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UM Policies & Procedures - HSRO/IRB
1. Preface
2. Background Topics
3. Authorities and Responsibilities
4. Conflict of Interest
5. Institutional Review Boards
6. IRB Meetings
7. General Principles for IRB Reviews
8. Definition of IRB Review Types
9. IRB Review of Initial Studies
10. IRB Review of Continuing Studies
11. Amendments
12. Closing Studies and Final Reports
13. Suspension, Termination and Administrative Closure of IRB Approved Research
14. Unanticipated Problems and Adverse Events
15. Study Violations
16. Compliance Audits
17. Data Safety Monitoring Boards
18. Ancillary Committees
19. External IRB's
20. Policies Specific to Certain Types of Research
21. Informed Consent
22. Participant Recruitment Methods, Advertising Materials and Recruitment-Relevant Payment Arrangements
23. Vulnerable Populations
24. Privacy, Security, Confidentiality and HIPAA
25. Subcontracts/Agreements for UM-Initiated Studies that Engage or Involve non-UM Institutions or Investigators
26. International Research
27. Emergency Use
28. Record Retention
Other Policies
UChart Forms & Guidance
HSRO Forms & Documents
University Fees
Ancillary Committee Information
eProst User Guide
Ethics, Federal Regulations & Guidance
HIPAA
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Western IRB (WIRB)
About the HSRO


Basic Folder Information

3.7 CITI Certification


Approval Date

Review Responsibility:

IRB Policy and Procedure Committee

Original Approval Date:

February 7, 2006

Revised: May 10, 2011



3.7(a) General Principles

3.7(a) General Principles

Federal regulations and guidelines require documented evidence that IRB members, principal investigators, co-investigators, collaborators, study coordinators and/or other individuals involved in human subject research are qualified and have the expertise needed to protect human subjects.  To meet this requirement and University ethical standards, University of Miami policy requires that all IRB members and those individuals considered to be engaged study personnel receive and maintain "CITI certification" (or its equivalent) in human subject protection prior to their involvement in human subject research.  This applies to existing and new personnel.

Pursuant to the above requirement, individuals are considered to be "engaged in human subject research" if they make a direct and significant contribution to a particular study and/or to the conduct of protocol requirements or who contribute in a substantive way to the scientific development of a project. This definition includes (but is not limited to) individuals who have direct contact with subjects, identifiable subject data, identifiable subject records, protected health information or biological samples collected and/or tested for research purposes.  Engaged personnel also includes clinical professionals who administer any study-related intervention being tested or evaluated under a research protocol. Engaged personnel are also those listed as such on a DHHS-supported grant that is sponsoring the study.  Students are considered engaged personnel if they meet any of the criteria described in this paragraph.  The definition of engaged personnel is not dependent upon whether or not the personnel receive compensation from the grant supporting the project.

The definition of engaged personnel does not include:

  1. individuals who have direct contact with subjects, subject data, subject records, protected health information or biological samples collected and/or tested for research purposes on a commercial basis pursuant to a contractual fee-for-service arrangement
  2. individuals who only contribute to the scientific development of a project unless: (1) they have direct contact with subjects or identifiable data; or (2) they have potential financial interest in the outcome of the research.
  3. clinical professionals who are simply performing a service typically required of their position (i.e. blood draw, infusion, chemo) and who are not contributing to the research in a substantive way such that:
    1. the services performed do not merit professional recognition or publication privileges;
    2. the services performed are typically performed by those clinical professionals for non-research purposes; and
    3. the clinical professionals do not administer any study intervention being tested or evaluated under a research protocol.

The following are some examples, assuming the services described would not merit professional recognition or publication privileges:

  • an appropriately qualified laboratory whose employees perform routine serum chemistry analyses of blood samples for investigators as a commercial service.
  • a transcription company whose employees transcribe research study interviews as a commercial service.
  • a hospital whose employees obtain blood through a blood draw or collect uring and provide such specimens to investigators as a service.
  • a radiology clinic whose employees perform chest x-rays and send the results to investigators as a service.

