Marshall University
Huntington, WV

 

SUBJECT:  Education and Training

 

PURPOSE:  To establish an educational program that ensures the Institutional Review Board (IRB) members, investigators and their research staff are knowledgeable about the ethical principals and the regulations covering the rights, welfare, and protection of human subjects. 

 

POLICY:   The IRB members, investigators, and their research staff must complete the initial educational training material that constitutes certification.  This training serves as an orientation to their responsibilities under the Human Research Protection Program (HRPP).  In addition, recertification is required every year in the form of a refresher course.  Additional training may be identified and required on an as-needed basis throughout the year.

 

SCOPE:  This policy applies to the Institutional Official, IRB members, principle investigators, co-investigators, technicians, their research staff and other persons identified by the Director, Office of Research Integrity (ORI).

 

RESPONSIBILITIES:

 

Institutional Official - The Vice President for Research, as the Institutional Official, has ultimate oversight and responsibility for HRPP.

 

Director, Office of Research Integrity - The Director, ORI has primary responsibility for program management and ensures orientation, education, and training are provided to the IRB members, investigators, research staff and others, as deemed appropriate.  He/she is held accountable for protecting the rights and safety of human subjects.

IRB Chairperson - The IRB Chairperson has the responsibility to ensure respective members complete the orientation program prior to assuming the duties as a member.  In addition, he/she has the responsibility to ensure continual education of the members at board meetings.  He/She is held accountable for protecting the rights and safety of human subjects.

IRB members - The IRB members have the responsibility to complete the orientation program, continual educational training, and recertification, as identified by the Director, ORI.  They are held accountable for protecting the rights and safety of human subjects.

Investigators - Principle investigators, other investigators, study coordinators, technicians, and other individuals involved with the research protocol are responsible for completion of all required orientation, education, and training identified by the Director, ORI before submitting protocols to the IRB.  Everyone involved with the research protocol is held accountable for protecting the rights and safety of human subjects.

ORI Educational Coordinator - The ORI Educational Coordinator is responsible for the distribution of educational training materials, scheduling orientation and educational meetings, and monitoring educational compliance.  The ORI Educational Coordinator will conduct a semi-annual audit of training for the IRB.  He/She will notify the Director, ORI of anyone found not to be in compliance with the educational requirements. 

 

 

IRB EDUCATIONAL PROCEDURES:

 

Review of the orientation educational material is required for all new IRB members, study coordinators, investigators, and their staff conducting human research protocols.  Investigators and their staff will be required to submit evidence of completion of the educational requirements prior to approval of submitted protocols.  Evidence of completion is accomplished by submitting the Completion Report that becomes available after achievement of required modules.

 

Individual training and education sessions will be made available based on ORI Educational Coordinator’s availability and scheduled accordingly.  Emphasis will be placed on adherence to subject safety, regulatory and IRB requirements, informed consent process, and AE/SAE reporting.  The ORI Educational Coordinator will report to the IRB a summary of the educational activities.

 

Initial Orientation

 

An individual is considered certified after completion of the HRPP mandated orientation which includes:

 

  1. Belmont Report - Please read the Belmont Report as it forms the basis of the Marshall University HRPP.  This report can be found on the Education/Training page of the ORI website, and you must understand and be willing to abide by it.
     
  2. Human Subject Assurance Training - Access to the web-based Collaborative IRB Training Initiative (CITI) Course can be found on the Educational/Training page of the ORI website.  Once a course account is established, you will choose the applicable group (i.e., IRB#1 Member, IRB#1 Investigator/Staff, IRB#2 Member, IRB#2 Investigator/Staff).  The course contains a Grade Book page that displays required modules and dates of completion.  Each comprehensive module is followed by a short quiz.  A quiz score of 80% or higher constitutes a passing score and module completion.  Upon achievement of the required modules, a copy of the completion report must be included in the protocol application.  The ORI Educational Coordinator will document the training in the educational tracking program.

   

  1. Standard Operating Procedures (SOP) - IRB members and investigators will need to review the Marshall University HRPP SOPs.  They are responsible for familiarizing themselves with all SOPs and abiding by the procedures contained therein.   

 

The above three (3) requirements constitute initial certification.  Completing the above requirements or submitting written documentation of seminars, course or other educational forums equivalent to the requirements can document recertification.  The Director, ORI will determine what educational forums meet the certification requirements.  The IRB members, principle investigators, and other research staff, as identified by the Director, Office of Research Integrity, may be required to complete additional CITI modules prior to reviewing or beginning research protocols involving certain specific topics.  The ORI Educational Coordinator will notify the appropriate individuals at least two weeks prior to the protocol being presented at the IRB meeting to ensure sufficient time to complete the modules. 

 

The investigator and others involved with the protocol are required to complete the educational requirements BEFORE submitting the research protocol to the IRB Coordinator.

 

Required CITI Educational Modules

 

The following CITI basic course modules must be completed with an overall 80% quiz score to fulfill the educational requirements:

 

IRB#1 (Medical):

 

IRB#2 (Social/Behavioral):

 

Annually, each person who continues in human subject research will be required to complete the CITI refresher course.  This will be done at the time of the continuing review or upon the submission of a new study if one year has elapsed since their last course completion.

 

Additional Continuing Education

The CITI Course offers continuing education modules that are scenarios applicable to the required modules.  Completion of the continuing education modules will be required on an annual basis, however, course availability extends at any time to all desiring to expand or refresh their knowledge.

The ORI Educational Coordinator will inform the IRB members of the continuing educational requirements every twelve months from the date of initial certification.  Investigators and staff are required to complete the continuing education modules prior to submitting the continuing review assessment form.

Handouts and educational materials on relevant regulatory and human subjects' protection issues are routinely distributed prior to or during IRB meetings.  Institution-wide training and seminars pertinent to protection of human subjects are made a part of the continuing education program, as well.  

 

Annual Periodic Evaluation

The Director, ORI will meet at least annually with the Educational Coordinator to evaluate current educational requirements and outreach activities.

 

 

Follow Up Responsibility:  Director, Office of Research Integrity

 

References:  Office of Human Research Protection

                      Human Research Protection Program Best Practice Guide

                      Marshall University Federalwide Assurance (section 7)

 

 

Revised 10-1-2007