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Continuing Research Education Credit (CREC) Program: Frequently Asked Questions Who is required to participate in the program? All Responsible Investigators (regardless of funding) and all Key Personnel listed on a NIH grant applications are required to participate in the program. This is a multi-institutional program involving Case Western Reserve University, University Hospitals of Cleveland, The MetroHealth System, and the Louis Stokes Cleveland Department of Veterans Affairs Medical Center. Key Personnel on non-NIH grants or non-funded studies are not required to complete this training at this time. What is the definition of a Responsible Investigator? A Responsible Investigator is the main Principal Investigator who is listed on the IRB protocol. Only faculty members can be considered as Responsible Investigators, or a non-faculty investigator that has received approval to act as a Responsible Investigator by having an approved Responsible Investigator Certification Form. Why was the program created? All four institutions are required to create and maintain an ongoing education program according to the Multiple Project Assurance (Part 2, Section I-L). In addition, the program is in compliance with the NIH Key Personnel Training Requirement and is the first step towards compliance with the Office of Research Integrity’s Responsible Conduct in Research Training requirements. The initial certification or first stage of our institutional program was implemented on September 1, 2000. All Responsible Investigators were required to read Protecting Study Volunteers in Research and pass a fifty-question multiple choice and true/false test in order to maintain their IRB privileges. The Key Personnel Training Form and Letter Template, available on the web, were created to facilitate compliance with the NIH mandate This re-certification or second stage of the program focuses on continuing education of the same individuals – Responsible Investigators and NIH Key Personnel. This program was implemented as of September 1, 2001. The future third stage of the program will address training requirements for all key personnel involved in human subject research regardless of funding. The institutional definition of key personnel has not yet been defined. No future implementation date has been identified. How does the second stage of the program work? This stage was modeled after the Continuing Medical Education (CME) Program. The IRB Advisory Committee (IAC) chose this model because it offers the greatest flexibility for investigators involved in biomedical and non-biomedical research. It also allows investigators to choose courses based on their level of knowledge (e.g. beginner to expert level). Responsible Investigators (RIs) and Key Personnel who were certified on or before September 1, 2001 will be required to obtain 12 Continuing Research Education (CRE) credits before September 1, 2004 in order to maintain IRB privileges after September 1, 2004. Those RIs and Key Personnel who were certified after September 1, 2001 will be required to obtain 12 CRE credits within three years of their initial certification date. Re-certification is required every three years thereafter. How do I determine my original certification date? If you took the test or were listed on an ORA approved KPTF on or before September 1, 2001, your certification date is September 1, 2001. You will need to obtain 12 credits between September 1, 2001 and September 1, 2004. Anyone who obtains their first stage certification after September 1, 2001 (e.g. October 4, 2001) will have three years (e.g. October 4, 2004) to obtain twelve credits to be re-certified. How do I obtain 12 CRE credits? The list of Approved CRE Activities is available on the web and will be updated on a regular basis. For most activities participation will be automatically be recorded (e.g. automatic documentation by web-based tutorial or sign-up sheet at seminar). However, some activities indicate that documentation needs to be sent (or emailed) to ORA to receive credit. The program will also allow investigators to request credit for educational and training activities that are not listed by filing the Application for Non-accredited Educational Activities with ORA. Investigators will be informed by e-mail if the application has been accepted and how many CRE credits were approved for the activity. Additional credits obtained during a certification period cannot be applied to future certification periods. For example if an investigator obtains 24 credits by August 30, 2004, he/she will have 0 CRE credits on September 1, 2004 and will need to begin to accumulate 12 more credits before September 1, 2007. Certifications will be sent once a week for investigators who obtain 12 CRE credits. What happens if I do not have 12 CRE credits by my re-certification date? All RIs and Key Personnel who have passed the first stage certification will maintain their human subject research privileges until September 1, 2004 or until their certification date expires. All RIs who have not re-certified by that time will not receive approval for any new protocols submitted to any of the four IRBs or receive approval to renew previously approved protocols until re-certification is obtained. All Key Personnel must have current certification before an institutional official in ORA will sign the NIH-required documentation. What do I do if I am a new faculty member or new key personnel? New faculty members which have documentation from their former institution that they have received human subjects training have one year from their hire date in order to complete Phase I of the education program. New faculty members without such documentation will need to complete Phase I before their IRB privileges are granted. New key personnel must complete one of the Phase I options before ORA will provide an institutional signature. Are key personnel from other institutions required to complete our continuing education program? No, if they have current documentation from their institution that they have been properly trained it can be provided with the Key Personnel Training Form. However, if key personnel are relying on our program, they must complete the continuing education requirements. Can faculty, staff, or students recommend activities to be included on the approved list? Yes! Investigator feedback is critical to maintain a list of meaningful training activities that meet the research needs of the community. Continuing education would be much easier if all the information could be processed on-line. We agree! We are diligently working on such a system and will keep you updated on its progress. Who do I call if I have questions about the education program? Administrative questions should be forwarded to Maureen Dore-Arshenovitz at mxd4@po.cwru.edu or 216-368-6925. Programmatic or content questions should be forwarded to Christian LaMantia at clt@po.cwru.edu or 216-368-4513. Questions about a specific IRB protocol should be directed to the appropriate IRB office. |
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