Tips for UM-Flint Faculty Advisors to Students Conducting Human Subjects Research
What is the faculty advisor's role in student conducted research?
The faculty advisor is an active mentor to the student researcher and shares the responsibility for the ethical conduct of the research with the student. All human subjects research projects must complete a review process using the eResearch system in the Regulatory Management section BEFORE research (including subject recruitment) can begin. The advisor is expected to discuss the general principles of research ethics prior to the initiation of any project involving human subjects, help students determine whether their project requires IRB review or is eligible for self-determination, and guide students through the eResearch IRB application process. The advisor must support the student in the conduct of the research after the eResearch review is completed.
When the self-determination process is used it is the faculty's responsibility to carefully review the accuracy and completeness of the application as a part of "accepting their role" on the project. Self-determination indicates it is the faculty member who accepts oversight for protecting the human subjects as the IRB does not review the application.
Does my student’s project require IRB oversight?
Not all research activities that involve people, their data, or specimens require IRB oversight. See the Human Research Protections Program Operations Manual, Part 4, for examples of projects that do not require IRB oversight. http://research-compliance.umich.edu/operations-manual-activities-subjec...
Class activities-Activities that are designed for educational purposes to teach research methods or demonstrate course concepts are not intended to create new knowledge do not require IRB review. For details see:
Student Internships and Research Practica-Student activities associated with internships or practica may or may not require IRB oversight depending on the design of the activity and whether the student is engaged in the conduct of the research.
What are the faculty advisor’s responsibilities for student-conducted human subjects research?
Training in human subject’s protection. - All UM researchers (including faculty advisors) must have up to date certification by completing the PEERRS human subjects training module. http://my.research.umich.edu/peerrs/. Advisors are expected to be familiar with the ethical and regulatory requirements for the conduct of human subjects research and to discuss research ethics with students, including the professional ethics of the discipline.
Assist students in designing and planning the research projects. Student research projects must be appropriate to their level of training and experience. IRB policy requires undergraduate investigators to design projects that pose no more than minimal risk to subjects. Students must allocate time for IRB review and approval in their process, especially for projects conducted in international settings, projects involving non-UM collaborators, or involving federal sponsorship. Be sure students understand that IRB approval must be in place before they can begin their work.
Overseeing preparation of the IRB application via eResearch- A clear, concise, and consistent application will move more quickly through the IRB review process. Be sure the application includes informed consent documents, recruitment materials, and any surveys or other data collection instruments.
Accepting roles and submitting the application via eResearch- Advisors are required to accept their role and acknowledge their responsibility for the student application before it can be submitted to the IRB for review. This is your opportunity to check the application for the accuracy, quality and completeness of the responses prior to submission. In the case of an IRB application for a dissertation or thesis proposal, the faculty advisor should make sure that the student's dissertation or thesis is complete and officially approved by department standards before accepting as role of responsible sponsorship of the IRB application to supervise the student's study. The IRB copies advisors on communications and may communicate directly with the advisor if the application reflects a need for faculty involvement. IRB approval will be sent via an eResearch email notice.
Support students conducting research in field settings, particularly international research- Advisors must be sure that students are aware of local customs and regulations for safety of their subjects and the students themselves. Provide assistance with establishing local contacts or sponsorship.
Establish a communication plan with students. Develop effective plans for data security.
Monitor student research- Check in with students to ensure that research is being conducted as approved, that no problems have been encountered, and that all study modifications are submitted to the IRB for approval.
Ensure any adverse events or other problems or incidents are promptly reported to the IRB via eResearch.
UM-Flint IRB 810-762-3384 irb-flint.edu