Last Revised: 10.2015
Prior Version: 7.2007
Certification in Human Subject Protections
Introduction
The CWRU IRB collaborates with the other institutional review boards, including University
Hospital Case Medical Center (UHCMC) and MetroHealth Medical Center in a common
program for human subject protections certification. The Continuing Research Education Credit
(CREC) program provides documented training on the protection of human subjects in research
and meets the requirements for human subject certification for both the National Institutes of
Health (NIH) and the IRB.
Definitions
Collaborative Institutional Training Initiative (CITI) is a web-based educational program in
the ethics and protection of human subject research and may be used for both core initial
certification as well as continuing education requirements. The program is sponsored by the
University of Miami (Florida) and may be accessed at https://www.citiprogram.org/
CREC is an acronym for Continuing Research Education Credit.
Policy
The IRB requires that the Principal Investigator, all study personnel, including all students who:
 collect or have access to private identifiable data or PHI (Protected Health Information),
and/or
 recruit, consent human subjects and/or
 interact with subjects on any research study must be CREC-certified.
In addition, the IRB certification requirements are applicable to research determined by the IRB
to be exempt from IRB review and approval.
Once certified, investigators must maintain valid certification by participating in on-going
continuing research education programs. Certified investigators and research staff members (key
personnel and/or individuals obtaining informed consent) must earn 12 CRECs (Continuing
Research Education Credits) every three years to maintain their certification in human subjects’
protections.
Protocols may be submitted to the IRB pending investigator certifications; however, approvals
will not be issued until investigator certification is complete. If certification lapses, recertification must be complete before approval for the continuing review will be issued.
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Prior Version: 7.2007
Failure to meet the requirements for human subjects’ protections certification means that the
investigator and/or research staff cannot participate in an IRB-approved protocol. Nor can an
investigator and/or research staff obtain approval for a pending protocol application. If CREC
certification expires during the course of an IRB-approved protocol’s approval period, then the
protocol cannot be approved via continuing review. If CREC certification expires during the
course of an IRB-approved protocol’s approval period and an investigator requests an
amendment/change, then the amendment cannot be approved.
IRB Members and alternates must be CREC-certified, and must maintain their certification while
serving on the IRB.
Previously Certified at Other Institutions Now at CWRU
An individual may have current training in the protection of human subjects in research from
another institution. If individuals are from an institution affiliated with CWRU, i.e., the Louis
Stokes Cleveland Department of Veterans Affairs Medical Center or the Cleveland Clinic, the
CREC Program will honor their certification, if complete and current. The individual will be
enrolled into the CREC Program once sufficient documentation of this training is provided.
Individuals from non-affiliated institutions with current CITI certification may be enrolled into
the CREC Program upon completion of the CITI Refresher course.
Investigators at Other Institutions on Protocols Approved by the IRB
Investigators at other institutions, who are named on a CWRU IRB study, must be certified in
human subject protection following his or her institution’s or CWRU’s policy. Proof of
certification from the investigator’s institution must be submitted to the IRB.
Initial CWRU Certification Conditions
Successful completion of the Collaborative Institutional Training Initiative (CITI) course is the
only way to enter the Case Western Reserve University's CREC program. Passing the course
with a cumulative score of 85% is required in order to enter the CREC Program. Any of the
following training groups for research faculty, staff, and students may be taken to meet the initial
certification requirement:

Group 1 focuses on Biomedical Research

Group 2 focuses on Social & Behavioral Research

IRB Reference Resource is a comprehensive compilation of both research perspectives

IRB Members is designed with IRB members in mind
The following link provides additional information and the direct link to the CITI Online
Education Program: https://www.citiprogram.org/
Specific instructions for completing the CITI training registration can be found at the following
link: http://www.case.edu/research/faculty-staff/education/crec/
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Prior Version: 7.2007
Initial certification lasts for three years. The only option for initial certification is the CITI
Online Training course. All training is done online and can be completed in multiple sessions.
Continuing Education Options
Once initial certification has been received, investigators, key personnel, and other members of
the research team must accumulate 12 Continuing Research Education Credits (CRECs) every
three years to be re-certified. Certification is required for as long as they are involved in human
subject research. For continuing education, investigators may combine CRECs from the Options
below to meet the required 12 CRECs for re-certification. Responsible Conduct of Research
(RCR) training is NOT valid for CREC. Passing the course with a cumulative score of 85% is
required for each option in order to earn CREC. There are multiple options for earning CRECs
for re-certification:
Option 1: CITI Basic – 8 credits
Since CITI updates their modules with the most current information available, those who wish to
take the course to earn continuing credits for recertification may do so once per 3-year cycle.
Option 2: CITI Refresher Course – 6 credits
This is a more appropriate course for experienced researchers and requires less time to complete.
CREC Program participants can earn a maximum of 6 credits toward recertification per 3-year
cycle for taking a Refresher Course. Participants may choose either the Biomedical or Social and
Behavioral course. Credit will not be given for both Refresher courses in the same cycle.
Option 3: CITI Good Clinical Practices (GCP) (6 credits)
This course covers not only human subjects research, but also recordkeeping and other GCP
topics.
Option 4: CITI Health Information Privacy & Security (HIPS) (4 credits)
This course is provided as a resource to meet some of the training requirements of Case Western
Reserve University and our affiliated hospitals for the Health Insurance Portability and
Accountability Act (HIPAA).
Option 5: CREC Video Seminars and Quizzes (1 - 4 CREC per seminar)
This option allows participants to view some of our past CREC seminars and take an online quiz
for credit.
Option 6: CREC Seminars through the Case Research Seminar Series
The CWRU Office of Research Administration offers a variety of seminars each semester that
have been pre-evaluated for CREC. The number of credits is listed if the seminar qualifies for
CREC. Our online system allows individuals to see a listing of upcoming seminar descriptions
and register to attend the events.
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Option 7: CREC Credit Application
Appropriate education and training activities that are not sponsored by the Office of Research
Administration (such as departmental or external seminars and conferences) may also qualify for
CREC. CREC are awarded based on the amount of time dedicated specifically to a discussion of
the ethical conduct of human subjects’ research. An individual may apply for credit for a group
or for him/herself. The Office of Research Administration will accept applications, with
appropriate supporting documentation, prior to the event or upon its completion.
Complete the CREC Credit application and attach:

Program agenda

Seminar handouts

Sign-in attendance sheet (if applicable)
Submit the application to the CWRU Office of Research Administration.
References or Regulatory Citations


NIH Education Requirements
Office of Research Administration CREC page
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