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Research
Involving Human Participants
Required
Education & Attestation
OUHSC
REQUIRED EDUCATION
In
a memo dated August 1, 2005, Joseph J. Ferretti, Ph.D., Senior Vice
President and Provost, outlined the certification requirements for
faculty and staff of the University of Oklahoma Health Sciences
Center engaged in research involving human participants. A copy
of this memo is reproduced at the following site: OUHSC
Required Education
OUHSC
policy mandates that all faculty and staff engaged in research involving
human subjects complete both the initial certification and continuing
education requirements as described below.
Initial
Certification Requirements
1.
Completion of the CITI (Collaborative IRB Training Initiative)
Basic
Web-Based Course:
The CITI Basic Course in the Protection of Human Research Subjects
consists of modules covering both biomedical and social/behavioral
research. Each module includes a brief quiz. The
entire course takes approximately 4-6 hours to complete.
The program allows users to log on multiple times in order to
complete all modules. Users can print a completion report
and the program will automatically forward a copy of that report
to the IRB Office. To register for the course, refer to
CITI Web-Based
Course.
NOTE VAMC Investigators: When registering, select University of
Oklahoma Health Sciences Center for your institution.
NOTE:
The CITI Basic Course replaces the previous Dunn & Chadwick
Manual Exam requirement. If you have already completed
the Dunn & Chadwick Manual Exam and have submitted your completion
certificate to the IRB Office, you do not need to complete the
CITI Basic Course.
2.
Attendance at the IRB In-House Education Program: This
program provides a comprehensive review of research topics such
as ethics, IRB submission, HIPAA, informed consent issues, and
good clinical practice (GCP). Scheduled dates can be found
here: Courses and Dates.
Note:
For Investigators affiliated with the VAMC, the VAMC will accept
the OUHSC IRB in-House Education Program in lieu of the VAMC web-based
GCP Course for the current year.
3.
Written Attestation: This
is required of faculty and
staff engaged in research involving human participants.
This attestation requires your signature to certify familiarity
with and the agreement to follow applicable federal regulations
governing research involving human participants. A PDF version
of this statement is located here: Written
Attestation
Continuing
Education Requirement
- The
education status of faculty & staff will be verified on a
routine basis. Notification will be on an individual basis
via email.
- CITI
Refresher Web-Based Course - completion required
every two years
The
CITI Refresher Course is a comprehensive review of the basic course
modules covering both biomedical and social/behavioral topics.
It includes updated material as it becomes available.
The program takes approximately 4-5 hours to complete. To register
for the course, refer to CITI
Refresher Course.
Note:
the CITI Refresher course is different from the CITI Basic Course
as outlined in #1 above.
The
IRB will offer hour-long workshops that will cover practical steps
on topics such as consenting, documentation and record-keeping.
You will receive notification when these courses are available.
PowerPoint Presentation Discussing Changes to SOPs and Forms 6/2007
Revised: 6/20/2007
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