As revisions to the regulations governing human subjects research (the “Common Rule”) are scheduled to go into effect on Jan. 21, the UNMC Institutional Review Board’s online application (research support system, or RSS) will be unavailable for new applications from Wednesday, Jan. 16, through Jan. 23, to facilitate transition to the new rule.
The changes to the Common Rule will have significant and far ranging effects on the regulation of human subject research at UNMC, Nebraska Medicine, UNO, Bellevue Medical Center and Children’s Hospital & Medical Center, said Bruce Gordon, M.D., assistant vice chancellor for regulatory affairs and executive chair of the IRB, in an email to investigators Monday.
Some of the revisions will be more visible to investigators than others, including:
- Changes to consent form format and boilerplate language, and including the requirement for a “concise and focused presentation of the key information” (as a two-page “Executive Summary”).
- Elimination of the requirement for Continuing Review for certain classes of research.
See more information on changes here.
All new research submitted on or after Jan. 21, and any research submitted before Jan. 21 but not yet approved, is subject to the new rule.
An extensively revised new IRB application compliant with the new rule, and with new consent form templates, will be available shortly in RSS.
To facilitate transition to the new rule, applications already started may be continued and completed or may be transferred to the new online application.