All individuals involved in the design and conduct of research with human subjects are required to undertake training in the protection of human participants before commencing any proposed research activity involving human subjects regardless of whether the study is funded or non-funded research.
The conduct of human subjects research is not limited to direct interaction with subjects. Environments where researchers are working with subject data that are identifiable or potentially identifiable (for example, where a subject code key exists) are also included within training guidelines. Therefore, the training requirement is not only applicable to Principal Investigators and other senior personnel, but may also extend to staff and student assistants. Careful attention also is required for issues related to conflict of interest that might affect both the research and the reporting of it.
All personnel involved with human subjects research are strongly encouraged to undertake the training regardless of whether they fall within or outside of the mandatory training pool. Becoming certified under this program is an excellent training opportunity. Any individual who plays any role in these types of research endeavor will benefit. The courses themselves can also easily become part of a research course curriculum.
Importantly, submission of proof-of-training completion reports by the Principal Investigator(s) and other appropriate project personnel must be included with proposals submitted to the HSIRB for review; the Principal Investigator must submit to the Board proof of training completion for any individual who joins an approved project during its life before that person may commence work with subjects or identifiable data.
Any proposal approved prior to January 31, 2016 will continue to be covered under the National Institute of Health’s training program or CITI training curriculum for the duration of the research project and any subsequent required annual continuation reviews.
Effective February 1, 2016, mandatory training requirements are met by completing the Collaborative Institutional Training Initiative at the University of Miami (CITI) training program in Human Subjects Research for all new proposals submitted for review, regardless of previous NIH mandatory training completed.
To access the CITI training curriculum:
Biomedical Research – Basic: Required Modules & Supplemental Modules:
Time to Complete. Completion of each course may generally take up to 30 minutes. Courses can be taken over time until the curriculum is completed.
Validity of Training. Completion of the required curriculum training and completion of any supplemental course is valid for three years.
The HSIRB welcomes any constructive feedback you wish to provide about the new training program as part of our ongoing efforts to improve IRB processes. If you have any questions about the new CITI training program, please feel free to contact Dr. June Kume, HSIRB Chair, at firstname.lastname@example.org, Assistant Professor Diana Daus, HSIRB Vice Chair, at email@example.com or Glenn Davis, Director of the Office of Sponsored Programs, at firstname.lastname@example.org.