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Human Subjects Training

Human subject training is an integral part of an institution’s human subject compliance
program. Training is required of all UMD personnel including faculty, staff and students,
involved in research with human subjects and must be completed prior to submitting and
application to the IRB. This includes new applications, annual renewals and amendments.

Training is required of all individuals who:
• enroll subjects
• interact with subjects by conducting invasive or noninvasive procedures
• actively participate in obtaining informed consent
• collect data, including identifiable private information, from or follow up with
participants
• conduct surveys
• have access to information that directly links data to individual names or
identifiers
• act as authoritative representatives for the investigators
• are members of the IRB committee
• are IRB administrators or managers

The University of Massachusetts Dartmouth (UMD) has implemented the CITI Course in
the protection of Human Research Subjects. CITI is a collaborative online training
program maintained by the University of Miami. Professionals from around the country
have contributed to the training and testing materials. The program offers both initial and
refresher training. Certificates are issued upon satisfactory completion of the online
course and test. Initial certificates are valid for three years, after which investigators and
other personnel continuing research with human subjects must take the refresher course.
Researchers coming from another institution who have completed training at the other
institution will be allowed to carry their training over to UMD for three years from the
date of initial training upon presentation of the certificate of completion.
As of December 31, 2007 all individuals actively engaged in research with human
subjects or submitting applications, annual renewals or amendments to the IRB must
have completed the CITI training or presented certificates of training from other
institutions. All IRB memebrs must also have completed the course. Participation in any
activities involving research with human subjects is not permitted without the
certification. As a reminder, IRB approvals are given for a one year period; a renewal
application must be submitted to continue after the expiration date.
The CITI program is accessed at https://www.citiprogram.org. Please contact Michelle
Plaud in ORA(x8509 or email mplaud@umassd.edu) with any questions.