Untitled Document

NOTICE

Change in Human Subject Research Training for UNTHSC Researchers

Background

In accordance with federal regulations, it is necessary for all individuals identified as “key personnel” on a research project involving human research subjects to complete required educational training on the protection of human research subjects.

Current UNTHSC IRB Policy requires that, when submitting a protocol for IRB review (both new and continuing /review), the Principal Investigator must include written verification that each of the key personnel on that project has successfully completed the online educational tutorial located on the UNTHSC web site (http://www.hsc.unt.edu/research/irbreview/index.cfm). No protocols can be reviewed for new or continuing reviews that are not in compliance with this requirement.

As federal regulations have evolved, our existing training requirement is no longer adequate. To develop researchers awareness of sound ethical research conduct involving human subjects, and to meet federal requirements for appropriate human subjects research training, a new required educational training program is being implemented.

New Educational Training Requirement

When submitting a protocol for IRB review (both new and continuing review), the Principal Investigator must include written verification that each of the key personnel has successfully completed the appropriate educational tutorial/program designated by the UNTHSC Office for the Protection of Human Subjects (OPHS) through the CITI (Collaborative IRB Training Initiative) Course in the Protection of Human Subjects, with links located on the UNTHSC IRB web site (http://research.hsc.unt.edu/dhhs/irb.html). This is now the basic standard training requirement for all faculty, staff, and students engaged in research involving human subjects.

(For the full policy change and details about the CITI training program, visit our website)

How to log onto to the CITI website:

Go to the CITI website at www.citiprogram.org

Once there, simply click on the link “Register for CITI course”.

Under institution selection, select “University of North Texas Health Science Center” in the “All others” drop down box.

Next, proceed to create your own username and password and select the CITI Recommended Learner group. Choose whichever group best fits your research areas and interests:

Biomedical-Clinical
Social-Behavioral
Interdisciplinary Researchers
IRB Members

For any questions, call Ms. Mary Wilson at OPHS (817)-735-0409 or email me at: bgladue@hsc.unt.edu

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Policy Statements

Previous Policy:

SECTION 4.2 REQUIRED EDUCATIONAL TRAINING

In accordance with federal regulations, it is necessary for all individuals identified as “key personnel” to complete required educational training on the protection of human research subjects. Key personnel include all individuals responsible for the design and conduct of the study.

When submitting a protocol for IRB review (both new and continuing review), the Principal Investigator must include written verification that each of the key personnel has successfully completed the online educational tutorial located on the UNTHSC web site (http://research.hsc.unt.edu/dhhs/irb.html). No protocols will be reviewed for new or continuing review that are not in compliance with this requirement.

New Policy:

SECTION 4.2 REQUIRED EDUCATIONAL TRAINING

In accordance with federal regulations, it is necessary for all individuals identified as “key personnel” to complete required educational training on the protection of human research subjects. Each Investigator/key personnel who is directly involved in the treatment or evaluation of research subjects in the covered study must successfully complete an appropriate and approved training program.

When submitting a protocol for IRB review (both new and continuing review), the Principal Investigator must include written verification that each of the key personnel has successfully completed the appropriate educational tutorial/program designated by the UNTHSC Office for the Protection of Human Subjects (OPHS) through the CITI (Collaborative IRB Training Initiative) Course in the Protection of Human Subjects, with links located on the UNTHSC IRB web site (http://research.hsc.unt.edu/dhhs/irb.html). This is the basic standard training requirement for all faculty, staff, and students engaged in research involving human subjects.
Alternatively, the educational training requirement can be met through any one of the following:

Documentation of current active certification as either a Clinical Research Coordinator (CRC) or Clinical Trial Investigator (CTI) as designated and verified by the Association of Clinical Research professionals (ACRP). Persons desiring to use this alternative to CITI training must present a copy of a valid and current certification.
Documentation of current active certification as a Certified IRB Professional (CIP) as designated and verified by Public Responsibility in Medicine and Research (PRIM&R) Council for Certification of IRB Professionals (CCIP). Persons desiring to use this alternative to CITI training must present a copy of a valid and current certification as documented by that organization.
Successful completion (passing grade) of the course BMSC 5400 “Regulation of Human Subject Research” offered by UNTHSC.
Previous completion of CITI training at another institution. Note that CITI certification applies to a given individual across all institutions.

Note that all other non-CITI on-line training by other universities, programs or organizations does not meet this educational requirement. Although such programs, such as that offered by NIH through the National Cancer Institute (“Human Participant Protections Education for Research Teams”) at http://cme.cancer.gov/clinicaltrials/learning/humanparticipant-protections.asp) can provide useful information, they do not qualify as a substitute for CITI educational training program under this policy.