As already announced, all remaining human subject research Institutional Review Board (IRB) protocols paused due to the COVID-19 pandemic can now apply to restart. Principal investigators must request permission by completing and submitting a Research Safety Plan using this link.
The Human Subjects Research Safety Review Committee (HSRSR) will evaluate the plan and then the IRB will give final permission to restart. The following are key points about this evolving process:
- The principal investigator will need to contact the administrator/manager over the area where the study is to be conducted to confirm current policies and procedures in the area, and obtain “approval” to restart based on learning what is required for that particular protocol. Individuals designated to approve based on the area, would be as below:
- The Fred & Pamela Buffett Cancer Center, contact Apar Ganti, MD.
- UNMC Clinical Research Center, contact LuAnn Larson.
- If unsure about who the manager is for other areas of Nebraska Medicine or Bellevue Medical Center, contact Dawn Straub, Nebraska Medicine.
- Omaha VA, please include communication from Frederick Hamel, PhD, Omaha VA.
- UNO, contact Sara Myers, PhD, UNO assistant vice chancellor for research and creativity.
- Children’s Hospital & Medical Center, contact Ann Anderson Berry, MD, director, Child Health Research Institute
- If the visit is to be separate from any established clinic visit, it is assumed that the research team may need to meet the potential subject at the door and provide a mask for the subject, as well as for their own team.
- They need to follow the visitor and eye protection policies of the area, as well.
- Some areas may require SARS-CoV-2 testing first, such as an operation or pulmonary function tests, which if being performed for research purposes only, is the financial responsibility of the study team.
New IRB applications also will ask questions regarding plans to protect human subjects, as well, for any protocols involving face-to-face contact.
- They also may be asked for written approval from the manager or other accountable person over the area or clinic where the study if the study is to be performed separate from clinical care.
- Some new proposals also may be asked to complete the Research Safety Plan and be reviewed first by the Human Subjects Research Safety Committee.
As circumstances change, such as with shortages of PPE or competition for a specific location, this process and form may be modified. Direct questions regarding the process to the chair of the HSRSR committee, Matt Lunning, DO, or the IRB.