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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: 4/4/2020

Previous Updates: 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 here. 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

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

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

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)

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

Description

Link

4/4/2020

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. 

Click here to review the temporary suspension notice.

4/2/2020

The Downstate IRB has issued guidance on how to eliminate hazards associated with COVID-19. Modifications to a previously IRB approved research activity in order to eliminate any apparent immediate hazard due to COVID-19, may be initiated immediately without IRB approval. However, the Principal Investigator must report any such change to the IRB in IRBNet within 5 days in IRBNet using the Application Form for Reportable Event.

This guidance may be also be used to:

  • Develop new studies when anticipating the recruitment of participants with COVID-19 or Patients Under Investigation (PUI).
  • Modify studies in response to lifting a suspension of research activities, during the pandemic.

 

Click here to download the guidance.

3/31/2020

FDA has issued guidance on the conduct of clinical trials of medical products during COVID-19 pandemic. 

Click here for FDA Website

 

Click here for a PDF of the guidance document.

3/30/2020

The Downstate IRB has issued a call for information on anticipated research related to COVID-19.

For details, please review the notice at the top of the IRB Electronic Submission Process webpage.

3/30/2020

The Downstate IRB has issued guidance for new applications, including new COVID-19 studies that will take place during the pandemic.

For details, please review the notice at the top of the IRB Electronic Submission Process webpage.

3/24/2020

The Downstate IRB has issued guidance on how to lift a suspension of research activities related to COVID-19.

Click here to download the guidance.

3/12/2020

The Downstate IRB may issue a formal suspension notice, when applicable to the research.

Click here for a sample notice.

3/12/2020

The Downstate IRB is monitoring the situation with Novel coronavirus (COVID-19) and issued a special update to inform our research community on its possible impact on new and ongoing human research operations.  This special IRB Update has been reviewed by the Downstate Coronavirus Task Force.

Click here to download this Special IRB Update memo

 

 

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