Policy Title / IRB Member Training

Policy

Members of IRB-Spokane will receive training in human subjects protections to ensure that members are familiar with the basic ethical principles, the federal regulations, state law and institutional policies for the protection of human subjects enrolled in research.

Procedure

New member training –

  • The IRB administrator will provide in-person orientation to new members appointed to the board. Each new member will receive the IRB Member Manual. The materials included in the manual are covered during the in-person training:
  • The ethical principles governing research with human subjects as outlined in the Belmont Report. Members also receive copies of the Nuremberg Code and The Declaration of Helsinki.
  • Federal regulations 45 CFR 46; 21 CFR 50 and 21 CFR 56.
  • IRB Policies and procedures
  • Overview of IRB, including review process for new and continuing studies required full IRB review; reviewer checklists; IRB application forms, IRB member roster. New IRB members receive information about the contents and distribution of the IRB review packet including when it is sent and access to member-only area of IRB website.
  • Overview of documentation of IRB business and who to contact within the IRB office.
  • New members who have not completed on-line training in human subjects protections are required to complete the Web-based Collaborative IRB Training Initiative (CITI) Confirmation of completion is sent electronically to the IRB Administrator from the University of Miami (host of the CITI training site).
  • New members will receive additional training and resources as needed.
  • Upon initiation of a member’s first time review of expedited continuing review reports a designated IRB staff member will provide one-on-one orientation on expedited applicability criteria and categories, criteria for IRB approval, and general responsibilities as an expedited reviewer.

Ongoing Education of Members –

  • All members are required to complete the IRB members refresher course through the Web-based Collaborative IRB Training Initiative (CITI) every three years.
  • The IRB maintains a current e-mail list which will be used on an on-going basis to send IRB members a variety of materials such as copies of pertinent articles, regulatory updates, web references to resource materials or government reports or communications regarding a specific protocol review. IRB members that do not have access to e-mail will receive paper copies.
  • Upon request or as appropriate the IRB staff will present training on selected topics or invite a specialist in a specific area to address the IRB.
  • Periodically, IRB staff will include copies of educational articles or information collected at professional meetings in the IRB review packet.

Form(s)

  • None

Version date 4-21-2008 Page 1 of 2