21. Training Requirements for Human Research
Updated December 18, 2024
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 all applicable 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. No investigator may conduct human research activities on a project that requires IRB approval without completing the required training. In addition, each person should apply relevant professional and discipline-specific 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 all training requirements and to comply with those requirements.
| Type of Research/Researcher | Required Training |
|---|---|
|
University and Affiliate Researchers |
(CITI) ethics training courses Either: Social-Behavioral-Educational (SBE) Comprehensive or Biomedical (Biomed) Comprehensive Training must be renewed every four years. (Note: If you have taken the CITI training at your prior institution, you can transfer your training by re-affiliating with 推荐杏吧原创 in CITI. 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. |
| Researchers working with Protected Health Information (PHI), including UNR Med and Clinical Affiliate Researchers |
(CITI) ethics training courses Biomedical (Biomed) Comprehensive Training must be renewed every four years. HIPAA for Education and Research (or other HIPAA courses as applicable) HIPAA training must be renewed every year. |
| 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. |
| Renown Health |
All investigators and research team members who propose to conduct research at Renown Health must satisfy Renown training requirements. For information about Renown training requirements, contact the Office of Clinical Research at (775) 982-3646 or renown-crd@renown.org. |
Providing the IRB with Training Documentation
Research Integrity & Security monitors compliance with human research training requirements through the following methods:
- Training records can be verified directly through CITI for all University and Affiliate researchers who have affiliated their CITI account with the 推荐杏吧原创.
- Training records can be uploaded as a document in the IRBNet project submission for all collaborating investigators from other institutions or independent collaborating investigators, as well as University and Affiliate researchers who have completed human research training through a non-CITI course such as THOR.
- Researchers can register with IRBNet and upload their training certificates to their user profiles. The researcher's account must be shared on the IRBNet project for their training to be visible to Research Integrity & Security.
During the review process for exempt and non-exempt new projects, continuing reviews, and modifications involving the addition of research personnel, Research Integrity & Security 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.