MSU HRPP Manual Section 11-1-C

11-1-C, HRPP Staff Education

Human Research Protection Program (HRPP) staff will be trained through an initial orientation process and continuing education to ensure that all HRPP staff are appropriately educated about the regulatory requirements and ethical considerations for the protection of human subjects involved in research.

Orientation
New HRPP staff members are required to complete an orientation process. Orientation should provide new HRPP staff members with the knowledge and skills to uphold federal, state, and local laws and regulations, university policy and procedures, and ethical standards on the protection of human research subjects. While all new HRPP staff members will be required to go through an orientation process, additional time and guidance will be provided to individuals unfamiliar with federal, state, local laws and regulations, and university policy and procedures related to human subjects protection.

New HRPP staff will be educated, at a minimum, on ethical principles, federal, state, and local laws and regulations, and university policies and procedures on the protection of human subjects (e.g. Belmont Report, 45 CFR 46, 21 CFR 50, 21 CFR 56). Relevant training will be provided based on the job position within the IRB or Compliance office (e.g. 21 CFR 312, 21 CFR 812, clinical research billing compliance requirements).

New HRPP staff members will be required to take the “Overview of Human Research Protection at MSU” and the “Ethical and Regulatory Considerations” online modules through the Saba Learning Management System, if not already completed, and relevant Collaborative Institutional Training Initiative (CITI) courses in the Protection of Human Research Subjects. Individuals are expected to complete the online training modules within the first six months of being in the relevant HRPP job position. Each new HRPP staff member will attend at least one convened IRB meeting as a guest and observe a site visit.

In addition, new HRPP staff members will work with other HRPP staff members through on the job training for the relevant HRPP job position (e.g. IRB office, Compliance office).

A checklist will be used to document the orientation process. The HRPP managers will customize the orientation schedule based on the needs of the new HRPP staff member (e.g. experience, role). The HRPP director will develop the orientation schedule for the HRPP managers.

All HRPP staff involved in reviewing human subject’s research will complete the training requirement(s). The HRPP managers will determine the appropriate work assignments relevant to the position. The following items should be taken into consideration by the HRPP managers:

  • Prior experience with human research protection programs

  • Demonstrated understanding of processes and procedures

  • Evaluation through the completion of certifications, or annual performance reviews

 The HRPP managers will determine when the HRPP staff member has the requisite knowledge and skills for the relevant work assignment.

Continuing education
Education will be provided to HRPP staff on an on-going basis. With changing regulations and guidance, it is important to maintain current knowledge of policies and procedures on the protection of human subjects. After initial orientation, the HRPP managers will develop a customized continuing education plan based on the needs of each individual and assess continuing education needs on an individual basis at least yearly. The HRPP director will develop such plans for the HRPP managers.

Continuing education encompasses many additional activities, such as national certification, educational workshops, IRB/Compliance office staff meetings, and others.

National Certification
HRPP staff are encouraged to obtain national certification relevant to their position (e.g. Certified IRB Professional (CIP®) through the Public Responsibility in Medicine and Research; Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Associate (CCRA) through the Association of Clinical Research Professionals (ACRP)). Continuing education is expected to maintain certification; otherwise the individual must typically retake the certification exam.

HRPP Staff Meetings
HRPP staff meetings are typically held twice monthly. One meeting is used to share information with the HRPP staff and IRB chairs and to discuss office procedures and any other issues. The other monthly meeting is to provide dedicated time for continuing education of the HRPP staff.

IRB and Compliance Staff Meetings
Monthly meetings of each office of the HRPP are also typically held in addition to HRPP staff meetings in order to discuss policies and procedures for that particular office and to have additional time dedicated for continuing education that focuses more specifically on the IRB or Compliance staff’s educational needs.

Conferences
Funds are budgeted for HRPP staff to attend HRPP educational conferences sponsored by other institutions or entities. The HRPP staff members attending such conferences will be encouraged to share the knowledge gained with other HRPP staff members upon their return.

List-Servs
Other examples of educational resources include relevant list-servs. For example, when list-serv notifications from OHRP are received, the Human Research Protection Program (HRPP) director will forward such emails to the pertinent HRPP staff.

Other Activities
Other continuing education activities include IRB conferences, workshops, the HRPP strategic planning meeting, subscriptions, and the ORA resource library. See HRPP Manual 11-1-A “Investigators and Research Staff” and 11-1-B “IRB Members” for a description of these activities.

Fulfillment of Requirements
Education requirements are monitored by the HRPP managers. The HRPP director monitors such requirements for the HRPP managers. Documentation of education activities will be maintained. If an HRPP staff member does not complete training required by the HRPP manager, the HRPP manager will initiate corrective actions which may include not being involved in processing IRB applications until the requirement is satisfied. The HRPP director will perform such function for the HRPP managers.

Additional Considerations
For research studies subject to the requirements of the U.S. Department of Defense, see HRPP Manual 2-2-A “U.S. Department of Defense.”

This policy and procedure supersedes those previously drafted.

Approved By: President of Research and Graduate Studies, 3-3-2005. Revision 1 approved by VP Research & Graduate Studies on 7-22-2011. Revision 2 approved by Assistant VP Regulatory Affairs on 12-9-2015.

Related HRPP Manual Sections

Approved PDF Version

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