Many students in the College of Public Health are involved in research, either for their own degree requirements or in work assignments with faculty members or others. It is essential that students learn and abide by the applicable rules concerning research involving human or animal subjects. This topic will be covered in some courses as appropriate. This summary is intended to provide an overview. You are strongly advised to contact your faculty advisor or employer about the procedures described below.
What research is covered by this policy?
All research involving human subjects, even if it is limited to the use of existing data sources from human subjects needs to be approved by the OSU Institutional Review Board (IRB). All research involving animals needs approval from OSU Institutional Animal Care and Use Committee (IACUC). This includes culminating projects, these and doctoral dissertations. In a few rare cases, practicum placements might also need approval if it involves collecting research-type data. When IRB or IACUC approval are necessary, such approval must be obtained before any data collection begins. Allow 6 weeks or more from submission to approval.
Research with human subjects
When do projects need IRB approval?
The linked document from Ohio State’s Human Research Protection Program defines clearly what constitutes “research” and what types of research require IRB oversight. The document can be found here: http://orrp.osu.edu/irb/osupolicies/documents/ResearchInvolvingHumanSubjects.pdf .Table 1, on pages 6-8, is a very useful guide to when IRB oversight is required. If your research seems to fall into a “gray area” not clearly covered by this document, contact Ohio State’s Office of Responsible Research Practices for help.
Procedures for human subjects research approval
Students should work closely with their faculty advisor to complete the necessary materials to secure approval for research with human subjects. Guidance, forms and directions are available through the Office of Responsible Research Practices: http://orrp.osu.edu/irb.
All faculty, staff and students participating in human subjects research at Ohio State are required to complete the Collaborative Institutional Training Initiative (CITI) web-based course on human subjects available at http://orrp.osu.edu/irb/training-requirements/citi/. The Office of Responsible Research Practices also offers regular training for researchers. Additional information is available at http://orrp.osu.edu/irb/training/. In addition to completing CITI training, everyone (faculty, staff, and students) involved in sponsored research or other research which is reviewed by the IRB must also complete a Conflict of Interest disclosure, which can be found at http://orc.osu.edu/regulations-policies/coi/ecoi/.
Additionally, Ohio State is now requiring everyone who is eligible to conduct research to be trained in the Responsible Conduct of Research (RCR). As a first step, all research eligible individuals must take the Collaborative Institutional Training Institute “CITI” RCR course. This requirement is in addition to any other RCR training that you may have taken to date. For additional information and to register for the RCR training go to http://orc.osu.edu/regulations-policies/rcr/.
Some low-risk research may qualify for “exemption” from full IRB review; however, the determination that the research is exempt must be made by the university’s Office of Responsible Research practices (ORRP), and cannot be assumed by the student or investigator. Students who will be using data previously collected by faculty members for a theses, dissertation, or culminating project will also need to obtain IRB approval, frequently via the exempt status form. Requests for exempt determinations are made using the Buck-IRB online system.
For all student research reviewed by the IRB, the IRB application must list the student’s advisor as the “Principal Investigator,” i.e., the person responsible for the research. The student is a “co-investigator.” Both the student and the advisor must have completed the on-line human subjects training (CITI). The IRB will not review an application unless everyone listed as principal or co-investigator has completed the on-line training.
Research with animals
All animal protocols should be submitted in via the university’s e-Protocol system. Directions to secure approval for research with animals are available through the Office of Responsible Research Practices. Approval requires completion of the Animal Usage Orientation Course (either classroom or online) and the Occupational Health and Safety Training Course (online only). Information regarding these courses is available online at http://orrp.osu.edu/iacuc/.
You are encouraged to contact your faculty advisor or employer about research, including the requirements for responsible research practices. You may also speak with Dr. Chrstopher Weghorst, PhD, Associate Dean for Research in the College of Public Health, if you have questions or concerns.
If you have additional questions or need to discuss specific issues concerning research you are undertaking, contact:
Office of Responsible Research Practices
The Ohio State University
300 Research Administration Building
1960 Kenny Road Columbus, Ohio 43210-1063
Phone: (614) 688-8457 Fax: (614) 688-0366