21. Training Requirements for Human Research
Updated July 26, 2021
Investigators and study staff should be qualified by training and experience for their roles and responsibilities in conducting research so that they follow the protocol and abide by the organization’s policies and procedures. Investigators and study staff should have the knowledge to follow laws, regulations, codes, and guidance such as those concerning IRB review, consent requirements, and reporting requirements. All persons involved in the design, implementation, review, and oversight of human research must complete and maintain the required training to comply with regulatory requirements; to conduct ethical and scientifically-sound research; and to adequately protect participants. In addition, each person should apply relevant professional standards that are applicable to their research. A federal agency or sponsor funding the research may require additional training and/or at an increased frequency. It is the responsibility of the Principal Investigator and study team members to be aware of the additional training requirement and to comply with the training requirements.
| Type of Research/Researcher | Required Training |
|---|---|
|
University and Affiliate Researchers *Renown Health has different education requirements listed below |
Collaborative Institutional Training Initiative (CITI) ethics training courses Group 1: Social Behavioral Research Investigators and Key Personnel Group Group 2: Biomedical Research Investigators and Key Personnel Group Training must be renewed every four years and linked to the researcher’s user profile IRBNet. (Note: If you have taken the CITI training at your prior institution, you can transfer your training by re-affiliating with University of Nevada, Reno; there may be additional questions to complete, as each institution has different training requirements.) Additional training is required for research conducted or supported by the Public Health Service or National Science Foundation. |
| VA Sierra Nevada Health Care System | All investigators and research team members who propose to conduct research at the VASNHCS must satisfy VA training requirements. For information about VA training requirements, contact the VASNHCS Research Office at (775) 328-1486. |
| Clinical Trials/Registries UNR Med and Affiliate Researchers at Renown Health/Saint Mary’s Medical Center |
Collaborative Institutional Training Initiative (CITI) ethics training courses Group 2: Biomedical Research Investigators and Key Personnel Group Training must be renewed every four years and linked to the researcher’s user profile IRBNet. |
| Renown Health |
Collaborative Institutional Training Initiative (CITI) ethics training courses Group 2: Biomedical Research Investigators and Key Personnel Group Training must be renewed every five years and linked to the researcher’s user profile IRBNet. Good Clinical Practice 1- Basic Course or Good Clinical Practice Course (US FDA focus)” GCP training must be renewed every three years and linked to the researcher’s user profile IRBNet. |
| If you conduct research that is funded by a federal funding agency (PHS NSF) you are required to take the Conflict of Interest Basic course in CITI every 4 years. |
Collaborative Institutional Training Initiative (CITI) Conflict of Interest Training Basic Module |
Providing the IRB with Training Documentation
Research Integrity monitors compliance with human research protection training requirements through an option available from IRBNet as follows:
- All University and Affiliate researchers are encouraged to register with IRBNet and upload their CITI training certificates to their user profiles.
- All collaborating investigators from other institutions or independent collaborating investigators, as well as University and Affiliate researchers who do not have IRBNet user accounts, must provide evidence of compliance with training requirements to the PI to be uploaded in the project submission.
During the review process for exempt and non-exempt new projects, continuing reviews, and modifications involving the addition of research personnel, Research Integrity staff verifies training information for all researchers on the project. Exemption determinations and approvals can only be granted if all research team members have fulfilled their training requirements.