Research Compliance/CITI Training
Research training is a federally mandated requirement for researchers involved with human subjects, biosafety and animal research. NIH and NSF have also implemented required Responsible Conduct of Research training for researchers involved with approved grants as of January 2010.*
Principal Investigator compliance with training must be verified before acceptance of an award.
To comply with these mandates, Ohio Northern University has joined the Collaborative Institutional Training Initiatives (CITI) www.citiprogram.org.* CITI provides a number of discipline specific online training modules (social and behavioral, humanities, biomedical and physical sciences). These educational modules related to research allows ONU to satisfy mandates in the following areas:
- The Protection of Human Research Subjects.
- CITI Refresher Courses.
- Good Clinical Practice (GCP) Course.
- Health Information Privacy and Security (HIPS) Course
- Laboratory Animal Research Courses for Investigators
- Responsible Conduct of Research (RCR) Course
- Bio-Safety and Bio-Security Course
- Conflict of Interest Course
Each course consists of a series of modules with a quiz at the end of each module. The course is hosted on secure servers at the University of Miami and the CITI office at the University of Miami retains all records in strict confidence.
When the user completes the required course materials:
- The learners can print/download a Completion Report that details the learners accomplishments.
- A copy of the Completion Report is e-mailed to the institutional key person. At ONU, the e-mails will be directed to Tammy Everhart in the Academic Affairs Office who will act as an administrator.
- All faculty researchers utilizing undergraduate and graduate students and post doctoral candidates in research must provide Tammy with a list of names in order to be able to track who has completed the training.
- The learner may complete a voluntary satisfaction survey.
- The learner may return to the course site and download a copy of the completion report as needed.
- Administrators at each institution will have access to the CITI Report Utilities to view the progress of an individual learner or to download aggregate training data.
- Administrators also have access to the comments submitted by their learners about the course site.
- All ONU Faculty interested in conducting research that involves humans or animals, or that will involve biohazard or bloodborne materials must complete the appropriate courses for your position and type of research such as Protection of Human Research Subjects and the Bio-Safety and Bio-Security courses. Those of you who have already completed training on these topics for this academic year must complete the CITI courses by the end of this academic year. However, any undergraduates working with the PI on research must complete the appropriate CITI modules for Students Conducting Research.
Additionally, all faculty, post docs, laboratory staff and undergraduates supported by NIH or NSF research grants as of January 2010 must complete the Responsible Conduct of Research Course (RCR).
There are different courses in RCR designed for different users.
- Biomedical Responsible Conduct of Research Course
- Social and Behavioral Responsible Conduct of Research Course
- Physical Science Responsible Conduct of Research Course
- Humanities Responsible Conduct of Research Course
- Responsible Conduct of Research for Engineers
- Responsible Conduct of Research for Administrators
You are required to log-in at the CITI site which is well organized and provides everything you need to know, including course overviews and how to enroll in the training modules. Please help your students involved in research choose the appropriate courses.
Should you have questions regarding this, please contact the following CITI administrators at ONU:
- Phil Zoladz - IRB chair –Protection of Human Research Subjects
- Amy Stockert, Bio-safety chair - Bio-Safety and Bio-Security
- Boyd Rorabaugh, IACUC chair
- Julie Hurtig - Responsible Conduct of Research, Export Control
*Human Subject - The Department of Health and Human Services (DHHS) has mandated that researchers receive training in human subject protections and the ethical conduct of research, regardless of funding source.
Animal welfare - The use of animals in research, testing and education is subject to a multitude of laws, policies, regulations and standards. Two such laws/policies include the Animal Welfare Act (AWA) and the Public Health Service (PHS) policy, which require documentation that personnel are appropriately trained in animal care and use.
Biosafety - The NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) requires OUHSC to provide appropriate training for Principal Investigators (PIs) and laboratory staff regarding laboratory biosafety and implementation of the NIH Guidelines. Moreover, the Centers for Disease Control and Prevention (CDC) require training for persons working with infectious materials and toxins
RCR (NIH and NSF) National Science Foundation (NSF)Responsible Conduct of Research (RCR) -Section 7009: Statutory Requirement requires that each institution that applies for financial assistance from NSF for science and engineering research or education describe in its grant proposal a plan to provide appropriate training and oversight in the responsible and ethical conduct of research to undergraduate students, graduate students, and postdoctoral researchers participating in the proposed research project.
National Institute of Health (NIH) Responsible Conduct of Research (RCR) Policy requires that all trainees, fellows, participants, and scholars receiving support through any NIH training, career development award (individual or institutional), research education grant, and dissertation research grant must receive instruction in responsible conduct of research. This policy will take effect with all new and renewal applications submitted on or after January 25, 2010, and for all continuation (Type 5) applications with deadlines on or after January 1, 2011. This policy also applies to any other NIH-funded programs supporting research training, career development, or research education that require instruction in responsible conduct of research as stated in the relevant funding opportunity announcements.
Responsibility of Applicants for Promoting Objectivity for Research for Which Public Health Service Funding is Sought and Responsible Prospective Contractors focuses on the regulations applicable to research funded under PHS grants and cooperative agreements (42 CFR Part 30, Subpart F) and to institutions conducting research as contractors of NIH (45 CFR Part 94). These regulations were revised in August 2011 and must be implemented by institutions no later than Aug. 24, 2012. Separate standards on conflict of interest apply to research funded by NSF and the U.S. Food and Drug Administration.
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