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What is “CREC”?
Who is required to participate in the program?
What if I am from The Cleveland Clinic or LSCDVAMC and have taken their required training?
What is the definition of a Responsible Investigator?
What is the faculty member’s role in student research?
What should I do if I am a new faculty member or new key personnel?
Are NIH Key Personnel from other institutions required to complete our continuing education program?
How do I obtain “Core” certification?
How and when will I receive confirmation that I have successfully obtained CREC certification?
How can I gain access to my CREC account information?
How do I earn CRECs for “continuing” certification?
Can I earn more than 12 CREC during the 3-year certification period?
What happens if I do not obtain 12 CREC during my 3-year certification period?
Q. What is “CREC”?
A. CREC stands for the Case Western Reserve University’s Continuing Research Education Credit (CREC) Program, developed to provide documented training in the protection of human participants in research that is conducted at University Hospitals Case Medical Center, The MetroHealth System, and Case Western Reserve University. In some instances, researchers from the Louis Stokes Cleveland Department of Veterans Affairs Medical Center (LSCDVAMC) and The Cleveland Clinic may also participate in the CREC Program.
The CREC Program was created to provide documented training for all Responsible Investigators, regardless of sponsorship, as well as those Key Personnel listed on NIH grants. Investigators must meet the “Core” CREC requirements before the IRB will grant approval, and must obtain a specified number of points (12) over a specified time (3 years) to retain CREC certification. For further information on the CREC program and a link to the program, please see: http://ora.ra.cwru.edu/research/orc/crec/index.cfm.
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Q. Who is required to participate in the program?
A. You are required to be CREC certified if:
*You are involved in human subjects research and are listed as Key Personnel on an NIH
grant, and/or;
*You are listed as the Responsible Investigator on a Case IRB protocol, and/or;
*You are obtaining consent under a University Hospitals of Cleveland or a MetroHealth
System IRB protocol.
*Researchers who wish to participate in the CREC program, but are not officially required
to do so may use the program at no charge.
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Q. What if I am from The Cleveland Clinic or LSCDVAMC and have taken their required training?
A. Cleveland Clinic researchers listed as Key Personnel on NIH grants administered by Case may meet their educational requirement through The Cleveland Clinic’s educational program.
LSCDVAMC researchers do not have to participate in CREC if they do not meet any of the above criteria. They are, however, required to meet VA educational requirements.
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Q. What is the definition of a Responsible Investigator?
A. A Responsible Investigator is usually a Case faculty member who is current in his/her certification for training in the protection of human subjects. If an individual is not a faculty member but is certified as someone, “with whom the university has or intends to have an ongoing contractual relationship,” then he/she must have a RI Authorization Form on file with the Case IRB. The form can be found at the following link: http://ora.ra.cwru.edu/research/orc/Attachments/Case%20IRB/Responsible_Investigator_Certification_Form.pdf
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Q. What is the faculty member’s role in student research?
A. “A faculty member assigning research projects involving human subjects must take an active role in assuring that the subjects of student research are adequately protected. The University expects that advisors will take an active part in preparing students for the role of researcher, instructing them in the ethical conduct of research and assisting in the preparation of IRB applications. After protocol approval the advisor should meet regularly with the student in order to review their work and progress. While a student serves as the primary researcher for the protocol, the faculty advisor is ultimately responsible for the protection of human subjects. A faculty member’s signature on the application indicates their willingness to comply with all administrative and federal regulations” (University Policy on the Involvement of Human Participants in Research).
To comply with this policy, the faculty member who is acting as the Responsible Investigator is required to educate and mentor the research team, but is also responsible for maintaining research records as required by University Policy and Federal Regulations.
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Q. What should I do if I am a new faculty member or new key personnel?
A. New faculty members who have documented training in the protection of human subjects in research from their former institution have one year from their hire date in order to obtain “Core” CREC certification. New faculty members without such documentation will need to complete the “Core” CREC Certification before their IRB privileges are granted.
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Q. Are NIH Key Personnel from other institutions required to complete our continuing education program?
A. No, if they have current documentation from their institution that they have been properly trained. However, if external NIH Key Personnel have not received training from another institution they must participate in the CREC Program.
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Q. How do I obtain “Core” certification?
