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SUNY Downstate Health Sciences University

Office of Research Administration

COVID-19 Updates

Potential Impact to Researchers at Downstate

Date Created: 3/17/2020

Updated: 07/17/2020

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.

Human Resources FAQs

Telecommuting Agreement  ( Adobe Acrobat Reader;  Install Acrobat Reader)

 

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.

Find COVID-19 Funding Opportunities

COVID-19 Research Dataset (CORD-19)

 

City Council Discretionary Funding

Guidance for Human Service Providers

Department of Health and Human Services (DHHS)

Preparation of Potential Impact on Contract and Contractor Performance

Department of Defense (DOD)

Frequently Asked Questions (FAQs) for Applicants and Awardees

NIH

NIH Director, Mike Lauer, speaks to the research community and shares answers to commonly asked FAQs

Frequently Asked Questions (FAQs)

Late Application Policy due to Public Health Emergency for Covid-19: UPDATE

Flexibilities Allowable to Applicants and Award Recipients

NIH Message to Applicants and Recipients of NIH Funds on Flexibilities Needed for COVID-19

Guidance for NIH-funded Clinical Trials and Human Subject Studies

Coronavirus Disease: Information for Applicants and Recipients

NIH Extramural Response to Natural Disasters and Other Emergencies

NSF

Frequently Asked Questions (FAQs)

NEW: Repurposing Existing Federal Financial Assistance Programs and Awards to Support the Emergency Response to the Novel Coronavirus (COVID-19)

Impact on Existing Deadlines

Substance Abuse and Mental Health Services Administration (SAMHSA)

Frequently Asked Questions (FAQs)

COVID-19 Sample Budget template

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. 

Frequently Asked Questions (FAQs)

 

Institutional Review Board

 

Date Posted

Links

Description

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.

 6/22/2020
Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency Guidance for Industry

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.

6/3/2020

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.   

4/17/2020

(updated)

FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic 
FDA has issued guidance on the conduct of clinical trials of medical products during COVID-19 pandemic. 
4/10/2020
OHRP Guidance on COVID-19
OHRP issued “OHRP Guidance on COVID-19.” 
4/4/2020
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. 

Click here to access the latest information