COVID-19 Update: ORI-HS

The Office of Research Integrity – Human Subjects (ORI-HS) is operating with all staff members working remotely. IRB Meetings are continuing at the previously scheduled days/times with web conferencing. If you have questions, we encourage you to email IRB@unlv.edu.

In an effort to eliminate apparent immediate hazards to subjects (45 CFR 46.108(3)(iii)) as well as the UNLV community, all face to face visits for research previously approved by the UNLV IRB/ORI-HS must either be postponed or modified to remove this interaction. This applies to all ongoing and new research (including exempt determinations) that is conducted by UNLV researchers. Non-contact methods that can continue uninterrupted include research including phone/web interviews, online surveys, etc.

Should an investigator need to change research plans in order to eliminate immediate hazards to research subjects, these changes should be made and then must be reported to ORI Human Subjects through a modification submission in IRBNet as soon as the researcher is able but within 30 days after the change. Eliminating immediate hazards may include actions to reduce potential exposure to COVID-19 such as:

  1. Decreasing the number of protocol-mandated in-person study visits or moving to remote study/teleconferencing study visits
  2. Delaying study visits to outside the defined schedule to ensure participants aren’t traveling unnecessarily, among other options.

In the modification submission, please specify the changes made, the date the change was made and the purpose for making the change. These changes will proceed with the IRB review process as usual.

Information About New Studies Regarding COVID-19

In addition, we understand that the UNLV research community will want to study various aspects of the COVID-19 pandemic and will need a faster route to approval. If your research falls in this category, please include COVID-19 in the title so that it will be routed properly. If you have further concerns about the review process for these proposals, we invite you to contact us at IRB@unlv.edu.

Restart of Face-to-Face Research

UNLV's phased approach to restarting university research activity can be found at the UNLV Guide to Restarting Research page. In order to assist researchers, the Office of Research Integrity - Human Subjects has created guidance on how to move forward with face-to-face human subjects research.

Face-to-Face Research with Human Subjects during the COVID-19 Pandemic

Information On FDA Clinical Trials

Per FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic:

  • "Sponsors and clinical investigators are encouraged to engage with IRBs/IEC as early as possible when urgent or emergent changes to the protocol or informed consent are anticipated as a result of COVID-19. Such changes to the protocol or investigational plan to minimize or eliminate immediate hazards or to protect the life and well-being of research participants (e.g., to limit exposure to COVID-19) may be implemented without IRB approval or before filing an amendment to the IND or IDE, but are required to be reported afterwards." (pg.6)
  • “If scheduled visits at clinical sites will be significantly impacted, certain investigational products, such as those that are typically distributed for self-administration, may be amenable to alternative secure delivery methods. For other investigational products that are normally administered in a health care setting, consulting FDA review divisions on plans for alternative administration (e.g., home nursing or alternative sites by trained but non-study personnel) is recommended. In all cases, existing regulatory requirements for 4 See 21 CFR 56.108(a)(4), 21 CFR 56.104(c), 21 CFR 312.30(b)(2)(ii), and 21 CFR 812.35(a)(2). Contains Nonbinding Recommendations 8 maintaining investigational product accountability remain and should be addressed and documented.” (pg. 7-8)