A. Successful completion of the Collaborative IRB Training Initiative (CITI) course is the only way to enter the case Western Reserve University’s CREC Program. Created by the University of Miami, this course offers three select training groups for research faculty, staff and students:
● Group 1 focuses on Biomedical research
● Group 2 focuses on Social & Behavioral research
● IRB Reference Resource is a compilation of both research perspectives
The following link provides additional information and the direct link to the CITI Online Education Program: http://ora.ra.cwru.edu/research/orc/crec/index.cfm
Specific instructions for completing the CITI training registration can be found at the following link:
http://ora.ra.cwru.edu/research/orc/Attachments/Education/Instructions%20Sheet%20for%20CITI%20Basic.doc
**We recommend printing these instructions to have available while completing the training.**
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Q. Do I need a Case Network (CWRUnet) ID in order to register for any of the training listed?
A. The answer is No. On several of the registration forms, however there will be a field asking for a Case Network ID. If you have one please provide it. If you do not have a Case Network ID please enter your affiliate e-mail address.
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Q. How and when will I receive confirmation that I have successfully obtained CREC certification?
A. Once you have successfully completed the training course, CITI will notify the CREC coordinator directly. Your demographic information and grade book will be downloaded, a CREC account will be created for you in a database giving Case and all affiliated IRBs access for confirming your certification. Within a week, you will receive an e-mail confirmation and downloadable Certificate of Achievement for your records.
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Q. How can I gain access to my CREC account information?
A. You may access your CREC information through the SPIDERWEB database using a Case Network ID and password. This site provides a portal to information about your grants, contracts and, as applicable, regulatory protocols pertaining to the use of human subjects, animals or recombinant DNA in your research. It also provides you with the ability to enter and retrieve data that are needed for sponsored project administration and protocols, online conflict of interest updating, and CREC information.
To view your CREC Information on Spiderweb, follow these instructions:
- Go to Spiderweb
- Type in your Case Network ID and Password
- Choose "COI/CREC Summary" from the menu
- View your personal CREC History
- In the Search Box at the bottom of the page, type in any CREC Program participant's last name and view his/her certification status, expiration date and download his/her certificate.
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Q. How do I earn CRECs for “continuing” certification?
A. After completing the “core” certification, researchers are certified for 3 years, during which time they must acquire 12 credits for re-certification. A variety of training options are listed on the Office of Research Compliance CREC web pages entitled, “Online Continuing CREC and Other Continuing CREC”. http://ora.ra.cwru.edu/research/orc/crec/index.cfm
There you’ll find the University offers several training options eligible for continuing CREC including:
● Our Case Research Seminar Series allows you to choose from a variety seminars that have been predetermined to meet regulatory requirements. Some of these seminars such as “IRB 101” as well as new “hot topics” are offered each year covering basic level and more experienced researchers.
● Education and training activities that are not listed on this site yet focus on the ethical conduct of human subjects protection may be considered for CREC credits by submitting a CREC Credit Application along with appropriate documentation to the Case office of Research Compliance. This tool can be used to request continuing CREC for an individual or group.
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Q. Can I earn more than 12 CREC during the 3-year certification period?
A. Additional credits (more than 12) obtained during a certification period will not be applied to future certification periods. For example if you were CREC certified on 9/1/2004, your certification expires on 9/1/2007. If during that 3-year cycle you obtained 20 continuing CRECs, you will automatically be re-certified on 9/1/2007. However, starting on 9/1/2007 you will have 0 continuing CREC and are required to obtain at least 12 CREC by 9/1/2010 for re-certification. This is to ensure that individuals continue to receive the most current guidance through up-to-date educational activities.
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Q. What happens if I do not obtain 12 CREC during my 3-year certification period?
A. Your certification will expire and you will delay the approval of any protocol submissions (new or continuing review) to the Institutional Review Boards (IRBs). IRB approvals will be held until you have obtained the appropriate number of continuing CRECs for your re-certification. If your certification expires and the expiration does not affect any IRB protocol submissions, you will only have one year available to utilize continuing CREC training options in your efforts to obtain recertification. If one year passes and you have not obtained your recertification, you would be required to successfully complete the Collaborative IRB Training Initiative (CITI) Basic Course again in order to be reinstated into the CREC Program.
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