The University of Miami is a leader in developing educational programs to train its faculty, staff and others in the regulations and responsibilities of human subject research and to raise the level of awareness to human subject protection issues.  The web based Collaborative IRB Training Initiative (CITI) Program in The Protection of Human Research Subjects is hosted and administered by the Office of Research Education at the University of Miami and provided to over 550 institutions around the world.  The course is available 24/7/365, it is accessible from any office or home computer and it provides a “user friendly” presentation model and assessment tools.

Completion of the CITI "Core" Course (at least one from Groups 1-4) is required to become certified to conduct human subject research at the University of Miami.  Re-certification is required at two-year intervals and is accomplished by completing the CITI Continuing Education course.

It is the responsibility of the Principal Investigator to ensure that all engaged personnel are currently CITI-certified before they can participate in human subject research.  UM key personnel may take the Collaborative IRB Training Initiative (CITI) online (accessible from the HSRO website) for certification or receive certification from other equivalent programs approved by the Associate Vice Provost for Human Subject Research.  Re-certification of engaged personnel must be conducted as required.  A CITI certificate issued by another institution may be honored at UM if all UM-required modules were completed with the UM-required total passing score.

For studies initiated by students pursuant to dissertation requirements, the faculty member who serves as the principal investigator (or who is the faculty advisor if the student serves as principal investigator) and the student-investigator must both hold current CITI-certification.  Dissertation committee members who meet the UM definition of engaged personnel must also hold this certification.  Dissertation committee members who are involved only as mentors or advisors without direct subject contact or other responsibilities of engaged personnel are not required to hold CITI certification.



3.7(b) Operational Policy

3.7(b) Operational Policy

Training for certification is provided through the University's Collaborative IRB Training Initiative Program (CITI Program) which was developed by UM and national experts in bioethics and the IRB process.

It is essential that position descriptions submitted to the Human Resources Office for individuals involved in human subject research include the requirement for CITI certification within 30 days of hire.  This requirement should also be included in offer letters to candidates.  Open positions currently in the Human Resources Office that include human subject research activities require an updated job description to include the requirement for CITI certification.  If required certification is not obtained within the first 30 days of hire, the staff member must not be permitted to participate in human subject research and shall be subject to disciplinary action up to and including termination.

Please know that the CITI Program offers excellent courses for new certifications; all personnel involved in human subject research must complete at least one of the following courses to become "CITI-certified":

1.  CITI Biomedical Course: Required for all personnel involved primarily in biomedical research; and for all personnel performing both biomedical and social/behavioral research

2.  CITI Social/Behavioral Course: Required for all personnel involved primarily in social and behavioral research.  The IRB reserves the right to make this course a requirement for research personnel involved in both biomedical and social/behavioral research

The program courses are grouped so that investigators and others can choose one of the relevant training courses based on the following criteria:

Group 1 is for investigators and staff who:

·          Have direct contact with subjects or with subject records

·          Are involved in drug or device studies

·          Work ONLY at/with the U of Miami/Jackson Hospital

 

Group 2 is for investigators and staff who:

·          Have direct contact with subjects or subject records

·          Are NOT involved in drug or device studies

·          Work ONLY at/with the U of Miami/ Jackson Hospital

 

Group 3 is for investigators and staff who:

·          Have NO clinical contact with subjects

·          Conduct records based research or laboratory research with biological samples

·          Work ONLY at/with the U of Miami/Jackson Hospital

 

Group 4 is for investigators and staff who:

·          Conduct Social/Behavioral Research only

·          Have direct contact with subjects or subject records

·          Work ONLY at/with the U of Miami

 

Group 5 is for IRB Chairs, IRB members and alternate members, HSRO administrators and HSRO staff only

Upon successful completion of the appropriate CITI course including the corresponding groups as listed above, research personnel will be "CITI-certified" for a period of two years.  Re-certification is required within two years of the initial CITI-certification.

IRB members who do not engage in human subject research and HSRO staff who complete Group 5 will be "CITI-certified" for a period of three years. Re-certification is required within three years of the initial and/or last CITI-certification. HSRO staff and others who are Certified IRB Professionals (CIP) are exempt from the CITI certification requirement as CIP re-certification is required every three years.

To improve efficiencies and streamline processes, efforts are underway to integrate CITI certification records into the eProst system which is central to the management of human subject-IRB information and processes.

For questions or concerns related to this issue, please contact the Human Subject research Office at 305-243-3195 or email the HSRO Help desk at eprost@med.miami.edu.



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