In accordance with institutional, local, and federal research regulations, it may be necessary for SODM researchers to obtain certification/credentialing or complete training programs. The most common requirements are CITI Certification and UH Research Credentialing. Any required certifications and/or training must be completed before research activities occur to ensure responsible conduct of research
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) 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.
The Collaborative Institutional Training Initiative (CITI) Program is an online training service to which CWRU subscribes that fulfills both federal and local requirements on human subjects protection research training. CITI provides comprehensive educational programs in various areas of human subjects research and good clinical practice (GCP) guidelines. CITI certification under CWRU is accepted when conducting research with other local research institutions, including University Hospitals, Cleveland Clinic, MetroHealth, and VA. Click on the link below to be taken to the CITI homepage.
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 its 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 found here.
Certification can be maintained through the following:
Do I need to be CREC certified if I am...
- Conducting a chart review?
YES, if you are obtaining the information directly from a patient's medical/dental record. Chart reviews inherently contain identifiable information on research subjects, even if you aren't specifically collecting that type of information for your research. Because of the risk for breach of confidentiality, CREC certification is necessary to ensure that you have been educated on the proper conduct of research involving PHI and that you will respect the privacy of patient data.
- A student/resident/research assistant working on a database from a faculty research project that has already collected data?
Most likely YES, if you are working with or have direct access to identifiable information collected on the subjects. If there is no foreseeable instance where you would have access to identifiable information/PHI, the requirement of HSP training may vary based on IRB. However, CITI Certification is highly recommended for anyone having the remote possibility of coming into contact with identifiable information/PHI to protect against risk of accidental disclosure.
- Working with samples/biospecimens (e.g. blood, saliva, tissue) collected from subjects?
Most likely YES, if you are working with samples that are connected to identifiable information. If the samples have already been de-identified, the requirement of HSP training may vary based on IRB. However, CITI Certification is highly recommended for anyone having the remote possibility of coming into contact with identifiable information/PHI to protect against risk of accidental disclosure.
UH Research Credentialing
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.
The following documents must be completed and uploaded into the online application before final submission:
The UH Research Office has designated Dr. Ferretti to sign-off on all Chairman Certification Forms originating from SODM faculty, staff, residents, and students. The signed form will be returned to the applicant to upload into the application.
4. UH-Nonlicensed Researchers Form (non-MD, DMD, DDS, RN)
The following training modules are required and be completed before final submission:
The Initial Application requires a background check for all applicants. The Research Credentialing SOP suggests the use of C5 Background Check. However, SODM personnel having already completed background checks for student admission or employment may be able to upload a copy of the results into the online application.
Applicants will be notified by the UH Research Office via email upon approval of their application. If a UH email address and/or access to UH systems (e.g. LMS, EMR, SoftDent, Dexis, or Oracle) is required, the SODM Research Compliance Officer will work with applicants to complete access requests.