HRPP policies & procedures manual

103: Training and education

1. Purpose

The purpose of this policy is to describe the training and educational requirements for IRB members and staff.

2. Policy

Training of ORA staff and IRB members is critical if the IRB is to fulfill its mandate to protect the rights and welfare of research participants in a consistent manner throughout the WSU research community. IRB members, ORA staff and others charged with responsibility for reviewing, approving, and overseeing human subjects research should receive detailed training in the regulations, guidelines, ethics, and policies.

3. Specific policies

3.1 Training

ORA staff and IRB members who oversee research on human participants that is managed, funded, or taking place in an entity under the jurisdiction of WSU will receive initial and ongoing training regarding the responsible review and oversight of research and these policies and accompanying procedures.

The ORA director establishes the educational and training requirements for IRB members and IRB staff.

Members of the IRB will be provided an orientation to the IRB by the IRB coordinator. Members will be encouraged to participate in initial and continuing training every 5 years in the CITI training program. The chairpersons will receive additional training in areas relevant to their additional responsibilities. All new and existing members who have yet to complete their minimum training obligations will be requested to meet this requirement within a 90-day timeframe or withdraw their membership from the committee.

ORA staff will receive initial and continuing training in the areas relevant to their responsibilities. Continuing education of the IRB members is done through an annual education meeting as well as educational information distributed to members through newsletters and discussions at full board meetings. The IRB staff and ORA director may attend conferences throughout the year for continuing education about regulatory changes and current IRB issues.

IRB members and ORA staff will be encouraged to attend workshops and other educational opportunities focused on IRB functions. WSU will support such activities to the extent possible and as appropriate to the responsibilities of members and staff.

3.2 Documentation

Training and continuing education will be documented and added to ORA personnel files.

3.3 Community outreach

The WSU IRB provides information to the research community regarding the rights of a research participant as a volunteer. The IRB encourages and promotes community outreach efforts through feedback materials, surveys and presentations on campus whenever possible.

Procedure for maintaining community outreach efforts offered
      • The Office of Human Research Protection provides resources for research participants, prospective participants, researchers and the community.
      • The IRB members or staff conduct trainings or make presentations upon request regarding the rights of research participants.

4. Applicable regulations and guidelines

21 CFR 56.107, 45 CFR 46.107

5. Forms


6. Procedures employed to implement this policy & assignment of responsibility

ORA directorEstablish training, educational requirements and content for IRB
members and ORA staff. Set annual budget.
IRB coordinatorBased on requirements and budget, determine training and education
schedule. Schedule speakers, acquire outside publications, schedule
attendance at PRIM&R and seminars as budget allows.
Notify IRB members of available training materials and schedule.
Maintain documentation of all training and education completed.