Research Study Compliance
In accordance with institutional, local, and federal research regulations, it may be necessary for School of Nursing researchers to obtain certification/credentialing or complete training programs. The most common requirements are human subjects protection training through CREC and CITI Certification and UH Research Credentialing (for non UH employees. Any required certifications and/or training must be completed before research activities occur to ensure responsible conduct of research.
FPB Faculty, Staff or Student who need to be credentialed must first meet with Danielle Bunkley (firstname.lastname@example.org) who provides process guidance/instructions and assures that all necessary steps and forms are completed. This page includes background information and links you will need to complete the process.
Individuals must have an approved UH-IRB prior to credentialing. Individuals must be credentialed in order to access UH-Red-CAP and Electronic Medical Records.
The credentialing procedure is a 4-step process, consisting of a background check, UH HIPAA and Research-Duty to Protect Private Health Information, CITI and HIPS training, and final submission of the Credentialing Form.
CWRU CREC Program + CITI Certification
CWRU policy requires human subjects protection (HSP) training for all CWRU individuals involved in human subjects research. The CWRU Continuing Research Education Credit (CREC) Program provides documented HSP training for CWRU faculty, staff, and students. It confirms that individuals involved in conducting research have the necessary education to ensure the proper safety and privacy of human research subjects and their confidential data. Generally, all individuals (principal investigators, co-investigators, study coordinators, research assistants, laboratory technicians, student researchers) involved in research activities with direct contact with human subjects are required to complete training. Applicable research activities include:
- Contacting research participants or their guardians (including face-to-face, phone, mail, and email contact)
- Screening of potential research participants
- Consenting and enrolling eligible research participants
- Administering surveys/questionnaires or conducting interviews with research participants
- Performing clinical research procedures (including standard of care procedures being used for research)
- Accessing records or systems containing identifiable information/PHI (e.g. EMRs, GSD)
- Entering data that includes identifiable information/PHI into research databases
- Analyzing research data that includes identifiable information/PHI
Completion of the program may be required for IRB, depending on level of human subject involvement within research projects. IRB policies vary by institution.
Initial Certification - CITI Basic Course
The CITI Basic Course is the ONLY way to enter the CWRU CREC Program. Use the CWRU CITI Instruction Form for directions. Depending on your field of research, you can select to complete the Basic Course in the following areas:
- Group 1 - Biomedical Research
- Group 2 - Social & Behavioral Research
Successful Completion of the CITI Basic Course certifies researchers for three years, which is the equivalent of 12 CREC points. Documentation of your completion is automatically updated within the electronic CWRU Spiderweb system, so it is not necessary to save and print copies of your certification for uploading to the IRB.
To complete the CITI Basic Course, follow the instruction guide
UH Research Credentialing
Danielle Bunkley, Grant Specialists on the CFRS staff will guide you through the steps required for credentialing of all non-UH employees. All CWRU researchers (non-UH employees) requesting access to UH PHI or UH systems containing PHI for research purposes are required to obtain credentialing through the University Hospitals Office of Research Compliance and Education. The process provides UH credentials on an annual basis. Credentials include:
- Access to UH patient/UH systems for research purposes ONLY (e.g. UH REDCap, EMR)
- UH-based title (Research Faculty/Associate)
- UH email address and username (optional)
Additional details are provided at the University Hospitals Research Credentialing site.