Chapter 22 - Education and Training

It is policy of the University of Pittsburgh IRB that all involved in the review, conduct and oversight of human subject research (investigators, research staff, key personnel, mentors, IRB members, IRB chairs and IRB staff) must complete initial and continuing education in human research protections.  

General Initial Training and Education Requirements

As of March 5, 2012, the University of Pittsburgh IRB utilizes CITI (Collaborative Institutional Training Institute) as its human subjects training program. Individuals engaged in human subjects research, as well as faculty mentors, are required to complete the Responsible Conduct of Research course as well as one of the following human subjects courses:

  • Biomedical Research (including all Health Science students)
  • Social & Behavioral Research
  • Undergraduate Student Research (Note: research must not be more than minimal risk)

In addition, all investigators and research team members who are engaged in the conduct, oversight or management of clinical trials (as defined by the NIH) are required to complete the CITI GCP training course regardless of funding before participating in any research activities. There are two GCP training courses available: GCP for Clinical Trials Involving FDA regulated research and GCP for Clinical Trials Involving Behavioral or non-FDA regulated research. HRPO considers research to be FDA-regulated if it falls under one of the following sections of the Federal Food, Drug, and Cosmetic Act: section 505 (New Drug Application) or 520 (Devices intended for human use). Clinical investigations that support applications for research or marketing permits for products regulated by the FDA, including food and color additives, drugs for human use, medical devices for human use, biological products for human use, and electronic products are also considered to be FDA-regulated research.

Continuing Education Requirements

In order to meet Continuing Education Requirements, individuals engaged in human subjects research, as well as faculty mentors, must complete the CITI Refresher Course at least every four years. In addition, it is recommended that three hours of continuing education credit related to human subjects protection or ethical considerations in the conduct of human subject research be completed over a four year period. Examples of available programs include:

  • Designated IRB-sponsored programs
  • Other Modules through CITI
  • Research Coordinator Orientation program
  • Participation in a Research Investigator Start-up Education (RISE) Interview
  • FDA Training Continuing Education Courses
  • Attendance at IRB-approved bioethics programs
  • Attendance at programs sponsored by PRIM&R or its affiliates on human subjects protections

Educational requirements that are unique to various groups are outlined below:
 

IRB Committees Members

In-House Orientation

All prospective IRB Committee members are required to complete an initial two hour orientation session prior to serving on the IRB.  The orientation session is conducted by the IRB Medical Director or IRB Chair and the Associate Director or designee.  All new members are provided the following information and complete the CITI IRB member module in addition to those noted above:

  • IRB Policy and Procedure Manual;
  • DHHS regulations (45 CFR 46), FDA regulations (21 CFR 50 and 56);
  • Belmont Report;
  • Declaration of Helsinki;
  • Nuremberg Code;
  • University of Pittsburgh Conflict of Interest Policy;
  • HIPAA Q&A;
  • Institutional Review Board, Member Handbook;
  • Relevant IRB Forms.

 Observation of IRB Meeting

All new IRB Committee members are required to observe at least one IRB committee meeting prior to functioning as a voting member.

OSIRIS Training

All new IRB Committee members will be trained by the Associate Director or designee in the use of the electronic submission system (OSIRIS).  This training includes how to review electronic applications, post reviewer notes, and access checklists and other supporting documentation.

Continuing Education

IRB members will receive, on an ongoing basis, continuing education related to human subject protection issues and requirements.

  • Every month, the IRB Chair and Associate Director will identify a topic to be reviewed at each scheduled committee meeting.  In order to ensure consistency with the information provided to the Committee members, the Associate Director or designee will make a presentation at the beginning of each meeting. The content will be recorded in the minutes for the meeting as well as the members present at the meeting
  • In addition, IRB members are invited to educational presentations held throughout the year on topics related to the protection of human subjects.
  • The IRB Chair, IRB Vice Chairs, Medical Director, and HRPO staff are routinely available to address any questions or concerns of the IRB members.
  • IRB members are provided access to reference materials and research protocol files maintained within HRPO as such  access may relate to their functions as an IRB member.
  • Committee members are required to complete the refresher course available through CITI if their term exceeds four years.

IRB Staff Training

Initial Education and Orientation

New hires to the University of Pittsburgh must complete a general orientation conducted by the University of Pittsburgh, Office of Human Resources.  The University orientation is an introduction to the University working environment and includes an overview of University policies and procedures, employment expectations, performance and relationships, and mandatory training requirements set forth by the University.

New IRB staff members will spend their provisional period of employment (six months) under the direct supervision of the Manager of Operations and Associate Director and will be oriented to the following:

  • The Belmont Report;
  • Federal Regulations (DHHS 45 CFR 46 and FDA 21 CFR 50 and 56);
  • Full Board Committee Review Process;
  • Expedited Review Process;
  • Exempt Review Process;
  • University of Pittsburgh IRB Policies and Procedures;
  • Job Description and Core Duties;
  • Performance Evaluation Process.

