Form, which a student investigator must include with the materials submitted for IRB review.
While the proposal is in review, the Research Advisor must ensure that the investigator does not initiate the research until after receiving notification of IRB approval.
After IRB approval
Once an application receives written IRB approval, the Research Advisor should make adequate time to consult with the student investigator on a regular basis to monitor research progress. Research Advisors are expected to
- Assist and supervise the student investigator with responding to challenges, problems, and questions that arise in the course of conducting research.
- Ensure the confidentiality and security of all information obtained from and about human subjects, and the privacy of subjects is maintained.
- Support the student investigator in communicating with the IRB in a timely manner any request for modifications to approved protocols.
- Ensure all research activities have IRB approval and implement the research activity as it was approved by the IRB.
- Work with student investigators to promptly report any adverse events, protocol deviations, or other unanticipated problems involving risks to participants or others and other reportable events to the IRB.