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SUNY Downstate Health Sciences University

Office of Research Administration

Policies and Guidance:

Policy IRB-01: Human Research Protections Program 

COVID-19 Guidance

Date Posted Links Description
8/27/2020(updated) 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.
8/20/2020(updated) Ramp up Plan for SUNY Downstate Research Activities This website refers to the required ramp up plan for research activities.
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. 
4/17/2020 IRB guidance for triaging reviews The Downstate IRB successfully responded to the COVID-19 health emergency and the disruptions it created with the research enterprise, including implementation of new guidance, a Rapid Response IRB for COVID-19 clinical trials, and remote research operations.  As of August 2020, the Downstate IRB has received nearly 200 COVID-19 related submissions, including many new clinical trials. During the height of the pandemic in Brooklyn, Downstate experienced a 325% increase in full board submissions, a 32% increase in expedited review submissions, and a 72% increase in exempt submissions.  The IRB continues to provide a critical service during this health emergency and while ramping up the research. In general, this guidance will be followed when the daily workload is extremely high. This guidance includes information on the following: a) New Studies b) Triage Priority c) Rapid Response (COVID-19) IRB d) Review Process and e)Table of Triage Priorities.

 

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. This posting is retained for reference purposes; however, the suspension was lifted on 8/20/2020.  Please refer the the Ramp Up Plan guidance noted above for more information.
3/17/2020 Office of Research Foundation COVID-19 Updates Please refer to this website for additional information about Sponsored Research Programs, IACUC, and DCM.

IRB guidance for Investigators

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Guidance for IRB Members

Guidance for IRB Office Staff

Compliance Documents