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Training

All persons involved in the design, implementation, review, and oversight of human research conducted or supported by the University must complete and maintain the required training to fulfill their obligations to comply with regulatory requirements; to conduct ethical and scientifically-sound research; and to adequately protect human participants.

Training Overview for University and Non-VA* Affiliate Researchers

University and affiliate researchers are required to complete one or more Collaborative Institutional Training Initiative (CITI) ethics training courses.
Researchers, IRB members and chairs, and the RIO Director and staff must complete the requisite CITI modules with an overall competency level of 80%.

*VA researchers must comply with VA training requirements. For information, see the VA Human Subject Research page of the RIO website.

Required Training for Researchers

The IRB will not approve research involving human participants until certification of completion of the required training is confirmed for all members of the research team.

Basic Training Requirements for Researchers

Before becoming involved in a human research project, all University and affiliate researchers must register on the CITI website and complete one of two Human Subject Research courses, according to the type of research being conducted:

  1. Group 1: Social Behavioral Research Investigators and Key Personnel Group
    Must be renewed every five years and linked to relevant projects in IRBNet.
  2. Group 2: Biomedical Research Investigators and Key Personnel Group
    Must be renewed every five years and linked to relevant projects in IRBNet.

Additional Training Requirements for Researchers

Additional training requirements apply for all personnel involved in research conducted or supported by the Public health Service or the National Science Foundation:

•       Public Health Service training
Must be renewed every four years and linked to relevant projects in IRBNet.

•       National Science Foundation training (i.e., Responsible Conduct of Research)
Must be linked to relevant projects in IRBNet.

Optional Training for Researchers

The QA/QI Officer and senior RIO staff periodically offer in-person group or individual training to faculty, students, researchers and other interested persons.

Senior RIO staff also work with individual researchers during the development of new or amendments to existing IRB projects, and during the review process to enhance researcher understanding of regulatory requirements and the protection of human participants.

Required Training for IRB Members and Chairs

Orientation is required for new IRB members before they may participate as voting members of an IRB. Orientation is conducted by the RIO QA/QI Officer or designee.

IRB members must register on the CITI website and complete one of the two Human Subject Research courses, as appropriate for the IRB on which they will serve:

  1. Group 1: Social Behavioral Research Investigators and Key Personnel Group or
  2. Group 2: Biomedical Research Investigators and Key Personnel Group.
IRB chairs and members must complete the course before reviewing an IRB project, including exemptions, or before participating in other IRB review activities.

Required Training for the RIO Director and Staff

The RIO Director and RIO staff must register on the CITI website and complete one of the two Human Subject Research courses, as appropriate for the IRB with which they will be working:

  1. Group 1: Social Behavioral Research Investigators and Key Personnel Group or
  2. Group 2: Biomedical Research Investigators and Key Personnel Group.
RIO staff must complete the course before participating in IRB review activities including exempt reviews.

New personnel will also complete an in-office human research protection training "boot camp." The training includes review of federal regulations, the OHRP Guidebook, guidance documents, and other materials identified by the RIO Director. Training will be customized to reflect the knowledge and experience of the individual employee. New personnel will also attend a PRIM&R IRB 101 (as funding allows).

Other Training Activities for IRB Members and Chairs, and the RIO Director and Staff

  1. Regularly scheduled in-service trainings at IRB meetings
  2. New information relevant to the University's HRPP which is disseminated via email, or presented during IRB meetings
  3. Webinars, presentations, and conferences from reputable sources (e.g., PRIM&R, AAHRPP), as funding and schedules allow
  4. Unlimited access to the RIO resource library
Additionally, the RIO Director and staff are expected to remain current with emerging topics and new developments in the field of human research protection through regular monitoring of federal regulations, local and state laws, federal and peer institution web sites, list-serves, professional journals, and lay-publications.

Training Requirements for Collaborating Researchers from External Institutions

When collaborating investigators are employed at external institutions that have requirements for human research protection training, the University IRB will accept documentation that the external institution's training requirements have been met and are current.

Collaborating investigators employed at external institutions that do not have requirements for human research protection training must comply with University training requirements.

Providing the IRB with Training Documentation

RIO is able to verify and monitor compliance with human research protection training requirements through an option available from IRBNet as follows:

  1. All researchers are required to register with IRBNet and link to their CITI training.

  1. Before submitting a new project, or a personnel change or an amendment to an existing project, the PI Shares access and links CITI training records to the project for each researcher involved in the project.

  1. If the required training for a researcher is not available in IRBNet, the PI must insure the researcher has access to the project, is registered in IRBNet, and has uploaded and submitted her/his training information.

During the review process, for new projects and continuing reviews, and for modifications involving the addition of research personnel, RIO staff verifies training information for all researchers on the project.
Instructions for printing a certificate of training completion from the CITI website.
NOTE: Training documentation for collaborating researchers from other institutions must be attached to the researchers' Training and Credentials in IRBNet and linked to the relevant projects in IRBNet.


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