Overview of reference websites which include the following:

  • University of Pittsburgh Institutional Review Board;
  • University of Pittsburgh Research Conduct and Compliance Office;
  • Office for Human Research Protections;
  • Food and Drug Administration;
  • Health Insurance Portability and Accountability Act (HIPAA);
  • Public Responsibility in Medicine and Research (PRIM&R).

New staff must also fulfill the following requirements:

  • Complete additional courses on IRB Member Education, Good Clinical Practice, and Conflict of Interest
  • Observe at least three IRB Committee meetings during the first three months of employment.  The new staff member will then review the minutes from the committee meeting with the assigned Research Review Coordinator.
  • Attend the Research Coordinators’ Orientation Program.  This course consists of an overview of human subject research, a description of the ethical principles underlying the concept of human subject research, and an overview of the federal regulations governing IRB operations and human subject research.

After completion of the outlined training procedures, the Manager of Operations and Associate Director make the determination if the research review coordinator has obtained sufficient experience to work independently.  This will be documented in the employee record.  All research review coordinators (full board and exempt and expedited) are members of the IRB. 

Continuing Education

IRB Staff members are expected to take part in additional continuing education activities as follows:

  • As part of their professional development, IRB staff members are expected to continue their education.  Each is offered the opportunity to attend (at a minimum) one local, regional, or national conference in human subject protection during each year of employment. The office routinely subscribes to webinars for the staff and invites guest speakers to address the staff at several time points throughout the year.
  • It is expected that staff obtain the Certified IRB Professional (CIP) certificate after three years of employment.

IRB Chair and Vice Chair Training

Initial Education and Orientation

All newly appointed IRB Chairs and Vice Chairs, who were not currently members of the IRB, are required to undergo the initial orientation as outlined in the section entitled Education and Training –IRB Committee Members.

Newly appointed IRB Chairs and Vice Chairs receive training and support respective to the duties and functions of the position.  This training and support will be provided by the IRB Chair, the other current IRB Vice Chairs, Director, Associate Director, and the HRPO staff.

The IRB Chair or Associate Director are required to attend all IRB meetings overseen by the newly appointed Vice Chair until such time that the latter individual has achieved an appropriate level of experience and comfort with this position.

In addition to the courses noted above, Vice Chairs are required to complete the following training modules:

  • Good Clinical Practice;
  • Conflict of Interest

Continuing Education

The IRB Vice Chairs meet on a monthly basis to discuss issues relevant to human subject protections.

IRB Vice Chairs will receive, on an ongoing basis, continuing education related to human subject protection issues and requirements.

  • Every month, the IRB Chair and Associate Director will identify a topic to be reviewed at each scheduled committee meeting. In order to ensure consistency with the information provided to the IRB Vice Chairs and Committee members, the Associate Director or designee will make a presentation at the beginning of each meeting. The content will be recorded in the minutes for the meeting as well as the members present at the meeting.
     
  • The IRB Chair, Director, Associate Director, and HRPO staff are routinely available to address any questions or concerns of the IRB Vice Chairs. IRB Vice Chairs are provided access to reference materials and research protocol files maintained within HRPO as such  access may relate to their functions as an IRB member.

Investigator and Research Personnel

Additional Resources

There are also several other modules that can be used as resources for the research community. The modules can be accessed through the CITI program (www.citi.pitt.edu).

The IRB website at www.hrpo.pitt.edu provides guidance documents to assist in navigating the IRB process and adhering to federal regulations as well as IRB policies and procedures related to human research protections.  In additional links are provided for local, state, and federal entities.

Electronic Communication

Each member of the research community has the opportunity to become a member of the IRB’s distribution e-mail list. All announcements related to upcoming HRPO programs, updates in federal regulations, and revisions to the Policy and Procedure Manual are communicated to the research community through this medium.

The IRB has a designated email address, askirb@pitt.edu, to be used to answer general questions in a timely fashion.

Outreach Programs

The HRPO engages in outreach programs that include, but are not limited to:

  • HRPO Workshops
  • IRB 101
  • OSIRIS TrainingOpen Office Hours

Investigators conducting research funded by the Department of Defense (DOD) may be subject to additional DOD continuing education requirements.  Please contact your Program Official to determine these requirements.

The Principal Investigator is responsible for maintaining the records of completion for all members of the research team.  These documents must be available for audit by the Education and Compliance Office for Human Subject Research (ECO-HSR).  Failure to complete the requirements will result in the inability to access the online submission application (OSIRIS).  At the discretion of the IRB Chair or other member of the HRPO Leadership Team, exceptions to this rule will be made permitting access to OSIRIS for the submission of adverse events, other unanticipated problems, or protocol modifications to ensure the safety and well-being of the research subjects.

version 12.10.2015; revised 11.11.2016