SUNY Downstate Health Sciences University
Office of Research Administration
Potential Impact to Researchers at Downstate
Date Created: 3/17/2020
Previous Updates: 07/03/2020, 07/01/2020; 6/30/2020; 6/29/2020; 6/22/2020, 6/3/2020; 5/9/2020; 4/25/2020; 4/17/2020; 4/16/2020; 4/15/2020; 4/13/2020; 4/10/2020; 4/9/2020; 4/8/2020; 4/6/2020; 4/5/2020; 4/4/2020; 4/2/2020; 3/31/2020; 3/30/2020; 3/27/2020; 3/26/2020; 3/25/2020; 3/24/2020; 3/23/2020; 3/21/2020; 3/20/2020; 3/19/2020
The Office of Research Administration is closely monitoring COVID-19 and the impact on your research. Sponsor policies and guidelines, along with institutional policies and changes in procedures can be found below. We will continue to update this page as more information becomes available and we encourage you to check back often for updates.
Sponsored Programs Administration
The Office of Management and Budget (OMB) recently issued an important memoranda to the federal agencies directing them to implement flexibilities to provide “short-term relief for administrative, financial management, and audit requirements” under the Uniform Guidance. We will continue to monitor any changes in guidelines our sponsors may develop in response to this request.
City Council Discretionary Funding
Department of Health and Human Services (DHHS)
Department of Defense (DOD)
Substance Abuse and Mental Health Services Administration (SAMHSA)
United States Army Medical Research Acquisition Activity (USAMRAA)
Update: USAMRAA has changed their guidelines to fall in line with the recently issued notice from the Office of Management and Budget (OMB) and the flexibilities offered by other federal sponsors.
Institutional Review Board
|7/17/2020||Consolidated IRB guidance related to COVID-19||
This guidance updates, consolidates, and replaces previously issued IRB guidance related to the COVID-19 public health emergency.
FDA is issuing this guidance to provide recommendations on statistical considerations to address the impact of COVID-19 on meeting trial objectives for clinical trials conducted during the duration of the COVID-19 public health emergency. The COVID-19 pandemic has impacted clinical development and ongoing clinical trials across investigational product areas. Public health measures to control the virus may impact the ability to collect data, for example, if trial participants are not able to visit clinical sites for endpoint assessments. The guidance outlines considerations for the statistical analysis of the primary and key secondary endpoints in a trial affected by COVID-19 to help ensure that the trial will provide interpretable findings with correct statistical quantification of uncertainty.
|FDA Information on COVID MyStudies Application (App)||The FDA is making an app available to investigators as a free platform to obtain informed consent securely from patients for eligible clinical trials when face-to-face contact is not possible or practical due to COVID-19 control measures.|
|FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic||
||OHRP Guidance on COVID-19||
||Temporary suspension notice||On April 4, 2020, the Downstate Coronavirus Task Force suspended all in-person face-to-face interventions in all human research studies without a prospect of therapeutic benefit to the research participants, in order to protect research participants and others, including the Downstate workforce, from the threats of the Coronavirus Disease 2019 (COVID-19) pandemic.|
IACUC and DCM
The IACUC and DCM are monitoring the situation in regards to COVID-19 and is providing researchers and facility users this special update on new and ongoing operations.