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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: 5/9/2020

Previous Updates: 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

Link

Description

4/25/2020

IRB Guidance for obtaining consent from a Legally Authorized Representative (LAR or Surrogate) or permission from a parent or legal guardian during the COVID-19 pandemic.

This guidance posted in both PDF and WORD format, so that signature lines can be copied from this document and placed in the consent form.

When planning for surrogate consent, please work with hospital administration before making plans to reach out to family members who are not able to be with their loved ones, to ensure contact is done in the most respectful manner.

4/17/2020

(updated)

Triage for IRB reviews during the COVID-19 pandemic
As of April 16, the IRB has provided guidance to investigators on how to submit approximately 50 new COVID-19 studies to the IRB.  As the pandemic continues, the number of submissions is expected to rise; therefore, the IRB must triage reviews of study at times when the daily workload is extremely high. This guidance includes information on the following:
  • New Studies
  • Triage Priority
  • Rapid Response (COVID-19) IRB
  • Review Process
  • Table of Triage Priorities

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. 
4/13/2020
Sample IRBNet notice to confirm a sponsored study meets the criteria for temporary suspension
Based on the suspension notice that was issued on April 4 (see below), the Downstate IRB has evaluated all sponsored research studies to determine if the research meets the criteria for the temporary suspension of in-person face-to-face interactions when there are no therapeutic benefits to the research participants.
  • Sponsored Programs Administration has been notified of this determination so that the sponsor can be notified.
  • The Downstate IRB will publish a notice for each of these studies in IRBNet.
4/10/2020
OHRP Guidance on COVID-19
OHRP issued “OHRP Guidance on COVID-19.”  OHRP offers guidance on the following topics:
  • Public Health and Clinical Activities
  • Excluded Public Health Surveillance Activities
  • Legally Required Reporting
  • Research Changes to Eliminate Apparent Immediate Hazards
  • Proposing and Reviewing Study Changes
  • Whether Suspensions of Research Must be Reported
 4/9/2020
(updated)
Eliminating hazards associated with COVID-19
The Downstate IRB has issued guidance on eliminating 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 also be used to:
  • Develop new studies when anticipating the recruitment of participants with COVID-19 or Patients Under Investigation (PUI).
  • Modify other studies in response to lifting a suspension of research activities, during the pandemic.
  • Modify existing informed consent documents, when anticipating the recruitment of participants with COVID-19 or Patients Under Investigation (PUI).
This guidance includes information about:
  • General considerations
  • Safety considerations
  • Informed consent process for patients with COVID-19
  • Other important considerations
  • COVID-19 screening language and advocacy
 4/9/2020
(updated)
Lifting temporary suspension of research activities
The Downstate IRB has issued guidance on lifting a suspension of research activities related to COVID-19.This guidance includes two options:
  1. Request to lift suspension via an amendment request
  2. Process for requesting an urgent or immediate exception
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. 
3/30/2020
Call for Information
The Downstate IRB has issued a call for information on anticipated research related to COVID-19.
3/30/2020
New IRB Applications
The Downstate IRB has issued guidance for new applications, including new COVID-19 studies that will take place during the pandemic.
3/12/2020
Special IRB Update memo
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.

 

 

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