Research Compliance

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.

IRB

Institutional Review Boards are committees of scientific experts, employees, faculty members, and community representatives who are responsible for Reviewing Human Subjects research conducted at a given institution.  For students, please note that while a student may serve as the primary researcher, the IRB requires that a faculty advisor sign as the responsible/principle investigator with ultimate responsibility for human subject projection.

Case Cancer Center PRMC (Required for Cancer Center studies prior to IRB approval.)

CWRU's SpartaIRB

University Hospitals IRB

Which IRB Should I use?

CWRU has agreements to allow approval from five different local IRBs through the Cleveland Area Reliant Review Process. Choosing the right IRB for submission depends on multiple factors, including type of research, location of data collection, and home institution of investigator. Research involving cancer studies may be required to be reviewed by the Case Comprehensive Cancer Center's Protocol Review and Monitoring Committee.  

  1. CWRU IRB
    • The CWRU IRB currently accepts studies involving only social or behavioral research.
  2. University Hospitals Cleveland Medical Center IRB
    • The UHCMC IRB generally receives the majority of CWRU projects involving biomedical research or clinical interventions.
  3. Cleveland Clinic IRB
    • Contact Assistant Dean for Research Sara Douglas (sld4@case.edu)
  4. Veterans Affairs IRB
    • Contact Assistant Dean for Research Sara Douglas (sld4@case.edu)
  5. MetroHealth Medical Center IRB
    • Contact Assistant Dean for Research Sara Douglas (sld4@case.edu)

Types of Submissions

  1. Initial Review
    • First submission to the IRB for initial approval.
  2. Amendments
    • Requests for revisions or changes to currently approved, active protocols.
      • Requests must include a description of the proposed change(s) and rationale, a copy of the new or revised materials (e.g. protocol, consent document, questionnaires, scripts), and other relevant documents (e.g. letters of cooperation).
  3. Personnel Change Requests
    • Requests to change, add, or remove personnel involved in the study. 
  4. Continuing Review
    • Mandatory reviews of approved, active protocols at least once per year.
  5. Protocol Deviations/Unanticipated Problems
    • Any event or problem occurring that was not sanctioned by the submitted protocol or IRB approval. 
  6. Adverse Events
    • Any social, psychological, legal, or physical problems that occur as a result of the research.
      • Investigators generally must report adverse events within a given number of days of discovery of the event.
  7. Study Close-out
    • Termination of a study, ending its IRB approval.

Departmental Review

Cancer 

Research involving cancer studies requires review and approval by the Case Comprehensive Cancer Center's Protocol Review and Monitoring Committee.  

University Hospitals

Research involving the Department of Medicine at University Hospitals Case Medical Center may require additional approval from the Department of Medicine Clinical Research Review Committee.

 

COI

In compliance with federal regulations, CWRU requires Faculty, Investigators, and Senior Staff to complete the Outside Financial Interest Disclosure Form, also known as the Conflict of Interest (COI) disclosure. COI must be updated within 30 days whenever there is a disclosable change in outside financial interests. Up to date COI disclosure is required for all grant submissions and is completed in SpartaCOI. Contact CFRS, cfrs@case.edu, if you are completing your COI for the first time.

Find more information on COI at the main CWRU Research website.

CITI/CREC

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.

CITI Certification (Initial CREC Certification)

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.

CITI Program

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 guidelines set out by Graduate Studies.

Maintaining CREC Certification

Certification can be maintained through the following

Researchers are responsible for maintaining their own certification. For further instruction, please view the CWRU's CREC informational page or contact CFRS with any questions.

Frequently Asked Questions about CREC/CITI

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.

Credentialing

FPB Faculty, Staff or Students who need to be credentialed must first contact Danielle Bunkley (cfrs@case.edu) and/or Assistant Dean of Research Sara Douglas (sld4@case.edu). They provide process guidance/instructions and assures all necessary steps and forms are completed.

Credentialing is required for all non-employee researchers at University Hospitals, Cleveland Clinic, and MetroHealth Medical Center.

The credentialing process varies for each hospital. Please contact Danielle or Sara for more details. The typical process involves a background check, HIPAA training, CITI and HIPS training, an approved IRB, and a final submission of the credentialing form.

Training

A wide array of training resources are available for school of nursing faculty, staff, and students. CWRU offers training focused on the Responsible Conduct of Research (RCR) as well as good clinical practice through Continuing Research Education Credit and the Collaborative Institutional Training Initiative.

CWRU Research Education Guide